Injection Education—How to Administer Injectable Medicine
VISUAL
CABENUVA logo elements appear separated with the two active ingredients' names.
VOICE-OVER
This is an instructional video for the
TEXT ON SCREEN
cabotegravir
rilpivirine
VISUAL
CABENUVA logo elements join to recreate the CABENUVA logo.
The CABENUVA trade name appears.
VOICE-OVER
administration of every-2-month and once-monthly CABENUVA.
TEXT ON SCREEN
CABENUVA
cabotegravir 200 mg/mL; rilpivirine 300 mg/mL
extended-release injectable suspensions
VISUAL
Video introduction is displayed.
VOICE-OVER
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Please see Important Safety Information for CABENUVA covered later in this video.
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
VISUAL
Video introduction is displayed.
VOICE-OVER
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
• Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
• Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please see Important Safety Information for CABENUVA covered later in this video.
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
• Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
• Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please see Important Safety Information for CABENUVA covered later in this video.
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
VISUAL
Video introduction is displayed.
VOICE-OVER
Please read the full Instructions for Use (IFU) contained in the 2 CABENUVA Dosing Kits and available at CABENUVAhcp.com
CABENUVA is for Healthcare Professional administration only.
TEXT ON SCREEN
Please read the full Instructions for Use (IFU) contained in the 2 CABENUVA Dosing Kits and available at CABENUVAhcp.com
CABENUVA is for Healthcare Professional administration only.
VISUAL
This scene will outline the purpose of the video, its objectives, and the chapters.
VOICE-OVER
Two topics will be reviewed in this video: Chapter 1 explains the preparation steps for every-2-month and once-monthly CABENUVA, with Chapter 2 focusing on the steps for injection.
TEXT ON SCREEN
Administration Video
Chapter 1 – Preparation
Chapter 2 – Injection
VISUAL
Lightbulb icon explanation.
VOICE-OVER
The information in this video is based on the CABENUVA Instructions for Use leaflet.
However, where supplementary information is provided, which is not contained in the Instructions for Use leaflet, a lightbulb icon will appear to signify that this is the case.
TEXT ON SCREEN
The information in this video is based on the CABENUVA Instructions for Use leaflet.
However, where supplementary information is provided, which is not contained in the Instructions for Use leaflet, a lightbulb will appear to signify that this is the case.
VISUAL
Dimensions of the outer boxes are shown to support HCPs considering the storage space they may require.
VOICE-OVER
CABENUVA is available in 2 separate dosing kits: the 600-mg/900-mg (3-mL) kit for use in every-2-month initiation injections, every-2-month continuation injections, and once-monthly initiation injections, and the 400-mg/600-mg (2-mL) kit for use in once-monthly continuation injections only. In this video, the 600-mg/900-mg kit will be used for demonstration. The preparation and administration instructions are the same for both dosing kits.
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600-mg/900-mg Dosing Kit
- Every-2-month initiation injections
- Every-2-month continuation injections
- Once-monthly initiation injections
400-mg/600-mg Dosing Kit
- Once-monthly continuation injections only
The preparation steps for both the 600-mg/900-mg and 400-mg/600-mg Dosing Kits are the same.
VISUAL
Vial information is shown.
Vials will be rotating.
VOICE-OVER
Each Dosing Kit contains one single-dose vial each of cabotegravir and rilpivirine extended-release suspensions for injection.
A complete dose requires two injections: one each of cabotegravir and rilpivirine.
They do not need further dilution or reconstitution.
Cabotegravir and rilpivirine are for gluteal intramuscular use only and must be administered to separate gluteal intramuscular sites on opposite sides or at least 2 cm apart during the same visit.
The order of administration is not important.
This video will focus on the 600-mg/900-mg Dosing Kit.
TEXT ON SCREEN
600-mg/900-mg Dosing Kit
single-dose vials
cabotegravir 600 mg/3 mL
rilpivirine 900 mg/3 mL
400-mg/600-mg Dosing Kit
single-dose vials
cabotegravir 400 mg/2 mL
rilpivirine 600 mg/2 mL
VISUAL
Storage information is shown.
VOICE-OVER
CABENUVA should be stored in its original packaging in the refrigerator between 36 and 46 degrees Fahrenheit. Do not freeze.
TEXT ON SCREEN
Store in refrigerator at 36°F to 46°F (2°C to 8°C) in the original packaging until ready to use.
Do not freeze.
VISUAL
The Chapter 1 – Preparation cover appears
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Chapter 1 – Preparation
VISUAL
A fridge containing the Dosing Kits is displayed. The camera zooms in, a hand opens the fridge, then takes one of the 600-mg/900-mg Dosing Kits to start the preparation.
VOICE-OVER
The preparation steps for both medicines are the same.
First, ensure you select the appropriate dosing kit prior to preparation. Take this dosing kit out of the refrigerator at least 15 minutes prior to giving the injections to allow the suspensions to come to room temperature. It is best to inject the medicine as soon as it reaches room temperature.
TEXT ON SCREEN
Remove Dosing Kit from refrigerator
VISUAL
The hand puts the Dosing Kit on the table. The visual text appears. Then the hand opens the Dosing Kit.
VOICE-OVER
Before giving the injections, the vials may sit in the packaging at room temperature (maximum temperature of 77 degrees Fahrenheit) for up to 6 hours.
TEXT ON SCREEN
The vials may sit in the packaging at room temperature, maximum 77°F (25°C), for up to 6 hours.
VISUAL
The second part of visual text appears on the same scene.
VOICE-OVER
If not used within 6 hours, the medication must be discarded.
Once the vials are removed from the refrigerator, they must be used or discarded. They cannot be cycled in and out of the refrigerator.
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If not used within 6 hours, the medication must be discarded.
Once the vials are removed from the refrigerator, they must be used or discarded.
VISUAL
The Dosing Kit contents are collected on a table covered by a medical paper sheet.
Each component will be highlighted one at a time, with information call-outs.
VOICE-OVER
When opening the Dosing Kit of CABENUVA, you will find:
- An Instructions for Use leaflet
- One single-dose vial containing 600 milligrams of cabotegravir
This vial has a brown tint to the glass with an orange cap
- One single-dose vial containing 900 milligrams of rilpivirine
This vial is clear with a yellow cap
- Two 23-gauge, 1½-inch injection needles
- Two syringes
- Two syringe labels
- Two vial adapters
TEXT ON SCREEN
Instructions for Use leaflet
cabotegravir vial
rilpivirine vial
2 injection needles (23G, 1½-inch)
2 syringes
2 syringe labels
2 vial adapters
The cabotegravir vial has a brown tint to the glass.
VISUAL
Text appears showing needle length information.
VOICE-OVER
While the Dosing Kit contains a 23-gauge, 1½-inch needle, you should consider the patient’s build and use medical judgment to select an appropriate needle length.
TEXT ON SCREEN
Consider the patient’s build and use medical judgment to select an appropriate injection needle length.
See Prescribing Information for further details.
VISUAL
Text appears showing needle length information.
VOICE-OVER
If 2-inch safety needles are required to reach the gluteus muscle, please order by visiting fisherhealthcare.com/2inchsafetyneedle.
TEXT ON SCREEN
If 2-inch safety needles are required to reach the gluteus muscle, please order by visiting www.fisherhealthcare.com/2inchsafetyneedle.
VISUAL
The camera moves on the right revealing the other components needed (not included) collected on the same table. Call-outs and a pop-up with information appear.
VOICE-OVER
You will also require additional supplies, not included in the packaging:
- Non-sterile gloves
- 4 alcohol wipes
- 4 gauze pads
Adhesive bandages may be used if bleeding occurs.
TEXT ON SCREEN
Non-sterile gloves (not included)
4 alcohol wipes (not included)
4 gauze pads (not included)
Adhesive bandages may be used if bleeding occurs.
VISUAL
The callout moves to reveal the sharps disposal container.
VOICE-OVER
And a suitable sharps container.
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Non-sterile gloves (not included)
4 alcohol wipes (not included)
4 gauze pads (not included)
Sharps container (not included)
VISUAL
The hand enters the scene with the vial upside down. A balloon with the zoomed vial pops up showing the expiration date. Then it disappears.
VOICE-OVER
Before proceeding, inspect both vials. If the expiration date has passed,
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Check the expiration date and medicine.
Do not use if the expiration date has passed or you can see foreign matter in the vial.
VISUAL
The hand turns the vial to better see the medicine inside the vial. A balloon with the zoomed vial pops up showing the medicine.
VOICE-OVER
or if you can see foreign matter in the vial, do not use.
TEXT ON SCREEN
Check the expiration date and medicine.
Do not use if the expiration date has passed or you can see foreign matter in the vial.
VISUAL
Once the expiration date and medicine are checked, the hand puts the vial back onto the table to let it come to room temperature.
VOICE-OVER
Wait at least 15 minutes to allow the medicines to come to room temperature.
TEXT ON SCREEN
Wait at least 15 minutes to allow the medicines to come to room temperature.
VISUAL
A pop-up appears to advise taking out of fridge when patient checks in to your clinic.
VOICE-OVER
It is best to let the vials come to room temperature naturally.
You may consider using the warmth of your hands to warm the vials more quickly, but make sure the vials do not get above 77 degrees Fahrenheit.
Do not use any other heating methods.
TEXT ON SCREEN
Consider taking out of fridge when patient checks in to your clinic to allow the vials to come to room temperature.
VISUAL
The hand takes the vial.
VOICE-OVER
Once the vial is at room temperature,
VISUAL
The hand shakes the vial vigorously for a full 10 seconds.
VOICE-OVER
hold it firmly and vigorously shake for a full 10 seconds as demonstrated to resuspend the contents.
TEXT ON SCREEN
10 seconds
VISUAL
Zoom in to show the medicine inspection. The zoomed balloon shows the correct suspension.
VOICE-OVER
Next, invert the vial and check the suspension. Confirm the suspension is uniform. If it is not, shake the vial again. It is normal to see some small air bubbles.
TEXT ON SCREEN
Correct suspension should look uniform
VISUAL
The hand positions the vial on the table to allow accumulated bubbles to subside.
VOICE-OVER
In order to accurately administer the exact dose, allow for any excessive bubbles accumulated to subside.
TEXT ON SCREEN
Allow accumulated bubbles to subside.
VISUAL
The hands remove vial cap.
VOICE-OVER
Next, remove the cap from the vial.
VISUAL
The hands clean the rubber stopper.
VOICE-OVER
Clean the rubber stopper with an alcohol wipe and do not allow anything to touch it afterwards.
TEXT ON SCREEN
Do not allow anything to touch the rubber stopper after wiping it.
VISUAL
The hand takes the vial adapter and opens it.
VOICE-OVER
Keeping the vial adapter in the packaging, peel off the paper backing in preparation for the next step.
TEXT ON SCREEN
Keep the adapter in place in the packaging for the next step.
VISUAL
The hand takes the vial adapter and opens it.
VOICE-OVER
With the vial resting in an upright position on a flat surface,
VISUAL
The hand takes the vial adapter and attaches it to the vial.
VOICE-OVER
press the vial adapter straight down onto the vial using the packaging, as shown.
The vial adapter should snap securely into place.
VISUAL
The hand takes the packaging off the vial adapter.
VOICE-OVER
When you are ready, lift off the vial adapter packaging.
VISUAL
The hands take the syringe and withdraw 1 mL of air.
VOICE-OVER
Remove the syringe from the packaging and draw 1 milliliter of air into the syringe.
This will make it easier to draw up the medicine later. If this step is not completed, some medicine may flow back into the vial unintentionally, leaving less than intended in the syringe.
TEXT ON SCREEN
1 mL of air
VISUAL
The hands attach the syringe to vial adapter by screwing the syringe firmly.
VOICE-OVER
With the vial on a flat surface, hold the vial adapter and vial firmly, as shown.
Screw the syringe securely onto the vial adapter.
Press the plunger all the way down
VISUAL
The hand presses the plunger to push air in the vial.
VOICE-OVER
to push the air into the vial.
VISUAL
The hands invert syringe and vial together and withdraw all the medicine possible.
VOICE-OVER
Invert the syringe and vial and slowly withdraw as much of the medicine as possible into the syringe.
It is worth noting that there may be more medicine than the dose amount.
VISUAL
The hands unscrew the syringe from vial adapter.
VOICE-OVER
Holding the vial and vial adapter, keep the syringe upright to avoid leakage and unscrew the syringe from the vial adapter.
Check again that the medication looks uniform and milky white.
Once the medication has been drawn into the syringe, it is best to inject as soon as possible.
TEXT ON SCREEN
Keep the syringe upright to avoid leakage.
Check that the medication looks uniform and milky white.*
*Cabotegravir coloring may vary slightly, ranging from white to light pink.
VISUAL
The hand holds the syringe.
VOICE-OVER
However, the medication can remain in the syringes for up to 2 hours before injecting.
You must discard the filled syringes and needles if this time limit is exceeded. The filled syringes should not be placed in the refrigerator.
TEXT ON SCREEN
The medication can remain in the syringes for up to 2 hours before injecting. The filled syringes
should not be placed in the refrigerator.
Discard if this time limit is exceeded.
VISUAL
The hands peel open the needle packaging part way to expose the needle base.
VOICE-OVER
Now, peel open the needle packaging partway to expose
VISUAL
The needle is positioned with its packaging on the table for later.
VOICE-OVER
the needle base.
VISUAL
The hands take the needle with its packaging and attach the needle, firmly twisting the syringe onto the needle.
VOICE-OVER
While keeping the syringe upright, firmly twist the needle onto the syringe,
VISUAL
The needle packaging is removed.
VOICE-OVER
then finally remove the needle from its packaging fully.
VISUAL
A hand holds the label on which has just been written the name of the medicine.
VOICE-OVER
Write the name of the medicine on the syringe label.
It is recommended to also label the syringe with the time that the medication is drawn into the syringe if the medication is not administered immediately.
TEXT ON SCREEN
It is recommended to also label the syringe with the time that the medication is drawn into the syringe if the medication is not administered immediately.
VISUAL
Then the hand applies the label on the syringe.
VOICE-OVER
Affix the label to the syringe, making sure the gradations remain visible.
Preparation is now complete.
VISUAL
The Chapter 2 Injection cover appears
VOICE-OVER
Now you're ready for the injection steps.
TEXT ON SCREEN
CHAPTER 2
Injection
VISUAL
A neutral torso appears. The torso turns while explanations of the correct injection site appear.
VOICE-OVER
The first step is to identify the injection site.
It is important to note that these injections are for gluteal intramuscular use only.
Do not administer intravenously.
There are two possible sites for injection: the ventrogluteal and the upper outer quadrant of the dorsogluteal site.
TEXT ON SCREEN
The first step is to identify the injection site.
Injections of CABENUVA are for gluteal intramuscular use only.
Do not inject intravenously.
VISUAL
The torso turns to show both sides of the body (left and right) while the ventrogluteal site explanation appears.
VOICE-OVER
The ventrogluteal site is recommended.
TEXT ON SCREEN
The ventrogluteal site is recommended.
VISUAL
A pop-up appears to explain the dorsogluteal alternative.
VOICE-OVER
You may also consider the upper outer quadrant of the dorsogluteal injection site, shown here.
Ensure that each injection is administered at separate intramuscular gluteal sites (on opposite sides or at least 2 centimeters apart) during the same visit.
TEXT ON SCREEN
You may also consider the upper outer quadrant of the dorsogluteal injection site.
VISUAL
A pop-up appears to explain the options for the patient position during the injection.
VOICE-OVER
To receive an injection at the ventrogluteal site, the patient can lie in one of two positions.
The first option for the patient is to lie on their side, with the knee bent.
The second option is to lie facedown.
Regardless of the patient's body position, it is important to make sure that the muscle is relaxed prior to injection.
TEXT ON SCREEN
To receive an injection at the ventrogluteal site, the patient can lie in one of two positions:
On their side (with the knee bent)
Lying prone (face down)
Make sure that the muscle is relaxed prior to injection.
VISUAL
We now see the patient lying facedown.
VOICE-OVER
To locate the injection site,
VISUAL
The x-ray view becomes more prominent and call-outs appear to identify landmarks.
VOICE-OVER
place the heel of the hand over the patient's greater trochanter
TEXT ON SCREEN
Greater trochanter of femur
Gluteus medius
Iliac crest
Anterior superior iliac spine
VISUAL
The muscle disappears to let the bones be visible and permit the hand to enter the scene and start the identification of the injection site. The hand is semitransparent to allow the bones to be seen under it.
VOICE-OVER
using the left hand for the patient's right hip or the right hand for the patient's left hip. Position the index finger on or toward the anterior superior iliac spine. Stretch the middle finger away from the index finger, creating a "V" or triangle.
TEXT ON SCREEN
Greater trochanter of femur
Iliac crest
Anterior superior iliac spine
VISUAL
The injection area is now selected and a bull’s-eye appears to mark the site.
VOICE-OVER
The injection site is located within the triangle created by the index finger, the middle finger, and the iliac crest.
TEXT ON SCREEN
Greater trochanter of femur
Iliac crest
Anterior superior iliac spine
VISUAL
We now see the right hand entering the scene with an alcohol swab to clean the injection site.
VOICE-OVER
Clean the injection site with an alcohol wipe. Allow the skin to air dry before continuing. Once the site has been identified and the patient is in the correct position, you can proceed to administer the injection.
TEXT ON SCREEN
Clean the injection site with an alcohol wipe.
Allow the skin to air dry before continuing.
VISUAL
Holding the syringe upright, the left hand takes the needle guard and folds it away from the needle.
VOICE-OVER
Fold the needle guard away from the needle
VISUAL
The needle cap is removed.
VOICE-OVER
and pull off the injection needle cap.
VISUAL
The camera zooms in to show the correct 3-mL dosage.
VOICE-OVER
Hold the syringe with the needle pointing up. Press the plunger to the 3-mL mark for every-2-month doses to remove extra medicine and any air bubbles, ensuring you have the correct dose prepared.
TEXT ON SCREEN
3 mL
VISUAL
A cross-section pop-up of the skin will appear to show z-track mechanism following the procedure in the scene.
VOICE-OVER
Use the z-track injection technique to minimize medication leakage from the injection site.
TEXT ON SCREEN
Skin
Subcutaneous tissue
Muscle
VISUAL
The left hand stretches the skin about 1 inch to show z-track technique.
VOICE-OVER
Firmly drag the skin covering the injection site, displacing it by about an inch.
Keep it held in this position for the injection.
TEXT ON SCREEN
1 inch (2.5 cm)
Skin
Subcutaneous tissue
Muscle
VISUAL
X-ray vision appears. While the left hand keeps the skin stretched to maintain the z-track, the right hand inserts the needle perpendicularly.
VOICE-OVER
Insert the needle to its full depth, or deep enough to reach the muscle.
TEXT ON SCREEN
Skin
Subcutaneous tissue
Muscle
VISUAL
The thumb slowly presses the plunger down to inject the dose.
VOICE-OVER
Still holding the stretched skin, slowly press the plunger all the way down and ensure that the syringe is empty.
TEXT ON SCREEN
Skin
Subcutaneous tissue
Muscle
Medication
VISUAL
The right hand withdraws the needle and the left one releases the skin immediately. Then the cross-section pop-up will disappear.
VOICE-OVER
Withdraw the needle and release the stretched skin immediately.
TEXT ON SCREEN
Skin
Subcutaneous tissue
Muscle
Medication
VISUAL
We now see the right hand entering the scene with gauze, to apply pressure on the injection site.
VOICE-OVER
Once the needle has been removed, apply pressure to the injection site using gauze.
Do not massage the area. A small adhesive bandage may be used if bleeding occurs.
TEXT ON SCREEN
Do not massage the area.
VISUAL
The right hand, holding the syringe with needle, applies pressure on the table to make the needle guard fold again and make the needle safe.
VOICE-OVER
Fold the needle guard over the needle.
Gently apply pressure using a hard surface to lock the needle guard in place.
VISUAL
The right hand, holding the syringe with needle, applies pressure on the table to make the needle guard fold again and make the needle safe. A click is heard.
VOICE-OVER
The needle guard will make a click when it locks.
TEXT ON SCREEN
click
VISUAL
The right hand enters the scene with syringe and needle to insert them in the sharps disposal container,
VOICE-OVER
Dispose of the used needle, syringe, vial, and adapter
VISUAL
then also disposes the vial with vial adapter.
VOICE-OVER
according to local health and safety laws.
VISUAL
The right hand enters the scene, takes the cabotegravir vial, and exits the scene.
VOICE-OVER
Repeat the preparation and injection steps for the second medicine. It is not important which medicine is injected first or second.
The second medicine must be injected into a separate gluteal intramuscular site (on the opposite side or at least 2 centimeters from the first injection).
TEXT ON SCREEN
Repeat preparation and injection steps for the second medicine.
VISUAL
Closing scene with voice-over that accompanies to the end of the video.
VOICE-OVER
Thank you for watching this step-by-step guide for the preparation and injection of CABENUVA.
For more information, visit CABENUVAhcp.com.
Please see Important Safety Information next.
TEXT ON SCREEN
For additional resources and support, visit CABENUVAhcp.com.
Please see Important Safety Information next.
VISUAL
ISI will be displayed.
VOICE-OVER
IMPORTANT SAFETY INFORMATION continued
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
VISUAL
ISI will be displayed.
VOICE-OVER
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
• Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
• Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
VISUAL
ISI will be displayed.
VOICE-OVER
• Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hypersensitivity Reactions:
• Serious or severe hypersensitivity reactions have been reported in association with other
integrase inhibitors and could occur with CABENUVA
VISUAL
ISI will be displayed.
VOICE-OVER
• Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hypersensitivity Reactions:
• Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
VISUAL
ISI will be displayed.
VOICE-OVER
Post-Injection Reactions:
• Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Post-Injection Reactions:
• Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
VISUAL
ISI will be displayed.
VOICE-OVER
• Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Post-Injection Reactions:
• Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
VISUAL
ISI will be displayed.
VOICE-OVER
Hepatotoxicity:
• Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hepatotoxicity:
• Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
VISUAL
ISI will be displayed.
VOICE-OVER
• Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hepatotoxicity:
• Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
VISUAL
ISI will be displayed.
VOICE-OVER
• Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hepatotoxicity:
• Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
VISUAL
ISI will be displayed.
VOICE-OVER
Depressive disorders:
•Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
• Promptly evaluate patients with depressive symptoms
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Depressive disorders:
•Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
• Promptly evaluate patients with depressive symptoms
VISUAL
ISI will be displayed.
VOICE-OVER
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
• The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
• The concomitant use of CABENUVA and other drugs may result in known or potentially
significant drug interactions (see Contraindications and Drug Interactions)
VISUAL
ISI will be displayed.
VOICE-OVER
• Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
• Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
VISUAL
ISI will be displayed.
VOICE-OVER
Long-Acting Properties and Potential Associated Risks with CABENUVA:
• Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Long-Acting Properties and Potential Associated Risks with CABENUVA:
• Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
VISUAL
ISI will be displayed.
VOICE-OVER
• To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Long-Acting Properties and Potential Associated Risks with CABENUVA:
• To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
VISUAL
ISI will be displayed.
VOICE-OVER
ADVERSE REACTIONS
• The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
• The safety of CABENUVA in adolescents is expected to be similar to adults
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
ADVERSE REACTIONS
• The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
• The safety of CABENUVA in adolescents is expected to be similar to adults
VISUAL
ISI will be displayed.
VOICE-OVER
DRUG INTERACTIONS
• Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
• Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
• Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
DRUG INTERACTIONS
• Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
• Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
• Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
VISUAL
ISI will be displayed.
VOICE-OVER
USE IN SPECIFIC POPULATIONS
• Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
USE IN SPECIFIC POPULATIONS
• Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
VISUAL
ISI will be displayed.
VOICE-OVER
USE IN SPECIFIC POPULATIONS
• Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
TEXT ON SCREEN
IMPORTANT SAFETY INFORMATION (cont’d)
USE IN SPECIFIC POPULATIONS
• Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
VISUAL
References will be displayed.
TEXT ON SCREEN
References
1. Greenway K. Using the ventrogluteal site for intramuscular injection. Nurs Stand. 2004;18(25):39-42. doi:10.7748/ns2004.03.18.25.39.c3560
2. Kara D, Uzelli D, Karaman D. Using ventrogluteal site in intramuscular injections is a priority or an alternative? Int J Caring Sci. 2015;8(2):507-513.
3. Hunt CW. Which site is best for an I.M. injection? Nursing. 2008;38(11):62.
doi:10.1097/01.NURSE.0000341089.14071.1e
4. Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000;31(3):574-582. doi:10.1046/j.1365-2648.2000.01312.x
Trademarks are property of their respective owners.
©2022 ViiV Healthcare or licensor.
CBRVID210018 April 2022
Produced in USA.
Access Resources
What is a Specialty Drug?
What is a Specialty Drug? Manuscript
SUPER: The Access and Acquisition Series: WHAT IS A SPECIALTY DRUG?
VISUAL: A park appears onscreen. A leaf enters the frame. The leaf sweeps across the park to the right.
VO: The HIV landscape has broadened in recent years to include long-acting specialty drugs.
VISUAL: A healthcare professional's (HCP's) office forms. An HCP works at her desk. The HCP continues working.
VO: Understanding how to integrate these specialty drugs into your practice can help meet the ever-changing needs of your patients.
VISUAL: The camera’s view pans past the HCP. The HCP's hand is shown scribbling notes on a piece of paper. The shot moves past a series of plants. The camera zooms out, showing the HCP in profile as the words "What is a specialty drug?" appear on screen.
VO: Before discussing how to prepare your practice for accessing these drugs in other videos, let's first discover what defines a specialty drug.
VISUAL: The HCP and their office space slide off to the left; only the copy remains on the screen. "Rare, chronic, complex diseases” appears on the screen.
VO: Specialty drugs often treat or prevent rare, chronic, and complex diseases.
VISUAL: "A specialty drug may require specific” appears on the screen, with a hand adjacent. The hand draws a box to the right of the copy. Copy populates beneath the phrase "A specialty drug may require specific" as the VO reads the words off. The box opens and a vial lifts out of it. The vial rotates. The copy continues cycling. The box closes and slides off the screen to the right.
VO: They differ from traditional medication in that they often have specific storage, handling, and administration requirements.
VISUAL: The vial appears at the center of the screen. The vial is shown.
VO: Many specialty drugs are injectable medications.
VISUAL: The vial is shown. A hand appears from the bottom of the frame, grabbing the vial. The camera zooms out, showing an HCP grabbing the vial while her patient sits behind her. The doctor looks at her patient.
VO: While some are self-administered, other specialty injectable drugs must be administered in a clinical setting by a healthcare professional.
VISUAL: The view slides right past the doctor and patient, beginning to reveal a container with boxes inside. The container continues moving into the frame. The container slides out of the frame to the left as the thermometer slides in from the right. The camera zooms in on the thermometer.
VO: Some specialty injectable drugs may also require precise temperature control throughout shipment and storage until it is time to administer them to your patient.
VISUAL: The thermometer slides off to the left as the exterior of a retail pharmacy slides in from the right. The retail pharmacy holds on the screen. A shopper exits the store with a bag. The camera slides past the pharmacy, revealing an HCP's office.
VO: Because of these key differences, your patients cannot acquire physician-administered specialty drugs through a retail pharmacy in the same way they can go and pick up a traditional oral medication.
VISUAL: The camera holds on the HCP office. The camera zooms in on the window of the HCP office, revealing a doctor and patient having a conversation. The camera slides to the right of the window. A sign is revealed. The sign comes into focus, revealing iconography for "specialty pharmacy" and "specialty distributor."
VO: To acquire a specialty injectable drug, your practice will either coordinate with a specialty pharmacy or a specialty distributor.
VISUAL: The iconography animates. The sign slides off to the left as papers slide in from the right.
VO: Your patient's insurance coverage often determines how you will acquire the drug.
VISUAL: The paper checklist and hand come into view.
VO: Acquiring specialty injectable drugs is different from traditional oral medication.
VISUAL: The camera moves out, showing an office manager’s hand using the pen on a piece of paper. The office manager is shown at their desk with a patient. The Access and Acquisition Series appears on their screen. The camera zooms out and more patients populate the screen. The office manager sits facing the patients. The office manager addresses the patients. The camera travels through the patients and the doors, revealing an outdoor setting.
VO: Yet, as the HIV landscape evolves, understanding specialty injectable drug acquisition is important so you can continue to support your patients' experience with their prescribed HIV medications. Contact your ViiV Team or visit ViiVinjectables.com to learn more.
SUPER: ViiVinjectables.com
VISUAL: The camera pans to show people at a picnic. The camera pans to reveal the ending frame with the words: "THE ACCESS AND ACQUISITION SERIES"
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220013 September 2022 Produced in USA.
VO: And for more on acquiring specialty injectable drugs, continue watching the videos in this series.
Specialty Injectable Drug Coverage Options
Specialty Drug Coverage Transcript
SUPER: The Access and Acquisition Series: Specialty injectable drug coverage options
VISUAL: The Access and Acquisition Series: Specialty injectable drug coverage options
VISUAL: A vial appears on the screen with the text "Acquire, handle, and administer. " The vial remains as the copy "Specialty drugs" slides in. The vial and "specialty drugs" remain.
VO: The way you acquire, handle, and administer specialty drugs can differ from oral medications available at traditional retail pharmacies.
VISUAL: The hand grabs the vial. The hand holds the vial.
VO: How your patients' insurance covers these drugs also differs. Let's learn about the various ways payers can cover these specialty injectable drugs.
VISUAL: Icons begin flying in. Icons continue flying in. A piece of paper flies off the clipboard. The paper and the clipboard remain in the frame. The paper and clipboard remain in place while a hand and the word “Medicaid” appear on the right.
VO: As you may know, commercial insurance, Medicare, and Medicaid structure their benefits differently.
VISUAL: The clipboard moves to the back of the screen as the other icons fade away. The paper comes to the front of the frame, while a hand holding a vial comes in from the left.
VO: This can impact how you acquire these drugs. These payers may cover drugs, services, and treatments through different benefits. Depending on how your patients’ insurance policies are written,
VISUAL: The paper and the hand remain, while a gloved hand holding a syringe comes in from the right. As the paper moves, it flips, revealing “Insurance Policy” written across the top. Hands appear from the edges of the screen. The hands appear on screen. The paper moves off the screen, while a doctor comes in from the lower right. "Medical benefit" appears on the screen. "Pharmacy benefit" appears, shifting "medical benefit" to the left. A plus animates between the medical and pharmacy benefit iconography.
VO: and whether their drugs are self-administered or administered by a healthcare provider, their specialty injectable drugs may be covered under a medical benefit, meaning their medical insurance, a pharmacy benefit, or some combination of the two. A benefit verification will detail your patient’s specific coverage—and remember, no matter what coverage your patient has,
VISUAL: A check mark appears above the iconography.
VO: these drugs may require a prior authorization before approval.
VISUAL: The hand sweeps across the screen and sweeps away the iconography. The hand continues sweeping across the screen, revealing the copy "What does it mean for your practice?" The hand exits the frame; the text remains. The "medical benefit" iconography appears with a medical building and doctor. The shot pans to reveal a warehouse. "Specialty Distributor" appears next to the warehouse as the door opens.
VO: So, what does this all mean for your practice working to acquire a specialty injectable drug? If the payer covers your patient’s drug under their medical benefit, it may be acquired through a specialty distributor,
VISUAL: A truck drives out of the open door with the words "Buy & Bill" on it. The truck drives toward the foreground of the shot. A container forms. The doctor, taking notes, appears to the right of the container.
VO: via a process commonly known as Buy & Bill. This is when your practice purchases and stores the drug until you administer it to a patient.
VISUAL: The doctor and container sweep off the screen to the left and a hand holding a vial swings in from the right. The hand lands center screen and places the vial down as the copy "pharmacy benefit" appears adjacent to it.
VO: If the payer covers your patient’s drug under their pharmacy benefit,
VISUAL: Vials and a mortar and pestle appear on the screen alongside a call center operator as the words "specialty pharmacy" populate. The "specialty pharmacy" icon begins moving off the screen to the left as a paper moves into the shot from the right. The paper is revealed to be a prescription pad with a doctor's handwriting on it. The hand moves off the screen and a vial slides out from behind the pad.
VO: it may be acquired through a specialty pharmacy. With a specialty pharmacy, a prescription is written for that patient and the drug is sent to your practice
VISUAL: The paper continues moving around the vial. The vial and prescription paper fall into the bag. The vial and prescription paper enter the bag. The bag’s top is closed. “White Bagging” copy appears.
VO: when it is nearing the time of administration. This is also called "white-bagging."
VISUAL: The shot pans out to reveal the doctor holding the bag. The doctor and a medical building appear on screen. The "medical benefit" and "specialty pharmacy" iconography appear, with an unidentified link shown between them. The unidentified link is populated with “assignment of benefits (AOB)” iconography.
VO: If your patient’s insurance covers the drug under the medical benefit, but you and your practice would prefer working with a specialty pharmacy instead of a specialty distributor, your practice may have the option to acquire the drug through an Assignment of Benefits, or AOB.
VISUAL: The screen splits, revealing a call center operator and a health care professional (HCP) on the phone. The split screen collapses, leaving the HCP onscreen. A door appears.
VO: You will determine if working with a specialty pharmacy is possible given your patient's coverage.
VISUAL: The doctor begins speaking to a patient. The shot continues moving; the doctor and patient move off the screen to the left. An office manager at her desk begins appearing from the window.
VO: Please note that this process varies by payer and will not be an option in all cases. As you can see, specialty injectable drugs are covered differently and may require adopting a new process in your practice.
VISUAL: A patient is shown sitting across from the office manager. More patients populate behind the seated patient. Camera pans right to show more patients onscreen. More patients are revealed as the camera continues to pan right. Camera zooms in through doors, revealing a park where various activities are taking place.
VO: To help more people access HIV medications, assistance from ViiVConnect is available. ViiVConnect is committed to helping inform healthcare providers about the options available for acquiring ViiV medicines so you can continue to support your appropriate patients. Contact your ViiV Team or visit ViiVinjectables.com to learn more.
SUPER: ViiVinjectables.com
VISUAL: Camera continues to pan to reveal people taking part in various activities, like walking a dog.
VO: Be sure to watch other videos within the ViiV Access and Acquisition series to learn more about working with specialty distributors and specialty pharmacies.
VISUAL: The camera pans to reveal the final frame, which says: The Access and Acquisition Series
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220014 September 2022 Produced in USA.
Specialty Pharmacy Acquisition Process
Specialty Pharmacy Manuscript
SUPER: The ViiV Access and Acquisition Series: Specialty pharmacy acquisition process
SUPER: Specialty Drugs
VISUAL: A park appears with a person walking through it. A leaf floats off to the right. The leaf moves across the screen. "Specialty Drugs" appears on the screen along with a vial. An HCP sits at their desk with a patient across from them. The text "Specialty Drugs" and vial continue floating above the HCP and patient.
VO: Accessing specialty drugs may be a new experience for your practice, but learning to integrate these drugs can provide additional options for your patients.
SUPER: Differs from traditional oral medication
SUPER: Insurance Coverage
VISUAL: The HCP walks out of their office toward a filing cabinet. The HCP reviews a paper from the filing cabinet. The HCP continues reviewing the paper. “Pharmacy Benefit” appears on the screen.
VO: The way your practice acquires specialty injectable drugs differs from traditional oral medication. This acquisition method is highly dependent on your patient’s insurance coverage. Let’s discuss the details of acquiring a specialty injectable drug when the patient’s insurance covers it under the pharmacy benefit.
SUPER: Pharmacy Benefit
VISUAL: The HCP and text slide down off the screen. The specialty pharmacist appears with a paper that reads “Specialty Pharmacy.”
VO: When covered under a patient's pharmacy benefit, you will acquire the drug through a specialty pharmacy.
SUPER: Specialty Pharmacy
A specialty pharmacy is not a standard "walk-in" retail pharmacy. They:
- Help coordinate several aspects of patient care
- Deliver medications with special handling, storage, and distribution requirements
VISUAL: The “Specialty Pharmacy” definition begins animating in. The definition and icon remain on the screen.
VO: A specialty pharmacy is not a standard "walk-in" retail pharmacy. They coordinate several aspects of patient care and deliver medications with special handling, storage, and distribution requirements.
SUPER: Benefit Verification
The process of verifying the patient’s current medical coverage with the insurance company.
VISUAL: The HCP appears onscreen from the right as the paper flies off. The paper reappears from the top of the screen. “Benefit Verification” animates onto the paper. The HCP rotates as the Benefit Verification definition animates in. The clipboard grows closer as the pages are rifled through. A page of the clipboard reveals a checkbox with the word "Coverage" next to it. The pages of the clipboard return back down.
VO: Once an appropriate patient is identified for the prescription of a specialty injectable, your practice will conduct a benefit verification to confirm your patient’s coverage and detail any prior authorization requirements. Please remember that prior authorizations are rather common for these drugs.
VISUAL: The clipboard and definition move off the screen to the left as a specialty pharmacy storefront slides in from the right. The specialty pharmacy centers on the screen. The camera zooms out as additional specialty pharmacy storefronts appear. The storefronts line up across the screen. Various storefronts are highlighted. The storefronts remain. The shot pans out to reveal the specialty pharmacy character. The highlighted storefronts rise. The man circles the selected storefronts. The man and storefronts remain.
VO: Once the patient’s insurer confirms that the drug is covered under the pharmacy benefit, your practice should inquire about which specialty pharmacies are in-network with the patient’s insurance, and then select the ones your practice would like to work with. Remember that the choice of pharmacy is sometimes dictated by the patient's insurance and the availability of the drug.
SUPER: Prior Authorization
The approval from a health plan that may be required before a patient receives a service or a therapy.
VISUAL: The person slides off the screen to the right, along with all but one specialty pharmacy storefront. An HCP begins appearing from the left. The HCP comes fully into the frame with the specialty pharmacy storefront. A piece of paper from the HCP flies off toward the specialty pharmacy. A paper with a patient photo appears on the left of the storefront. Checkboxes populate below the patient photo. The patient photo disappears as “Prior Authorization” replaces it. The Prior Authorization definition appears along with a checkbox with the word “Approved” below it. The shot pans in on the specialty pharmacy, the definition disappearing behind it. The camera continues panning in on the pharmacy. The shot pans into the pharmacy, revealing a technician on the phone at a desk. An exclamation mark is revealed to emphasize importance.
VO: Your ViiV Team can supply you with a list of specialty pharmacies to work with. Once verified, you can send a prescription to the specialty pharmacy for the drug. They may require additional details, like information regarding the patient's diagnosis. The specialty pharmacy will confirm any outstanding items, including whether a prior authorization is needed, and coordinate a shipment date for the drug so it arrives around the time of the patient’s injection appointment. The specialty pharmacy may contact the patient to obtain permission to bill their insurance company, discuss co-payment or other financial responsibilities, as well as gain their consent to ship the medication.
VISUAL: The shot reveals a staff member in the specialty pharmacy from the right, opening a package. The staff member picks up the phone. The patient is shown receiving the call on the right. The pharmacy tech slides off the screen.
VO: It is very important that the patient answers any communications from the specialty pharmacy to ensure their shipment isn’t delayed. The specialty pharmacy will then ship the drug
SUPER: White Bagging
An arrangement between payers and specialty pharmacies to ship a patient’s medication directly to the physician’s office.
VISUAL: The pharmacy tech and patient move off the screen as a box and the "white bagging" definition slide in from the top. A physician's office facade slides in from the right. The box begins moving into the physician's office. The box enters the office through the doors. A staff member receives the box. The staff member receives the box and verifies the information on it. The staff member holds the box. The camera rotates around the staff member. The staff member places the box in a container. The container moves across the screen to the left as an HCP enters from the right. The container moves off the screen to the left as a calendar appears to the right of the HCP. The HCP and calendar move off the screen to the left.
VO: to your practice, commonly referred to as “white bagging.” Keep in mind that specialty injectable drugs obtained through a specialty pharmacy are for a specific patient and should not be administered to other patients. Once received, be sure to store and handle the drug as required, and finally administer the injection at the patient’s scheduled appointment.
VISUAL: An office is shown, with papers flying into an envelope on top of a desk. The shot pans in on the papers sliding into the envelope. A stamp appears on the desk. A hand presses the stamp onto the envelope. The stamp is removed, revealing the “specialty pharmacy” icon. The envelope remains in the shot. The “specialty pharmacy” icon remains on the screen.
VO: Unlike medications acquired under buy-and-bill, when submitting claims for specialty pharmacy-acquired drugs, you may be able to bill for administration, but not the cost of the drug. Billing for the specialty drug is handled by the specialty pharmacy, so your patient will pay any drug-related co-pays or coinsurance directly to the specialty pharmacy.
VISUAL: The “specialty pharmacy” icon remains on the screen. The "specialty pharmacy" icon remains center screen. The "specialty distributor" icon joins, moving the "specialty pharmacy" icon to the left. The icons begin moving off the screen to the right.
VO: Please note that not all patients’ insurers will cover acquisition through the pharmacy benefit and specialty pharmacy, so it is important to understand the different types of acquisition methods available.
VISUAL: A doctor’s office waiting room is revealed, showing patients sitting in chairs. The seated patients continue moving across the screen to the left. The shot pans in on a seated patient. The shot further tightens on the patient. Leaves begin flying by the patient.
VO: Remember, your ViiV team is available to support you throughout the entire acquisition process, and ViiVConnect is here for your practice—and most importantly your patients—regarding appropriate access, if you choose to utilize the service.
SUPER: ViiVinjectables.com
SUPER: The Access and Acquisition Series
VISUAL: The shot pans out, revealing people having a picnic outside. The shot continues panning out, revealing a person biking by. "The Access and Acquisition Series" appears onscreen and then swipes away, fading to white.
VO: Contact your ViiV Team or visit ViiVinjectables.com to learn more. For more on accessing and acquiring specialty injectable drugs, review the other videos in this series.
VISUAL:
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220016 September 2022 Produced in USA.
Buy & Bill Acquisition Process
Video 3: Specialty Distributor with Buy & Bill Transcript
SUPER: The Access and Acquisition Series: Buy & Bill acquisition process
SUPER: Specialty Drugs
SUPER: Treatment and prevention
VISUAL: A park scene appears, with the wind blowing. A leaf blows into the frame. The leaf blows past faces of patients and the words Specialty Drugs slide in from the right. The words Specialty Drugs are now in full view, while the figures continue to slide to the left. The words Treatment and prevention appear in the frame. The people and text slide off to the left as a clipboard animates in.
VO: Accessing specialty drugs may be a new experience for your practice. But understanding how to integrate these specialty drugs into your practice can help provide additional options for your patients. Obtaining these drugs requires processes that may differ from oral medications.
SUPER: Commercial Insurance, Medicare, Medicaid
SUPER: Medical Benefit
VISUAL: Supers appear onscreen with their corresponding icons. The icons fall off the screen. The HCP animates in. The Medical Benefit iconography animates in. The Medical Benefit icon and words swoop up out of the frame.
VO: The method you will use to acquire these drugs is dependent on your patient’s insurance coverage. In this video, we’ll discuss the specifics of acquiring a specialty injectable drug when your patient’s insurance covers it under the medical benefit.
SUPER: 3 options
SUPER: Buy & Bill
SUPER: AOB Assignment of Benefits
SUPER: ASA Alternative Site of Administration
VISUAL: Paper swirls around a vial that spins and comes into the frame, and the words 3 options appear. Buy & Bill and its icon appear in the center of the screen. AOB Assignment of Benefits and its icon appear in the center of the screen. ASA Alternative Site of Administration and its icon appear in the center of the screen.
VO: Under the medical benefit, there are three options: the Buy & Bill process with a specialty distributor, an Assignment of Benefits, or "AOB," or through an "ASA," which stands for Alternative Site of Administration.
SUPER: Buy & Bill
SUPER: Specialty Distributor
VISUAL: The Buy & Bill icon is at the center of the frame. The Buy & Bill text and icon shift to the left as a woman on the phone comes in from the right. A cube comes in from the left, shifting focus away from the woman on the phone. The building increases in detail revealing the specialty distributor building with the words Specialty Distributor appearing next to the building.
VO: Let’s begin with Buy & Bill. Buy & Bill is the most common acquisition method under the medical benefit. The process is known as Buy & Bill as your practice will purchase the drug directly from a specialty distributor and bill the payer for reimbursement.
SUPER: 5 Key Steps
SUPER: 1 - Benefit Verification and Payer Contract Review
2 - Prior Authorization
3 - Purchasing and Stocking the Drug
4 - Administration
5 - Billing and Reimbursement
VISUAL: Copy appears onscreen. A piece of paper is seen with the words Benefit Verification on it. Two icons appear on either side. A hand checks a box on the piece of paper. The icons all shift clockwise and an image of vials in a box appears; one is out of the box more than the others. The images shift again–clockwise–and a vial and syringe take the center of the frame. The image shifts clockwise again while a hand appears with a bill. The syringe and paper disappear and only the box with vials and a bill are onscreen. The bill swoops away from the rest of the imagery on the frame.
VO: There are five key steps in the Buy & Bill process: benefit verification and payer contract review, prior authorization, purchasing and stocking the drug, administration, and finally, billing and reimbursement.
SUPER: Medical Benefit
VISUAL: A piece of paper swirls onscreen. A hand reaches for the swirling paper and writes on it. Two health care professionals (HCPs) stand looking over the paper. One HCP slides off screen to the right; the other remains. The HCP receives a clipboard. The Medical Benefit iconography reappears. The Medical Benefit icon shifts as a manila folder with Prior Authorization appears.
VO: First, your practice will conduct a benefit verification. This step is always needed to confirm your patient’s coverage and detail any prior authorization requirements. For drugs covered under the medical benefit, a prior authorization is usually needed.
VISUAL: The manila folder shifts to the left and paperwork comes in from the right. The paperwork goes into the folder. A doctor writing a letter appears from the right. The doctor fades away and the letter goes into the manila envelope. Charts appear from the right. The charts go into the manila folder. A paper with Test Results appears from the right. The test results go into the manila folder. A paper and a vial appear from the right. The paper and vial go into the manila folder. A checklist and hand appear from the right. A stamp appears and the paper swoops up.
VO: To obtain a prior authorization, some payers require the completion of a specific form, and others require documentation such as a letter of medical necessity, chart notes, test results, or the Prescribing Information for the drug. Your patient’s payer should supply you with a list of requirements to properly complete their prior authorization process.
VISUAL: The prior authorization folder returns to the center of the frame and the stamp presses on the folder leaving an approval check. The stamp increases in size. The stamp moves out of the frame. A bill comes out of the folder. Another bill comes out of the folder and sits below the first bill. The folder now says Payer Contract. The papers return to the folder and fall on the HCP's desk. The shot zooms in on the folder as the papers file into it. The folder swirls on the screen.
VO: While verifying your patient’s benefits, your practice should confirm contract details with the payer to understand reimbursement for the administration and product costs for the drug. These contracts should be in place for all the payers your practice works with.
SUPER: Specialty Distributor
VISUAL: A hand holding a checklist appears. Another hand with a pen appears. A large box animates above the paper. The hand checks off boxes on the paper. The paper floats out of the hands and swirls upward. The Specialty Distributor icon appears. A truck pulls out of the Specialty Distributor warehouse. The truck drives away from the Specialty Distributor warehouse. The box opens and a vial rises out.
VO: Once the payer contract is confirmed and prior authorization is approved, your practice will contact a specialty distributor to acquire the drug. Your ViiV team can supply you with a list of specialty distributors to work with.
VISUAL: The vial rotates above the box. The vial returns and the box closes. The box appears in its storage container. The HCP is shown to the right of the container.
VO: Your practice will then place an order for the specialty injectable drug to stock on-site so it is available when needed.
SUPER: What are the return or payment terms with the specialty distributor?
When will the product be shipped?
Is the patient scheduled for administration after the shipment arrives?
Does the product require special handling or storage?
VISUAL: The HCP reviews the boxes in the container. Papers begin swirling around the HCP. Papers begin swirling around the HCP. A paper sits on the left of the screen with a list of questions beginning to appear on the right. The paper is replaced with a calendar and a hand truck with a box. Another question appears to the right. The hand truck disappears and a person in a chair appears behind the calendar. Another question appears on the right. A thermometer, vial, and box appear on the left. Another question appears on the right.
VO: There are a few key questions to keep in mind as you’re working with the specialty distributor on your order. What are the return or payment terms with the specialty distributor? When will the product be shipped? Is the patient scheduled for administration after the shipment arrives? Does the product require special handling or storage?
VISUAL: A calendar appears. A syringe lands on a day on the calendar. The calendar page turns to reveal a patient sitting across from an HCP. The patient and HCP slide offscreen to the right and an envelope and bill appear on the left. The bill is now in the center of the screen. The bill starts to go into the envelope.
VO: Once your practice has ordered or stocked the drug, you can schedule an administration appointment for your patient. After administration, your practice will bill the patient's insurance to get reimbursed for the administration and product costs for the specialty injectable drug.
SUPER: Product
SUPER: Administration
VISUAL: The bill folds into the envelope. The envelope seals and a hand remains in the frame. A magnifying glass looks at the barcode on the bottom right corner of the envelope. A billing code is revealed.
VO: Your practice is responsible for collecting any co-pays or coinsurance for the product, office visit, or additional administration fees from the patient. To facilitate accurate reimbursement, ensure your billing codes are correct.
VISUAL: A woman appears on the phone. Between the woman on the phone and the bill, a man in a call center appears in the center of the screen, dividing the frame into three parts. The bill on the left side of the frame swoops to the right of the screen over the two people on the phone. An office setting appears. The envelope continues off the screen and a check mark appears to the right of the man in the office. The envelope flies into another office with another person working on a computer. The envelope swoops past the man on the computer and another check mark appears on screen.
VO: You can contact your ViiV team to support you with billing information before submission to the payer. Some provider offices even assign specific individuals within the practice to own different steps of this process. Working as a team can help with accountability and efficiency for the Buy & Bill process.
SUPER: Buy & Bill
VISUAL: The man in an office and man in a call center appear in the background as a doctor appears in the center of the screen with a barcode and the words Buy & Bill in the top right. The doctor moves to the left of the screen while a cell phone with the word ViiV moves to the center. The frame transitions with the flip of a page from the top right. A container appears next to the barcode. A box is removed from the container and a vial comes out of the box. The box returns to the container. The container slides off the screen to the left and the barcode moves into a person's hand to the right.
VO: If it is your practice’s first time doing the Buy & Bill process, we recommend connecting with a member of your ViiV Team before beginning to help prepare your practice. The Buy & Bill process allows your practice to have the specialty injectable available on site and ready for appropriate patients.
SUPER: You may have other options
SUPER: Medical Benefit
SUPER: Assignment of Benefits (AOB)
SUPER: Assignment of Benefits (AOB), Specialty Pharmacy, Specialty Distributor, Specialty Drugs
VISUAL: The hand gestures to the right and the hand and barcode move off screen. The camera zooms out from the hand revealing the Medical Benefit icon. The camera pans around the HCP. The Assignment of Benefits icon appears. The specialty pharmacy and specialty drug icons begin forming. The screen fills with the flow chart of assignment of benefits to specialty pharmacy to specialty drug. The camera continues to pan, revealing the flow chart of assignment of benefits to a specialty pharmacy to specialty drug. Specialty distributor is crossed out in the background.
VO: Another method that may be covered by your patient's insurance under the medical benefit is Assignment of Benefits, or AOB. An Assignment of Benefits is a process under the medical benefit that may allow you to access a drug through a specialty pharmacy instead of a distributor.
VISUAL: The Specialty Distributor icon fades away. The Alternative Site of Administration icon begins to come into the frame and the other icons fade away to the left.
VO: Please note that this process varies by payer and will not be an option if your patient's plan does not allow for assignment of benefits for a specialty pharmacy under a medical benefit.
SUPER: Alternative Site of Administration (ASA)
VISUAL: The Alternative Site of Administration icon takes center frame. The camera zooms out, revealing an HCP holding a screen with a map on it. The camera zooms out further to reveal an HCP showing the screen to a patient. The setting changes and the patient is now at the alternative site of administration shaking a doctor’s hand. A paper swooshes across the screen. The paper comes to the center of the frame with the words Benefits Verification across it. The page peels back, revealing a doctor with a box, a thermometer, and a vial next to them. The doctor turns and moves to the left as a bill is being inserted into an envelope on the right. The screen is split between the doctor with the bill and an HCP with a clipboard.
VO: An additional option is utilizing an alternative site of administration, or ASA. This is a facility, oftentimes an infusion center, that can conduct a patient’s benefit verifications, acquire and administer the specialty injectable drug, and handle the billing and reimbursement instead of your practice.
VISUAL: The split screen transitions to focus on the HCP in their office. The camera pans around the HCP revealing their laptop screen. The HCP sits in front of her laptop. Another HCP appears. The laptop screen displays the ViiV Healthcare logo. The three people and laptop slide to the left and a doctor's office slides in from the right with patients sitting in a waiting room. The patients sitting in the waiting room continue to slide to the left.
VO: In summary, learning to navigate the medical benefit is vital to bringing specialty injectable drugs to your patients. Your ViiV Team is available to support you throughout the entire acquisition process, and ViiVConnect is available to help further support you and your staff through working with payers if you choose to utilize the service.
SUPER: ViiVinjectables.com
SUPER: The Access and Acquisition Series
SUPER:
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220015 September 2022 Produced in USA.
VISUAL: The camera zooms in on a person in front of a computer. The woman in front of a computer comes into the frame. The camera pans around the woman at her desk. The camera continues to pan around the woman at her desk. The woman is shown at their desk with a patient. Additional individuals populate around the seated patient. The camera shows a group of patients. A leaf blows past the patient and the background shifts to an outdoor space revealing a patient walking with his partner and dog. The camera pans to reveal the ending frame with the words The Access and Acquisition Series.
VO: For more on accessing and acquiring specialty injectable drugs, review the other videos in this series. And, if you have questions about acquiring specialty injectable drugs covered under the medical benefit, or how ViiVConnect can support you and your patients in this process, please reach out to your ViiV Team or visit ViiVinjectables.com to learn more.
Patient Perspectives
As a healthcare provider, experiencing personal stories from your patients can make a difference in your HIV treatment approach. It’s important to understand the patient experience, and these resources can help. Hear from real patients about their experiences in this video library.
Steve VO: I was always concerned that somebody would find my pills.
SUPER: Steve has been compensated by ViiV Healthcare and is receiving CABENUVA.
CABENUVA logo
SUPER: You can uncover the struggles of taking a daily oral HIV treatment
SUPER: Change is possible too... but it starts with a conversation
VO: CABENUVA is indicated as a complete regimen for the treatment of HIV-1 to replace the current stable antiretroviral regimen in virologically suppressed adults and adolescents 12 years of age and older and weighing at least 35 kg with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
SUPER:INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
VO: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
CABENUVA is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine, and in patients receiving the medications shown here.
Please watch the full video for additional Important Safety Information.
Please see full Prescribing Information for CABENUVA.
SUPER: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
CABENUVA logo
Please watch the full video for additional Important Safety Information.
Please click the link to view the full Prescribing Information for CABENUVA.
SUPER: Steve’s struggle with taking a daily oral HIV treatment and what led to change
Steve VO: I've been living with HIV a little over eight years.
SUPER: Steve Patient Ambassador
SUPER: What do you wish the public knew about living with HIV?
Steve VO: What I wish the public knew about living with HIV is the “living” part, so it is living with HIV. There’s still this fear, this stigma, around people living with HIV, and that would be the biggest thing I’d want the public to know is that just, you know, I’m fine. I’m going to be living a long, normal life.
SUPER: A typical day of daily oral HIV medication
Steve VO: A typical day for me on oral HIV regimen was that, I like to take it first thing in the morning. Learning to make sure that I was doing it at the same time every day in order to maintain the efficacy of the treatment. There was a few times where I would wonder, wait, did I remember to take it or not? There was this whole other kind of effect related to the pill. And it was this concept of, the way I like to describe it is almost like...shame and stigma distilled into a pill that you had to take each day. So each day, the start of my day, was kind of a reminder of the fact that I did have HIV, that I was living with HIV.
SUPER: How did missing doses make you feel?
Steve VO: If I missed a dose of my daily HIV regimen, it made me feel, to be honest, like a little bit of a failure? Come on, like, get your act together.
Beyond that, it was more just fear of if I missed a number of doses, what’s that going to mean for my, my long-term health?
SUPER: How did the thought of missing doses affect your life?
Steve VO: For me it was more about traveling…was I going to forget the pills? If I had enough to last me through the duration of the trip. There was always this fear of what happens if I lose the pills when I’m abroad how am I going to get them refilled. If I didn’t take this pill every day, I could become detectable again. And if I failed to adhere to my regimen, I could develop a resistance and ultimately that could have serious negative health consequences.
SUPER: Did you worry about others finding your pill bottles or seeing you take the medication?
Steve VO: Before I was open about my status that I was living with HIV, it was a constant fear and concern of mine that someone would find my pill bottle and put the one and one together and figure out that I was HIV positive.
So some of the things I used to do included putting the pills into an empty bottle of an over-the-counter medication in order to try to mask the fact that these are HIV pills. I remember one time in particular, I had left them out on the counter and my brother had a key to my house. He decided he was gonna stop by the house, to drop something off for me…and I kind of had this panic ‘cuz I knew that I had left the pills out on my kitchen counter. He didn’t discover it, but I was just kind of in complete terror that he was before I had the chance, on my own, to kind of, let him and the rest of my family and friends, you know, know that I was living with HIV.
SUPER: What do you wish doctors knew about having to take a daily oral?
Steve VO: It’s not just about the physiological aspects of the treatment, making sure that the pills are working, that the patient’s staying undetectable. And sometimes don’t take the time to think about or ask the questions about how are you doing and to understand what kind of toll a daily pill has on their patient. And so I think that it’s such a key part of treating the whole patient.
Steve VO: The switch to CABENUVA... It starts with you
VO: Continue watching for additional Important Safety Information.
SUPER: The switch to CABENUVA
IT STARTS WITH YOU
Continue watching for additional Important Safety Information.
VO: IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms, have been reported during postmarketing experience with rilpivirine-containing regimens. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Serious hypersensitivity reactions have been associated with other INSTIs and could occur with CABENUVA.
Oral lead-in may be administered prior to administration of CABENUVA to help
identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to a loss of virologic response and development of resistance.
It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here.
The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine.
It is not recommended to coadminister CABENUVA with other antiretrovirals.
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
USE IN SPECIFIC POPULATIONS
There are insufficient data on the use of CABENUVA during pregnancy. Assess the benefit-risk of using during pregnancy and conception.
Breastfeeding is not recommended.
SUPER:
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Serious or severe hypersensitivity reactions have been reported in association
with other integrase inhibitors and could occur with CABENUVA
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine
with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because
non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
VO: Please see full Prescribing Information for CABENUVA.
SUPER: CABENUVA logo
Please see full Prescribing Information for CABENUVA.
Trademarks are property of their respective owners.
©2023 ViiV Healthcare or licensor.
CBRVID230003 August 2023
Produced in USA.
What patients wish their doctors knew
Will VO: I'm not just my HIV. Ask me a question about my life. Ask me something else other than my test results, my HIV, my physical condition. Because when that's all that I'm focused on, I feel like it's all that I am. And I'm, I'm so much more than just my diagnosis.
SUPER: All participants have been compensated by ViiV Healthcare and are receiving CABENUVA.
CABENUVA logo
SUPER: Shifting patients’ focus to the day ahead, not their daily HIV treatment
VO: CABENUVA is indicated as a complete regimen for the treatment of HIV-1 to replace the current stable antiretroviral regimen in virologically suppressed adults and adolescents 12 years of age and older and weighing at least 35 kg with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
SUPER: Will Patient Ambassador
SUPER: INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
CABENUVA logo
SUPER: Steve Patient Ambassador
VO: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
CABENUVA is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine, and in patients receiving the medications shown here.
Please watch the full video for additional Important Safety Information.
Please see full Prescribing Information for CABENUVA.
SUPER: Suzi Patient Ambassador
SUPER: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
CABENUVA logo
Please watch the full video for additional Important Safety Information.
Please see full Prescribing Information for CABENUVA.
SUPER: Shifting patients’ focus to the day ahead
SUPER: It starts with a conversation
SUPER: and it starts with finding out if people living with HIV struggle with taking daily oral therapy
SUPER: people like Steve
SUPER: and Will
SUPER: and Suzi
Will VO: I've been living positively with HIV for 30 years.
Steve VO: I've been living with HIV a little over 8 years.
Suzi VO: I've been living with HIV… it'll be 17 years, and I'm living my life to the fullest.
SUPER: What should doctors know about taking daily oral HIV Therapy?
Steve VO: I think for doctors that are treating people living with HIV, one of the difficult things for them to understand is truly the kind of emotional toll that that daily pill has on their patients.
It's not just about the physiological aspects of the treatment, making sure that the pills are working, that the patient's staying undetectable.
Suzi VO: I wish that doctors knew what a struggle it was for people and myself taking that HIV medication; it's a constant reminder of what we did and how we got it. And like I said, it's, it's truly hard sometimes because you can be having a normal day or, you know, and then you have to take that medication and boom, it all comes back to you. You know, and it's extremely hard.
Will VO: What I wish my doctor knew about the daily oral regimen was twofold… I want them to know that I'm grateful that the medication works. I mean, I'm really grateful, but, every day it feels the same, and that just sucks. And, that's odd to be so happy about something and then so miserable about it at the same time. But that's what it feels like. And that's exhausting.
SUPER: What conversation starters would you suggest for healthcare providers?
Will VO: I would suggest to a doctor who had a patient struggling with their HIV medications to ask about other components of their life…sometimes the struggle and the challenge of the pills may not be immediately the first thing that a patient wants to say.
Steve VO: A lot of the… times, I think… doctors are rushed, understandably, have very busy schedules and, and sometimes don't take the time… to think about or ask the questions about how are you doing; and so I think that it's such a key part of, kind of, treating the whole patient.
Suzi VO: If it was me and I went in there and I said, “Hey man, you know, I'm really struggling taking these HIV meds. I really don't wanna take them anymore. It's really a constant reminder. And it’s really giving me…I’m really struggling.”
Hopefully, the doctor would say, “Hey, we have CABENUVA. Why don't you look into this and see if you might be interested.”
SUPER: What would you say to a patient considering a switch to CABENUVA?
Will VO: There's none of the daily reminder. I love thinking about it for one quick morning in a positive way.
Suzi VO: I found that going from my HIV meds to the injectables was awesome. I don't have to look at… that—the HIV pill—every day.
Suzi VO: The switch to CABENUVA... It starts with you
VO: Continue watching for additional Important Safety Information.
SUPER: The switch to CABENUVA
IT STARTS WITH YOU
Continue watching for additional Important Safety Information.
VO: IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms, have been reported during postmarketing experience with rilpivirine-containing regimens. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Serious hypersensitivity reactions have been associated with other INSTIs and could occur with CABENUVA.
Oral lead-in may be administered prior to administration of CABENUVA to help
identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to a loss of virologic response and development of resistance.
It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here.
The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine.
It is not recommended to coadminister CABENUVA with other antiretrovirals.
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
USE IN SPECIFIC POPULATIONS
There are insufficient data on the use of CABENUVA during pregnancy. Assess the benefit-risk of using during pregnancy and conception.
Breastfeeding is not recommended.
SUPER:
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Serious or severe hypersensitivity reactions have been reported in association
with other integrase inhibitors and could occur with CABENUVA
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine
with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because
non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
VO: Please see full Prescribing Information for CABENUVA.
SUPER: CABENUVA logo
Please see full Prescribing Information for CABENUVA.
Trademarks are property of their respective owners.
©2023 ViiV Healthcare or licensor.
CBRVID230004 August 2023
Produced in USA.
Navigating switch conversations
NARRATOR VO:
Let's take a look beneath the surface of your patients’ interactions.
[Logo on screen]
ISI VO:
CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen. It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for Indication and full Important Safety Information.
GRAPHIC:
Video will start in [animated countdown]
SUPER:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for Indication and full Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
NARRATOR VO:
This is a dramatization of a fictional patient and HCP interaction, portrayed by actors and inspired by experiences of people living with HIV.
SUPER:
BENEATH THE SURFACE: NAVIGATING SWITCH CONVERSATIONS WITH YOUR PATIENTS
SUPER:
ACTOR PORTRAYAL
SUPER
[text message]:
How’d your appointment go?
[Sound Alert]:
Chime
SUPER
[text message]:
Ehh. It went [sad face emoji] …
SUPER
[text message]:
Sooo you didn’t talk about switching?
SUPER
[text message]:
Nah, didn’t bring it up. Today felt a bit rushed. …
SUPER
[text message]:
Guess you weren’t on the same page
SUPER
[text message]:
Kinda hoped it would’ve gone differently...
SUPER:
differently...
[Video rewinds and Javier is back in the doctor’s office. Doctor enters]
DOCTOR:
“Hey Javier. It’s good to see you. How have you been since we saw each other last?”
JAVIER:
“Everything’s alright for the most part.”
NARRATOR VO:
Remember that patients may have concerns or challenges beyond clinical considerations.
Recognizing where to probe deeper can reveal details your patients may have been reluctant to share.
SUPERS:
FEAR of disclosure
CHALLENGES with daily adherence
DAILY reminders of HIV
NARRATOR VO:
These concerns may be uncomfortable for your patients to discuss. Considering challenges of taking daily oral therapy, as well as clinical factors, can help create a more complete understanding of their experience.
GRAPHIC:
“COMFORT” bar graph
DOCTOR:
“Your labs look good. How’s the treatment working for you? Are you experiencing any side effects? Having any issues?”
JAVIER:
“I’m happy to hear my pills are still working. I’m just… kind of… never mind.”
GRAPHIC:
“HESITANCY” meter
DOCTOR:
“Javi, what’s on your mind?”
JAVIER:
“Um, I dunno. I feel like I’m struggling sometimes with the pills. It can all just feel like a lot.”
NARRATOR VO:
This is an opportunity to probe further into the challenges your patients may be facing.
DOCTOR:
“Can you tell me more about the struggles you feel?”
JAVIER:
“I guess whenever I take my meds, I think about my HIV; and I just don’t want to be thinking about it all the time.”
DOCTOR:
“I can see how that would be difficult.”
NARRATOR VO:
Here are some questions that may help uncover unsaid challenges such as: Do you hide your medication from those around you? Is it difficult to remember to take your oral treatment every day? Is your medication an uncomfortable reminder of your HIV status?
SUPERS:
QUESTIONS THAT MAY HELP uncover unsaid challenges:
- Do you hide your medication from those around you?
- Is it difficult to remember to take your oral treatment every day?
- Is your medication an uncomfortable reminder of your HIV status?
JAVIER:
“I meant to ask you. I was talking to a friend who mentioned some kind of shots. Is that an option for me?”
DOCTOR:
“There is an alternative to daily pills that’s available. It’s a long-acting injectable. After initiation injections, CABENUVA can be given every 2 months.”
GRAPHIC:
“DOSING” calendar
JAVIER:
“Oh! Not having to take something every day? Can you tell me more about that?”
DOCTOR:
“Well, it’s really just a different way to receive treatment; and I think it could be a good option for you given some of the concerns you’ve expressed. I have some other patients like you who have made the switch. Let’s talk about if you’re a good candidate.
So, one of the main requirements for using this medicine is that you need to be virologically suppressed, which you have been for some time so that’s good.
If you do decide to make the switch to injections, it’s very important that you stick to your appointments. There are additional considerations that we can discuss if you decide you’re interested in a change.”
GRAPHIC:
[Calendar with target treatment date checked]
NARRATOR VO:
Clinical considerations:
Virologically suppressed adults and adolescents with HIV-1
On a stable antiretroviral regimen
No history of treatment failure
No known or suspected resistance to either cabotegravir or rilpivirine
No contraindications
Consider potential drug-drug interactions
SUPERS:
CLINICAL CONSIDERATIONS: Virologically suppressed adults and adolescents with HIV-1
- On a stable antiretroviral regimen
- No history of treatment failure
- No known or suspected resistance to either cabotegravir or rilpivirine
No contraindications.
Consider potential drug-drug interactions.
JAVIER:
“How are the appointments different than what I do now?”
DOCTOR:
“You would come into the office and see either me or someone from the team. For most appointments, you’d be given 2 injections in the buttocks and we would monitor you for any reactions. Then you’re done ¢til your next appointment.
Why don’t I give you some information to review. Read through it and we can talk about it next time.”
JAVIER:
“Thanks. I’ll I’ll take a look.”
DOCTOR:
“The front desk will schedule your next appointment, and it’s great seeing you.”
NARRATOR VO:
We’ve now seen how a simple conversation can make a difference. And it all starts with you.
SUPER
[text message]:
How’d your appointment go?
SUPER:
A switch to CABENUVA could be right for your patients. Talk to them today.
[ISI appears and moves upward from bottom of screen]
VO:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 to replace the current stable antiretroviral regimen in virologically suppressed adults and adolescents 12 years of age and older and weighing at least 35 kg with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
SUPER:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known suspected resistance to either cabotegravir or rilpivirine.
VO:
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
CABENUVA is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine, and in patients receiving the medications shown here.
SUPER:
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms, have been reported during postmarketing experience with rilpivirine-containing regimens. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Serious hypersensitivity reactions have been associated with other INSTIs and
could occur with CABENUVA.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
SUPER:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
VO: Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in <1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
SUPER:
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
VO:
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or
rilpivirine with or without pre-existing hepatic disease or identifiable risk factors.
Patients with underlying liver disease prior to treatment may be at increased risk
with CABENUVA. Hepatic monitoring is recommended and discontinue if
hepatotoxicity is suspected.
SUPER:
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
VO:
Depressive Disorders
Depressive disorders have been reported with CABENUVA or the individual
components; promptly evaluate patients with depressive symptoms.
SUPER:
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
SUPER:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
VO:
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance.
It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
SUPER:
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here.
The safety of CABENUVA in adolescents is expected to be similar to adults.
SUPER:
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥ 2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
VO:
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine.
It is not recommended to coadminister CABENUVA with other antiretrovirals.
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
SUPER:
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
VO:
USE IN SPECIFIC POPULATIONS
There are insufficient data on the use of CABENUVA during pregnancy. Assess the benefit-risk of using during pregnancy and conception.
Breastfeeding is not recommended.
Please click the link to view the Prescribing Information for CABENUVA.
SUPER:
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: The CDC recommends that HIV‑1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
Please click the link to view the Prescribing Information for CABENUVA.
Trademarks are property of their respective owners.
©2023 ViiV Healthcare or licensor.
CBRVID220014 August 2023
Produced in USA.
Will’s switch to long-acting therapy
Will VO: So, for me, taking the oral once-a-day pills was a struggle, initially.
SUPER: Will Patient Ambassador
CABENUVA logo
Will has been compensated by ViiV Healthcare and is receiving CABENUVA.
Will VO: Since starting CABENUVA, I immediately let go of the daily grind, that reminder of just that I had to do this.
VO: CABENUVA is indicated as a complete regimen for the treatment of HIV-1 to replace the current stable antiretroviral regimen in virologically suppressed adults and adolescents 12 years of age and older and weighing at least 35 kg with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
SUPER: INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
CABENUVA logo
VO: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
CABENUVA is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine, and in patients receiving the medications shown here.
Please watch the full video for additional Important Safety Information.
Please click the link to view the full Prescribing Information for CABENUVA.
SUPER: IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
CABENUVA logo
Please watch the full video for additional Important Safety Information.
Please click the link to view the full Prescribing Information for CABENUVA.
SUPER: Shifting patients’ focus to the day ahead, not their daily HIV treatment
SUPER: That’s how CABENUVA can make a difference for patients like WILL.
SUPER: WILL, who started CABENUVA in 2018, now receives every-2-month injections.
CABENUVA is administered as 2 intramuscular injections by a healthcare professional every month or every 2 months. Adherence to the dosing schedule is strongly recommended.
SUPER: What was the turning point that made you decide to start CABENUVA?
Will VO: The turning point in switching to an injection therapy was dinner one night with a friend of mine who happens to be an HIV doctor. She mentioned that there was an injection therapy that was coming out.
I immediately wanted to know more about it, asked her about it, and then probably followed up the next morning with my doctor, to find out if it was an option for me.
I was ready from the first moment I knew it was an option. I didn’t even know the name.
SUPER: How has your treatment experience changed on an every-2-month injectable?
WIll VO: I actually enjoy my morning or my afternoon getting my care. There’s none of the daily reminder. Every 8 weeks I go in. It’s something that I enjoy as opposed to something that I used to dread.
SUPER: What are the benefits of an every-2-month injectable treatment?
Will VO: Recently, I was traveling on a trip and knew I wasn’t gonna get back for a couple days and it was no problem. I could just call the doctor and say, “Hey, I’m gonna be 3 days late.” Knowing that I had that window...just took all of that pressure out. I didn’t have to think of, “Do I have my pills with me? What do I have to do?”—there was none of the tension.
SUPER: Ensure patients agree to the every-2-month dosing schedule, and counsel patients about the importance of adherence to scheduled dosing visits. CABENUVA has dosing flexibility, allowing for injections to be given up to 7 days before or after the Target Treatment Date.
SUPER: What do you wish doctors knew about life on daily oral therapy for HIV?
Will VO: I want ‘em to know that I’m grateful...that the medication works…but, every day it feels the same and that’s odd to be so happy about something and then so miserable about it at the same time. And that’s exhausting.
If I could ask him or tell him something that I want him to know, it’s...that I’m not just my HIV. Ask me a question about my life. Ask me something else other than my test results, because when that’s all that I’m focused on, I feel like it’s all that I am. And I’m so much more than just my diagnosis.
SUPER: How would you describe life on CABENUVA?
Will VO: I am happy. I’m really happy that it’s working. I’m happy that it’s a style that fits my life choices and my timing and schedule. So CABENUVA just works for me.
Will VO: The switch to CABENUVA. It starts with you.
SUPER: The switch to CABENUVA
IT STARTS WITH YOU
VO: Continue watching for additional Important Safety Information.
SUPER: Continue watching for additional Important Safety Information.
VO: IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms, have been reported during postmarketing experience with rilpivirine-containing regimens. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Serious hypersensitivity reactions have been associated with other INSTIs and could occur with CABENUVA.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to a loss of virologic response and development of resistance.
It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here.
The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine.
It is not recommended to coadminister CABENUVA with other antiretrovirals.
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
USE IN SPECIFIC POPULATIONS
There are insufficient data on the use of CABENUVA during pregnancy. Assess the benefit-risk of using during pregnancy and conception.
Breastfeeding is not recommended.
SUPER: IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Serious or severe hypersensitivity reactions have been reported in association
with other integrase inhibitors and could occur with CABENUVA
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine
with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because
non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
VO: Please see full Prescribing Information for CABENUVA.
SUPER: CABENUVA logo
Please see full Prescribing Information for CABENUVA.
Trademarks are property of their respective owners.
©2023 ViiV Healthcare or licensor.
CBRVID230002 June 2023
Produced in USA.
Patient Perspectives | Little moments add up to big change
VISUAL:
CABENUVA logo appears and fades as Indication and Contraindications appear.
AUDIO:
Faint background music begins to play.
VO:
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 to replace the current stable antiretroviral regimen in virologically suppressed adults and adolescents 12 years of age and older and weighing at least 35 kg with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
CABENUVA is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine, and in patients receiving the medications shown here.
Please watch the full video for additional Important Safety Information.
SUPER:
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
·Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
·Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the full video for additional Important Safety Information.
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
SUPER:
For some people living with HIV, taking a pill every day can feel anything but small
CHRISTOPHER VO:
It’s crazy because most people would say, “It’s just one second, it’s just one pill.”
SUPER:
Individuals featured in this video have been compensated by ViiV Healthcare. The following stories reflect patient experiences on either every-2-month or once-monthly CABENUVA. Individual patient experiences may not be indicative of all patient experiences.
MARVIN VO:
But it held all my secrets and was the object of so much self-stigma.
SUZI VO:
It was more like a time machine transporting me back to the moment I was diagnosed 16 years ago.
WILL VO:
For years I was consumed by the gravity of daily adherence.
WILL VO:
I was living with a burden I just couldn't avoid.
MARVIN VO:
Through the years, my life has had so many intersections. But each path I chose has been dedicated to empowering others and inspiring them to live their truth, whether it's being a preacher or my platform as a life coach now.
SUZI VO:
Now, I’m proud of who I have become. It took time, but I learned how to love and respect myself again. My faith, family, and music. They saved me. They changed me.
WILL VO:
Me, my journey has had its ups and downs, but my diagnosis changed the direction of my future in the most positive way. I’ve transformed my life, rededicating my time to advocacy, pursuing my passions, and living in the present.
CHRISTOPHER VO:
Presently, I’m living an active life: leading people in their yoga practices, setting up theater performances, and planning spur-of-the-moment getaways. I find myself pausing to appreciate it all.
WILL VO:
There's been a complete transformation in how I approach my treatment.
WILL VO:
With CABENUVA, I’ve traded the countless hours spent obsessing about my daily pills for time focusing on doing things I enjoy.
SUZI VO:
Every day is a blessing: making memories with my grandkids, reminiscing with my family, catching up with friends. I know I’m still living with HIV, but with CABENUVA, I no longer think about pills every day.
CHRISTOPHER VO:
Now, I can be spontaneous. I have more time to explore without being bogged down by the logistics of traveling with pills. I go on road trips in between injections. I love the freedom from the daily routine.
MARVIN VO:
I was put on this earth with a purpose. I strive to show up every day, uninterrupted, without feeling stigmatized or limited by the daily routine. I’m just trying to do my part because everything we do makes a difference.
SUPER:
Little moments add up to BIG change
SUPER:
Please continue watching for additional Important Safety Information about CABENUVA
CABENUVA logo
VISUAL:
Video ends and ISI appears and begins to scroll.
VO:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms have been reported during postmarketing experience with rilpivirine-containing regimens. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Serious hypersensitivity reactions have been associated with other INSTIs and could occur with CABENUVA.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions: In clinical trials, serious post-injection reactions, such as those shown here, were reported in <1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
It is important to carefully follow the instructions for use and observe patients approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity: Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders: Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive disorders.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA: Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance.
It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here.
The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA for long-acting therapy, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals.
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
USE IN SPECIFIC POPULATIONS
There are insufficient data on the use of CABENUVA during pregnancy. Assess the benefit-risk of using during pregnancy and conception.
Breastfeeding is not recommended.
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
SUPER:
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
·Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
·Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
·Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
·Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
·Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
VISUAL:
Thirty seconds into the ISI, a blue bar with text fades in at the bottom of the screen.
SUPER:
See how CABENUVA can help transform your patients' treatment experience at CABENUVAhcp.com
Hepatotoxicity:
·Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
·Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
·Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
·Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products
·Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
·The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
·Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
·CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
·Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
·To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
·The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
·The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
·Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
·Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
·Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
·CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
·Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
·Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA
Please click on the link on the web page to view the full Prescribing Information for CABENUVA.
VISUAL
Cut to ViiV logo and end matter fades in.
TEXT ON SCREEN
Trademarks are property of their respective owners.
©2022 ViiV Healthcare or licensor. CBRVID220012 October 2022
Produced in USA.
