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:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
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
Assess the potential risks of using CABENUVA during conception, pregnancy, and
while breastfeeding.
SUPER: IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- 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
- 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, suicidal 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: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
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.
©2024 ViiV Healthcare or licensor.
CBRVID230026 January 2024
Produced in USA.
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 for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication onscreen. 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.
SUPER:
GRAPHIC: video will start in [animated countdown]
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.
[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:
Serious hypersensitivity reactions have been associated with other INSTIs and
could occur with CABENUVA.
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.
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:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- 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
- 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, suicide 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.
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: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
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.
©2024 ViiV Healthcare or licensor. PMUS-CBRVID230015 April 2024
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:
Serious hypersensitivity reactions have been associated with other INSTIs and
could occur with CABENUVA.
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.
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:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- 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
- 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, suicide 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.
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: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor.
PMUS-CBRVID220025 May 2024
Produced in USA.
Uncovering Patient Challenges Taking Daily Oral Therapy
Christopher Bettacchi, MD
Dr. Bettacchi describes his patients’ most common challenges taking daily oral therapy and shares techniques for starting conversations about compliance with patients.
Transcript: Uncovering Patient Challenges With Taking Daily HIV Treatment
PM-US-CBR-VID-230023
VISUAL: CABENUVA and ViiV logos, series title and video title are on screen over Dr Bettacchi and then move off screen.
AUDIO: Faint background music plays throughout video
SUPER:
Expert Perspectives: Conversations on CABENUVA
Uncovering Patient Challenges With Taking Daily HIV Treatment
CABENUVA Logo
ViiV Healthcare Logo
Dr Bettacchi: Hello, my name is Dr Christopher Bettacchi. I am an infectious disease specialist in Dallas, Texas. Please join me for a discussion on Unmet Needs of Patients on Daily HIV Treatment.
Before we begin, let us review Important Safety Information for CABENUVA.
VISUAL: Speaker on frame; graphics animate on screen
SUPER:
Speaker has been compensated by ViiV Healthcare
Christopher Bettacchi, MD
CABENUVA Logo
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 additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
VISUAL: ISI animates on screen
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 additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr Bettacchi: For over a decade, I have been part of a team of infectious disease specialists that treat a large and diverse population of people living with HIV. In our practice, which includes about 1000 people living with HIV, I participate in an LGBTQ+ health and wellness clinic, which is a primary care–focused resource center for our patients within that community.
Dr Bettacchi: The last few years of the COVID-19 pandemic have truly brought to light the power of conversations with my patients. Like many other clinics across the country, we transitioned briefly to primarily telehealth visits in 2020, and it actually was a great experience for our practice in terms of being able to spend more time speaking with patients.
It didn't take very long in these conversations to learn that a patient, who otherwise would have come in and quickly said, “I'm doing fine,” actually may be dealing with challenges taking their oral antiretroviral therapy. Although we have transitioned to a hybrid mix of in-person and telehealth clinic visits, that experience in 2020 uncovered my passion for these types of discussions with my patients. This approach helps to reveal their unmet needs with taking daily oral HIV therapy.
Dr Bettacchi: My approach to initiating conversations is through patient education, and that starts with us as providers. I start by discussing what is going on in the HIV treatment landscape. I think it is incumbent upon anyone who cares for patients with HIV to share this knowledge with patients. I stay abreast of the changing treatment landscape. This allows me to share an alternative therapy with a different method of HIV drug delivery, such as CABENUVA. Usually, this information sparks an interest in my patients, and they say, “tell me more.” From there, I probe to see if they have challenges with taking their current regimen.
VISUAL: Speaker on frame; split screen graphic animates on left-hand side; content animates on screen as Dr. Bettacchi speaks
SUPER:
Uncovering patients’ unmet needs in HIV treatment
- Patient education
- HIV treatment landscape
- Latest treatment options
- Taking daily oral HIV therapy
CABENUVA Logo
Dr Bettacchi: On the other hand, some patients start the conversation by asking about CABENUVA. In those instances, I share the clinical data that support CABENUVA’s efficacy, safety, and tolerability.
Dr Bettacchi: When I discuss with my patients the challenges that they experience with taking daily oral therapy, there are several topics that are often mentioned. First is that they worry about others unintentionally discovering their HIV status, and that comes in different varieties. Whereas it was once about being seen in a pharmacy picking up HIV medication, today unintentional discovery of their HIV status means so much more when viewed through the lens of social media, and my patients have expressed this concern. My patients also worry over having to take a pill every day and possibly forgetting to take their HIV medication. Another common challenge is that taking oral HIV medication every day is an uncomfortable reminder of their HIV status and the circumstances around their initial diagnosis. As diverse as our patient population is, I find that challenges around use of daily oral therapy cut across all patient demographics.
VISUAL: Speaker on frame; split screen graphic animates on left-hand side; content animates on screen as Dr. Bettacchi speaks
SUPER:
What are the challenges patient face with taking daily oral therapy?
- Unintentionally having their HIV status discovered
- Forgetting to take their HIV medication
- Uncomfortable reminder of their HIV status
CABENUVA Logo
Dr Bettacchi: We need to consider the different challenges people living with HIV face, which may be constant concerns in their lives, even if they are virologically suppressed.
Most recently, the phase 3b trial of CABENUVA, the SOLAR study, compared the efficacy and safety of switching to every-2-month CABENUVA versus remaining on BIKTARVY through 12 months in patients who were virologically suppressed on BIKTARVY for at least 6 months prior to the study. In addition, the SOLAR study had a baseline survey to address whether patients entering the trial experienced challenges with taking their daily oral therapy as an exploratory endpoint.
For a detailed discussion of SOLAR, please watch the video titled, “SOLAR: a head-to-head switch study of CABENUVA vs BIKTARVY,” which is hosted by Dr Moti Ramgopal, an investigator of SOLAR.
Dr Bettacchi: I think it is important to grasp how much these challenges can impact patients’ lives, whether it’s someone who is traveling and worries about inadvertently disclosing their HIV status because of their medication or that they might forget to take their daily oral therapy.
One must also be aware that patients may hesitate to voice these concerns because they don’t want to burden their healthcare providers. I have been treating several of my patients for many years, and some have a hard time admitting to challenges that they have with adherence because they don’t want to “let us down.” These patients often feel guilty about speaking of their challenges with daily oral therapy because they know it used to be a lot harder than it is now.
Dr Bettacchi: I think the best way to help patients express the challenges they live with in their HIV treatment is to initiate a comfortable conversation with the patients, which starts with us as their providers. If that can be accomplished, we can begin to bring down the barriers around awareness of unmet patient needs. I find it helps to ask specific questions to see if they relate to certain challenges, which can then be identified and discussed further. For example, I might ask my patients if they hide their medication from those around them, if it is difficult to remember to take their oral treatment every day, or if they feel that their HIV medication is an uncomfortable reminder of their status.
VISUAL: Speaker on frame; split screen graphic animates on left-hand side; icons and content animate on screen as Dr. Bettacchi speaks
SUPER:
Start a conversation with a patient who may be struggling with taking daily oral therapy
- Do you hide your medication from those around you?
- Is it difficult to remember to take your oral treatment every day?
- Do you feel that your HIV medication is an uncomfortable reminder of your HIV status?
CABENUVA Logo
Dr Bettacchi: To summarize our conversation today, some patients living with HIV may experience challenges regarding the use of daily oral antiretroviral therapy. As their providers, it’s important to meet our patients where they are and help them both recognize and overcome these challenges together.
On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about patient unmet needs and some strategies to uncover them.
Continue watching for additional Important Safety Information.
VISUAL: Speaker on frame; graphic animates on screen
SUPER:
Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
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.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- 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
- 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
CABENUVA Logo
VO: 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.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- 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, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
CABENUVA Logo
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.
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.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
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
CABENUVA Logo
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.
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.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
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
CABENUVA Logo
VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding
Please click the link to view the Prescribing Information for CABENUVA.
VISUAL: ISI animates on screen
SUPER:
IMPORTANT SAFETY INFORMATION (continued)
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: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
CABENUVA Logo
Dr. Bettacchi: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA”.
VISUAL: Full-screen graphics animate on screen then fade to black
SUPER:
Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
CABENUVA Logo
ViiV Healthcare Logo
Trademarks are property of their respective owners.
©2024 ViiV Healthcare or licensor. CBRVID230023 January 2024 Produced in USA.
For US Healthcare Professionals only.
