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 is administered as 2 intramuscular injections by a healthcare professional every month or every 2 months. Adherence to the dosing schedule is strongly recommended.

Transform the Treatment Experience With Every-2-Month CABENUVA

First and only long-acting complete injectable treatment regimen for HIV-1 administered as few as 6 times a year*

See Dosing Schedule

Durable virologic suppression through 96 weeks1-3†
Primary endpoint: proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 via FDA Snapshot Algorithm. Proportion of patients with HIV‑1 RNA ≥50 copies/mL at Week 48 was 2% for every-2-month CABENUVA vs 1% for once-monthly CABENUVA (non-inferior treatment difference: 0.8% [95% CI: -0.6, 2.2]) and was 2% for every-2-month CABENUVA vs 1% for once-monthly CABENUVA (non-inferior treatment difference: 1.0% (95% CI: -0.6, 2.5) at Week 96.

View Efficacy Data

Every-2-month CABENUVA was preferred by 9 of 10 trial patients3‡

In a secondary endpoint, at Week 48 in ATLAS-2M, 92% (300/327) of patients preferred every-2-month CABENUVA vs 1% (4/327) who preferred oral cabotegravir and rilpivirine that was taken as the oral lead-in, as required.
These results are descriptive in nature and should not be used to infer clinical significance.

Get More on Patient Preferences

^*Initiation injections (cabotegravir 600 mg/3 mL and rilpivirine 900 mg/3 mL) are required for both the once-monthly and every-2-month regimens. For the every-2-month regimen, additional initiation injections should be administered 1 month after the first initiation injections.

^†Based on a phase 3, open-label, non-inferiority trial (ATLAS-2M) in virologically suppressed (HIV-1 RNA <50 copies/mL) adults ≥18 years with HIV-1.^1,2 In ATLAS 2-M, patients with prior once-monthly CABENUVA experience (n=391) and patients with no prior once-monthly CABENUVA experience (n=654) were randomized 1:1 to receive either once-monthly CABENUVA (n=523) or every-2-month CABENUVA (n=522).¹ Patients transitioning from the ATLAS trial must have been on once-monthly CABENUVA or their current oral regimen for at least 52 weeks and had plasma HIV-1 RNA <50 copies/mL.¹ Patients with no prior experience with once-monthly CABENUVA were suppressed for ≥6 months (HIV-1 RNA <50 copies/mL), with suppression defined as HIV-1 RNA <50 copies/mL. Patients with prior once-monthly CABENUVA experience received either 400-mg cabotegravir and 600-mg rilpivirine once-monthly or 600-mg cabotegravir and 900-mg rilpivirine every 2 months. Patients with no prior experience with once-monthly CABENUVA received an oral lead-in regimen and then initiation injections followed by once-monthly or every-2-month injections.¹ Patients were excluded if they were pregnant or breastfeeding, had moderate to severe hepatic impairment, or evidence of HBV infection at screening.¹ At baseline for ATLAS-2M, the median age was 42 both for patients randomized to every-2-month and once-monthly CABENUVA.¹ In both arms, 7% of patients had a CD4+ T-cell count <350 cells/mm³.² Non-inferiority of CABENUVA would be shown if the upper bound of the 95% CI for the treatment difference was <4%.²

^‡Patient preference data collected from ATLAS-2M clinical trial participants with no prior experience with long-acting cabotegravir plus rilpivirine randomized to every-2-month CABENUVA who completed a questionnaire assessing their preference for CABENUVA vs cabotegravir and rilpivirine that was taken as the oral lead-in, as required.²

CI=confidence interval; FDA=Food and Drug Administration; HBV=hepatitis B virus.

"With CABENUVA injections, I feel a sense of independence from not having to take a pill at the same time every day and fearing that I missed it.

Instead of stressing about daily treatment, I can focus on treatment once a month. Even though it's just a few seconds a day to take a pill, I now don't have to remember to take my HIV treatment until my next appointment."

— Mark, clinical trial participant and patient ambassador

Patient experiences with CABENUVA after receiving 1 month of oral lead-in of cabotegravir and rilpivirine. Individual patient experiences are not indicative of all patient experiences or clinical trial results.

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"With CABENUVA, I now have 2 months between appointments.

This allows me to say yes to things where I don't really have to worry about taking a pill every day. I look forward to making it to my appointment every 2 months because I get to check in with my medical team and feel like I'm taking care of my health. So, that's important to me."

— Jayson, living with HIV.

Receiving CABENUVA.

For Your Practice

Learn about ATLAS, FLAIR, and ATLAS-2M Phase 3 clinical trials in virologically suppressed adult patients with HIV-1

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Review risks and side effects information, including safety and tolerability data, for CABENUVA

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Get information on dosing and administering CABENUVA, as well as potential drug interactions

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References:

Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
Data on File, ViiV Healthcare.
Jaeger H, Overton ET, Richmond G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. Published online October 11, 2021. doi: 10.1016/S2352-3018(21)00185-5
Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV‑1 infection. N Engl J Med. 2020;382(12):1124-1135.

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ARROW

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

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

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 full Prescribing Information for CABENUVA.

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To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for CABENUVA.

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CBRWCNT210044 December 2021

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