Home | APRETUDE (cabotegravir 200 mg/mL) Official HCP Website

APRETUDE is administered as an intramuscular injection by an HCP every 2 months after 2 initiation injections administered 1 month apart. Adherence to the dosing schedule is strongly recommended.

INDICATION

APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

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APRETUDE is the first and only long-acting injectable PrEP option

Superior

Significantly Lower Incidence of HIV-1 Infection vs a Daily Oral PrEP (TDF/FTC) Proven in 2 Double-blind Clinical Trials^1,2*†

69% (P=0.0003) and 90% (P<0.0001) lower incidence of HIV-1 infection in HPTN 083 and HPTN 084

Confident

Adherence You can Confirm With as Few as 6 In-office Injections Per Year^‡

Inclusive

The Most Diverse and Comprehensive Participant Population in HIV Prevention Trials Conducted to Date^1,2*†

Designed to include the key populations impacted by HIV-1^1,2
- Trials included cisgender men and transgender women who have sex with men and cisgender women, with the majority under age 30. In the US, trials included Black/African American and Latinx people

^*HPTN 083 (N=4566) was a randomized, double-blind, placebo-controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected men and transgender women who have sex with men and have evidence of high-risk behavior for HIV-1 infection. The primary endpoint was the rate of incident HIV-1 infections among participants randomized to daily oral cabotegravir and intramuscular injections of APRETUDE every 2 months compared with daily oral TDF/FTC (corrected for early stopping). The trial included the prespecified ability to test for superiority of APRETUDE over TDF/FTC. The primary analysis showed a 66% reduction in the risk of acquiring HIV-1 infection, hazard ratio (95% CI) 0.34 (0.18, 0.62). Further testing revealed 1 of the infections on APRETUDE to be prevalent, yielding a 69% reduction in the risk of HIV-1 incident infection relative to TDF/FTC, hazard ratio (95% CI) 0.31 (0.16-0.58); incidence rate 0.37/100 person-years vs 1.22/100 person-years for TDF/FTC.

^†HPTN 084 (N=3224) was a randomized, double-blind, placebo-controlled superiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in adult, uninfected cisgender women at risk of acquiring HIV-1. The primary endpoint was the rate of incident HIV-1 infections among participants randomized to oral cabotegravir and injections of APRETUDE compared with oral TDF/FTC (corrected for early stopping). The primary analysis showed an 88% reduction in the risk of acquiring HIV-1 infection, hazard ratio (95% CI) 0.12 (0.05, 0.31). Further testing revealed 1 of the infections on APRETUDE to be prevalent, yielding a 90% reduction in the risk of HIV-1 incident infection relative to TDF/FTC, hazard ratio (95% CI) 0.10 (0.04-0.27); APRETUDE incidence rate 0.15/100 person-years vs 1.85/100 person-years for TDF/FTC.

^‡After optional oral lead-in and initiation injections given 1 month apart for 2 consecutive months.

CI=confidence interval; FTC=emtricitabine; HPTN=HIV Prevention Trials Network; TDF=tenofovir disoproxil fumarate.

"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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Patient Access

Patient support options are available for prescribed APRETUDE.

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Resources

View the resource library to get more information about APRETUDE.

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Not actual patient

"I try to take my PrEP regularly since I don't always know the history of my partners. Sometimes I don't have it with me, so I don't always take it daily like I should. I worry I'm not as protected as I should be. Is there another option?"

Do you have someone like this in your practice on PrEP?

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For Your Practice

Clinical Trials

Learn more about 2 of the most diverse and inclusive HIV prevention trials to date

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Safety

Review risk and side effect information, including safety and tolerability data, for APRETUDE

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Dosing

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

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References:

Landovitz RJ, Donnell D, Clement C, et al; for the HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595-608. doi:10.1056/NEJMoa2101016
Delany-Moretlwe S; HPTN 084 Study Team. Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: interim results from HPTN 084. Presented at: HIV R4P Virtual Conference; January 27, 2021. Abstract LB1479.

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IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

CONTRAINDICATIONS

Do not use APRETUDE in individuals:

with unknown or positive HIV-1 status
with previous hypersensitivity reaction to cabotegravir
receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine

WARNINGS AND PRECAUTIONS

Comprehensive Management to Reduce the Risk of HIV-1 Infection:

Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)

Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection

When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs

Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment

Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Potential Risk of Resistance with APRETUDE:

There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance

Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE

Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors

Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Depressive Disorders:

Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE

Promptly evaluate patients with depressive symptoms

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE

Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

DRUG INTERACTIONS

Refer to the full Prescribing Information for important drug interactions with APRETUDE

Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

USE IN SPECIFIC POPULATIONS

Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation

Pediatrics: Not recommended in individuals weighing less than 35 kg

INDICATION

Please see full Prescribing Information, including Boxed Warning, for APRETUDE.

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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.

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CBTWCNT220014 September 2022 Produced in USA.

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