For HIV-1–negative, at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1. See full Indication.

APRETUDE must be administered by a healthcare professional (HCP). Prior to prescribing HCP-administered APRETUDE, HCPs should carefully select individuals who agree to the required dosing and testing schedule and counsel patients on the importance of adherence to help reduce the risk of HIV-1 infection and development of resistance.

Dosing and Testing Schedule

Confidence with adherence you can confirm in as few as 6 in-office injections per year^1*

Starting Your Patients on APRETUDE^†

M=month.

HIV-1 testing to confirm negative status:

Individuals must be tested for HIV-1 prior to initiating APRETUDE or oral cabotegravir and with each subsequent APRETUDE injection, using an FDA-approved or -cleared test for the diagnosis of acute or primary HIV-1
- If an antigen-/antibody-specific test provides negative results, confirm using an HIV RNA-specific assay, even if results are available after PrEP initiation
Additionally, HIV-1 testing should occur:
- When recent exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash) are present
- Upon diagnosis of any other sexually transmitted infection
If positive HIV-1 status is confirmed, transition to a complete HIV-1 treatment

^*After optional oral lead-in and initiation injections.
^†For patients concomitantly receiving rifabutin, please see the Drug Interactions table below for the adjusted recommended dosing schedule for APRETUDE.

FDA=Food and Drug Administration.

Optional oral lead-in¹

Oral lead-in may be used prior to the initiation of APRETUDE to assess the tolerability of cabotegravir.

Starting Your Patients on APRETUDE After Oral Lead-in

M=month.

The recommended oral lead-in dose is one 30-mg tablet of cabotegravir daily for approximately 1 month (at least 28 days)
The first initiation injection should be administered on the last day of oral lead-in, if used, or within 3 days thereafter

The APRETUDE Dosing Window

Adherence to the dosing schedule is strongly recommended. Before initiating APRETUDE, counsel your patients about the importance of adhering to the scheduled dosing visits to help reduce the risk of acquiring HIV-1 infection and development of resistance.

Setting a consistent injection date—the Target Injection Date—can help keep your patients on track. APRETUDE injections may be given up to 7 days before or after the patient's next scheduled Target Injection Date (after the first injection).

It is recommended that patients receive their injection on the same date every 2 months.

Injection visit

Missed Injections

Adherence to the injection dosing schedule is strongly recommended. Individuals who miss a Target Injection Date visit should be clinically reassessed to ensure resumption of APRETUDE remains appropriate. Below are dosing recommendations for missed injections.

Planned Missed Injections

Below are injection dosing recommendations if an individual plans to miss a scheduled every-2-month Target Injection Date by more than 7 days.

Continuing APRETUDE After Planned Missed Injection

^‡For oral PrEP durations >2 months, an alternative oral regimen is recommended.

Unplanned Missed Injections

If a Target Injection Date is missed or delayed by >7 days and oral dosing has not been taken in the interim, clinically reassess the individual to determine if resumption of injection dosing remains appropriate, and if so, confirm HIV-1–negative status prior to injection.

Continuing APRETUDE After Unplanned Missed Injection

PrEP=pre-exposure prophylaxis.

Drug Interactions

Recommendations are based on either drug interaction trials following oral administration of cabotegravir or predicted interactions due to the expected magnitude of the interaction. This chart includes potentially significant interactions but is not all inclusive.

↑ = Increase, ↓ = Decrease, ↔︎ = No Change

Dosing and Administration Guide

Download this guide to receive information on:

APRETUDE dosing kits and storage
The APRETUDE dosing schedule
Administering the initiation and continuation injections
Managing missed injections
Injection considerations to share with your patients

Reference:

APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.

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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

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.

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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Trademarks are owned by or licensed to the

ViiV Healthcare group of companies.

This site is funded and developed by

ViiV Healthcare.

This site is intended for US healthcare

professionals only.

CBTWCNT220014 September 2022 Produced in USA.

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