Dosing & Drug
Interactions of CABENUVA
Dosing and Drug Interactions
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 year1*
Starting Your Patients on APRETUDE†
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 RNA-specific assay, even if RNA assay 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
- 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.
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
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
- APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.