APRETUDE is administered as a single 600 mg gluteal intramuscular injection every 2 months (after 2 initiation injections, 1 month apart, and an optional oral lead-in), allowing HCPs to confirm adherence.[1]
Starting individuals on APRETUDE**[1]
APRETUDE offers the alternative option of an oral lead-in[1]
An optional oral lead-in may be used prior to the initiation of APRETUDE to assess the tolerability of cabotegravir. The recommended oral lead-in dose is 1 cabotegravir tablet (30 mg) once a day for approximately 1 month (at least 28 days). Initiation injections should be administered on the last day of oral lead-in, if used, or 3 days thereafter.[1]
APRETUDE injection schedule[1]
- Individuals should aim to receive their APRETUDE injection on the same date every 2 months – the Target Injection Date
- If needed, APRETUDE injections can be given up to 7 days before or after the Target Injection Date
- An optional oral lead-in may be used prior to starting APRETUDE injections to assess tolerability of cabotegravir
HCPs should carefully select individuals who agree to the required dosing and testing schedule, and counsel individuals on the importance of adherence to APRETUDE to help reduce the risk of HIV-1 acquisition and development of integrase strand transfer inhibitor (INSTI) resistance.[1]
The APRETUDE dosing window[1]
It is recommended that individuals receive their APRETUDE injection on the same date every 2 months, after initiation – the Target Injection Date. After the first injection, there is a dosing window of 7 days either side of the Target Injection Date, within which APRETUDE injections can be administered.[1]
If an individual misses their Target Injection Date by more than 7 days, you can still help keep them protected:[1]
Planned missed injections[1]
- Daily oral cabotegravir can be taken for up to 2 months‡
- The first dose of oral cabotegravir should be taken 2 months (+/- 7 days) after the last APRETUDE injection
- APRETUDE injections should be resumed on the final day of oral cabotegravir, or within 3 days thereafter
Reassess suitability[1]
- Adherence to the injection schedule is strongly recommended
- Individuals who miss their scheduled injection should have their HIV-negative status re-confirmed and be clinically reassessed to determine the suitability of resuming APRETUDE
Restarting APRETUDE after missed injections or following oral cabotegravir to replace an injection
Ongoing HIV-1 testing requirements
APRETUDE should only be used in people who are HIV-1 negative
- Individuals must be tested for HIV-1 prior to initiating APRETUDE and at each subsequent injection of APRETUDE.
- A combined antigen/antibody test as well as an HIV-RNA-based test should both be negative. Prescribers are advised to perform both tests, even if the result of the HIV-RNA-based test will become available after cabotegravir injection. If a combined testing strategy including both tests is not available, testing should follow local guidelines
- Test when recent exposure is suspected or clinical symptoms consistent with HIV-1 (e.g., fever, fatigue, myalgia, skin rash) are present
- Individuals who are confirmed to have HIV-1 should immediately begin antiretroviral therapy
APRETUDE carton contents
- 1 x vial of cabotegravir 600 mg 3 mL prolonged-release suspension for injection
* After 2 initiation injections and an optional oral lead-in.[1]
** Consider the potential for drug interactions prior to the use of APRETUDE. Please see the Summary of Product Characteristics for full details of drug interactions and corresponding dosing adjustments for APRETUDE.
‡ For oral PrEP durations greater than 2 months, an alternative oral regimen is recommended.[1]
HCP, healthcare professional; HIV-1, human immunodeficiency virus type 1; INSTI, integrase strand transfer inhibitor; PrEP, pre-exposure prophylaxis; RNA, ribonucleic acid.
References:
- APRETUDE (cabotegravir) Summary of Product Characteristics (SmPC).
- New cabotegravir formulations approved to help prevent HIV-1 infection in adults and adolescents, GOV.UK. Available at: https://www.gov.uk/government/news/new-cabotegravir-formulations-approved-to-help-prevent-hiv-1-infection-in-adults-and-adolescents. Accessed November 2024
- WHO implementation tool for pre-exposure prophylaxis of HIV infection: provider module for oral and long-acting PrEP. https://www.who.int/publications/i/item/9789240097230
PM-GB-CBT-WCNT-240005, November 2024
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.
If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.
