Apretude® (cabotegravir intramuscular injection)

Apretude (cabotegravir IM) is covered only for FDA‑approved HIV‑1 preexposure prophylaxis in at‑risk adults and adolescents weighing ≥35 kg (not covered for HIV treatment or patients <35 kg) provided there is a negative HIV‑1 test within 1 week, no signs/symptoms of acute HIV, it’s part of a documented comprehensive prevention strategy, and it is prescribed by or in consultation with an HIV specialist. Approval is limited to 12 months with required dosing of 600 mg IM at 0 and 1 month then 600 mg IM every 2 months (or per oral lead‑in timing), and documentation of weight, recent negative HIV test, absence of acute infection, prevention plan, specialist involvement, and dosing dates is required.

"Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection."