Apretude FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 2, 2022.
FDA Approved: Yes (First approved December 20, 2021)
Brand name: Apretude
Generic name: cabotegravir
Dosage form: Extended-Release Injectable Suspension
Company: ViiV Healthcare
Treatment for: Pre-Exposure Prophylaxis
Apretude (cabotegravir) is a long-acting injectable integrase strand transfer inhibitor (INSTI) indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
- Apretude is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. Oral medicines used for PrEP include Truvada (emtricitabine and tenofovir) and Descovy (emtricitabine and tenofovir alafenamide).
- Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for 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.
- Apretude is administered via gluteal intramuscular injection every month for the first 2 months, then every 2 months. Oral cabotegravir (Vocabria) may be taken once daily for the month prior to receiving Apretude to assess tolerability.
- Common adverse reactions include 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.
Development timeline for Apretude
Further information
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