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December 20, 2021December 20, 2021 – Vocabria® (cabotegravir – ViiV Healthcare) tablets have been approved for use in at-risk adults and adolescents weighing at least 35kg (77 pounds) for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
- Under the new indication, individuals must have a negative HIV-1 test prior to initiating Vocabria
for HIV-1 PrEP, and the drug may be used as:
- An oral lead-in therapy to assess the tolerability of cabotegravir prior to administration of Apretude® (cabotegravir – ViiV Healthcare) extended-release injectable suspension for HIV-1 PrEP; or
- An oral therapy for patients who will miss planned dosing with Apretude for HIV-1 PrEP.
- Recommended dosing for HIV-1 PrEP is:
- For Oral Lead-In to Apretude: One 30mg tablet taken by mouth once daily for at least 28 days, with Apretude begun on the last day of oral dosing or within three days of stopping oral lead-in treatment.
- For Replacement of a Missed Apretude Injection: One 30mg tablet taken once daily, starting approximately two months after the last dose of Apretude. Treatment with Apretude can be restarted on the final day of oral dosing or within three days of finishing oral dosing.
- Vocabria first received FDA approval in 2021 for use with Edurant® (rilpivirine – Janssen) to provide short-term treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The combination of Vocabria and Edurant can be used as oral lead-in therapy for Cabenuva® (cabotegravir/rilpivirine – ViiV Healthcare), an extended-release injectable medication that is FDA approved to treat HIV-1.