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March 30, 2022March 30, 2022 – The FDA has approved updated prescribing information for Cabenuva® (cabotegravir and rilpivirine), ViiV Healthcare’s long-lasting injectable HIV treatment. Cabenuva replaces the current antiretroviral regimen in individuals who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either of its active pharmaceutical ingredients (APIs).
- First approved in 2021, Cabenuva formerly required one month of oral lead-in dosing to assess the tolerability of its APIs before a patient switched to extended-release injections. Oral lead-in dosing is now optional.
- Cabenuva is also now indicated as a complete regimen to treat HIV-1 infection in pediatric patients who are at least 12 years old and weigh at least 35kg (77 pounds). It was previously approved only in adults.
- A healthcare provider must administer Cabenuva through gluteal intramuscular injection. The recommended dosing is:
- Monthly Dosing: Initiate Cabenuva injections of 600mg cabotegravir/900mg rilpivirine on the last day of current antiretroviral therapy or oral lead-in and continue with Cabenuva injections of 400mg cabotegravir/600mg rilpivirine monthly thereafter.
- Every Two-Months Dosing: Initiate Cabenuva injections of 600mg cabotegravir/900mg rilpivirine on the last day of current antiretroviral therapy or oral lead-in for two consecutive months and continue with Cabenuva injections at the same dosing strength once every two months thereafter.