*HIV-1 Treatment: VOCABRIA is an HIV-1 integrase strand transfer inhibitor
(INSTI) indicated in combination with EDURANT (rilpivirine) for short-term
treatment of HIV-1 infection in adults and adolescents 12 years of age and
older and weighing at least 35 kg who are virologically suppressed (HIV-1
RNA <50 copies/mL) on a stable antiretroviral regimen with no history of
treatment failure and with no known or suspected resistance to either
cabotegravir or rilpivirine.
*HIV-1 Pre-Exposure Prophylaxis: VOCABRIA is indicated in at-risk adults
and adolescents weighing at least 35 kg for short-term pre-exposure
prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
Individuals must have a negative HIV-1 test prior to initiating VOCABRIA
for HIV-1 PrEP.
*VOCABRIA may be used as:
• oral lead-in to assess the tolerability of cabotegravir prior to
administration of CABENUVA (cabotegravir extended-release injectable
suspension; rilpivirine extended-release injectable suspension) for HIV-1
treatment or APRETUDE (cabotegravir extended-release injectable
suspension) for HIV-1 PrEP.
• oral therapy for patients who will miss planned injection dosing with
CABENUVA for HIV-1 treatment or APRETUDE for HIV-1 PrEP.
