darunavir ethanolate and cobicistat
Drug Details
- Generic Name
- darunavir ethanolate and cobicistat
- Brand Names
- N/A
- Application Number
- Sponsor
- Janssen Ortho LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- N/A
- Active Ingredients
- COBICISTAT, DARUNAVIR ETHANOLATE
Indications and Usage
1 INDICATIONS AND USAGE PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). PREZCOBIX is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). ( 1 )