Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DARUNAVIR ETHANOLATE (UNII: 33O78XF0BW) (DARUNAVIR - UNII:YO603Y8113), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)
Janssen Products LP
DARUNAVIR ETHANOLATE
DARUNAVIR 800 mg
ORAL
PRESCRIPTION DRUG
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). Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. PREZCOBIX should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life threatening events (narrow therapeutic index). Darunavir and cobicistat are both substrates of the cytochrome P450 3A (CYP3A) isoform. Co-administration of PREZCOBIX with CYP3A inducers may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance. Examples of drugs that are contraindicated for co-administration w
PREZCOBIX ® (darunavir and cobicistat) tablets, 800/150 mg, are supplied as pink, oval-shaped, film-coated tablets debossed with "800" on one side and "TG" on the other side. PREZCOBIX is packaged in bottles of 30 tablets (NDC 59676-575-30). Storage: Store at 20–25°C (between 68–77°F); with excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Keep PREZCOBIX and all medicines out of reach of children.
New Drug Application
PREZCOBIX- DARUNAVIR ETHANOLATE AND COBICISTAT TABLET, FILM COATED JANSSEN PRODUCTS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PREZCOBIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREZCOBIX. PREZCOBIX (DARUNAVIR AND COBICISTAT) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2015 RECENT MAJOR CHANGES Contraindications ( 4) 04/2022 INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION Recommended dosage:One tablet taken once daily with food in adults and pediatric patients weighing at least 40 kg. ( 2.1) Testing Prior to Initiation:HIV genotypic testing is recommended for antiretroviral treatment experienced patients. Assess estimated creatinine clearance in all patients prior to starting PREZCOBIX. When used with tenofovir DF: Assess urine glucose and urine protein at baseline and monitor creatinine clearance, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. ( 2.2) DOSAGE FORMS AND STRENGTHS Tablets: 800 mg of darunavir and 150 mg of cobicistat. ( 3) CONTRAINDICATIONS PREZCOBIX is contraindicated in patients receiving certain co-administered drugs for which altered plasma concentrations are associated with serious and/or life-threatening events or loss of therapeutic effect. ( 4, 7.2) WARNINGS AND PRECAUTIONS Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis), liver injury, including some fatalities can occur with PREZCOBIX. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhos Lees het volledige document