PREZCOBIX- darunavir ethanolate and cobicistat tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DARUNAVIR ETHANOLATE (UNII: 33O78XF0BW) (DARUNAVIR - UNII:YO603Y8113), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)

Available from:

REMEDYREPACK INC.

INN (International Name):

DARUNAVIR ETHANOLATE

Composition:

DARUNAVIR 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). PREZCOBIX is contraindicated in patients receiving the following co-administered drugs PREZCOBIX is contraindicated in patients receiving the following co-administered drugs [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)]. - Alpha 1-adrenoreceptor antagonist: alfuzosin - Anticonvulsants: carbamazepine, phenobarbital, phenytoin - Anti-gout: colchicine, in patients with renal and/or hepatic impairment - Antimycobacterial: rifampin - Antipsychotics: lurasidone, pimozide - Cardiac Disorders: dronedarone, ivabradine, ranolazineCardiac Disorders: dronedarone, ivabradine, ranolazine - Ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine - GI motility agent: cisapride - He

Product summary:

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].

Authorization status:

New Drug Application

Summary of Product characteristics

PREZCOBIX- DARUNAVIR ETHANOLATE AND COBICISTAT TABLET, FILM COATED
REMEDYREPACK INC.
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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
Dosage and Administration, Not Recommended During Pregnancy ( 2.5)
06/2018
Contraindications ( 4)
05/2019
Warnings and Precautions, Immune Reconstitution Syndrome ( 5.10)
05/2019
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 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. ( 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 patien