PREZCOBIX- darunavir ethanolate and cobicistat tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Janssen Products LP

INN (Kansainvälinen yleisnimi):

DARUNAVIR ETHANOLATE

Koostumus:

DARUNAVIR 800 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

PREZCOBIX- DARUNAVIR ETHANOLATE AND COBICISTAT TABLET, FILM COATED
JANSSEN PRODUCTS LP
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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
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