Rx Item-Prezcobix cobicistat and darunavir 800 150Mg Tab 30 By J O M Pharma

For: HIV Infection

Prezcobix (darunavir and cobicistat) is a once-daily fixed-dose combination containing a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection. PREZCOBIX- darunavir ethanolate and cobicistat tablet, film coated
Janssen Products LP

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-na�ve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage
PREZCOBIX is a fixed-dose combination product containing 800 mg of darunavir and 150 mg of cobicistat. In treatment-na�ve and treatment-experienced adults with no darunavir resistance-associated substitutions, the recommended dosage of PREZCOBIX is one tablet taken once daily orally with food. Administer PREZCOBIX in conjunction with other antiretroviral agents.

2.2 Testing prior to Initiation of PREZCOBIX


HIV Genotypic Testing

HIV genotypic testing is recommended for antiretroviral treatment-experienced patients. However, when HIV genotypic testing is not feasible, PREZCOBIX can be used in protease inhibitor-na�ve patients, but is not recommended in protease inhibitor-experienced patients.

Creatinine Clearance

Prior to starting PREZCOBIX, assess estimated creatinine clearance because cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.1)]. When co-administering PREZCOBIX with tenofovir disoproxil fumarate (tenofovir DF) assess estimated creatinine clearance, urine glucose, and urine protein at baseline [see Warnings and Precautions (5.3)].

2.3 Patients with Renal Impairment
PREZCOBIX co-administered with tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL per minute [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

2.4 Patients with Hepatic Impairment
PREZCOBIX is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

PREZCOBIX is supplied as pink, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg cobicistat. Each tablet is debossed with "800″ on one side and "TG" on the other side.

RX ITEM-Prezcobix 800 150Mg Tab 30 By J
item No.:RX375170 NDC No.59676057530 5967657530 59676057530 UPC No.:359676575306 NDC No.59676-0575-30 UPC/GTIN No.3-59676-57530-6 359676-575306 MPN 57530

Prezcobix 800 150Mg Tab 30 By J O M Phar
BRAND: PREZCOBIX NDC: 59676-0575-30,59676057530 UPC: 3-59676-57530-6,359676575306 J/O/M Pharma Services

DARUNAVIR/COBICISTAT ORAL
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