Label: PREZCOBIX- darunavir ethanolate and cobicistat tablet, film coated

  • NDC Code(s): 59676-575-30, 59676-578-30
  • Packager: Janssen Products LP
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 2, 2025

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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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    PREZCOBIX is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage in Adults and Pediatric Patients Weighing at Least 25 kg - The recommended dosages of PREZCOBIX for adults and pediatric patients weighing at least 25 kg are shown in ...
  • 3 DOSAGE FORMS AND STRENGTHS
    PREZCOBIX 800 mg darunavir/150 mg cobicistat is a pink, oval-shaped, film-coated tablet debossed with “800” on one side and “TG” on the other side. PREZCOBIX 675 mg darunavir/150 mg cobicistat is ...
  • 4 CONTRAINDICATIONS
    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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hepatotoxicity - During the darunavir clinical development program (N=3063), where darunavir was co-administered with ritonavir 100 mg once or twice daily, drug-induced hepatitis (e.g., acute ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: Hepatotoxicity - [see - Warnings and Precautions (5.1)] Severe skin reactions - [see ...
  • 7 DRUG INTERACTIONS
    7.1 Potential for PREZCOBIX to Affect Other Drugs - Darunavir co-administered with cobicistat is an inhibitor of CYP3A and CYP2D6. Cobicistat inhibits the following transporters: P-glycoprotein ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PREZCOBIX during pregnancy. Healthcare providers ...
  • 10 OVERDOSAGE
    Human experience of acute overdose with PREZCOBIX is limited. No specific antidote is available for overdose with PREZCOBIX. Treatment of overdose with PREZCOBIX consists of general supportive ...
  • 11 DESCRIPTION
    PREZCOBIX - ® is a fixed-dose combination tablet containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - PREZCOBIX is a fixed-dose combination of an HIV-1 antiviral drug, darunavir and a CYP3A inhibitor, cobicistat - [see - Microbiology (12.4)]. 12.2 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis and Mutagenesis - Darunavir: Darunavir was evaluated for carcinogenic potential by oral gavage administration to ...
  • 14 CLINICAL STUDIES
    14.1 Clinical Trial Results in Adults with HIV-1 - The efficacy of PREZCOBIX in adults with HIV-1 is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    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. Bottle of 30 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Instructions for Use - Advise patients to take PREZCOBIX with food every day on a regular dosing schedule, as ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA - For patent information: www.janssenpatents.com - © Johnson & Johnson and its affiliates 2015, 2025
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 03/2025 - PATIENT INFORMATION - PREZCOBIX - ®(prez-koe-bix ...
  • PRINCIPAL DISPLAY PANEL - 800 mg/150 mg Tablet Bottle Label
    NDC59676-575-30 - PREZCOBIX - ® (darunavir and cobicistat) Tablets - 800 mg/150 mg - Each tablet contains darunavir - ethanolate (equivalent to - 800 mg of darunavir ...
  • PRINCIPAL DISPLAY PANEL - 675 mg/150 mg Tablet Bottle Carton
    NDC 59676-578-30 - PREZCOBIX - ® (darunavir and - cobicistat) Tablets - 675 mg/150 mg - ALERT: Find out about medicines that - should NOT be taken with PREZCOBIX - ® from your ...
  • INGREDIENTS AND APPEARANCE
    Product Information