Label: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

  • NDC Code(s): 0093-5234-56
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 28, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B

    Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), which are components of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets.

    Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Testing Prior to Initiation and During Treatment - with Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets - Prior to or when initiating efavirenz, emtricitabine and tenofovir ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are light-pink to pink, unscored, film-coated, modified capsule-shaped, debossed with “TV” on one side of the tablet and with ...
  • 4 CONTRAINDICATIONS
    Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV - All patients should be tested for the presence of chronic HBV before or when initiating antiretroviral ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    7.1 Efavirenz - Efavirenz has been shown in vivo to induce CYP3A and CYP2B6. Other compounds that are substrates of CYP3A or CYP2B6 may have decreased plasma concentrations when coadministered ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Antiretroviral Pregnancy Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and ...
  • 10 OVERDOSAGE
    If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Administration of activated charcoal may be used to aid ...
  • 11 DESCRIPTION
    Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing EFV USP, FTC, and TDF. EFV, USP is a non-nucleoside reverse transcriptase inhibitor ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination of antiviral drugs EFV, FTC, and TDF [see Microbiology ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Efavirenz: Long-term carcinogenicity studies in mice and rats were carried out with EFV. Mice were dosed with 0, 25, 75, 150, or 300 ...
  • 14 CLINICAL STUDIES
    Clinical Study 934 (NCT00112047) supports the use of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets in antiretroviral treatment-naïve HIV-1 infected patients. Clinical Study ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are available as follows: 600 mg/200 mg/300 mg - light-pink to pink, unscored, film-coated, modified capsule-shaped tablets ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV - Inform patients that ...
  • PATIENT INFORMATION
    Dispense with Patient Package Insert available at: www.tevausa.com/Patient PI  -  Efavirenz (ef" a vir' enz), Emtricitabine (em" trye sye' ta been) and Tenofovir Fumarate (ten of' oh vir ...
  • Package/Label Display Panel
    NDC 0093-5234-56 - Rx only - Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets - 600 mg/200 mg/300 mg* Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out ...
  • INGREDIENTS AND APPEARANCE
    Product Information