Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 18, 2025

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

    WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION


    Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1)] .
    Emtricitabine and tenofovir disoproxil fumarate used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions ( 5.2)] .

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  • 1 INDICATIONS AND USAGE
    1.1 Treatment of HIV-1 Infection - Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Testing Prior to Initiation of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for Treatment of HIV-1 Infection or for HIV-1 PrEP - Prior to or when initiating emtricitabine and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Emtricitabine and Tenofovir disoproxil fumarate is available as tablets. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg ...
  • 4 CONTRAINDICATIONS
    Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status - [see Warnings and Precautions ( 5.2) ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection - All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: •    Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection - [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs Affecting Renal Function - FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion - [see Clinical ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate ...
  • 10 OVERDOSAGE
    If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine:Hemodialysis treatment removes ...
  • 11 DESCRIPTION
    Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination of antiviral drugs FTC and TDF - [see Microbiology ( 12.4)] . 12.3 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Emtricitabine:In long-term oral carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at ...
  • 14 CLINICAL STUDIES
    14.1 Overview of Clinical Trials - The efficacy and safety of emtricitabine and tenofovir disoproxil fumarate have been evaluated in the studies summarized in Table 13. Table 13 Trials ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    The white to off-white, capsule shaped, film coated tablets contain 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil) ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Important Information for Uninfected Individuals Taking Emtricitabine and Tenofovir Disoproxil Fumarate for ...
  • MEDICATION GUIDE
    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets -   (em’’ trye sye’ ta been and ten of’ oh vir dye’’ soe prox’ il fue’ ma rate) Read this Medication ...
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