Clinical Information:EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Gen. Code and Des.
57883 emtricitabine/tenofovir (TDF) ORAL TABLET 200-300 MG
GCN and Des.
23152 emtricitabine/tenofovir (TDF) ORAL TABLET 200-300 MG
Strength
200-300 MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS
Active Ingredients
1321 emtricitabine 143491570
9358 tenofovir disoproxil fumarate 202138509
Inactive Ingredients
2432 lactose 64044515
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 AND TENOFOVIR DISOPROXIL FUMARATE TABLETS.
EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use
Initial U.S. Approval: 2004
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
See full prescribing information for complete boxed warning.
• Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely in these individuals who discontinue emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate anti-hepatitis B therapy may be warranted. (5.1)
• Emtricitabine and tenofovir disoproxil fumarate tablets 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 the use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. (5.2)
RECENT MAJOR CHANGES
Indications and Usage
HIV-1 Pre-Exposure Prophylaxis (PrEP) (1.2) 06/2020
Dosage and Administration
HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 (PrEP) (2.2) 06/2020
Warnings and Precautions
Comprehensive Management to Reduce the Risk of
Sexually Transmitted Infections, Including
HIV-1, and Development of HIV-1 Resistance When Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Is Used for HIV-1 PrEP (5.2) 06/2020
Immune Reconstitution Syndrome (5.4) 06/2020
INDICATIONS AND USAGE
HIV-1 Treatment (1.1)
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
• in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (1.2):
• Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.
DOSAGE AND ADMINISTRATION
• Testing: Prior to or when initiating emtricitabine and tenofovir disoproxil fumarate tablets test for hepatitis B virus infection. Prior to initiation and during use of emtricitabine and tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. (2.1)
• HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once every 3 months while taking Emtricitabine and tenofovir disoproxil fumarate tablets, and upon diagnosis of any other sexually transmitted infections (STIs). (2.2)
Treatment of HIV-1 Infection
• Recommended dosage in adults and pediatric patients weighing at least 35 kg: One Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. (2.3)
• Recommended dosage in pediatric patients weighing at least 17 kg: One emtricitabine and tenofovir disoproxil fumarate tablets low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food. (2.4)
• Recommended dosage in renally impaired HIV-1 infected adult patients:
o Creatinine clearance (CrCl) 30 to 49 mL/min: 1 tablet every 48 hours. (2.6)
o CrCl below 30 mL/min or hemodialysis: Emtricitabine and tenofovir disoproxil fumarate tablets is not recommended. (2.6)
HIV-1 Pre-Exposure Prophylaxis (PrEP)
• Recommended dosage in HIV-1 uninfected adults and adolescents weighing at least 35 kg: One emtricitabine and tenofovir disoproxil fumarate tablets (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. (2.5)
• Recommended dosage in renally impaired HIV-uninfected individuals: Emtricitabine and tenofovir disoproxil fumarate tablets is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min. (2.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. (3)
CONTRAINDICATIONS
Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status. (4)
WARNINGS AND PRECAUTIONS
• Comprehensive management to reduce the risk of acquiring HIV-1 when emtricitabine and tenofovir disoproxil fumarate is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule. (5.2)
• Management to reduce the risk of acquiring HIV-1 drug resistance when emtricitabine and tenofovir disoproxil fumarate is used for HIV-1 PrEP: refer to full prescribing information for additional detail. (5.2)
• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering Emtricitabine and tenofovir disoproxil fumarate tablets with concurrent or recent use of nephrotoxic drugs. (5.3)
• Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment. (5.4)
• Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. (5.5)
• Lactic acidosis/severe hepatomegaly with steatosis: Discontinue emtricitabine and tenofovir disoproxil fumarate tablets in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.6)
ADVERSE REACTIONS
• In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. (6.1)
• In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of emtricitabine and tenofovir disoproxil fumarate tablets participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
• Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. (7.2)
• Coadministration decreases atazanavir concentrations. When coadministered with emtricitabine and tenofovir disoproxil fumarate tablets, use atazanavir given with ritonavir. (7.2)
• Coadministration of emtricitabine and tenofovir disoproxil fumarate tablets with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. (7.2)
• Consult Full Prescribing Information prior to and during treatment for important drug interactions. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Mothers infected with HIV-1 or suspected of having acquired HIV-1 infection should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2022
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Table of Contents
Table of Contents
BOXED WARNING (What is this?)
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 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 tablets. 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 tablets. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].
Emtricitabine and tenofovir disoproxil fumarate tablets 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 tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate Emtricitabine and tenofovir disoproxil fumarate tablets 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 & USAGE
1.1 Treatment of HIV-1 Infection - Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in ...
2 DOSAGE & 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 & STRENGTHS
Emtricitabine and tenofovir disoproxil fumarate are available in single dose strength: • Tablet: 200 mg of emtricitabine and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil) ...
4 CONTRAINDICATIONS
Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is 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 - • Precautions ...
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 Pharmacology ...
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 tablets ...
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 approximately ...
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 tablets are 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 tablets have been evaluated in the studies summarized in Table 13. Table 13 Trials ...
16 HOW SUPPLIED/STORAGE AND HANDLING
Emtricitabine and tenofovir disoproxil fumarate tablets are available as follows: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir ...
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 Tablets ...
Medication Guide
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets - (EM-trye-SYE-ta-been and ten-OF-oh-vir DYE-soe-PROX-il FUEma-rate) Read this Medication Guide before you start taking emtricitabine ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rx Only - NDC 33342-106-07 - Emtricitabine and Tenofovir Disoproxil fumarate tablets - 200 mg/ 300 mg - 30 tablets
INGREDIENTS AND APPEARANCE
