Emtricitabine and tenofovir disoproxil fumarate
Tablet, Film Coated · Oral
Uses
1 INDICATIONS AND USAGE HIV-1 Treatment (1.1) Emtricitabine and tenofovir disoproxil fumarate 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. 1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate 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 [see Clinical Studies (14)] . 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) 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 [see Dosage and Administration (2.2), Warnings and Precautions (5.2)] .
Dosage and administration
Testing: Prior to or when initiating emtricitabine and tenofovir disoproxil fumarate test for hepatitis B virus infection. Prior to initiation and during use of emtricitabine and tenofovir disoproxil fumarate, 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 for HIV-1 PrEP and at least once every 3 months while taking emtricitabine and tenofovir disoproxil fumarate, 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 tablet (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 tablet 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: Creatinine clearance (CrCl) 30−49 mL/min: 1 tablet every 48 hours. (2.6) CrCl below 30 mL/min or hemodialysis: Emtricitabine and tenofovir disoproxil fumarate 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 tablet (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 is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min. (2.6) 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 tenofovir disoproxil fumarate, test individuals for hepatitis B virus infection [see Warnings and Precautions (5.1)]. Prior to initiation, and during use of emtricitabine and tenofovir disoproxil fumarate, 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 [see Warnings and Precautions (5.3)]. 2.2 HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP Screen all individuals for HIV-1 infection immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP and at least once every 3 months while taking emtricitabine and tenofovir disoproxil fumarate, and upon diagnosis of any other sexually transmitted infections (STIs) [see Indications and Usage (1.2), Contraindications (4) and Warnings and Precautions (5.2)]. If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection [see Warnings and Precautions (5.2), Use in Specific Populations (8.4), and Clinical Studies (14.3 and 14.4)]. 2.3 Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg Emtricitabine and tenofovir disoproxil fumarate is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of emtricitabine and tenofovir disoproxil fumarate in adults and in pediatric patients weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food [see Clinical Pharmacology (12.3)]. 2.4 Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Tablet The recommended oral dosage of emtricitabine and tenofovir disoproxil fumarate for pediatric patients weighing at least 17 kg and who can swallow a tablet is presented in Table 1. Tablets should be taken once daily with or without food. Weight should be monitored periodically and the emtricitabine and tenofovir disoproxil fumarate dose adjusted accordingly. Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 17 kg to less than 35 kg Body Weight (kg) Dosing of Emtricitabine and Tenofovir disoproxil fumarate tablets (FTC/TDF) 17 to less than 22 one 100 mg /150 mg tablet once daily 22 to less than 28 one 133 mg /200 mg tablet once daily 28 to less than 35 one 167 mg /250 mg tablet once daily 2.5 Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg The dosage of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food in HIV-1 uninfected adults and adolescents weighing at least 35 kg [see Clinical Pharmacology (12.3)] . 2.6 Dosage Adjustment in Individuals with Renal Impairment Treatment of HIV-1 Infection Table 2 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of the dosing interval adjustment recommendations in patients with moderate renal impairment (creatinine clearance 30–49 mL/min) have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.3)].
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 of tenofovir disoproxil). The tablets are white colored, capsule-shaped, film-coated, engraved TE on one side and plain on the other side. Tablets: 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate, respectively. (3)
Contraindications
Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)]. Emtricitabine and tenofovir disoproxil fumarate 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 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 in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.6) 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 emtricitabine and tenofovir disoproxil fumarate [see Dosage and Administration (2.1)]. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate. Individuals infected with HBV who discontinue emtricitabine and tenofovir disoproxil fumarate should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. HBV-uninfected individuals should be offered vaccination. 5.2 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 is Used for HIV-1 PrEP Use emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes other prevention measures, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). The time from initiation of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown . Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)' HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission). Inform uninfected individuals about and support their efforts in reducing sexual risk behavior. Use emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative . HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only emtricitabine and tenofovir disoproxil fumarate, because emtricitabine and tenofovir disoproxil fumarate alone does not constitute a complete regimen for HIV-1 treatment [see Microbiology (12.4)]; therefore, care should be taken to minimize the risk of initiating or continuing emtricitabine and tenofovir disoproxil fumarate before confirming the individual is HIV-1 negative. Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection. While using emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to an HIV treatment regimen until negative infection status is confirmed using a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection. Counsel HIV-1 uninfected individuals to strictly adhere to the once daily emtricitabine and tenofovir disoproxil fumarate dosing schedule. The effectiveness of emtricitabine and tenofovir disoproxil fumarate in reducing the risk of acquiring HIV-1 is strongly correlated with adherence, as demonstrated by measurable drug levels in clinical trials of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.
Side effects
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 (5.1)]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3)]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.4)]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5)]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6)]. 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 participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects Clinical Trials in Adult Subjects In Study 934, 511 antiretroviral-naïve subjects received efavirenz (EFV) administered in combination with either FTC+TDF (N=257) or zidovudine (AZT)/lamivudine (3TC) (N=254) for 144 weeks. The most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Table 3 provides the treatment-emergent adverse reactions (Grades 2–4) occurring in greater than or equal to 5% of subjects treated in any treatment group. Skin discoloration, manifested by hyperpigmentation, occurred in 3% of subjects taking FTC+TDF, and was generally mild and asymptomatic. The mechanism and clinical significance are unknown. Table 3 Selected Adverse Reactions a (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks) FTC+TDF+EFV b AZT/3TC+EFV N=257 N=254 Fatigue 9% 8% Depression 9% 7% Nausea 9% 7% Diarrhea 9% 5% Dizziness 8% 7% Upper respiratory tract infections 8% 5% Sinusitis 8% 4% Rash event c 7% 9% Headache 6% 5% Insomnia 5% 7% Nasopharyngitis 5% 3% Vomiting 2% 5% a. Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. b. From Weeks 96 to 144 of the trial, subjects received emtricitabine and tenofovir disoproxil fumarate with efavirenz in place of FTC+TDF with efavirenz. c. Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular. Laboratory Abnormalities : Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of TDF and/or FTC (Table 4). Table 4 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks) FTC+TDF+EFV a AZT/3TC+EFV N=257 N=254 Any ≥ Grade 3 Laboratory Abnormality 30% 26% Fasting Cholesterol (>240 mg/dL) 22% 24% Creatine Kinase (M: >990 U/L) (F: >845 U/L) 9% 7% Serum Amylase (>175 U/L) 8% 4% Alkaline Phosphatase (>550 U/L) 1% 0% AST (M: >180 U/L) (F: >170 U/L) 3% 3% ALT (M: >215 U/L) (F: >170 U/L) 2% 3% Hemoglobin (<8.0 mg/dL) 0% 4% Hyperglycemia (>250 mg/dL) 2% 1% Hematuria (>75 RBC/HPF) 3% 2% Glycosuria (≥3+) <1% 1% Neutrophils (<750/mm3) 3% 5% Fasting Triglycerides (>750 mg/dL) 4% 2% a. From Weeks 96 to 144 of the trial, subjects received emtricitabine and tenofovir disoproxil fumarate with efavirenz in place of FTC+TDF with efavirenz. Clinical Trials in Pediatric Subjects Emtricitabine: In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with FTC in the larger of two open-label, uncontrolled pediatric trials (N=116). Tenofovir Disoproxil Fumarate : In pediatric clinical trials (Studies 352 and 321) conducted in 184 HIV-1 infected subjects 2 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with TDF were consistent with those observed in clinical trials of TDF in adults. In Study 352 (2 to less than 12 years of age), 89 pediatric subjects received TDF for a median exposure of 104 weeks. Of these, 4 subjects discontinued from the trial due to adverse reactions consistent with proximal renal tubulopathy. Three of these 4 subjects presented with hypophosphatemia and had decreases in total body or spine BMD Z-score [see Warnings and Precautions (5.5)]. Total body BMD gain at Week 48 was less in the TDF group compared to the stavudine (d4T) or zidovudine (AZT) treatment groups. The mean rate of BMD gain in lumbar spine was similar between treatment groups. One TDF-treated subject and none of the d4T- or AZT-treated subjects experienced significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline in BMD Z-scores were −0.012 for lumbar spine and −0.338 for total body in the 64 subjects who were treated with TDF for 96 weeks. In Study 321 (12 to less than 18 years of age), the mean rate of BMD gain at Week 48 was less in the TDF compared to the placebo treatment group. Six TDF-treated subjects and one placebo-treated subject had significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline BMD Z-scores were −0.341 for lumbar spine and −0.458 for total body in the 28 subjects who were treated with TDF for 96 weeks.
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, use atazanavir given with ritonavir. (7.2) Coadministration of emtricitabine and tenofovir disoproxil fumarate 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) 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 (12.3)]. No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration of emtricitabine and tenofovir disoproxil fumarate with drugs that are eliminated by active tubular secretion may increase concentrations of FTC, tenofovir, and/or the coadministered drug. Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3)]. Drugs that decrease renal function may increase concentrations of FTC and/or tenofovir. 7.2 Established and Significant Interactions Table 7 provides a listing of established or clinically significant drug interactions. The drug interactions described are based on studies conducted with either emtricitabine and tenofovir disoproxil fumarate, the components of emtricitabine and tenofovir disoproxil fumarate (FTC and TDF) as individual agents and/or in combination, or are predicted drug interactions that may occur with emtricitabine and tenofovir disoproxil fumarate [see Clinical Pharmacology (12.3)]. Table 7 Established and Significant a Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Trials Concomitant Drug Class: Drug Name Effect on Concentration b Clinical Comment NRTI: didanosine c ↑ didanosine Patients receiving emtricitabine and tenofovir disoproxil fumarate and didanosine should be monitored closely for didanosine-associated adverse reactions. Discontinue didanosine in patients who develop didanosine-associated adverse reactions. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving TDF with didanosine 400 mg daily. In patients weighing greater than 60 kg, reduce the didanosine dose to 250 mg when it is coadministered with emtricitabine and tenofovir disoproxil fumarate. Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg. When coadministered, emtricitabine and tenofovir disoproxil fumarate and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% fat). HIV-1 Protease Inhibitors: atazanavir c lopinavir/ritonavir c atazanavir/ritonavir c darunavir/ritonavir c ↓ atazanavir ↑ tenofovir When coadministered with emtricitabine and tenofovir disoproxil fumarate, atazanavir 300 mg should be given with ritonavir 100 mg. Monitor patients receiving emtricitabine and tenofovir disoproxil fumarate concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir for TDF-associated adverse reactions. Discontinue emtricitabine and tenofovir disoproxil fumarate in patients who develop TDF-associated adverse reactions. Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir c sofosbuvir/velpatasvir/voxilaprevir c ledipasvir/sofosbuvir c ↑ tenofovir Monitor patients receiving emtricitabine and tenofovir disoproxil fumarate concomitantly with EPCLUSA® (sofosbuvir/velpatasvir) or VOSEVI® (sofosbuvir/velpatasvir/voxilaprevir) for adverse reactions associated with TDF. Monitor patients receiving emtricitabine and tenofovir disoproxil fumarate concomitantly with HARVONI® (ledipasvir/sofosbuvir) without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination for adverse reactions associated with TDF. In patients receiving emtricitabine and tenofovir disoproxil fumarate concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative HCV or antiretroviral therapy, as the safety of increased tenofovir concentrations in this setting has not been established. If coadministration is necessary, monitor for adverse reactions associated with TDF. a. This table is not all inclusive. b. ↑=Increase, ↓=Decrease c. Indicates that a drug-drug interaction trial was conducted.
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) 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 during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of emtricitabine and tenofovir disoproxil fumarate during pregnancy from observational studies have shown no increased risk of major birth defects. Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) . The rate of miscarriage for individual drugs is not reported in the APR. In the U.S. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. In animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate were administered separately at doses/exposures ≥60 (FTC), ≥14 (TDF) and 2.7 (tenofovir) times those of the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate ( see Data ). Clinical Considerations Disease-associated maternal and/or embryo/fetal risk HIV-1 PrEP: Published studies indicate an increased risk of HIV-1 infection during pregnancy and an increased risk of mother to child transmission during acute HIV-1 infection. In women at risk of acquiring HIV-1, consideration should be given to methods to prevent acquisition of HIV, including continuing or initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP, during pregnancy. Data Human Data Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP: In an observational study based on prospective reports to the APR, 78 HIV-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy delivered live-born infants with no major malformations. All but one were first trimester exposures, and the median duration of exposure was 10.5 weeks. There were no new safety findings in the women receiving emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP compared with HIV-1 infected women treated with other antiretroviral medications. Emtricitabine : Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 3,300 exposed in the first trimester and over 1,300 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.6% (95% CI: 2.1% to 3.2%) and 2.3% (95% CI: 1.6% to 3.3%) following first and second/third trimester exposure, respectively, to FTC-containing regimens. Tenofovir Disoproxil Fumarate: Based on prospective reports to the APR of exposures to TDF-containing regimens during pregnancy resulting in live births (including over 4,000 exposed in the first trimester and over 1,700 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.4% (95% CI: 2.0% to 2.9%) and 2.4% (95% CI: 1.7% to 3.2%) following first and second/third trimester exposure, respectively, to TDF-containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. Additionally, published observational studies on emtricitabine and tenofovir exposure in pregnancy have not shown an increased risk for major malformations. Animal Data Emtricitabine: FTC was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (AUC) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. In a pre/postnatal development study in mice, FTC was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended daily dose. Tenofovir Disoproxil Fumarate: TDF was administered orally to pregnant rats (at 0, 50, 150, or 450 mg/kg/day) and rabbits (at 0, 30, 100, or 300 mg/kg/day) through organogenesis (on gestation days 7 through 17, and 6 through 18, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with TDF in rats at doses up to 14 times the human dose based on body surface area comparisons and in rabbits at doses up to 19 times the human dose based on body surface area comparisons. In a pre/postnatal development study in rats, TDF was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate. 8.2 Lactation Risk Summary Based on published data, FTC and tenofovir have been shown to be present in human breast milk (see Data).
Pregnancy
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 during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of emtricitabine and tenofovir disoproxil fumarate during pregnancy from observational studies have shown no increased risk of major birth defects. Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) . The rate of miscarriage for individual drugs is not reported in the APR. In the U.S. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. In animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate were administered separately at doses/exposures ≥60 (FTC), ≥14 (TDF) and 2.7 (tenofovir) times those of the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate ( see Data ). Clinical Considerations Disease-associated maternal and/or embryo/fetal risk HIV-1 PrEP: Published studies indicate an increased risk of HIV-1 infection during pregnancy and an increased risk of mother to child transmission during acute HIV-1 infection. In women at risk of acquiring HIV-1, consideration should be given to methods to prevent acquisition of HIV, including continuing or initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP, during pregnancy. Data Human Data Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP: In an observational study based on prospective reports to the APR, 78 HIV-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy delivered live-born infants with no major malformations. All but one were first trimester exposures, and the median duration of exposure was 10.5 weeks. There were no new safety findings in the women receiving emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP compared with HIV-1 infected women treated with other antiretroviral medications. Emtricitabine : Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 3,300 exposed in the first trimester and over 1,300 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.6% (95% CI: 2.1% to 3.2%) and 2.3% (95% CI: 1.6% to 3.3%) following first and second/third trimester exposure, respectively, to FTC-containing regimens. Tenofovir Disoproxil Fumarate: Based on prospective reports to the APR of exposures to TDF-containing regimens during pregnancy resulting in live births (including over 4,000 exposed in the first trimester and over 1,700 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.4% (95% CI: 2.0% to 2.9%) and 2.4% (95% CI: 1.7% to 3.2%) following first and second/third trimester exposure, respectively, to TDF-containing regimens. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. Additionally, published observational studies on emtricitabine and tenofovir exposure in pregnancy have not shown an increased risk for major malformations. Animal Data Emtricitabine: FTC was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (AUC) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. In a pre/postnatal development study in mice, FTC was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended daily dose. Tenofovir Disoproxil Fumarate: TDF was administered orally to pregnant rats (at 0, 50, 150, or 450 mg/kg/day) and rabbits (at 0, 30, 100, or 300 mg/kg/day) through organogenesis (on gestation days 7 through 17, and 6 through 18, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with TDF in rats at doses up to 14 times the human dose based on body surface area comparisons and in rabbits at doses up to 19 times the human dose based on body surface area comparisons. In a pre/postnatal development study in rats, TDF was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate.
Pediatric use
8.4 Pediatric Use Treatment of HIV-1 Infection No pediatric clinical trial was conducted to evaluate the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate in patients with HIV-1 infection. Data from previously conducted trials with the individual drug products, FTC and TDF, were relied upon to support dosage recommendations for emtricitabine and tenofovir disoproxil fumarate. For additional information, consult the prescribing information for EMTRIVA and VIREAD. Emtricitabine and tenofovir disoproxil fumarate should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a tablet. Because it is a fixed-dose combination tablet, emtricitabine and tenofovir disoproxil fumarate cannot be adjusted for patients of lower weight [see Warnings and Precautions (5.5), Adverse Reactions (6.1) and Clinical Pharmacology (12.3)] . Emtricitabine and tenofovir disoproxil fumarate is not approved for use in pediatric patients weighing less than 17 kg. HIV-1 PrEP The safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg is supported by data from adequate and well-controlled studies of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TDF, in HIV-1 infected adults and pediatric subjects [see Dosage and Administration (2.5), Adverse Reactions (6.1), Clinical Pharmacology (12.3 and 12.4), and Clinical Studies (14.3 and 14.4)]. Safety, adherence, and resistance were evaluated in a single-arm, open-label clinical trial (ATN113) in which 67 HIV-1 uninfected at-risk adolescent men who have sex with men received emtricitabine and tenofovir disoproxil fumarate once daily for HIV-1 PrEP. The mean age of subjects was 17 years (range 15 to 18 years); 46% were Hispanic, 52% Black, and 37% White. The safety profile of emtricitabine and tenofovir disoproxil fumarate in ATN113 was similar to that observed in the adult HIV-1 PrEP trials [see Adverse Reactions (6.1)] . In the ATN113 trial, HIV-1 seroconversion occurred in 3 subjects. Tenofovir diphosphate levels in dried blood spot assays indicate that these subjects had poor adherence. No tenofovir- or FTC- associated HIV-1 resistance substitutions were detected in virus isolated from the 3 subjects who seroconverted [see Microbiology (12.4)]. Adherence to study drug, as demonstrated by tenofovir diphosphate levels in dried blood spot assays, declined markedly after Week 12 once subjects switched from monthly to quarterly visits, suggesting that adolescents may benefit from more frequent visits and counseling [see Warnings and Precautions (5.2)] . Safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP in pediatric patients weighing less than 35 kg have not been established.
Geriatric use
8.5 Geriatric Use Clinical trials of FTC, TDF, or emtricitabine and tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis. Tenofovir Disoproxil Fumarate: Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of TDF, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
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 analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxy methyl)-1,3-oxathiolan-5- yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: FTC is a white to almost white crystalline powder and freely soluble in methonal and water, practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is −0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy] phosphinyl] methoxy] propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P · C 4 H 4 O 4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder and Soluble in methanol, slightly soluble in water. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. Emtricitabine and Tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths: Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry white Y-1-7000, which contains hypromellose 2910 (5cP), polyethylene glycol 400 (macrogol) & titanium dioxide. Structure Structure
Mechanism of action
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)].
How supplied
The white colored, capsule shaped, biconvex, film coated tablets contain 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil), tablets engraved TE on one side and plain on the other side., and are available in unit of use bottles (75CC), containing a dessicant [silica gel canister or sachet] and closed with a child-resistant closure/screw cap of: 30 tablets (NDC-64380-719-04) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Keep container tightly closed Dispense only in original container Do not use if seal over bottle opening is broken or missing
Patient 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 HIV-1 PrEP Advise HIV-uninfected individuals about the following [see Warnings and Precautions (5.2)]: The need to confirm that they are HIV-negative before starting to take emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1. That HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking emtricitabine and tenofovir disoproxil fumarate, because emtricitabine and tenofovir disoproxil fumarate alone does not constitute a complete regimen for HIV-1 treatment. The importance of taking emtricitabine and tenofovir disoproxil fumarate on a regular dosing schedule and strict adherence to the recommended dosing schedule to reduce the risk of acquiring HIV-1. Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses. That emtricitabine and tenofovir disoproxil fumarate does not prevent other sexually acquired infections and should only be used as part of a complete prevention strategy including other prevention measures. To use condoms consistently and correctly to lower the chances of sexual contact with any body fluids such as semen, vaginal secretions, or blood. The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s). The importance of virologic suppression in their partner(s) with HIV-1. The need to get tested regularly for HIV-1 (at least every 3 months, or more frequently for some individuals such as adolescents) and to ask their partner(s) to get tested as well. To report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately. That the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal). To get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea, that may facilitate HIV-1 transmission. To assess their sexual risk behavior and get support to help reduce sexual risk behavior. Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued emtricitabine and tenofovir disoproxil fumarate [see Warnings and Precautions (5.1)]. Advise HBV-infected individuals to not discontinue emtricitabine and tenofovir disoproxil fumarate without first informing their healthcare provider. New Onset or Worsening Renal Impairment Inform HIV-1 infected patients and uninfected individuals that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of TDF, a component of emtricitabine and tenofovir disoproxil fumarate. Advise patients to avoid emtricitabine and tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions (5.3)] . The dosing interval of emtricitabine and tenofovir disoproxil fumarate may need adjustment in HIV-1 infected patients with renal impairment. Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP should not be used in HIV-1 uninfected individuals if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Dosage and Administration (2.6)] . Immune Reconstitution Syndrome Inform HIV-1 infected patients that in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [see Warnings and Precautions (5.4)]. Bone Loss and Mineralization Defects Inform patients that decreases in bone mineral density have been observed with the use of TDF or emtricitabine and tenofovir disoproxil fumarate. Consider bone monitoring in patients and uninfected individuals who have a history of pathologic bone fracture or at risk for osteopenia [see Warnings and Precautions (5.5)]. Lactic Acidosis and Severe Hepatomegaly Inform HIV-1 infected patients and uninfected individuals that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with emtricitabine and tenofovir disoproxil fumarate should be suspended in any person who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.6)] . Drug Interactions Advise individuals that emtricitabine and tenofovir disoproxil fumarate may interact with many drugs; therefore, advise individuals to report to their healthcare provider the use of any other medication, including other HIV drugs and drugs for treatment of hepatitis C virus [see Warnings and Precautions (5.7) and Drug Interactions (7)]. Dosage Recommendations for Treatment of HIV-1 Infection Inform HIV-1 infected patients that it is important to take emtricitabine and tenofovir disoproxil fumarate with other antiretroviral drugs for the treatment of HIV-1 on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance.
Label text from the FDA structured product label by Strides Pharma Science Limited (revised Jan 8, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Emtricitabine in 43 products
- Tenofovir Disoproxil Fumarate in 43 products
Emtricitabine and tenofovir disoproxil fumarate NDC products (43)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6494 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7719 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-8028 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 69238-2092 | Emtricitabine 100 mg/1; Tenofovir Disoproxil Fumarate 150 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-2093 | Emtricitabine 133 mg/1; Tenofovir Disoproxil Fumarate 200 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-2094 | Emtricitabine 167 mg/1; Tenofovir Disoproxil Fumarate 250 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-2095 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 60219-2095 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 59651-166 | Emtricitabine 133 mg/1; Tenofovir Disoproxil Fumarate 200 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-354 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-167 | Emtricitabine 167 mg/1; Tenofovir Disoproxil Fumarate 250 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-165 | Emtricitabine 100 mg/1; Tenofovir Disoproxil Fumarate 150 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 42291-980 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 71335-2650 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-560 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 69097-209 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Cipla USA Inc. | ANDA |
| 69097-741 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Cipla USA Inc. | ANDA |
| 72189-312 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | DirectRx | ANDA |
| 76282-677 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Exelan Pharmaceuticals, Inc. | ANDA |
| 51407-112 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 42385-953 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 68180-287 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-106 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7172 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 16714-534 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 68071-3986 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3831 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3695 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 82804-086 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-776 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82009-109 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA |
| 67296-2198 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 42543-719 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 64380-719 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 0093-7704 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 70771-1620 | Emtricitabine 100 mg/1; Tenofovir Disoproxil Fumarate 150 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1621 | Emtricitabine 133 mg/1; Tenofovir Disoproxil Fumarate 200 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1622 | Emtricitabine 167 mg/1; Tenofovir Disoproxil Fumarate 250 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1709 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70710-1365 | Emtricitabine 133 mg/1; Tenofovir Disoproxil Fumarate 200 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1366 | Emtricitabine 167 mg/1; Tenofovir Disoproxil Fumarate 250 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1367 | Emtricitabine 200 mg/1; Tenofovir Disoproxil Fumarate 300 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1364 | Emtricitabine 100 mg/1; Tenofovir Disoproxil Fumarate 150 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
Frequently asked questions
What is Emtricitabine and tenofovir disoproxil fumarate used for?
1 INDICATIONS AND USAGE HIV-1 Treatment (1.1) Emtricitabine and tenofovir disoproxil fumarate 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…
What are the side effects of Emtricitabine and tenofovir disoproxil fumarate?
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 (5.1)]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3)]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.4)]. Bone Loss and Mineralization Defects [see Warnings and… See the full label for the complete list.
Who makes Emtricitabine and tenofovir disoproxil fumarate?
Emtricitabine and tenofovir disoproxil fumarate is listed by 24 labelers in the FDA NDC directory, including A-S Medication Solutions, Amneal Pharmaceuticals NY LLC, Aurobindo Pharma Limited, AvKARE.