Emtricitabine with Tenofovir Disoproxil Fumarate (trade names include Truvada, Ricovir-EM, Tavin-EM, Tenvir-EM) is a fixed-dose combination antiretroviral medication containing antivirals for treatment of HIV infections. This medicine is indicated to treat and prevent HIV/AIDS (HIV-1 treatment and HIV-1 PrEP). It can be used either alone or with other antiretroviral drugs.
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Dolutegravir, Lamivudine, Tenofovir (Viropil)
Efavirenz, Emtricitabine, Tenofovir (Atripla)
Lamivudine, Zidovudine (Combivir)
Lopinavir, Ritonavir (Kaletra)
Tenofovir Alafenamide (Vemlidy)
Tenofovir Disoproxil Fumarate (Viread)
Pharmacological and medical categories:
Fixed-dose combination antiretroviral medications
HIV/AIDS infection treatment medicines
Nucleoside reverse transcriptase inhibitors (NRTI)
J - Antiinfectives for systemic use
J05 - Antivirals for systemic use
J05A - Direct acting antivirals
J05AR - Antivirals for treatment of HIV infections, combinations
J05AR03 - Tenofovir Disoproxil and Emtricitabine
Human immunodeficiency virus [HIV] disease - B20
Indications and usage:
Truvada 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.
Truvada tablets are 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-1infection. Individuals must have a negative HIV-1 test immediately prior to initiating Truvada for HIV-1 PrEP.
Dosage and administration:
Testing: Prior to or when initiating Truvada test for hepatitis B virus infection. Prior to initiation and during use of Truvada, 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.
HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating Truvada for HIV-1 PrEP and at least once every 3 months while taking this medication, and upon diagnosis of any other sexually transmitted infections (STIs).
Treatment of HIV-1 Infection
Recommended dosage in adultsand pediatric patients weighing at least 35 kg: One Truvada tablet (containing 200 mg of FTCand 300 mg of TDF) once daily taken orally with or without food.
Recommended dosage in pediatric patients weighing at least 17 kg: One Truvada 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.
Recommended dosage in renally impaired HIV-1 infected adult patients:
- Creatinine clearance (CrCl) 30?49 mL/min: 1 tablet every 48 hours.
- CrCl below 30 mL/min or hemodialysis: Truvada is not recommended.
HIV-1 Pre-Exposure Prophylaxis (PrEP)
Recommended dosage in HIV-1 uninfected adultsand adolescents weighing at least 35 kg: One Truvada tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
Recommended dosage in renally impaired HIV-uninfected individuals: Truvada is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min.
Dosage forms and strengths:
Truvada tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate, respectively.
If overdose by Truvada (Emtricitabine, Tenofovir Disoproxil Fumarate) tablets 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 400mL/min and a dialysate flow rate of 600mL/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 300mg dose of TDF, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
Truvada for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
Warnings and precautions:
Comprehensive management to reduce the risk of acquiring HIV-1when Truvada is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.
Management to reduce the risk of acquiring HIV-1 drug resistancewhen Truvada is used for HIV-1 PrEP: refer to full prescribing information for additional detail.
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering Truvada with concurrent or recent use of nephrotoxic drugs.
Immune reconstitution syndromeduring treatment of HIV-1 infection: May necessitate further evaluation and treatment.
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.
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue Truvada in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Side effects, adverse reactions:
In HIV-1 infected patients, the most common adverse reactions of Truvada tablets (incidence greater than or equal to 10%) are nausea, diarrhea, fatigue, dizziness, headache, depression, abnormal dreams, insomnia, and rash.
In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of Truvada participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased.
To report suspected adverse reactions, contact Gilead Sciences, Inc. or your local FDA.
Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted.
Coadministration decreases atazanavir concentrations. When coadministered with Truvada, use atazanavir given with ritonavir.
Coadministration of Truvada with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.
Consult full prescribing information prior to and during treatment for important drug interactions.
Use in specific populations:
Lactation: Mothers infected with HIV-1 or suspected of having acquired HIV-1 infection should be instructed not to breastfeeddue to the potential for HIV transmission.
Pediatric use: No pediatric clinical trial was conducted to evaluate the safety and efficacy of Truvada in patients with HIV-1 infection.
Geriatric use: Clinical trials of FTC, TDF, or Truvada did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Renal impairment: The dosing interval for Truvada should be modified in HIV-infected adult individuals with estimated creatinine clearance of 30-49 mL/min. This drug is not recommended in individuals with estimated creatinine clearance below 30 mL/min and in individuals with end-stagerenal disease requiring dialysis.
B3 - Australia
N - United States (Not classified yet)
Salts and other forms:
Emtricitabine Base, Tenofovir Disoproxil Fumarate
Synonyms, international and chemical names:
Emtricitabina / Tenofovir
Emtricitabino / Tenofoviro
Emtrisitabin / Tenofovir
Tenofovir / Emtricitabin
Tenofovir / Emtricitabina
Brands, generics, trade names:
Emtricitabine, Tenofovir - Amneal Pharmaceuticals, Aurobindo, Hetero Drugs, Matrix Laboratories, Teva
Ricovir-EM - Mylan, Atlanta Medicare
Tavin-EM - Emcure Pharmaceuticals
Tenvir-EM - Cipla
Truvada - Gilead, Bristol-Myers Squibb, Especificos Stendhal, IDS Group, LF Asia Pharmaceutical Division
APIs used in medicine in combinations with emtricitabine and tenofovir:
Here is a list of popular medications containing emtricitabine with tenofovir as main active pharmaceutical ingredients; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:
|Trade name of the drug
||Pharmaceutical forms and doses
||Tablets, Film-Coated; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg
||Tablets; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg
||Tablets, Film-Coated; Oral; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg
||GileadBristol-Myers SquibbEspecificos StendhalIDS GroupLF Asia Pharmaceutical Division
Emtricitabine/tenofovir main article on Wikipedia: https://en.wikipedia.org/wiki/Emtricitabine/tenofovir
Emtricitabine and tenofovir disoproxil fumarate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Emtricitabine-and-tenofovir-disoproxil-fumarate
Emtricitabine on DrugBank: https://go.drugbank.com/drugs/DB00879
Tenofovir Disoproxil on DrugBank: https://go.drugbank.com/drugs/DB00300
Emtricitabine and Tenofovir FAQ on MedlinePlus (revised 09/15/2020): https://medlineplus.gov/druginfo/meds/a612036.html
Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) tablets film-coated drug label info on DailyMed (revised December 21, 2020): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Amneal Emtricitabine and Tenofovir Disoproxil Fumarate tablets film-coated drug label info on DailyMed (revised July 20, 2020): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Emtricitabine containing drugs on Drugs-About.com: https://drugs-about.com/ing/emtricitabine.html
Tenofovir containing drugs on Drugs-About.com: https://drugs-about.com/ing/tenofovir.html
Emtricitabine with Tenofovir for sale on Pharma Doctor: https://pharma-doctor.com/emtricitabine-tenofovir.html
Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) tablets for oral use official prescribing information and medication guide from the U.S. FDA (revised 05/2018): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) tablets for oral use prescribing information and medication guide from Gilead pharmaceutical company (revised 06/2020): https://www.gilead.com/~/media/files/pdfs/medicines/hiv/truvada/truvada_pi.pdf
Truvada for PrEP (Pre-Exposure Prophylaxis) official website: https://www.truvada.com/
Tenvir-EM tablets (Emtricitabine + Tenofovir Disoproxil Fumarate) prescribing information from Cipla pharmaceutical company (revised May 2018): https://www.ciplamed.com/content/tenvir-em-tablets
Truvada (Emtricitabine/Tenofovir Disoproxil) film-coated tablets package information leaflet on Medicines.org.uk (revised 01/2021): https://www.medicines.org.uk/emc/files/pil.3890.pdf
Revised: February 2021
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