Dosage of Truvada in details
Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More
The recommended dose of Truvada in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of Emtricitabine (Truvada) and 300 mg of Tenofovir (Truvada) disoproxil fumarate) once daily taken orally with or without food.
Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Whole Tablet
The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one Truvada low strength tablet (Emtricitabine (Truvada) [FTC]/Tenofovir (Truvada) disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food.
The recommended oral dosage of Truvada low strength tablets is presented in Table 1. Weight should be monitored periodically and the Truvada dose adjusted accordingly.
|Body Weight (kg)||Dosing of FTC (mg)/TDF (mg)|
|17 to less than 22||one 100/150 tablet once daily|
|22 to less than 28||one 133/200 tablet once daily|
|28 to less than 35||one 167/250 tablet once daily|
Recommended Dose for Pre-exposure Prophylaxis
The dose of Truvada in HIV-1 uninfected adults is one tablet (containing 200 mg of Emtricitabine (Truvada) and 300 mg of Tenofovir (Truvada) disoproxil fumarate) once daily taken orally with or without food.
Dose Adjustment for Renal Impairment
Treatment of HIV-1 Infection
Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment. Therefore, adjust the dosing interval of Truvada in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 2. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients.
No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.
|Creatinine Clearance (mL/min)*|
(Including Patients Requiring Hemodialysis)
|Recommended Dosing Interval||Every 24 hours||Every 48 hours||Truvada should not be administered.|
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment.
Do not use Truvada for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Truvada for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.
What other drugs will affect Truvada?
Emtricitabine (Truvada) and Tenofovir (Truvada) can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medications, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).
Other drugs may interact with Emtricitabine (Truvada) and Tenofovir (Truvada), including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
No drug interaction trials have been conducted using TRUVADA tablets. Drug interaction trials have been conducted with Emtricitabine (Truvada) and Tenofovir (Truvada) disoproxil fumarate, the components of TRUVADA. This section describes clinically relevant drug interactions observed with Emtricitabine (Truvada) and Tenofovir (Truvada) disoproxil fumarate.
Coadministration of TRUVADA and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosineassociated adverse reactions. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions.
When Tenofovir (Truvada) disoproxil fumarate was administered with didanosine the Cmax and AUC of didanosine increased significantly. The mechanism of this interaction is unknown. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving Tenofovir (Truvada) DF with didanosine 400 mg daily.
In patients weighing greater than 60 kg, the didanosine dose should be reduced to 250 mg when it is coadministered with TRUVADA. Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg. When coadministered, TRUVADA and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% fat).
HIV-1 Protease Inhibitors
Tenofovir (Truvada) decreases the AUC and Cmin of atazanavir. When coadministered with TRUVADA, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. TRUVADA should not be coadministered with atazanavir without ritonavir.
Lopinavir/ritonavir, atazanavir coadministered with ritonavir, and darunavir coadministered with ritonavir have been shown to increase Tenofovir (Truvada) concentrations. Tenofovir (Truvada) disoproxil fumarate is a substrate of Pglycoprotein (Pgp) and breast cancer resistance protein (BCRP) transporters. When Tenofovir (Truvada) disoproxil fumarate is co-administered with an inhibitor of these transporters, an increase in absorption may be observed. Patients receiving TRUVADA concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir should be monitored for Tenofovir (Truvada) disoproxil fumarate-associated adverse reactions. TRUVADA should be discontinued in patients who develop Tenofovir (Truvada) disoproxil fumarate -associated adverse reactions.
Hepatitis C Antiviral Agents
Coadministration of Tenofovir (Truvada) disoproxil fumarate and HARVONI® (ledipasvir/sofosbuvir) has been shown to increase Tenofovir (Truvada) exposure.
In patients receiving TRUVADA concomitantly with HARVONI without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, monitor for adverse reactions associated with Tenofovir (Truvada) disoproxil fumarate.
In patients receiving TRUVADA 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 (Truvada) concentrations in this setting has not been established. If coadministration is necessary, monitor for adverse reactions associated with Tenofovir (Truvada) disoproxil fumarate.
Drugs Affecting Renal Function
Emtricitabine (Truvada) and Tenofovir (Truvada) are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion. No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration of TRUVADA with drugs that are eliminated by active tubular secretion may increase concentrations of Emtricitabine (Truvada), Tenofovir (Truvada), 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. Drugs that decrease renal function may increase concentrations of Emtricitabine (Truvada) and/or Tenofovir (Truvada).
- DailyMed. "EMTRICITABINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "G70B4ETF4S: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Truvada are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Truvada. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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Information checked by Dr. Sachin Kumar, MD Pharmacology