The Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet label was recently updated to expand the indication to include pediatric patients weighing at least 12 kilograms and the addition of the following strength tablets (100/150 mg, 133/200 mg and 167/250 mg). Below is a summary of the changes.
DOSAGE AND ADMINISTRATION
Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17kg or More 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 [FTC]/tenofovir 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.
Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using TRUVADA Low Strength Tablets
| 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 |
DOSAGE FORMS AND STRENGTHS
TRUVADA tablets are available in three new dose strengths:
- Tablet: 100 mg of emtricitabine and 150 mg of tenofovir disoproxil fumarate (equivalent to 123 mg of tenofovir disoproxil): blue, oval-shaped, film-coated, debossed with “GSI” on one side and with “703” on the other side.
- Tablet: 133 mg of emtricitabine and 200 mg of tenofovir disoproxil fumarate (equivalent to 163 mg of tenofovir disoproxil): blue, rectangular-shaped, film-coated, debossed with “GSI” on one side and with “704” on the other side.
- Tablet: 167 mg of emtricitabine and 250 mg of tenofovir disoproxil fumarate (equivalent to 204 mg of tenofovir disoproxil): blue, modified capsule-shaped, film-coated, debossed with “GSI” on one side and with “705” on the other side.
ADVERSE REACTIONS
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 VIREAD were consistent with those observed in clinical trials of VIREAD in adults.
Eighty-nine pediatric subjects (2 to less than 12 years of age) received VIREAD in Study 352 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 also had decreases in total body or spine BMD Z score [See Warnings and Precautions (5.5)]. For additional information, please consult the VIREAD prescribing information.
Pediatric Use
No pediatric clinical trial was conducted to evaluate the safety and efficacy of TRUVADA. Data from previously conducted trials with the individual drug products, EMTRIVA and VIREAD, were relied upon to support dosing recommendations for TRUVADA. For additional information, please consult the prescribing information for EMTRIVA and VIREAD.
TRUVADA 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 whole tablet. Because it is a fixed-dose combination tablet, TRUVADA cannot be adjusted for patients of lower weight [See Warnings and Precautions (5.5), Adverse Reactions (6.1) and Clinical Pharmacology (12.3)]. TRUVADA has not been evaluated for use in pediatric patients weighing less than 17 kg.
Pharmacokinetics
Pediatric Patients
The pharmacokinetic data for tenofovir and emtricitabine following administration of TRUVADA in pediatric subjects weighing 17 kg and above are not available. The dosing recommendations of TRUVADA in this population are based on the dosing recommendations of EMTRIVA and VIREAD in this population. Refer to the EMTRIVA and VIREAD prescribing information for pharmacokinetic information on the individual products in pediatric patients.
The updated label is available at Drugs@FDA (http://www.accessdata.fda.
Truvada is a product of Gilead Sciences, Inc.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
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