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Pediatric Labeling Expanded, and Additional Tablet Strengths for FTC/TDF

May/June 2016

The combined formulation of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablet label was recently updated to expand the indication to include pediatric patients weighing at least 17 kilograms.

New strength tablets are available: 100/150 mg, 133/200 mg and 167/250 mg.

A summary of the changes is included below but please see prescribing information for full details.


Recommended Dose

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 low strength FTC/TDF tablet (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 dose adjusted accordingly.


Table 1. Dosing for Pediatric Patients Weighing 17 kg to Less Than 35 kg Using FTC/TDF 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


Dose Forms and Strengths

TRUVADA tablets are available in three new dose strengths:

  • Tablet: 100 mg of FTC and 150 mg of TDF (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 FTC and 200 mg of TDF (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 FTC and 250 mg of TDF (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.


Reference

Truvada (emtricitabine/tenofovir disoproxil fumarate) pediatric labeling expanded, & additional tablet strengths added.
www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf (PDF)




This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 

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