Paediatric labeling expanded, and additional tablet strengths for FTC/TDF

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

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 paediatric 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

Table 1. Dosing for paediatric 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.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021752s047lbl.pdf (PDF)