FDA approves etravirine for treatment-experienced children 6 to 18 years of age and new scored 25 mg tablet for paediatric dosing

On 26 March 2012, the United States Food and Drug Administration (FDA) approved dosing recommendations for etravirine (Intelence) for treatment-experienced paediatric patients 6 to 18 years of age and weighing at least 16 kg.

In addition a new scored 25 mg tablet was approved for use in paediatric patients. Listed below are a summary of major changes to the product labelling.

2.2 Paediatric patients (6 years to <18 years)

The recommended dose of etravirine for paediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight not exceeding the recommended adult dose. Etravirine tablet(s) should be taken orally, following a meal. The type of food does not affect the exposure to etravirine. The safety and efficacy of etravirine have not been established in children less than 6 years of age.

Healthcare professionals should pay special attention to the accurate dose selection of etravirine, the transcription of the medication order, the dispensing information and the dosing instructions to minimise the risk of medication errors, overdosing, and underdosing.

2.3 Method of administration

Patients should be instructed to swallow the etravirine tablet(s) whole with a liquid such as water. Patients who are unable to swallow the etravirine tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following:

  • Place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medication.
  • Stir well until the water looks milky, if desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water). The use of grapefruit juice or warm (greater than 40°C) or carbonated beverages should be avoided.
  • Drink it immediately.
  • Rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.


The safety assessment in children and adolescents is based on the Week 24 analysis of the single-arm, Phase 2 trial TMC125-C213 in 101 particiapants. The frequency, type and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adult subjects, except for rash, which was observed more frequently in pediatric subjects.

8.4 Paediatric use

Treatment with etravirine is not recommended in children less than 6 years of age.

For full details see the complete labeling posted on the FDA web site.

Source: FDA list serve. (26 March 2012).

Links to other websites are current at date of posting but not maintained.