Active Ingredient: Etravirine
Etravirine, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and in antiretroviral treatment-experienced paediatric patients from 2 years of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 200 milligrams etravirine, 2 times daily.
The recommended dose of etravirine for adults is 200 mg taken orally twice daily following a meal.
If the patient misses a dose of etravirine within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time. If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking the medicine, another dose of etravirine should be taken following a meal as soon as possible. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
There is limited information regarding the use of etravirine in patients >65 years of age, therefore caution should be used in this population.
Take after meal.
For:
Regimen A: In case that patient weight is ≥ 10 kg and patient weight is < 20 kg, oral, 100 milligrams etravirine, 2 times daily.
Regimen B: In case that patient weight is ≥ 20 kg and patient weight is < 25 kg, oral, 125 milligrams etravirine, 2 times daily.
Regimen C: In case that patient weight is ≥ 25 kg and patient weight is < 30 kg, oral, 150 milligrams etravirine, 2 times daily.
Regimen D: In case that patient weight is ≥ 30 kg, oral, 200 milligrams etravirine, 2 times daily.
The recommended dose of etravirine for paediatric patients (2 years to less than 18 years of age and weighing at least 10 kg) is based on body weight (see table below). Etravirine should be taken orally, following a meal.
Recommended dose of etravirine for paediatric patients 2 years to less than 18 years of age:
| Body weight | Dose | Tablets |
|---|---|---|
| ≥10 to <20 kg | 100 mg twice daily | four 25 mg tablets twice daily or one 100 mg tablet twice daily |
| ≥20 to <25 kg | 125 mg twice daily | five 25 mg tablets twice daily or one 100 mg tablet and one 25 mg tablet twice daily |
| ≥25 to <30 kg | 150 mg twice daily | six 25 mg tablets twice daily or one 100 mg tablet and two 25 mg tablets twice daily |
| ≥30 kg | 200 mg twice daily | eight 25 mg tablets twice daily or two 100 mg tablets twice daily or one 200 mg tablet twice daily |
If the patient misses a dose of etravirine within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time. If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking the medicine, another dose of etravirine should be taken following a meal as soon as possible. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
Take after meal.
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