Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)
Last Updated: April 16, 2019; Last Reviewed: April 16, 2019
Etravirine (ETR, Intelence)
|Etravirine (ETR, Intelence)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
|Tablets: 25 mg, 100 mg, 200 mg
||Selected Adverse Events
- Etravirine is not approved for use in neonates/infants.
- Etravirine is not approved for use in children aged <2 years. Studies in infants and children aged 2 months to 2 years are under way.
Etravirine Dosing Table for Antiretroviral-Experienced Children and Adolescents Aged 2 Years to 18 Years and Weighing ≥10 kg
|10 kg to <20 kg
||100 mg twice daily
|20 kg to <25 kg
||125 mg twice daily
|25 kg to <30 kg
||150 mg twice daily
||200 mg twice daily
Adult Dose (Antiretroviral-Experienced Patients):
- 200 mg twice daily with food
- Rash, including Stevens-Johnson syndrome
- Hypersensitivity with rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure
Instructions for Dispersing Etravirine Tablets in Liquid:
- Area under the curve of etravirine is decreased by about 50% when the drug is taken on an empty stomach. Always administer etravirine with food. The type of food does not affect the exposure to etravirine.
- Patients who are unable to swallow etravirine tablets may disperse the tablets in liquid.
- Place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication, and stir well until the water looks milky. Add approximately 15 mL (1 tablespoon) of additional liquid. Water may be used, but other liquids, such as orange juice or milk, may improve the taste of the medication. Patients should not place the tablets in orange juice or milk without first adding water. Warm beverages (with temperatures >104°F or >40°C) or carbonated beverages should be avoided.
- Drink immediately, then rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the entire dose is consumed.
- Etravirine tablets are sensitive to moisture; store the tablets at room temperature in the original container with desiccant.
Etravirine Dosing in Patients with Hepatic Impairment:
- Etravirine is an inducer of cytochrome P450 (CYP) 3A4 and an inhibitor of CYP2C9, CYP2C19, and P-glycoprotein. It is a substrate for CYP3A4, CYP2C9, and CYP2C19.
- Etravirine is involved in multiple interactions with antiretroviral agents and other drugs (see text below).
Etravirine Dosing in Patients with Renal Impairment:
- No dose adjustment is required when using etravirine in patients with mild or moderate hepatic insufficiency. No dosing information is available for patients with severe hepatic impairment.
- No dose adjustment is required for patients with renal impairment.