Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)

Etravirine

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/
Formulations
Tablets: 25 mg, 100 mg, 200 mg
Dosing Recommendations Selected Adverse Events
Neonate/Infant Dose:
  • Etravirine is not approved for use in neonates/infants.
Child Dose:
  • 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
Body Weight Dose
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
≥30 kg 200 mg twice daily

Adult Dose (Antiretroviral-Experienced Patients)
:
  • 200 mg twice daily with food
  • Nausea
  • Diarrhea
  • Rash, including Stevens-Johnson syndrome
  • Hypersensitivity with rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure
Special Instructions
  • 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.
Instructions for Dispersing Etravirine Tablets in Liquid:
  • 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.
Metabolism/Elimination
  • 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 Hepatic 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.
Etravirine Dosing in Patients with Renal Impairment:
  • No dose adjustment is required for patients with renal impairment.

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