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 14, 2020; Last Reviewed: April 14, 2020

Etravirine (ETR, Intelence)
Etravirine (ETR, Intelence)
Formulations
Tablets: 25 mg, 100 mg, 200 mg
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Etravirine (ETR) is not approved for use in neonates or infants.
Child Dose:
  • ETR 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 Therapy-Experienced Children and Adolescents Aged 2 to 18 Years and Weighing ≥10 kg
Body Weight Twice-Daily Dose
10 kg to <20 kg 100 mg
20 kg to <25 kg 125 mg
25 kg to <30 kg 150 mg
≥30 kg 200 mg


Adult Dose for Antiretroviral Therapy-Experienced Patients:
  • ETR 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
  • ETR tablets are sensitive to moisture; store the tablets at room temperature in the original container with desiccant.
  • Area under the curve of ETR is decreased by about 50% when the drug is taken on an empty stomach. Always administer ETR with food. The type of food does not affect the exposure to ETR.
  • Swallowing ETR tablets whole is the preferred means of administration and although the package insert contains instructions for dispersing ETR tablets in water or other liquids, using this administration method generally results in lower ETR exposures than swallowing tablets whole. Children who receive dispersed ETR tablets should switch to swallowing tablets whole as soon as they are able.
Metabolism/Elimination
  • ETR 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.
  • ETR 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 ETR 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 when using ETR in patients with renal impairment.

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