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: May 22, 2018; Last Reviewed: May 22, 2018

Etravirine (ETR, Intelence, TMC 125)
Etravirine (ETR, Intelence, TMC 125)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablets: 25 mg, 100 mg, and 200 mg
Dosing Recommendations Selected Adverse Events
Neonate/Infant Dose:
  • Not approved for use in neonates/infants.
Pediatric Dose:
  • Not approved for use in children aged <6 years. Studies in infants and children aged 2 months to 6 years are under way.
Antiretroviral-Experienced Children and Adolescents Aged 6–18 Years and Weighing ≥16 kg
Body Weight Dose
16 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 following a meal
  • Nausea
  • Diarrhea
  • Rash, including Stevens-Johnson syndrome
  • Hypersensitivity with rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure
Special Instructions
  • Always administer etravirine following a meal. Area under the curve of etravirine is decreased by about 50% when the drug is taken on an empty stomach. The type of food does not affect the exposure to etravirine.
  • Etravirine tablets are sensitive to moisture; store at room temperature in original container with desiccant.
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 enough liquid to cover the medication, and stir well until the water looks milky. If desired, add more water or, alternatively, orange juice or milk. Note: Patients should not place the tablets in orange juice or milk without first adding water. The use of grapefruit juice, warm (>40°C) drinks, 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.
Metabolism/Elimination
  • Etravirine is an inducer of cytochrome P450 3A4 (CYP3A4) and an inhibitor of CYP2C9, CYP2C19, and P-glycoprotein. It is a substrate for CYP3A4, 2C9, and 2C19.
  • 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 necessary for patients with mild-to-moderate hepatic insufficiency. No dosing information is available for patients with severe hepatic impairment.
Etravirine Dosing in Patients with Renal Impairment:
  • Dose adjustment is not required in patients with renal impairment.

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