Classes
DEA Class; Rx
Common Brand Names; Intelence
- HIV, NNRTIs
Description
Non-nucleoside reverse transcriptase inhibitor (NNRTI)
Used with other antiretroviral drugs to treat HIV-1 infections in treatment-experienced patients 2 years and older
Associated with severe and potentially life-threatening rashes
Indications
Treatment of HIV-1 infection in combination with ≥2 additional antiretroviral agents in treatment-experienced patients exhibiting viral replication with documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance
Adverse Effects
- Rash (16.9%)
- Nausea (13.9%)
- Increased LDL (13%)
- GI disorders (2.3-5.2%)
- Fatigue (3.3%)
- Peripheral neuropathy (4%)
- Increased creatinine (2%)
- Diarrhea (2%)
- Stevens-Johnson syndrome
- Erythema multiforme
- Angina
- Angioedema
- Toxic epidermal necrolysis (including reports of fatalities)
- Hypersensitivity reactions (including cases of hepatic failure)
Warnings
Hypersensitivity
Risk of severe skin reactions (eg, Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis)
Hypersensitivity reactions including drug rash with eosinophilia and systemic symptoms (DRESS) reported; characterized by rash, constitutional findings, and sometimes organ dysfunction; discontinue if severe rash develops and initiate appropriate therapy
Risk of immune reconstitution syndrome
50% decrease in absorption when administered under fasting conditions: only take with meal
Pregnancy and Lactation
Etravirine use during pregnancy evaluated in a limited number of individuals as reported by the APR, and available data show 1 birth defect in 66 first trimester exposures to etravirine-containing regimens
The Centers for Disease Control and Prevention recommend HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV
Based on limited data, etravirine has been shown to be present in human breast milk
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
weighing 30 kg or more: 400 mg/day PO.
weighing 25 to 29 kg: 300 mg/day PO.
2 to 12 years weighing 30 kg or more: 400 mg/day PO.
2 to 12 years weighing 25 to 29 kg: 300 mg/day PO.
2 to 12 years weighing 20 to 24 kg: 250 mg/day PO.
2 to 12 years weighing 10 to 19 kg: 200 mg/day PO.
less than 2 years or less than 10 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Etravirine
tablet
- 25mg
- 100mg
- 200mg
