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Pharmacologic classification: non-nucleoside reverse transcriptase inhibitor (NNRTI)
Therapeutic classification: antiretroviral
Pregnancy risk category: B
AVAILABLE FORMS
Tablets: 100 mg
INDICATIONS AND DOSAGES
In combination with other antiretrovirals to treat human immunodeficiency virus–1 (HIV-1) infection in treatment-experienced adults who have evidence of viral replication and HIV-1 strains resistant to a non-nucleotide reverse transcriptase inhibitor and other antiretrovirals--
Adults: 200 mg P.O. b.i.d., after a meal.
CONTRAINDICATIONS AND CAUTIONS
There are no known contraindications.
Use cautiously in pregnant women.
Safety and efficacy haven’t been established in children.
INTERACTIONS
Drug-drug.
Antiarrhythmics: May decrease antiarrhythmic effect. Monitor patient closely.
Azole antifungals: May increase serum level of antifungal. Monitor patient carefully and adjust antifungal dosage as appropriate.
Benzodiazepines (diazepam): May increase serum level of benzodiazepine. Use together cautiously.
Clarithromycin: May decrease antibiotic effect. Use an alternate antibiotic.
Corticosteroids: May decrease effectiveness of etravirine. Avoid using together.
CYP2C9 inducers (carbamazepine, phenobarbital, phenytoin): May decrease effectiveness of etravirine. Avoid using together.
Efavirenz, nevirapine rifampin, rifapentine, rifabutin: May decrease serum levels of these drugs. Avoid using together.
HMG-CoA reductase inhibitors (atorvastatin, simvastatin): May decrease effectiveness of these drugs. Monitor patient response.
Protease inhibitors (atazanavir, fosamprenavir, nelfinavir, indinavir) given without ritonavir: May significantly decrease serum level of etravirine. Avoid using together. Use low-dose ritonavir if protease inhibitors are necessary.
Ritonavir: May significantly decrease therapeutic effect of etravirine. Adjust ritonavir to less than standard dose of 600 mg b.i.d.
Tipranavir and ritonavir; fosamprenavir and ritonavir; atazanavir and ritonavir: May cause significant changes in therapeutic effect. Avoid using together.
Warfarin: May increase bleeding tendency. Monitor PT and INR closely and adjust dosage of warfarin as needed.
Drug-herb.
St. John’s wort: May decrease serum level of drug. Avoid using together.
ADVERSE REACTIONS
CNS: headache, peripheral neuropathy, vertigo, blurred vision, insomnia, anxiety, paresthesias.
CV: hypertension.
GI: diarrhea, nausea, abdominal pain, vomiting, dry mouth, flatulence.
Skin: rash, Steven-Johnson syndrome.
Other: fatigue, altered fat distribution, immune reconstitution syndrome.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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etravirine