Indications for INTELENCE:

HIV-1 infection, in combination with other antiretrovirals, in treatment-experienced patients ≥6yrs of age with evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretrovirals.

Adult:

Take after meals. May disperse tabs in water and drink. ≥18yrs: 200mg twice daily.

Children:

Take after meals. May disperse tabs in water and drink. <6yrs or <16kg: not established. ≥6yrs: ≥16kg–<20kg: 100mg twice daily. ≥20kg–<25kg: 125mg twice daily. ≥25kg–<30kg: 150mg twice daily. ≥30kg: 200mg twice daily.

Pharmacological Class:

Non-nucleoside reverse transcriptase inhibitor.

Warnings/Precautions:

Severe hepatic impairment. Discontinue if severe rash, severe hypersensitivity, or liver transaminase elevations develop; monitor closely. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concomitant tipranivir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, PIs without ritonavir (eg, atazanavir, fosamprenavir, nelfinavir, indinavir), ritonavir (600mg twice daily), NNRTIs (eg, efavirenz, nevirapine, delavirdine): not recommended. Avoid rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, phenobarbital; rifabutin with darunavir/ritonavir, lopinavir/ritonavir or saquinavir/ritonavir. May affect, or be affected by, drugs that induce or inhibit, or that are substrates of, CYP3A4, CYP2C9, CYP2C19 (eg, azole antifungals, immunosuppressants); monitor. May antagonize antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine) (monitor), sildenafil, clopidogrel (consider alternatives), antimalarials (eg, artemether/lumefantrine). May potentiate warfarin, diazepam. May be antagonized by anticonvulsants, dexamethasone. Clarithromycin (consider azithromycin for treating MAC). Adjust statin dose (except pravastatin, rosuvastatin). Rifabutin (adjust dose with etravirine monotherapy). See full labeling.

Adverse Reactions:

Severe skin reactions (may be fatal, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), hypersensitivity (eg, DRESS), peripheral neuropathy, diarrhea, fat redistribution, immune reconstitution syndrome, lab value changes (eg, lipids, blood glucose).

Note:

Report pregnant patients exposed to etravirine by calling (800) 258-4263.

How Supplied:

Tabs 25mg, 100mg—120; 200mg—60