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Intelence Generic Name & Formulations
Legal Class
Rx
General Description
Etravirine 25mg+, 100mg, 200mg; tabs, (+) scored.
Pharmacological Class
Non-nucleoside reverse transcriptase inhibitor.
How Supplied
Tabs 25mg, 100mg—120; 200mg—60
Manufacturer
Intelence Indications
Indications
HIV-1 infection, in combination with other antiretrovirals, in treatment-experienced patients ≥2yrs of age.
Intelence Dosage and Administration
Adult
Take after meals. Swallow whole with liquid; or, may disperse tabs in water and drink. ≥18yrs: 200mg twice daily.
Children
Take after meals. Swallow whole with liquid; or, may disperse tabs in water and drink. <2yrs or <10kg: not recommended. ≥2yrs (≥10kg–<20kg): 100mg twice daily; (≥20kg–<25kg): 125mg twice daily; (≥25kg–<30kg): 150mg twice daily; (≥30kg): 200mg twice daily.
Intelence Contraindications
Not Applicable
Intelence Boxed Warnings
Not Applicable
Intelence Warnings/Precautions
Warnings/Precautions
Discontinue immediately if severe skin or hypersensitivity reactions develop; monitor closely. Monitor clinical status including liver transaminases. Severe hepatic impairment. Elderly. Pregnancy. Nursing mothers: not recommended.
Intelence Pharmacokinetics
See Literature
Intelence Interactions
Interactions
Concomitant tipranivir/ritonavir, fosamprenavir/ritonavir, atazanavir/cobicistat, darunavir/cobicistat, PIs without ritonavir (eg, atazanavir, fosamprenavir, nelfinavir, indinavir), ritonavir (600mg twice daily), NNRTIs (eg, efavirenz, nevirapine, delavirdine, rilpivirine), anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), rifampin, rifapentine, St. John's wort, elbasvir/grazoprevir, simeprevir: not recommended. Antagonizes dolutegravir (should only be used with etravirine when concomitant with darunavir/ritonavir, lopinavir/ritonavir, or atazanavir/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 be antagonized by systemic dexamethasone (consider alternatives). May potentiate diazepam. Clarithromycin (consider azithromycin for treating MAC). Adjust statin (except pravastatin, rosuvastatin), maraviroc, daclatasvir dose. Monitor digoxin, warfarin, buprenorphine, buprenorphine/naloxone, methadone. Rifabutin (adjust dose with etravirine monotherapy). See full labeling.
Intelence Adverse Reactions
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.
Intelence Clinical Trials
See Literature
Intelence Note
Notes
Report pregnant patients exposed to etravirine by calling (800) 258-4263.
Intelence Patient Counseling
See Literature
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