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INTELENCE
Viral infections
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Drug Name:

INTELENCE Rx

Generic Name and Formulations:
Etravirine 25mg+, 100mg, 200mg; tabs, (+) scored.

Company:
Janssen Therapeutics

Therapeutic Use:

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.

Warnings/Precautions:

Discontinue if severe skin or hypersensitivity reactions develop; monitor closely. Monitor clinical status including liver transaminases. Severe hepatic impairment. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concomitant tipranivir/ritonavir, fosamprenavir/ritonavir, 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: not recommended. Antagonizes dolutegravir (should only be used with etravirine and when concomitant 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. Concomitant boceprevir in presence of other drugs (eg, darunavir/ritonavir, lopinavir/ritonavir, saquinavir/ritonavir, tenofovir disoproxil fumarate, or rifabutin): not recommended. 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 dexamethasone (consider alternatives). May potentiate warfarin, diazepam. Clarithromycin (consider azithromycin for treating MAC). Adjust statin dose (except pravastatin, rosuvastatin). Monitor digoxin, buprenorphine, buprenorphine/naloxone, methadone. Rifabutin (adjust dose with etravirine monotherapy). See full labeling.

Pharmacological Class:

Non-nucleoside reverse transcriptase inhibitor.

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, autoimmune disorders, 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

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