Warnings/Precautions:
Must have (–) pregnancy test before therapy, use 2 effective forms of contraception, and undergo monthly pregnancy test during treatment and for 6 months after. Risk of serious skin reactions (eg, Stevens-Johnson syndrome, DRESS, TEN); monitor. Moderate/severe hepatic impairment, decompensated liver disease: not recommended. Coinfection with HBV or HIV. Organ transplant recipients. Monitor hemoglobin and CBC with differential prior to and at weeks 2, 4, 8 and 12 during treatment. Monitor HCV-RNA at weeks 4 and 12, and clinical chemistry frequently. Elderly. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid concomitant atorvastatin. Concomitant colchicine w/renal or hepatic impairment, voriconazole; lopinavir, fosamprenavir, darunavir (all w/ritonavir): not recommended. May be potentiated by macrolides, azole antifungals. May be antagonized by anticonvulsants, rifabutin, dexamethasone, HIV protease inhibitors, efavirenz. May potentiate antiarrhythmics, digoxin, macrolides, carbamazepine, trazodone, azole antifungals, colchicine, rifabutin, alprazolam, midazolam, calcium channel blockers, corticosteroids, bosentan, atazanavir, tenofovir, immunosuppressants, salmeterol, PDE5 inhibitors for ED (reduce dose). May antagonize escitalopram, zolpidem, efavirenz, ethinyl estradiol, methadone. Monitor warfarin.

Adverse Reactions:
Rash (if serious; discontinue therapy and treat, do not restart), pruritus, anemia, GI upset, anorectal effects, dysgeusia, fatigue, hyperbilirubinemia, hyperuricemia.

Metabolism:
Hepatic (CYP3A4).

Elimination:
Fecal, renal.

Generic Availability:
NO

How Supplied:
Tabs—168 (7 blister strips x 6 tabs/ blister strip x 4 weekly cartons)