Select therapeutic use:
Indications for VICTRELIS:
Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy including prior null responders, partial responders, and relapsers. Not for use as monotherapy.
≥18yrs: Take with food. 800mg three times (every 7–9hrs) daily. Start after 4 weeks therapy with peginterferon and ribavirin. Without cirrhosis: continue treatment as indicated by HCV-RNA levels at Weeks 8, 12, and 24 (see full labeling). With cirrhosis: continue for 44 weeks. Do not reduce dose. Discontinue if HCV-RNA levels indicate futility (see full labeling).
<18yrs: not established.
Concomitant potent CYP3A4/5 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) or narrow therapeutic index CYP3A4/5 substrates (eg, alfuzosin, doxazosin, silodosin, tamsulosin, cisapride, ergot derivatives, lovastatin, simvastatin, drospirenone, pimozide, sildenafil or tadalafil for PAH, triazolam, oral midazolam). Pregnant women and men whose partners are pregnant (note: ribavirin is Cat.X). Review peginterferon and ribavirin contraindications.
Female patients and partners must have (–) pregnancy test before therapy; use at least 2 forms of effective contraception during and for ≥6 months after stopping therapy, and undergo monthly pregnancy test. Monitor CBCs w. differential, HCV-RNA. If Hgb <10g/dL: reduce or interrupt ribavirin; if Hgb <8.5g/dL: discontinue ribavirin; if ribavirin permanently discontinued, then peginterferon alfa and boceprevir must be discontinued. If decreases in neutrophil counts; may need to reduce dose or discontinue peginterferon alfa and ribavirin. Decompensated cirrhosis. Organ transplant recipients. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
See full labeling. Concomitant rifabutin, salmeterol, efavirenz, protease inhibitors, concomitant colchicine in renal or hepatic impairment: not recommended. Potentiates CYP3A4/5 substrates (eg, amiodarone, bepridil, propafenone, quinidine, trazodone, desipramine, azole antifungals, clarithromycin); monitor and consider dose adjustment. Potentiated by CYP3A4/5 inhibitors. Antagonizes ethinyl estradiol, escitalopram, etravirine. Monitor warfarin, digoxin, dihydropyridine calcium channel blockers, bosentan, immunosuppressants, opioids. Concomitant ketoconazole, itraconazole: max 200mg/day. Concomitant atorvastatin: max 40mg/day. Colchicine, PDE5 inhibitors for ED (eg, sildenafil, tadalafil, vardenafil), alprazolam, IV midazolam: reduce doses and monitor. Corticosteroids: avoid, monitor if needed.
HCV NS3/4A protease inhibitor.
Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia; hypersensitivity reactions (discontinue if occurs), pancytopenia.
Fecal (primarily), renal.
Bottles (12 caps/bottle)—28