Generic Name and Formulations:
Boceprevir 200mg; capsules.
Company:
Merck & Co., Inc.
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.
Adult Dose for VICTRELIS:
≥18yrs: Take with food. 800mg three times 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).
Children's Dose for VICTRELIS:
<18yrs: not recommended.
Pharmacological Class:
HCV NS3/4A protease inhibitor.
Contraindications:
Concomitant potent CYP3A4/5 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) or narrow therapeutic index CYP3A4/5 substrates (eg, alfuzosin, cisapride, ergot derivatives, lovastatin, simvastatin, drosperinone, 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.
Warnings/Precautions:
Female patients and partners must have (–) pregnancy test before therapy, use appropriate effective contraception, and undergo monthly pregnancy test. Monitor CBC w. differential, HCV-RNA. If hgb <10g/dL: reduce or interrupt ribavirin; if hgb <8.5g/dL: discontinue ribavirin; if ribavirin permanently discontinued, then peg-interferon alfa and Victrelis must be discontinued. Co-infection with HBV or HIV. Decompensated cirrhosis. Organ transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.
Interactions:
See literature. Concomitant rifabutin, salmeterol, efavirenz, concomitant colchicine in renal or hepatic impairment: not recommended. Potentiates CYP3A4/5 substrates (eg, amiodarone, bepridil, propafenone, quinidine, flecainide, trazodone, desipramine, azole antifungals, clarithromycin). Antagonizes ethinyl estradiol. Antagonized by potent CYP3A4/5 inhibitors. Monitor warfarin, digoxin, dihydropyridine calcium channel blockers, bosentan, protease inhibitors, 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.
Adverse Reactions:
Fatigue, nausea, headache, dysgeusia, worsening anemia, neutropenia; hypersensitivity reactions (discontinue if occurs).
Metabolism:
Hepatic.
Elimination:
Fecal (primarily), renal.
Generic Availability:
NO
How Supplied:
Bottles (12 caps/bottle)—28
----------------------------------------------------------------
HIGHLIGHTS OF PRESCRIBING INFORMATION
Indications And Usage
VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infecti