국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
BOCEPREVIR (UNII: 89BT58KELH) (BOCEPREVIR - UNII:89BT58KELH)
Merck Sharp & Dohme Corp.
BOCEPREVIR
BOCEPREVIR 200 mg
PRESCRIPTION DRUG
New Drug Application
VICTRELIS- BOCEPREVIR CAPSULE MERCK SHARP & DOHME CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VICTRELIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VICTRELIS. VICTRELIS (BOCEPREVIR) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2011 RECENT MAJOR CHANGES Contraindications (4) 01/2017 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 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. (1) VICTRELIS must not be used as a monotherapy and should only be used in combination with peginterferon alfa and ribavirin. (1) The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors. (1) DOSAGE AND ADMINISTRATION 800 mg administered orally three times daily (every 7 to 9 hours) with food (a meal or light snack). (2) VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. Initiate therapy with peginterferon alfa and ribavirin for 4 weeks, then add VICTRELIS to peginterferon alfa and ribavirin regimen. The duration of treatment is based on viral response, prior response status and presence of cirrhosis. (2) Refer to the prescribing information for peginterferon alfa and ribavirin for specific dosing instructions. (2) DOSAGE FORMS AND STRENGTHS Capsules: 200 mg (3) CONTRAINDICATIONS ALL CONTRAINDICATIONS TO PEGINTERFERON ALFA AND RIBAVIRIN ALSO APPLY SINCE VICTRELIS MUST BE ADMINISTERED WITH PEGINTERFERON ALFA AND RIBAVIRIN. (4) Because ribavirin may cause birth defects and fetal death, boceprevir in combination with peginterferon alfa and ribavir 전체 문서 읽기