VICTRELIS boceprevir capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

BOCEPREVIR (UNII: 89BT58KELH) (BOCEPREVIR - UNII:89BT58KELH)

Предлага се от:

Merck Sharp & Dohme Corp.

INN (Международно Name):

BOCEPREVIR

Композиция:

BOCEPREVIR 200 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

VICTRELIS- BOCEPREVIR CAPSULE
MERCK SHARP & DOHME CORP.
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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