Victrelis Capsule 200mg

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

Boceprevir

Доступна з:

MSD PHARMA (SINGAPORE) PTE. LTD.

Код атс:

J05AX

Дозування:

200mg

Фармацевтична форма:

CAPSULE

Адміністрація маршрут:

ORAL

Тип рецепту:

Prescription Only

Виробник:

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)

Дата Авторизація:

2012-03-07

інформаційний буклет

 
Singapore_Victrelis_Product Insert 13 May 2013 
- 1 - 
FULL PRESCRIBING INFORMATION 
1 INDICATIONS 
AND 
USAGE 
VICTRELIS®

(boceprevir) is indicated for the treatment of chronic hepatitis C
genotype 1 infection, in 
combination with peginterferon alfa and ribavirin, in adult
patients (18 years and older) with compensated 
liver disease, including cirrhosis, who are
previously untreated or who have failed
previous interferon and 
ribavirin therapy_ [see Clinical Studies (13)].  _

The following points should be considered when initiating VICTRELIS
for treatment of chronic hepatitis C 
infection: 

  VICTRELIS must not be used as monotherapy and should only be
used in combination with 
peginterferon alfa and ribavirin. 

  VICTRELIS efficacy 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. 

  VICTRELIS in combination with peginterferon alfa and
ribavirin has not been studied in patients 
documented to be historical null responders (less than a 2-log
10
 HCV-RNA decline by treatment week 
12) during prior therapy with peginterferon alfa and ribavirin.
The clinical studies included subjects 
who were poorly interferon responsive. Subjects with less than
0.5-log
10
 HCV-RNA decline in viral 
load at Treatment Week 4 with peginterferon alfa plus
ribavirin alone are predicted to have a null 
response (less than 2-log
10
 viral load decline at Treatment Week 12) to peginterferon alfa and 
ribavirin therapy _[see Clinical Studies (13)]._ 
  Poorly interferon responsive patients
who were treated with VICTRELIS in combination with 
peginterferon alfa and ribavirin have a lower likelihood
of achieving a sustained virologic response 
(SVR), and a higher rate of detection of
resistance-associated substitutions upon treatment failure, 
compared to patients wi