|Manufacturer:||Zydus Pharmaceuticals USA Inc.|
|Other Info:||Manufactured by:Cadila Healthcare Ltd.Ahmedabad, IndiaDistributed by:Zydus Pharmaceuticals USA Inc.Princeton, NJ 08540Rev: 06/08Revision Date: 06/12/2008|
Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
Ribavirin tablet is contraindicated in:Patients with known hypersensitivity to ribavirin tablets or to any component of the tablet.Women who are pregnant.Men whose female partners are pregnant.Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).Ribavirin tablets and peginterferon alfa-2a combination therapy is contraindicated in patients with:Autoimmune hepatitis.Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.
Ribavirin tablets must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection.
The safety and efficacy of ribavirin tablets have only been established when used together with peginterferon alfa-2a (pegylated interferon alfa-2a, recombinant).Ribavirin tablets and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.There are significant adverse events caused by ribavirin tablets/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes.The peginterferon alfa-2a package insert and MEDICATION GUIDE should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.