|Manufacturer:||Three Rivers Pharmaceuticals, LLC|
This Medication Guide has been approved by the U.S.
Food and Drug Administration.Rx OnlyManufactured byDSM PHARMACEUTICALS, INC.
Greenville, NC 27834for THREE RIVERS PHARMACEUTICALS, LLC Cranberry Township, PA 16066 XXXXXXXX¹ PEGASYS® is a registered trademark of Hoffmann - LaRoche December 2005Printed in USA Copyright © 2005 by Three Rivers Pharmaceuticals, LLC.All rights reserved.
RIBASPHERE (ribavirin, USP) in combination with peginterferon alfa-2a is 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).
RIBASPHERE (ribavirin, USP) 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 have only been established when used together with peginterferon alfa-2a, recombinant. RIBASPHERE (ribavirin, USP) 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/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 PEGASYS package insert and MEDICATION GUIDE should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.