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Basic Drug Info
Drug Name:RIBASPHERE
Manufacturer:Three Rivers Pharmaceuticals, LLC
Other Info:

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.



Clinical Trials:


Indications and Usage

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).
Virus Diseases -- A general term for diseases produced by viruses.

Liver diseases -- Pathological processes of the LIVER.

Contraindications
RIBASPHERE (ribavirin, USP) is contraindicated in:Patients with known hypersensitivity to RIBASPHERE (ribavirin, USP) 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). RIBASPHERE (ribavirin, USP) 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

hemoglobinopathies -- A group of inherited disorders characterized by structural alterations within the hemoglobin molecule.

Cooley's anemia --

Sickle Cell Anemia -- A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S.

Autoimmune hepatitis -- A chronic self-perpetuating hepatocellular INFLAMMATION of unknown cause, usually with HYPERGAMMAGLOBULINEMIA and serum AUTOANTIBODIES.

Warnings

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.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.