|Manufacturer:||Teva Pharmaceuticals USA|
Ribavirin capsules are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy.The safety and efficacy of ribavirin capsules with non-pegylated interferons other than INTRON A product have not been established.
-- Pathological processes of the LIVER.
-- The return of signs and symptoms of cancer after a period of improvement.
Ribavirin capsules may cause birth defects and/or death of the exposed fetus.
Ribavirin therapy is contraindicated for use in women who are pregnant or in men whose female partners are pregnant.
(See WARNINGS and PRECAUTIONS, Information for Patients and Pregnancy category X.)Ribavirin capsules are contraindicated in patients with a history of hypersensitivity to ribavirin or any component of the capsule.Patients with autoimmune hepatitis must not be treated with combination ribavirin/INTRON A therapy because using these medicines can make the hepatitis worse.Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) should not be treated with ribavirin capsules.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
-- A chronic self-perpetuating hepatocellular INFLAMMATION of unknown cause, usually with HYPERGAMMAGLOBULINEMIA and serum AUTOANTIBODIES.
-- INFLAMMATION of the LIVER.
-- A group of inherited disorders characterized by structural alterations within the hemoglobin molecule.
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.
Based on results of clinical trials ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection; therefore, ribavirin capsules must not be used alone.
The safety and efficacy of ribavirin capsules with non-pegylated interferons other than INTRON A product have not been established.There are significant adverse events caused by ribavirin/INTRON A therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes.
Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up.
The INTRON A package insert should be reviewed in its entirety prior to initiation of combination treatment for additional safety information.
The following US Branded drugs contain Ribavirin
-- SCHERING PLOUGH RESEARCH INSTITUTE
-- THREE RIVERS PHARMACEUTICALS LLC
-- VALEANT PHARMACEUTICALS INTERNATIONAL
-- SCHERING CORP
-- HOFFMANN LA ROCHE INC
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