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| |  FDA Approves Separate Marketing of Rebetol (Ribavirin) For Use in Combination With Intron A (Interferon Alfa-2b) For Chronic Hepatitis C KENILWORTH, NJ -- July 27, 2001 -- The United States Food and Drug Administration (FDA) has granted marketing approval to Rebetol® (ribavirin, USP) Capsules as a separately marketed product for use only in combination with Intron® A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. The safety and efficacy of Rebetol Capsules with interferons other than Intron A have not been established. Rebetol had been previously approved in the United States for this indication only as a component of Rebetron™ Combination Therapy, which contains Rebetol Capsules and Intron A Injection in a single package. Schering-Plough will continue to market Rebetron Combination Therapy in the United States. Rebetol Capsules, available by prescription only, are expected to be available nationwide sometime this fall. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has exclusive worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with ICN Pharmaceuticals, Inc. of Costa Mesa, California. Intron A is a recombinant version of naturally occurring alpha interferon. Schering-Plough markets Intron A, the world's largest-selling alpha interferon, for 16 major antiviral and anticancer indications worldwide. It is not known how Rebetol and Intron A work together to fight hepatitis C infection. Rebetol monotherapy is not effective for the treatment of chronic hepatitis C and should not be used alone for this indication. Anemia associated with Rebetol therapy may exacerbate cardiac disease that has lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Rebetol. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks two and four of therapy or more frequently if clinically indicated. Women, or male partners of women, who are or may become pregnant during therapy and during the six months after stopping therapy, must not use Rebetol therapy. Rebetol therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (two reliable forms) during treatment and during the six-month post- treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of Rebetol. If pregnancy occurs in a patient or partner of a patient during treatment or during the six months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064, the "Rebetron Physician Pregnancy Registry," run by Schering-Plough. Alpha interferons, including Intron A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping Intron A therapy. The most common adverse experiences associated with combination Rebetol/Intron A therapy are "flu-like" symptoms, such as headache, fatigue, myalgia, and fever, which appear to decrease in severity as treatment continues. Severe psychiatric adverse events, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides), and rare instances of homicidal ideation have occurred during combination Rebetol/Intron A therapy, both in patients with and without a previous psychiatric disorder.
SOURCE: Schering-Plough Corporation Related Link: Schering-Plough Corporation.
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