Hepatitis C, Rebetron, IMPORTANT SAFETY INFORMATION | Hepatitis Central

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Rebetron – Important Safety Information

Anemia associated with therapy may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.

The most common adverse experiences associated with REBETRON Combination 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 may manifest in patients receiving therapy with interferons, including INTRON A therapy. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, MAY OCCUR.

Combination REBETOL/INTRON A therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy.Combination REBETOL/INTRON A 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 6-month posttreatment 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 and during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.