Label Changes for:
Rebetol (ribavirin USP) 200 mg Capsules and 40 mg/mL Oral Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
What is the most important information I should know about REBETOL?
- If you or your female sexual partner becomes pregnant while taking REBETOL or within 6 months after you stop taking REBETOL, tell your health care provider right away. You or your health care provider should contact the REBETOL pregnancy registry by calling 1-800-593-2214. The REBETOL pregnancy registry collects information...
WARNINGS AND PRECAUTIONS
Concomitant administration of Azathioprine
- Pancytopenia (marked decreases in red blood cells, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine. In this limited number of patients (n=8), myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of both HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone. PegIntron, Rebetol and azathioprine should be discontinued for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine.