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Label Changes for:

Copegus (ribavirin) tablets

December 2010

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) June, October and December 2010

 

December 2010

CONTRAINDICATIONS

  • include information from a study in hepatitis C/HIV co-infected subjects


WARNINGS AND PRECAUTIONS

Hepatic Failure
  • Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. In Study NR15961 [see Clinical Studies]

  

October 2010

 

Label reformatted

ADVERSE REACTIONS

  • liver and renal graft rejections added

USE IN SPECIFIC POPULATIONS

  • update section to include important information on liver and renal transplant recipients

 

June 2010

WARNINGS

Other
  • liver and renal graft rejections added
  • update section to include important information on liver and renal transplant recipients
  • Pancytopenia (marked decreases in RBCs, 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. Pegasys, Copegus, and azathioprine should be discontinued for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine

 

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