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U.S. Department of Health and Human Services

Safety

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Rebif (Interferon Beta-1a) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

April 2014

Summary View

ADVERSE REACTIONS

added:

  • injection site reactions and cases of pseudo-relapses erythema multiforme and Stevens-Johnson syndrome
  • suicide and hepatic injury 
  • reports of thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, retinal vascular disorders, and convulsive disorders.
  • systemic lupus erythematosus, autoimmune hepatitis, and pancytopenia

MEDICATION GUIDE

What is the most important information....

  • added ..... injection site problems 

 

April 2013

Summary View

 

PRECAUTIONS

Pregnancy Category C
  • There are no adequate and well-controlled studies in pregnant women.  Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus…