Label Changes for:

Rebif (interferon beta-1a) injection

April 2014

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

April 2014

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 

 

 

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…

 

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