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U.S. Department of Health and Human Services

Safety

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Actemra (tocilizumab) injection for intravenous infusion

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions, Including Anaphylaxis
  • In the postmarketing setting, events of clinically significant hypersensitivity and anaphylaxis, including events with a fatal outcome, have occurred in patients treated with a range of doses of Actemra, with or without concomitant arthritis therapies. Events have occurred in patients who received premedication. Clinically significant hypersensitivity and anaphylaxis events have occurred both with and without previous hypersensitivity reactions and as early as the first infusion of Actemra