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U.S. Department of Health and Human Services

Safety

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Actemra (Tocilizumab) Injection

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

November 2014

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Stevens-Johnson Syndrome

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Laboratory Parameters
  • Monitor neutrophils 4 to 8 weeks after start of therapy and every 3 months thereafter. For recommended modifications based on ANC results see [Dosage and Administration (2.7)].
  • Monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter.
Hypersensitivity Reactions, Including Anaphylaxis
  • Hypersensitivity reactions, including anaphylaxis, have been reported in association with Actemra and anaphylactic events with a fatal outcome have been reported with intravenous infusion of Actemra. Anaphylaxis and other hypersensitivity reactions that required treatment discontinuation were reported…
  • In the postmarketing setting, events of hypersensitivity reactions, including anaphylaxis and death have occurred in patients treated with a range of doses of…

 

 

April 2013

Summary View 

WARNINGS AND PRECAUTIONS

  • Polyarticular and Systemic Juvenile Idiopathic Arthritis - A similar pattern of liver enzyme elevation, low neutrophil count, low platelet count and lipid elevations is noted with ACTEMRA treatment in the PJIA and SJIA populations…
Vaccinations
  • particularly PJIA and SJIA patients…