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U.S. Department of Health and Human Services

Safety

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Benlysta (belimumab)

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

 

December 2013

Summary View

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions, Including Anaphylaxis
  • Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with BENLYSTA. These events generally occurred within hours of the infusion; however they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Hypersensitivity, including serious reactions, has occurred in patients who have previously tolerated infusions of BENLYSTA… 

 

March 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions, Including Anaphylaxis
  • Hypersensitivity reactions, including anaphylaxis and death, have been reported in association with Benlysta. Delay in the onset of acute hypersensitivity reactions has been observed.
  • Limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.

 

ADVERSE REACTIONS

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Benlysta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Fatal anaphylaxis