Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

Benlysta (belimumab)

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