Kineret (anakinra) for injection

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

May 2016

Summary View


Clinical Studies Experience in RA


  • Cholesterol elevations were observed in some patients treated with Kineret.
Postmarketing Experience

Hematologic events:

  • thrombocytopenia, including severe thrombocytopenia (i.e platelet counts <10x109/L)


October 2013

Summary View


Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Kineret. 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.

Hepato-biliary disorders:
  • elevations of transaminases
  • non-infectious hepatitis


Page Last Updated: 06/10/2016
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