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Label Changes for:

Imbruvica (ibrutinib)

June 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

June 2016

ADVERSE REACTIONS

Postmarketing Experience
  • (Addition) Respiratory disorders: interstitial lung disease (includes multiple terms).
     

 

May 2016

ADVERSE REACTIONS

Postmarketing Experience (additions)
  • Hepatobiliary disorders: hepatic failure (includes multiple terms)
  • Metabolic and nutrition disorders: tumor lysis syndrome
  • Skin and subcutaneous tissue disorders: anaphylactic shock, angioedema, urticarial

 

January 2015

WARNINGS AND PRECAUTIONS

Hemorrhage
  • Fatal bleeding events have occurred in patients treated with IMBRUVICA.
Tumor Lysis Syndrome
  • Tumor lysis syndrome has been reported with IMBRUVICA therapy. Monitor patients closely and take appropriate precautions in patients at risk for tumor lysis syndrome (e.g. high tumor burden).

 

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