Label Changes for:
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)
- (Addition) Respiratory disorders: interstitial lung disease (includes multiple terms).
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
WARNINGS AND PRECAUTIONS
- 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).