Label Changes for:

Gleevec (imatinib mesylate) tablets

May 2014

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) 

 

May 2014

6 ADVERSE REACTIONS

6.13 Postmarketing Experience
  • Skin and subcutaneous tissue disorders: ...added... drug rash with eosinophilia and systemic symptoms (DRESS)

 

October 2013

WARNINGS AND PRECAUTIONS

Embryo-fetal Toxicity
  • Gleevec can cause fetal harm when administered to a pregnant woman. Imatinib mesylate was teratogenic in rats when administered during organogenesis at doses approximately equal to the maximum human dose of 800 mg/day based on body surface area. Significant post-implantation loss was seen in female rats administered imatinib mesylate at doses approximately one-half the maximum human dose of 800 mg/day based on body surface area. Sexually active female patients of reproductive potential taking Gleevec should use highly effective contraception. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

  • Gleevec can cause fetal harm when administered to a pregnant woman. There have been post-market reports of spontaneous abortions and infant congenital anomalies from women who have taken Gleevec. Imatinib was…

 

 

February 2013

ADVERSE REACTIONS

Additional Data from Multiple Clinical Trials
  • Vascular Disorders: subdural hematoma (SDH) [in oncology patients treated with imatinib]

 

April 2011

 

5 WARNINGS AND PRECAUTIONS

5.4 Hepatotoxicity
5.12 Children and Adolescents
  • ...growth retardation...
5.13 Tumor Lysis syndrome

 

6 ADVERSE REACTIONS

6.13 Postmarketing Experience
  • ...growth retardation...

 

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