Safety

Gleevec (imatinib mesylate) Tablets

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

January 2015

Summary View

WARNINGS AND PRECAUTIONS

Fluid Retention and Edema
  • In a randomized trial in patients with newly diagnosed Ph+CML in chronic phase comparing Gleevec and nilotinib, severe (Grade 3 or 4) fluid retention occurred in 2.5% of patients receiving Gleevec and in 3.9% of patients receiving nilotinib 300 mg bid. Effusions (including pleural effusion, pericardial effusion, ascites) or pulmonary edema were observed in 2.1% (none were Grade 3 or 4) of patients in the Gleevec arm and 2.2% (0.7% Grade 3 or 4) of patients in the nilotinib 300 mg bid arm.
Congestive Heart Failure and Left Ventricular Dysfunction
  • … In another randomized trial with newly diagnosed Ph+ CML patients in chronic phase that comparedGleevec and nilotinib, cardiac failure was observed in 1.1% of patient in the Gleevec arm and 2.2% of patients in the nilotinib 300 mg bid arm and severe (Grade 3 or 4) cardiac failure occurred in 0.7% of patients in each group…
Hemorrhage
  • In a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase comparing Gleevec and nilotinib, GI hemorrhage occurred in 1.4% of patients in the Gleevec arm, and in 2.9% of patients in the nilotinib 300 mg bid arm. None of these events were Grade 3 or 4 in the Gleevec arm; 0.7% were Grade 3 or 4 in the nilotinib 300 mg bid arm. In addition, gastric antral vascular ectasia has been reported in postmarketing experience.

 

May 2014

Summary View

6 ADVERSE REACTIONS

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

 

October 2013

Summary View

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

Summary View

ADVERSE REACTIONS

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

 

April 2011

Summary View

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...

 

Page Last Updated: 02/11/2015
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