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U.S. Department of Health and Human Services

Safety

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Revlimid (lenalidomide) Capsules

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

 

May 2012

Summary View

MEDICATION GUIDE

  • the risk of second primary malignancies
  • notification for the presence of lactose in Revlimid  
  • warning of the presence of Revlimid in human semen

 

 

 

March 2012 

Summary View

 

WARNINGS AND PRECAUTIONS

Second Primary Malignancies
  • Patients with multiple myeloma treated with lenalidomide in studies including melphalan and stem cell transplantation had a higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide. Monitor patients for the development of second malignancies. Take into account both the potential benefit of lenalidomide and the risk of second primary malignancies when considering treatment with lenalidomide.

 

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