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Label Changes for:

Revlimid (Lenalidomide) Capsules

November 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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



November 2013


  • Increased Mortality in Patients with CLL - In a prospective randomized (1:1) clinical trial in the first line treatment of patients with chronic lymphocytic leukemia, single agent Revlimid therapy increased the risk of death as compared to single agent chlorambucil… 


What is Revlimid

  • Revlimid should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

What are the possible side effects of Revlimid?

  • Increased risk of death in people who have chronic lymphocytic leukemia (CLL)…



May 2012


  • 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 



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.