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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) 

 

September 2014

Summary View

BOXED WARNING

VENOUS AND ARTERIAL THROMBOEMBOLISM

  • Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving REVLIMID with dexamethasone.

5 WARNINGS AND PRECAUTIONS

5.4 Venous and Arterial Thromboembolism
  • Venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboses are increased in patients treated with REVLIMID. A significantly increased risk of DVT (7.4%) and of PE (3.7%) occurred in patients with multiple myeloma who were treated with .....

17 PATIENT COUNSELING INSTRUCTIONS

Venous and Arterial Thromboembolism
  • Inform patients of the risk of thrombosis including DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Boxed Warnings and Warning and Precautions (5.4)].

NOTE: new additions to both the Medication Guide and related REMS materials related to the venous and arterial thromboembolism information in the PI above

 

November 2013

Summary View

WARNINGS AND PRECAUTIONS

  • 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… 

MEDICATION GUIDE

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

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.