FDA MedWatch - Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) - Increased Risk of PTLD and PML

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Thu, 07 Jul 2011 15:07:42 -0500

Title: 
FDA MedWatch - Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) - Increased Risk of PTLD and PML

Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS)
Increased Risk of Post-transplant Lymphoproliferative Disorder  (PTLD), predominantly involving the Central Nervous System (CNS), and  Progressive Multifocal Leukoencephalopathy (PML) 

AUDIENCE: Transplantation, Nephrology

ISSUE:  Bristol-Myers Squibb informed healthcare professionals about the REMS  that is required for Nulojix to ensure that the benefits of Nulojix  outweigh the risks of PTLD and PML, both of which can be fatal. Patients  treated with Nulojix are at an increased risk for developing PTLD,  predominantly involving the CNS. PML has been reported in patients  receiving Nulojix at higher than recommended doses as part of an  immunosuppressant regimen.

BACKGROUND: FDA may  require a REMS from a manufacturer before approval or post approval to  ensure that the benefits of a drug or biological product outweigh its  risks. Nulojix is a selective T-cell costimulation blocker recently  approved for prophylaxis of organ rejection in adult patients receiving a  kidney transplant. Nulojix is to be used in combination with  basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.  Nulojix is indicated for use only in transplant patients who are  Epstein-Barr virus (EBV) seropositive. Use in liver transplant patients  is not recommended due to an increased risk of graft loss and death. Use  of Nulojix for the prophylaxis of organ rejection in other transplanted  organs has not been established.
RECOMMENDATION:  Be sure to verify the patient’s EBV status before initiating therapy  with Nulojix. BMS established the ENLiST Registry to further evaluate  the safety profile of Nulojix. BMS encourages your participation in the  ENLiST Registry. 

Healthcare professionals and patients are  encouraged to report adverse events or side effects related to the use  of these products to the FDA's MedWatch Safety Information and Adverse  Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and  return to the address on the pre-addressed form, or submit by fax to  1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Dear Healthcare Professional Letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262210.htm

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