July 07, 2011
SAFETY ALERT: REMS Required for Nulojix for Post-Transplant Lymphoproliferative Disorder and Progressive Multifocal Leukoencephalopathy RiskBristol-Myers Squibb has notified healthcare professionals that a Risk Evaluation and Mitigation Strategy (REMS) is required for Nulojix (belatacept) to ensure that the benefits of Nulojix outweigh the risks of post-transplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML). Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the CNS. PML has also been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen. The FDA recommends that patients' Epstein-Barr virus status be verified before initiating therapy with Nulojix.
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, and corticosteroids. Nulojix is indicated for use only in transplant patients who are Epstein-Barr virus 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262210.htm.