FDA Notice: Nulojix (belatacept) – Risk Evaluation and Mitigation Strategy (REMS)

On July 7, 2011, Bristol-Myers Squibb (BMS) informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the Central Nervous System. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen. It is recommended that healthcare providers verify the patient’s Epstein-Barr virus status before initiating therapy with Nulojix. BMS established the ENLiST Registry to further evaluate the safety profile of Nulojix. BMS encourages provider participation in the ENLiST Registry. Click here for more information.