A Risk Evaluation and Mitigation Strategy is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.
BMS has worked with the FDA to develop materials to communicate the increased risk of post‑transplant lymphoproliferative disorder, predominantly involving the CNS, and progressive multifocal leukoencephalopathy (PML) associated with NULOJIX.
Ongoing Evaluation of NULOJIX Safety Profile
BMS established the ENLiST (Evaluating NULOJIX Long-Term Safety in Transplant) Registry to further evaluate the safety profile of NULOJIX.
ENLiST is intended to enroll all adult kidney transplant patients who are treated with NULOJIX, regardless of when NULOJIX is initiated. The primary objective of ENLiST is to determine the incidence rate of PTLD, CNS PTLD, and PML in US adult EBV seropositive kidney transplant recipients treated with NULOJIX. BMS encourages you to participate in the ENLiST Registry.
- To enroll patients in the ENLiST Registry, call BMS at 1-800-321-1335.
- For additional information about the ENLiST Registry, visit www.clinicaltrials.gov.
- To order Pre-Infusion Checklist tear pads, call BMS at 1-800-321-1335.
This presentation is not intended as a complete description of the risks and benefits associated with the use of NULOJIX. Please see Full Prescribing Information.
NULOJIX REMS VIDEO
Posted June 29, 2011 | Length 14:55