This communication is intended to inform AST about the important safety information for NULOJIX (r) (belatacept), a selective T-cell costimulation blocker recently approved by the Food and Drug Administration (FDA) for the 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 of NULOJIX for the prophylaxis of organ rejection in other transplanted organs has not been established.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary 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.
The NULOJIX REMS is designed to inform healthcare providers about the increased risk of PTLD, predominantly involving the central nervous system (CNS), and PML with NULOJIX. In order for Bristol-Myers Squibb to communicate certain risks about NULOJIX, Bristol-Myers Squibb has worked with the FDA to develop materials for a more complete description of the risks including PTLD and PML.
The NULOJIX Full Prescribing Information and REMS materials, are available below.
For more information, please visit: http://www.nulojix.com/REMS.aspx
The American Society of Transplantation is an international organization of professionals dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, and organ donation.