FDA Safety Alert: REMS required with belatacept

July 26, 2011

Patients treated with belatacept (Nulojix, Bristol-Myers-Squibb) are at increased risk of developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), which predominantly involves the central nervous system, and progressive multifocal leukoencephalopathy, according to a recent FDA Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV) and therefore is indicated for use only in transplant patients who are EBV seropositive.

Bristol-Myers Squibb has informed healthcare professionals about the Risk Evaluation and Mitigation Strategy (REMS) for belatacept (Nulojix) required by FDA to ensure that the benefits outweigh the risks for transplant patients who receive the drug.

According to a recent FDA Safety Alert, patients treated with belatacept are at increased risk of developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), which predominantly involves the central nervous system (CNS), and progressive multifocal leukoencephalopathy (PML). The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV) and therefore is indicated for use only in transplant patients who are EBV seropositive.

Nulojix is a selective T-cell costimulation blocker that was recently approved in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids to prevent acute rejection in adult patients who have had a kidney transplant. The drug helps to prevent organ rejection after a kidney transplant. It is not recommended for use by liver transplant patients because of an increased risk of graft loss and death, and its use by patients with other transplanted organs has not been established.

FDA recommends that healthcare providers verify the patient’s EBV status before initiating therapy with Nulojix. Bristol-Myers Squibb has established the ENLiST Registry to determine the incidence of PTLD, CNS PTLD, and PML in adult EBV seropositive kidney-transplant recipients in the United States who have been treated with Nulojix. The registry is intended to enroll all adult kidney-transplant patients who are treated with Nulojix. The manufacturer encourages participation, and more information will be available at www.clinicaltrials.gov. For enrollment information, call 800-321-1335.

Adverse events or side effects related to the use of Nulojix should be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program. (www.fda.gov/MedWatch/report.htm)