REMS required for belatacept

July 29, 2011

Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent 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.

Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent 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.

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 in liver transplant patients due to an increased risk of graft loss and death, and its use in 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 US adult EBV seropositive kidney transplant recipients 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 on clinicaltrials.gov and information on how to enroll can be gained by calling (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)