Belatacept [Nulojix]: Increased Risk of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML)
Last Updated on July 9, 2011 by Joseph Gut – thasso
The American Food and Drug Administration (FDA) may require a REMS from a manufacturer before approval or post approval to ensure that the benefits of a drug or biological product outweigh its risks. Belatacept [Nulojix] is a selective T-cell costimulation blocker recently approved for prophylaxis of organ rejection in adult patients receiving a kidney transplant. Belatacept [Nulojix] is to be used in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. Belatacept [Nulojix] is indicated for use only in transplant patients who are Epstein-Barr virus (EBV) seropositive. Use in liver transplant patients is not recommended due to an increased risk of graft loss and death. Use of Belatacept [Nulojix] for the prophylaxis of organ rejection in other transplanted organs has not been established.
Be sure to verify the patient’s EBV status before initiating therapy with Belatacept [Nulojix]. BMS established the ENLiST Registry to further evaluate the safety profile of Belatacept [Nulojix]. BMS encourages your participation in the ENLiST Registry.