Belatacept [Nulojix]: Increased Risk of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML)

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July 7, 2011 – Bristol-Myers Squibb (BMS) today informed healthcare professionals about a REMS (Risk Evaluation and Mitigation Strategy) that is required for Belatacept [Nulojix] to ensure that the benefits of Belatacept [Nulojix] outweigh the risks of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal. Patients treated with Belatacept [Nulojix] are at an increased risk for developing PTLD, predominantly involving the CNS. PML has been reported in patients receiving Belatacept [Nulojix] at higher than recommended doses as part of an immunosuppressant regimen.

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.

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Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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