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Clinicians prescribing belatacept (Nulojix, Bristol-Myers Squibb), a kidney transplant drug, need to keep in mind the increased risk for 2 potentially fatal complications, which were known when the medication was approved on June 15, the US Food and Drug Administration (FDA) announced today.

The 2 possible complications are posttransplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system, and progressive multifocal leukoencephalopathy (PML).

As part of its approval of belatacept, the FDA required the manufacturer to develop a risk evaluation and mitigation strategy (REMS) — educational in nature — to ensure that the benefits of the drug outweigh the risks for PTLD and PML. Last month Bristol-Myers Squibb distributed a "Dear Healthcare Professional" letter that reiterated label warnings about the 2 potential complications and directed clinicians to educational material on a product Web site. Informing patients about the serious risks associated with belatacept is another goal of the REMS.

Belatacept (Nulojix)

A selective T-cell co-stimulation blocker, belatacept is indicated for prevention of organ rejection in adults receiving a kidney transplant. It is intended for use in combination with corticosteroids, mycophenolate mofetil, and basiliximab induction. In addition, the FDA has approved the drug only for kidney transplant recipients who test positive for the Epstein-Barr virus (EBV). The risk for PTLD is higher in patients who have never been exposed to EBV.

Clinicians therefore should verify their patients' EBV status before initiating belatacept therapy. Adherence to dosing instructions also is critical because PML has been reported in patients receiving belatacept at doses higher than recommended.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to belatacept, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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