FDA Issues Reminder on Nulojix Risks

The U.S. Food & Drug Administration (FDA) has reminded healthcare providers that <"http://www.yourlawyer.com/topics/overview/PML">Nulojix (belatacept) is associated with an increased risk of two potentially fatal complications – posttransplant lymphoproliferative disorder (PTLD) and progressive multifocal leukoencephalopathy (PML). Both complications were known risks of Nulojix when it was approved on June 15, the agency said.

Nulojix is part of a class of drugs known as selective T-cell co-stimulation blockers. It is approved to treat organ rejection in adults receiving a kidney transplant, but ONLY in those who test positive for the Epstein-Barr virus (EBV). It is intended for use in combination with corticosteroids, mycophenolate mofetil, and basiliximab induction.

PTLD is a condition occurs if certain white blood cells grow out of control after an organ transplant due to a weakened immune system. PTLD can get worse and become a type of cancer. According to the FDA, PTLD is most likely to occur in Nulojix patients in the central nervous system. The risk for PTLD is higher in patients who have never been exposed to EBV, so EBV status of patients should be verified before they are treated with Nulojix.

PML is an infection that attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. According to the FDA, PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen.

When Nulojix was approved, the FDA required Bristol-Myers Squibb to develop a risk evaluation and mitigation strategy (REMS) 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 PML and PTLD, and directed clinicians to educational material on a product Web site.

This entry was posted in Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.