Clinicians Required to Register Patients Due to Nulojix Shortage
The Food and Drug Administration (FDA) announced a shortage in the supply of Nulojix (belatacept; Bristol-Myers Squibb) due to an increase in demand for the drug exacerbated by a delay in transition to a more efficient manufacturing process.
Nulojix, a selective T-cell costimulation blocker, is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
The report states that no disruption to existing patients is anticipated, however, effective March 15th, 2017 through the remainder of 2017, the company will limit distribution of Nulojix to only existing U.S. patients via the U.S. Nulojix Distribution Program. This program was developed to ensure continued access to existing patients being treated with Nulojix.
In order to make sure patients continue to receive Nulojix, clinicians must register existing patients in the program and receive a unique patient identification number. This number will be required when placing orders for Nulojix. As of March 15th, 2017, requests for new patients (first time users) will not be accommodated and new patients will not be registered into the Nulojix Distribution Program.
The Nulojix Distribution Program registration form can be found here.
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