REMS is No Longer Required for Nulojix (belatacept)

The REMS for NULOJIX (belatacept) was originally approved by the Food and Drug Administration (FDA) on June 15, 2011. On May 9, 2017, the FDA determined that a REMS is no longer required for NULOJIX and has eliminated the REMS requirement. As a consequence, the distribution of the Pre-Infusion Checklist within the NULOJIX carton will cease. The FDA determined that a communication plan was no longer necessary to include as an element of the approved REMS because the communication plan had been completed and the most recent assessment demonstrated that the communication plan had met its goals. Therefore, because the communication plan was no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for NULOJIX. The Medication Guide will continue to be part of the approved NULOJIX labeling. Read More