Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/15/11

Nulojix (belatacept) REMS

Goals of the NULOJIX (belatacept) REMS Program

The goals of the NULOJIX REMS are:

1. To inform healthcare providers of the increased risk of post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS), associated with NULOJIX

2. To inform healthcare providers of the increased risk of progressive multifocal leukoencephalopathy (PML), a CNS infection, associated with NULOJIX

3. To inform patients of the serious risks associated with NULOJIX

REMS Elements

• Medication Guide

• Comunication Plan

Open the Full REMS Notification

REMS Summary of Terms