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U.S. Department of Health and Human Services

Safety

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Nulojix (Belatacept) Intravenous Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Acute Rejection and Graft Loss With Corticosteriod Minimization:  In postmarketing experience, use of Nulojix in conjunction with Basiliximab induction, MMF, and corticosteroid minimization to 5 mg per day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III rejection…