Label Changes for:
Nulojix (Belatacept) Intravenous Injection
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013
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…