Label Changes for:
Orencia (abatacept) powder for injection
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009
Clinical Experience in MTX-Naive Patients
- Study VI was an active-controlled clinical trial in MTX-naive patients [see Clinical Studies (14.1)]. The safety experience in these patients was consistent with Studies I-V