Label Changes for:
Adagen (pegademase bovine) 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) -- September 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
- First Paragraph
- The following adverse reactions were reported during clinical trials...
- The following adverse reactions have been identified during post-approval use of Adagen (pegademase bovine) Injection...
- Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia
- Dermatological events: injection site erythema, urticaria