Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Post Marketing Experience
Musculoskeletal and connective tissue disorders:
- Osteonecrosis of the jaw
WARNINGS AND PRECAUTIONS
- Monitor proteinuria by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria during Zaltrap therapy. Patients with a dipstick of =2+ for protein or a UPCR greater than 1 should undergo a 24-hour urine collection.