Label Changes for:
Simponi (Golimumab) 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
- Melanoma has been reported in patients treated with TNF-blocking agents, including Simponi. Merkel cell carcinoma has been reported in patients treated with TNF-blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.