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Simponi (Golimumab) Injection
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.