Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS and PRECAUTIONS
- Viral Reactivation: The risk of herpes zoster is increased in patients treated with XELJANZ and appears to be higher in patients treated with XELJANZ in Japan.
USE IN SPECIFIC POPULATIONS
- Use in Diabetics: As there is a higher incidence of infection in diabetic population in general, caution should be used when treating patients with diabetes.
WARNINGS AND PRECAUTIONS
Non-Melanoma Skin Cancer
- Non-melanoma skin cancers (NMSCs) have been reported in patients treated with XELJANZ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer