Safety

Xeljanz (tofacitinib) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

December 2015

Summary View

WARNINGS AND PRECAUTIONS

Serious Infections
  • diverticulitis

ADVERSE REACTIONS

Clinical Trial Experience
  • diverticulitis

 

June 2015

Summary View

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.

 

March 2014

Summary View

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
     

 

Page Last Updated: 01/13/2016
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