Drug Safety Warnings and Updates: October-December 2017

Teresa Rubio, PharmD


February 16, 2018

Editorial Collaboration

Medscape &

In This Article

Tofacitinib citrate (Xeljanz®; Xeljanz® XR)

For more on this Drug Safety Labeling Change, click here and here.

For full prescribing information, click here.

Updated Boxed Warning

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR use.

  • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.

  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.