TOFACITINIB ORAL (XELJANZ) BOXED WARNINGS: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete Boxed Warning. • Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving XELJANZ. • If a serious infection develops, interrupt XELJANZ until the infection is controlled. • Prior to starting XELJANZ, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting XELJANZ. • Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. • Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus- associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications WARNINGS: • Serious Infections -Do not administer XELJANZ during an active infection, including localized infections. If a serious infection develops, interrupt XELJANZ until the infection is controlled. • Lymphomas and other malignancies have been reported in patients treated with XELJANZ. • Gastrointestinal Perforations - Use with caution in patients that may be at increased risk. • Laboratory monitoring - Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. • Immunizations - Live vaccines should not be given concurrently with XELJANZ. • Severe hepatic impairment - Not recommended HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * If you take too much, call your doctor or go to the nearest hospital emergency room right away. WARNINGS/PRECAUTIONS: TOP * Notify doctor if you are pregnant, if pregnancy is suspected, or if you intend to become pregnant. * Notify your doctor if signs of INFECTION develops (eg, fever, sore throat, chills, or unusual bruising or bleeding). * Notify doctor of any signs suggesting LIVER problems (eg, unusual fatigue, loss of appetite, nausea, vomiting, yellowing of eyes, dark urine). * This medication may cause stomach or intestine bleeding and ulceration. Contact your doctor immediately if heartburn or stomach discomfort occurs. * Report to your healthcare provider if you have or develop cancer Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved