Tofacitinib (toe-fa-SYE-ti-nib)

Treats rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular course juvenile idiopathic arthritis (pcJIA).

Brand Name(s):

Xeljanz, Xeljanz XR

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Measure the oral liquid medicine with an oral dosing syringe.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Use the oral liquid within 60 days of opening the bottle. Throw away any remaining oral liquid after 60 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tofacitinib works. Tell your doctor if you are using any of the following:
  • Medicines that weaken your immune system (including azathioprine, cyclosporine, methotrexate, tacrolimus)
  • Medicine to treat infection (including fluconazole, ketoconazole, rifampin)
  • NSAID medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine.
• Do not breastfeed during treatment with this medicine and for at least 18 hours after the last dose of Xeljanz® tablet or 36 hours after the last dose of Xeljanz® XR.
• Tell your doctor if you have kidney disease (including patients on dialysis), liver disease (including hepatitis B or C), lung disease (including interstitial lung disease), heart or blood vessel disease, HIV, cancer or a history of cancer, blood problems, diabetes, high cholesterol, stomach or bowel problems (including blockage, diverticulitis, ulcers), or a history of tuberculosis. Tell your doctor if you have a current infection or an infection that keeps coming back, or if you are a current or past smoker.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of certain cancers (including lymphoma, lung cancer, skin cancer)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Stomach or bowel perforation (tear or hole)
  • High cholesterol in the blood
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, difficult or painful urination
• Chest pain that may spread, trouble breathing, coughing up blood, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, night sweats, body aches
• Pain, redness, swelling, or tenderness in the arms or legs
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Skin or mole changes, sores that do not heal
• Stomach pain, cramping, bloody stools
• Sudden or severe headache, problems with vision, speech, or walking
• Swollen glands in your neck, armpits, or groin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088