When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tofacitinib.

How to Use This Medicine:
Tablet, Long Acting Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• 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.

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:
  
  • Fluconazole, ketoconazole, methotrexate, rifampin
  • Medicines that weaken your immune system (including azathioprine, cyclosporine, tacrolimus)
  • 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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis B or C), HIV, cancer or a history of cancer, diabetes, high cholesterol, stomach or bowel problems (such as a blockage, diverticulitis, ulcers), or a history of tuberculosis. Also tell your doctor if you have a current infection or an infection that keeps coming back.
• This medicine may cause the following problems:
  
  • Higher risk of certain cancers, such as nonmelanoma skin cancer or lymphoma
  • Gastrointestinal perforation
  • Increased cholesterol levels
  • Increased risk of shingles infection
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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.
• 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
• 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
• Skin or mole changes, sores that do not heal
• Stomach pain, cramping, bloody stools
• Swollen glands in your neck, armpits, or groin
• Unusual bleeding, bruising, or weakness

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