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Tofacitinib (By mouth)

Tofacitinib Citrate (toe-fa-SYE-ti-nib SI-trate)

Treats rheumatoid arthritis.

Brand Name(s):

Xeljanz

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to tofacitinib.

How to Use This Medicine:

Tablet

  • Take your medicine as directed.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • 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.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you are also using rifampin (Rifadin®, Rimactane®), other medicines to treat rheumatoid arthritis (such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, Actemra®, Cimzia®, Enbrel®, Humira®, Kineret®, Orencia®, Remicade®, Rituxan®, Simponi®), medicines to treat a fungal infection (such as fluconazole, ketoconazole, Nizoral®), or medicines that weaken your immune system (such as azathioprine, cyclosporine, tacrolimus, Gengraf®, Imuran®, Neoral®, Prograf®, Sandimmune®).
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Live virus vaccines should not be given to patients who are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis B or C), cancer, diabetes, high cholesterol or fat in the blood, stomach or bowel problems (such as diverticulitis, ulcers), tuberculosis, or if you have an infection that keeps coming back.
  • You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test or been exposed to tuberculosis.
  • This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. Avoid people who are sick. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
  • This medicine may weaken your immune system and make you more likely to get an infection. Call your doctor right away if you symptoms of an infection, such as fever, chills, headache, swelling, or redness.
  • Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Fever, chills, cough, sore throat, sweating, and body aches
  • Stomach pain that does not go away
  • 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


Last Updated: 7/4/2014


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