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Xeljanz

Generic Name: tofacitinib (TOE fa SYE ti nib)
Brand Names: Xeljanz, Xeljanz XR

Medically reviewed on February 4, 2018

What is Xeljanz?

See also: Otezla

Xeljanz (tofacitinib) works by blocking certain enzymes in the body that affect immune system function.

Xeljanz is used to treat moderate to severe rheumatoid arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms.

Xeljanz is sometimes given in combination with methotrexate or other arthritis medicines.

Xeljanz is used to treat adult patients with active psoriatic arthritis (PsA) who have tried methotrexate or other arthritis medicines without successful treatment of symptoms.

Xeljanz is also used to treat adult patients with moderately to severely active ulcerative colitis.

Important Information

You should not use Xeljanz if you have a serious infection. Before you start treatment, your doctor may perform tests to make sure you do not have an infection.

Serious and sometimes fatal infections may occur during treatment with Xeljanz. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, sores or white patches in your mouth or throat, night sweats, stomach pain, diarrhea, weight loss, skin redness and swelling, or cough and chest pain.

Before taking this medicine

You should not use Xeljanz if you are allergic to tofacitinib, or if you have severe liver disease.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure Xeljanz is safe for you, tell your doctor if you have ever had:

Xeljanz may increase your risk of certain cancers by changing the way your immune system works. If you have had a kidney transplant, Xeljanz may cause your body to produce too much of a certain type of white blood cell.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 4 weeks after your last dose.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Xeljanz on the baby.

It is not known whether tofacitinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Xeljanz?

Before you start treatment, your doctor may Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Before you start treatment with Xeljanz, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

You may take Xeljanz with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Tofacitinib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Further doses may be delayed based on the results of these tests. Your doctor may also want to check your skin for signs of cancer.

If you have hepatitis B or C you may develop liver symptoms while taking this medicine. Your doctor may want to check your liver function before and during your treatment with Xeljanz.

Store in the original container at room temperature away from moisture and heat.

Some tablet forms of Xeljanz are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of Xeljanz and will not make the medication less effective.

Xeljanz dosing information

Usual Adult Dose for Rheumatoid Arthritis:

-Immediate release: 5 mg orally 2 times a day
-Extended release: 11 mg orally once a day
-Patients treated with the 5 mg immediate release 2 times a day may be switched to the 11 mg extended release once a day the day following the last dose of 5 mg.

Comments:
-Do not start this drug in patients with a lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or a hemoglobin level less than 9 g/dL.
-Dose interruption is recommended for management of lymphopenia, neutropenia and anemia.
-Avoid use of this drug if a patient develops a serious infection until the infection is controlled.
-Use of this drug in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine> and cyclosporine is not recommended.

Use: Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Xeljanz?

Do not receive a "live" vaccine while using Xeljanz, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit and grapefruit juice may interact with tofacitinib and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Xeljanz side effects

Get emergency medical help if you have signs of an allergic reaction to Xeljanz: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Xeljanz. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills, tired feeling, night sweats;

  • stomach pain, loss of appetite, diarrhea, weight loss, or a change in your bowel habits;

  • pain or burning when you urinate;

  • body aches, sore throat, cough, flu symptoms, sores in your mouth and throat;

  • stabbing chest pain, wheezing, feeling short of breath, cough with mucus or blood; or

  • skin redness and swelling.

Xeljanz may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

  • low fever, itching, tiredness, body aches;

  • upper stomach pain, loss of appetite;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

Common Xeljanz side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Xeljanz?

Many drugs can interact with tofacitinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete and many other drugs can interact with tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xeljanz only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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