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

Medically reviewed by P. Thornton, DipPharm Last updated on Sep 6, 2019.

What is Xeljanz?

Xeljanz (tofacitinib) blocks the activity of certain enzymes in the body that affect immune system function.

Xeljanz is used to treat moderate to severe rheumatoid arthritis or active psoriatic arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms. Tofacitinib is sometimes given in combination with methotrexate or other arthritis medicines.

Xeljanz is also used to treat adults with moderate to severe ulcerative colitis in adults who cannot use certain other medications, or after other treatments have failed. Extended-release Xeljanz XR is not for use in treating 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.

Tofacitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, trouble breathing, skin sores, diarrhea, weight loss, or burning when you urinate.

If you've ever had hepatitis B or C, using Xeljanz can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not use Xeljanz if you are allergic to tofacitinib, or if you have any kind of infection.

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

  • liver disease (especially hepatitis B or C);

  • heart problems (especially if you are 50 or older);

  • lung disease;

  • a blood clot;

  • a chronic infection;

  • HIV, or a weak immune system;

  • a stomach or intestinal problem such as diverticulitis or an ulcer;

  • kidney disease (or if you are on dialysis);

  • diabetes; or

  • if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Using Xeljanz may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

It is not known whether tofacitinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tofacitinib may affect your ability to have children during treatment and in the future.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tofacitinib on the baby.

Do not breastfeed while you are using Xeljanz, and for at least 18 hours after your last dose (36 hours if you take extended-release tablets). If you use a breast pump during this time, do not feed the milk to your baby.

How should I take Xeljanz?

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

A safe dose of Xeljanz is not the same for all conditions. Avoid medication errors by using only the form and strength your doctor prescribes. You should not take extended-release Xeljanz XR to treat ulcerative colitis.

You may take Xeljanz with or without food.

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

Tofacitinib affects your immune system. You may get infections more easily, even serious or fatal infections.

If you've ever had shingles (herpes zoster) or hepatitis B or C, using Xeljanz can cause these viruses to become active or get worse. You may need frequent liver function tests.

Your doctor will need to examine you on a regular basis.

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

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine 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.

-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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

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.

Some people taking high dosages of Xeljanz have developed serious or fatal blood clots in the lungs. Stop taking tofacitinib and seek emergency medical attention if you have:

  • sudden shortness of breath;

  • pain while breathing;

  • cough with pink or red mucus;

  • pain in your chest or back;

  • clammy or blue-colored skin, heavy sweating; or

  • pain, swelling, or redness in an arm or a leg.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sweating, tiredness, muscle pain;

  • feeling short of breath;

  • skin sores with warmth, redness, or swelling;

  • increased urination, pain or burning when you urinate;

  • mouth sores, stomach pain, diarrhea; or

  • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

  • low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

  • signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • shingles - burning pain, numbness, tingling, itching, skin rash or blisters; or

  • signs of perforation (a hole or tear) in your stomach or intestines - fever, ongoing stomach pain, change in bowel habits.

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.

What other drugs will affect Xeljanz?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with tofacitinib, especially:

This list is not complete and many other drugs may interact tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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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