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Xeljanz

Pronunciation: zel-jans
Generic name: tofacitinib
Brand names: Xeljanz, Xeljanz XR, Xeljanz Oral Solution
Dosage form: oral tablet, extended-release tablet, oral solution
Drug class: Antirheumatics

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 22, 2024.

What is Xeljanz?

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor that may be used alone or with other medications to treat inflammatory and autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.

Xeljanz works by decreasing the activity of the immune system. It does this by blocking the activity of JAK enzymes (JAK1, JAK2, JAK3, TYK2) inside the cell – these enzymes are responsible for sending inflammatory signals in the body which are associated with cytokine release. Xeljanz's mechanism of action of blocking these enzymes helps to decrease the immune reaction which causes rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Xeljanz was FDA-approved on November 6, 2012, and was the first JAK inhibitor to be approved for rheumatoid arthritis.

Xeljanz uses

Xeljanz or Xeljanz XR may be used to treat the following conditions in adults who are unable to take or did not respond to one or more tumor necrosis factor (TNF) inhibitor medication(s):

Xeljanz and Xeljanz oral solution are also approved to treat polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

Using Xeljanz along with other medications that suppress the immune system can increase the risk of serious side effects. Tell your healthcare provider about all the medications you take.

Xeljanz side effects

The most common side effects of Xeljanz are:

Serious side effects and warnings

Xeljanz and Xeljanz XR carry a Boxed Warning for serious infections, death, cancer, cardiovascular events, and blood clots.

Serious infections. Xeljanz is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Some people can have serious infections while taking Xeljanz, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

After starting Xeljanz, call your healthcare provider right away if you have any symptoms of an infection. Xeljanzcan makes you more likely to get infections or make existing infections worse.

Taking Xeljanz is associated with an increased risk of death and major cardiovascular events (such as heart attack or stroke) in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor especially if they are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Xeljanz, including:

Cancer and immune system problems. Xeljanz may increase your risk of certain cancers by changing the way your immune system works. People taking Xeljanz have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. People with ulcerative colitis taking higher dosages of Xeljanz have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken Xeljanz with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots. Stop taking Xeljanzand tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

Tears (perforation) in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have a fever, stomach-area pain that does not go away, and a change in your bowel habits.

Allergic reactions. Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in people taking Xeljanz. Some of these reactions were serious. If any of these symptoms occur while you are taking Xeljanz, stop taking it and call your healthcare provider right away.

Hepatitis B or C activation in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use Xeljanz. Your healthcare provider may do blood tests before you start treatment with Xeljanz and while you are taking Xeljanz. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:

Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking Xeljanz and while you are taking it:

Your healthcare provider may stop your Xeljanz treatment for a period if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking Xeljanz, and as needed after that. Normal cholesterol levels are important to good heart health.

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 the FDA at 1-800-FDA-1088.

Before taking

Do not take Xeljanz if:

Before taking Xeljanz, tell your healthcare provider about all of your medical conditions, including if you:

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

Do not give this medicine to a child without medical advice. Xeljanz XR (extended-release) tablets are not approved for use by anyone younger than 18 years.

Pregnancy and fertility

It is not known if Xeljanz will harm an unborn baby. Having rheumatoid arthritis or ulcerative colitis during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating these conditions with Xeljanz may outweigh any risks to the baby.

Pfizer has a registry for pregnant women who take Xeljanz. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Xeljanz, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

If you are a woman, Xeljanz may affect your fertility and your ability to have children during treatment and in the future.

Breastfeeding

Do not breastfeed while you are using this medicine, 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 do I take Xeljanz, Xeljanz XR, or Xeljanz oral solution?

Take Xeljanz, Xeljanz XR, and Xeljaz oral solution exactly as your healthcare provider tells you to take it. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

For the treatment of psoriatic arthritis, take Xeljanz/Xeljanz XR in combination with methotrexate,
sulfasalazine, or leflunomide as instructed by your healthcare provider.

Do not use in people with severe liver disease.

Regular laboratory monitoring is recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

Xeljanz dosing information

Xeljanz dosing for adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis

OR

Notes:

Moderate to severe renal impairment or moderate hepatic impairment. Reduce the dosage to Xeljanz 5mg once daily.

Psoriatic arthritis: use in combination with nonbiologic DMARDs.

Xeljanz dosing for adults with ulcerative colitis

Notes:

If needed, induction dosages may be continued for up to 16 weeks; if adequate therapeutic response is not achieved after 16 weeks, the induction dosage should be discontinued.

For patients with loss of response during maintenance therapy, consider Xeljanz 10 mg orally twice a day or Xeljanz XR 22 mg orally once a day for a short duration. Use the lowest effective dose needed to maintain a response.

Xeljanz dosing for polyarticular course juvenile idiopathic arthritis

Doses are based on weight in children and teenagers who weigh less than 88 pounds (40 kg). Your child's dose may change if the child gains or loses weight.

Notes:

Children must be aged 2 years or older.

Entyvio, Otezla, Skyrizi, Cimzia, prednisone, naproxen, methotrexate, dexamethasone, hydroxychloroquine, Humira

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?

If you take too much Xeljanz, Xeljanz XR, or Xeljanz Oral Solution, call your healthcare provider, the Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What should I avoid while taking Xeljanz?

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Xeljanz?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xeljanz and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. This list is not complete and many other drugs may interact with tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Does Xeljanz interact with my other drugs?

Enter other medications to view a detailed interaction report.

Xeljanz ingredients

Active ingredient: tofacitinib citrate

Inactive ingredients:

Availability

Xeljanz tablets: 5 mg, 10 mg
Xeljanz XR Tablets: 11 mg, 22 mg tofacitinib
Xeljanz Oral Solution: 1 mg/mL tofacitinib

Storage

Store Xeljanz and Xeljanz XR at room temperature between 68°F to 77°F (20°C to 25°C).

Store Xeljanz Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C). Use within 60 days of opening the bottle. Throw away (discard) the remaining solution after 60 days. Write the date when you first start to use the solution on the carton.

Keep it in the original bottle and carton to protect it from light.

Keep out of reach of children.

Who makes Xeljanz, Xeljanz XR, and Xeljanz oral solution?

Pfizer Inc. manufactures Xeljanz, Xeljanz XR, and Xeljanz oral solution.

Popular FAQ

What are JAK inhibitors and how do they work?

Janus kinase (JAK) inhibitors are a group of medicines that help block immune system signals in the body that can lead to swelling (inflammation) and pain in conditions like rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. They work by blocking enzymes that lead to overactivity of the immune system. Continue reading

What happens when you stop taking Xeljanz?

Stopping treatment with Xeljanz may cause the symptoms of your condition to return. However, some patients are able to stop Xeljanz without their symptoms flaring up, according to the results of research conducted in patients with rheumatoid arthritis. You should not stop taking Xeljanz without consulting your doctor. Continue reading

Which JAK inhibitors are approved in the U.S?

List of JAK inhibitors approved in the United States include:

  • Cibinqo (abrocitinib)
  • Inrebic (fedratinib)
  • Jakafi (ruxolitinib)
  • Litfulo (ritlecitinib)
  • Ojjaara (momelotinib)
  • Olumiant (baricitinib)
  • Opzelura (ruxolitinib)
  • Rinvoq (upadacitinib)
  • Vonjo (pacritinib)
  • Xeljanz (tofacitinib)
Continue reading
How long does it take to work?

Xeljanz can work in as little as three days for patients with ulcerative colitis. Some patients with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis will notice an improvement in their symptoms within two weeks, but others may have to wait up to three to four months for Xeljanz to work.

Xeljanz (tofacitinib citrate) is a Janus kinase (JAK) inhibitor and disease modifying anti-rheumatic drug (DMARD), which works by suppressing the immune system. Continue reading

Can I drink alcohol while taking Xeljanz?

Although the manufacturer of Xeljanz, Pfizer, does not warn of an interaction between alcohol and Xeljanz, you should not drink excessive amounts of alcohol while you are taking Xeljanz because both are metabolized by the liver and can cause liver damage. The risk may be higher if you take other immunosuppressants or medications that also affect the liver, such as methotrexate, or already have liver disease. There have already been numerous Xeljanz lawsuits filed by people who believe Pfizer should have warned them about the dangers of combining alcohol and Xeljanz. Continue reading

Does it cause hair loss?

Hair loss is not a side effect of Xeljanz. In fact, Xeljanz is sometimes used off-label to treat hair loss in patients with alopecia areata. Treatment with Xeljanz leads to hair regrowth in some patients with alopecia areata, although hair shedding occurs once treatment is stopped. Continue reading

What is it used for and is it a biologic?

Xeljanz (tofacitinib) is a biologic medicine classified as Janus kinus (JAK) inhibitor and is used in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults and for polyarticular juvenile idiopathic arthritis in patients 2 years and older. Continue reading

Is Xeljanz an immunosuppressant?

Yes, Xeljanz is an immunosuppressant drug and reduces the activity of the immune system. This can make it harder for you to fight an infection. You should not use Xeljanz if you have a serious infection. Your doctor may perform tests before you start treatment to be sure you do not have an infection. Continue reading

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Further information

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