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Xeljanz

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

Medically reviewed by Nicole France, BPharm. Last updated on Jul 18, 2022.

What is Xeljanz?

Xeljanz (tofacitinib) is a small molecule drug used to treat inflammatory and autoimmune conditions. It is available as a tablet, an oral solution and an extended-release tablet known as Xeljanz XR.

Xeljanz is used to treat people who have used 1 or more biological drugs known as tumor necrosis factor (TNF) blockers and it did not work well or could not be tolerated.

Xeljanz is a disease modifying anti-rheumatic drug (DMARD) that belongs to a group of drugs known as janus kinase (JAK) inhibitors.

Xeljanz works by blocking the activity of JAK enzymes, which belong to a group of enzymes known as tyrosine kinases. JAK enzymes are essential for cytokine signaling. Blocking the activity of JAK enzymes interrupts certain signaling pathways inside your cells that produce inflammation. Xeljanz also suppresses the immune system.

Xeljanz was first approved by the US Food and Drug Administration in 2012.

What is Xeljanz used for?

Xeljanz and Xeljanz XR are used to treat adults with the following conditions when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated:

Xeljanz and Xeljanz oral solution are used to treat patients 2 years of age and older with active polyarticular course juvenile arthritis when 1 or more TNF blockers have been used, and did not work well or cannot be tolerated. It is not know if they are safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if any of the different formulations of Xeljanz are safe and effective in people with hepatitis B or C and they are not recommended for people with severe liver problems.

It is not known if the extended-release tablets - Xeljanz XR - are safe and effective in children.

Important information

Xeljanz, Xeljanz XR and Xeljanz oral solution may cause serious side effects including:

1. Serious infections

These medications affect your immune system. They can lower the ability of your immune system to fight infections. Some people can have serious infections while taking these medications, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

  • Your healthcare provider should test you for TB before starting Xeljanz, Xeljanz XR and Xeljanz oral solution and during treatment.
  • Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking these medications if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

People with ulcerative colitis taking the higher dose of Xeljanz (10 mg twice daily) or Xeljanz XR (22 mg one time each day) have a higher risk of serious infections and shingles.

Before starting Xeljanz, Xeljanz XR and Xeljanz oral solution, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweating, or chills
    • cough
    • blood in phlegm
    • warm, red, or painful skin or sores on your body
    • burning when you urinate or urinating more often than normal
    • muscle aches
    • shortness of breath
    • weight loss
    • diarrhea or stomach pain
    • feeling very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB, or have been in close contact with someone with TB.
  • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you take these medications. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B or C.

After starting Xeljanz, Xeljanz XR and Xeljanz oral solution, call your healthcare provider right away if you have any symptoms of an infection. These medications can make you more likely to get infections or make worse any infection that you have.

2. Increased risk of death

An increased risk of death has been observed in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily.

3. Cancer and immune system problems

Xeljanz, Xeljanz XR and Xeljanz oral solution may increase your risk of certain cancers by changing the way your immune system works.

  • Lymphoma and other cancers including skin cancers can happen in people taking these medications. People taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily 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 the higher dose of Xeljanz (10 mg twice daily) or Xeljanz XR (22 mg one time each day) 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).

4. Increased risk of major cardiovascular events

An increased risk of major cardiovascular events such as heart attack, stroke or death has been observed in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Xeljanz 5 mg twice daily or Xeljanz 10 mg twice daily, especially if you 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:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

5. 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 Xeljanz, Xeljanz XR and Xeljanz oral solution and 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.

6. Tears (perforation) in the stomach or intestines.

Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Xeljanz, Xeljanz XR and Xeljanz oral solution can get tears in their 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 fever and stomach-area pain that does not go away, and a change in your bowel habits.

7. 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 and Xeljanz XR. Some of these reactions were serious. If any of these symptoms occur, stop taking the medication and call your healthcare provider right away.

8. Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking Xeljanz, Xeljanz XR or Xeljanz oral solution and while you are on it to check for the following side effects:

  • changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
  • low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
  • low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not take these medications if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high.

Your healthcare provider may stop your treatment for a period of time 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 these medications, and as needed after that. Normal cholesterol levels are important to good heart health.

See "What are the possible side effects of Xeljanz?" below" for more information about side effects.

What should I tell my doctor before taking Xeljanz?

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

  • have an infection. See "Important information" above.
  • are a current or past smoker.
  • have had any type of cancer.
  • have had a heart attack, other heart problems or stroke.
  • have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
  • have liver problems.
  • have kidney problems.
  • have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
  • have had a reaction to tofacitinib or any of the other inactive ingredients in your medication.
  • have recently received or are scheduled to receive a vaccine. People who take these medications should not receive live vaccines. People taking Xeljanz, Xeljanz XR and Xeljanz oral solution can receive non-live vaccines.

How should I take Xeljanz and Xeljanz XR?

  • Take your medication exactly as your healthcare provider tells you to take it.
  • Take Xeljanz 2 times a day with or without food.
  • Take Xeljanz XR 1 time a day with or without food.
  • Swallow Xeljanz XR tablets whole and intact. Do not crush, split, or chew.
  • When you take Xeljanz XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
  • For the treatment of psoriatic arthritis, take Xeljanz or Xeljanz XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.
  • Xeljanz XR should not be used instead of the oral solution.

How should I take Xeljanz oral solution?

  • Take your medication exactly as your healthcare provider tells you to take it.
  • Take Xeljanz oral solution 2 times a day with or without food.
  • To prepare and administer the oral solution:
    • Step 1. Open the carton and remove the bottle of oral solution
    • Step 2. Open the bottle by pushing down on the child-resistant cap and turning it to the left (counter-clockwise) as shown. Remove the seal off the top of the bottle (first time only).
      Do not throw away the child-resistant cap.
      Note: The bottle does not need to be shaken before use.
    • Step 3. Insert press-in bottle adapter (first time only).
      Remove the press-in bottle adapter and oral dosing syringe from the plastic overwrap. With the bottle on a flat surface, push the ribbed end of the press-in bottle adapter all the way into the neck of the bottle with your thumbs while holding the bottle firmly.
      Note: Do not remove the press-in bottle adapter from the bottle after it is inserted.
    • Step 4. Remove air from oral dosing syringe. Push the oral dosing syringe plunger all the way down to the tip of the syringe barrel to remove excess air.
    • Step 5. Insert the oral dosing syringe tip into the upright bottle through the opening of the press-in bottle adapter until it is firmly in place.
    • Step 6. Withdraw dose from bottle. With the oral dosing syringe in place, turn the bottle upside down. Pull down on the plunger until the bottom of the plunger is even with the markings on the oral dosing syringe for your prescribed dose of oral solution.
      If you see air bubbles in the oral dosing syringe, fully push the plunger in so that the oral solution flows back into the bottle. Then withdraw your prescribed dose of oral solution.
    • Step 7. Remove oral dosing syringe. Turn the bottle upright and place the bottle on a flat surface. Remove the oral dosing syringe from the press-in bottle adapter and bottle by pulling straight up on the oral dosing syringe barrel.
    • Step 8. Check the dose. Check that the correct dose was drawn up into the oral dosing syringe.
      If the dose is not correct, insert the oral dosing syringe tip firmly into the press-in bottle adapter. Fully push in the plunger so that the oral solution flows back into the bottle. Repeat Step 6 and Step 7.
    • Step 9. Take the dose of Xeljanz oral solution. Place the tip of the oral dosing syringe into the inside of the cheek.
      Slowly push the plunger all the way down to give all of the medicine in the oral dosing syringe. Make sure there is time to swallow the medicine.
  • After taking the oral solution:
    • Step 10. Close the bottle. Close the bottle tightly by turning the child-resistant cap to the right (clockwise), leaving the press-in bottle adapter in place.
      Place the bottle back into the carton.
      Close the carton to protect the oral solution from light.
    • Step 11. Clean oral dosing syringe. Remove the plunger from the barrel by pulling the plunger and the barrel away from each other.
      Rinse both with water after each use.
      Allow to air dry. When the barrel and plunger are dry, put the oral dosing syringe back together by inserting the plunger into the barrel.

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 or go to the nearest hospital emergency room right away.

Dosing information

The recommended dose in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily.

The recommended induction dose in patients with ulcerative colitis is Xeljanz 10 mg twice daily or Xeljanz XR 22 mg once daily for 8 weeks. The recommended maintenance dose in patients with ulcerative colitis is Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily.

The recommended dose in patients with polyarticular course juvenile idiopathic arthritis is Xeljanz or Xeljanz oral solution 5 mg twice daily or weight-based equivalent twice daily.

Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment.

See full prescribing information for further details about Xeljanz, Xeljanz XR and Xeljanz oral solution dosing.

What are the side effects of Xeljanz?

Xeljanz, Xeljanz XR and Xeljanz oral solution may cause serious side effects, including:

  • See "Important information" above.
  • Hepatitis B or C activation infection 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 these medications. Your healthcare provider may do blood tests before you start treatment and while you are taking the medication. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
    • feel very tired
    • little or no appetite
    • clay-colored bowel movements
    • chills
    • muscle aches
    • skin rash
    • skin or eyes look yellow
    • vomiting
    • fevers
    • stomach discomfort
    • dark urine

Common side effects of Xeljanz and Xeljanz XR in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include:

  • upper respiratory tract infections (common cold, sinus infections)
  • headache
  • diarrhea
  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • high blood pressure (hypertension)

Common side effects of Xeljanz and Xeljanz XR in people with ulcerative colitis include:

  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • increased cholesterol levels
  • headache
  • upper respiratory tract infections (common cold, sinus infections)
  • increased muscle enzyme levels
  • rash
  • diarrhea
  • shingles (herpes zoster)

Common side effects of Xeljanz and Xeljanz oral solution in people with polyarticular course juvenile arthritis include:

  • upper respiratory tract infections (common cold, sinus infections)
  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • headache
  • fever
  • nausea
  • vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

Interactions

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

Especially tell your healthcare provider if you take:

  • any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis or polyarticular course juvenile arthritis. You should not take the following while taking Xeljanz, Xeljanz XR and Xeljanz oral solution:
  • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you plan to become pregnant or are pregnant. Xeljanz, Xeljanz XR and Xeljanz oral solution may affect the ability of females to get pregnant. It is not known if this will change after stopping these medications. It is not known if they will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take Xeljanz, Xeljanz XR and Xeljanz oral solution. 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 these medications, 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.

Tell your doctor if you plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take your medication or breastfeed. You should not do both. After you stop your treatment with Xeljanz, Xeljanz XR or Xeljanz oral solution do not start breastfeeding again until:

  • 18 hours after your last dose of Xeljanz or Xeljanz oral solution or
  • 36 hours after your last dose of Xeljanz XR

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) in the original bottle and carton to protect from light.
  • Store the oral dosing syringe with the oral solution.
  • Do not throw away the oral dosing syringe.
  • Safely throw away any oral solution that is out of date or no longer needed. Use the oral solution within 60 days of opening the bottle. Throw away (discard) remaining oral solution after 60 days.

Keep out of the reach of children.

What are the ingredients in Xeljanz?

Active ingredient: tofacitinib citrate

Inactive ingredients:

Xeljanz 5 mg: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Xeljanz 10 mg: croscarmellose sodium, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Xeljanz XR 11 mg: cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, and triacetin. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron, propylene glycol, and shellac glaze.

Xeljanz XR 22 mg: cellulose acetate, copovidone, FD&C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze.

Xeljanz oral solution: grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol.

Xeljanz, Xeljanz XR and Xeljanz oral solution are distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017.

Popular FAQ

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

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

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

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

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

Weight gain and weight loss were not identified as side effects during clinical development of Xeljanz. 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.