Uses

What is Xeljanz used for?

Xeljanz (tofacitinib) is commonly used for the following conditions.

  • Rheumatoid arthritis, which is an autoimmune condition that affects the joints
  • Psoriatic arthritis, which is an autoimmune condition that affects the skin and the joints
  • Ankylosing spondylitis, which is an autoimmune condition that causes inflammation of the joints (arthritis) in the spine
  • Ulcerative colitis, which is a condition that causes inflammation of the large intestine
  • Polyarticular course juvenile idiopathic arthritis (pcJIA), which is a type of arthritis that affects multiple joints in children

Learn more about managing rheumatoid arthritis with Xeljanz

Learn more about Xeljanz for ulcerative colitis.

Xeljanz may also be used for other conditions as determined by your healthcare provider.

How does Xeljanz work (mechanism of action)?

Xeljanz is a JAK inhibitor that works from inside your cells to stop the pathways that cause inflammation. This helps to regulate your overactive immune system.

How is Xeljanz supplied (dosage forms)?

Brands and other names

  • Xeljanz 
  • Xeljanz XR

Dosage forms and strengths

  • 1 mg/mL oral solution
  • 11 mg extended-release oral tablets
  • 22 mg extended-release oral tablets
  • 5 mg oral tablets
  • 10 mg oral tablets

How should I store Xeljanz?

Xeljanz should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Oral Liquid. Store Xeljanz oral liquid in the original bottle and carton and use it within 60 days of opening. Protect from light.

Side Effects

What are the most common side effects of Xeljanz?

The most common side effects of Xeljanz are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Diarrhea
  • Headache
  • High cholesterol levels
  • High creatine phosphokinase levels, which is a protein found in your muscles
  • Rash
  • Herpes zoster, also called shingles
  • High blood pressure
  • Acne
  • Fever
  • Nausea or vomiting

There may be other side effects of Xeljanz that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Xeljanz?

While less common, the most serious side effects of Xeljanz are described below, along with what to do if they happen.

Severe Allergic Reactions. Xeljanz may cause allergic reactions, which can be serious. Stop taking Xeljanz and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Xeljanz can increase the risk of infections, including serious infections. Xeljanz may also reactivate viruses in your body that were previously inactive, which can cause symptoms of infection. Before you start treatment with Xeljanz, tell your healthcare provider if you have ever had tuberculosis (TB)hepatitis B, or any other serious infections. Call your healthcare provider if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Warm, red, or painful skin or sores on your body
  • Tiredness

Cancer. Xeljanz can increase the risk of developing certain cancers, such as lung cancerbreast cancermelanomaprostate cancer, lymphoma, and pancreatic cancer. Make sure you keep all appointments with your healthcare provider and tell your healthcare provider about any new symptoms that you may get.

Heart Attack, Stroke, and Death. Xeljanz can increase your risk of a heart attack or stroke that can lead to death, especially in people over age 50 who have at least one risk factor for heart disease. This risk is increased in people with existing heart disease and with longer use of Xeljanz and higher doses. Do not take Xeljanz if you have had a recent heart attack or stroke without talking to your healthcare provider. This could increase your risk of having another heart attack or stroke. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

Blood Clots. Xeljanz may cause blood clots in your veins or arteries. This could lead to a blood clot in your legs or arms (deep vein thrombosis) or a blood clot in your lungs (pulmonary embolism). Stop taking Xeljanz and get emergency help right away if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Pain, swelling, redness, or tenderness in your arm or leg that will not go away

Stomach Tears. Xeljanz can increase your risk of tears (perforation) in your gut. The risk is higher if you have a history of stomach ulcers, have a history of inflammation in your large intestines (diverticulitis), have bleeding problems, or take certain other medicines. Stop taking Xeljanz and get emergency help right away if you have any of the following symptoms.

  • Fever
  • Change in your bowel movements
  • Stomach pain that does not go away

Blood Disorders. Taking Xeljanz can cause blood disorders, such as changes in white blood cell (lymphocyte) levels, low neutrophil white blood cell levels (neutropenia), and low red blood cell levels (anemia). Your healthcare provider may check your blood levels before and while you are taking Xeljanz and may temporarily or permanently stop Xeljanz if certain blood levels are too low. Stop taking Xeljanz and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Changes in Laboratory Tests. Taking Xeljanz can cause your liver enzymes to increase or your cholesterol levels to increase. Your healthcare provider may run blood tests around four to eight weeks after you have started taking Xeljanz to monitor your blood levels. Keep all appointments for blood work.

Hepatitis. If you have hepatitis B or hepatitis C virus in your blood (which can affect the liver), Xeljanz could make the virus active again. You may not have symptoms of hepatitis B or hepatitis C. Keep all appointments for blood work before starting Xeljanz and during treatment. Call your healthcare provider right away if you develop any of the following symptoms of hepatitis.

  • Unusual weakness or tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Loss of appetite 
  • Vomiting
  • Stool (poop) that is clay-colored
  • Fever
  • Chills
  • Stomach discomfort
  • Muscle aches
  • Dark urine
  • Skin rash

Warnings & Precautions

Who should not use Xeljanz?

Allergies to Ingredients. People who are allergic to any of the following should not take Xeljanz.

  • Xeljanz
  • Tofacitinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Xeljanz.

What should I know about Xeljanz before using it?

Do not take Xeljanz unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Xeljanz with other people, even if they have the same condition as you. It may harm them.

Keep Xeljanz out of the reach of children.

If you are taking Xeljanz XR, do not chew, cut, or crush the tablets. You may see something that looks like a tablet in your stool. This is the empty shell from the Xeljanz XR tablet after the medicine has been absorbed by your body.

If you are prescribed Xeljanz oral liquid, use the syringe that comes with the medicine to measure your dose. Follow the Instructions for Use that comes with the medicine to ensure that you are measuring your dose correctly.

People who are 50 years of age or older can be at greater risk for some side effects from Xeljanz. Talk to your healthcare provider about your risks if you are in this age group.

What should I tell my healthcare provider before using Xeljanz?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Xeljanz is right for you.

In particular, make sure that you discuss any of the following.

Risk for Infection. Tell your healthcare provider if you have any of the following factors that may increase your risk of having an infection while taking Xeljanz.

  • Are currently being treated for an infection
  • Have had a lot of infections, or infections that keep coming back
  • Have diabetes, chronic lung disease, human immunodeficiency virus (HIV), or a weak immune system 
  • Have tuberculosis (TB) or have been in close contact with someone who has tuberculosis 
  • Have lived in or traveled to certain parts of the United States (Ohio and Mississippi River Valleys, Southwest)
  • Currently have or have had hepatitis B or hepatitis C (which are infections of the liver) or shingles (herpes zoster)

Smoking. Tell your healthcare provider if you currently smoke or have smoked in the past. Taking Xeljanz while smoking or if you have a history of smoking may put you at higher risk of developing certain cancers or heart problems.

Other Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Kidney problems, including a prior kidney transplant
  • Liver problems
  • Diverticulitis or ulcers in your stomach
  • History of cancer
  • History of heart problems, heart attack, or stroke
  • History of blood clots
  • High cholesterol
  • Blood disorders
  • Narrowing of the esophagus, stomach, or intestines (strictures)

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before or while taking Xeljanz. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Other Medicines and Supplements. Xeljanz may interact with other medicines and supplements. Before using Xeljanz, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Xeljanz could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Xeljanz while you are pregnant or trying to get pregnant. If you become pregnant while taking Xeljanz, you can register for the Xeljanz/Xeljanz XR/Xeljanz Oral Solution pregnancy registry by calling 877-311-8972. This registry collects safety information about the use of Xeljanz during pregnancy.

Breastfeeding. It is not known if Xeljanz passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Xeljanz. It is not recommended to breastfeed for at least 18 hours after your last dose of Xeljanz or Xeljanz Oral Solution. It is not recommended to breastfeed for at least 36 hours after your last dose of Xeljanz XR.

How can I get more information about Xeljanz?

For more information about Xeljanz, you can visit the manufacturer’s website at www.xeljanz.com or call them at 800-438-1985.

Interactions

Does Xeljanz interact with foods or drinks?

There are no known interactions between Xeljanz and foods or drinks.

It is unknown if drinking alcohol will affect Xeljanz.

Does Xeljanz interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Xeljanz.

  • Ketoconazole or fluconazole, which is a medicine used to treat fungal infections
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Any other medicine that suppresses your immune system, such as azathioprine, tacrolimus, or cyclosporine
  • Any other medicine used to treat autoimmune conditions, such as tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), or ixekizumab (Taltz)

Some other medicines may alter the blood levels of Xeljanz. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Xeljanz. Always check with your healthcare provider.

Does Xeljanz (tofacitinib) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Xeljanz?

If you or someone else has used too much Xeljanz, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Xeljanz?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

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