Clinical Trials

The efficacy and safety of XELJANZ® (tofacitinib) were tested in 6 clinical trials that included adult patients with moderate to severe rheumatoid arthritis (RA). In each study, participants were divided randomly into treatment groups, and 1,589 participants were treated with XELJANZ 5 mg twice daily.

Approximately

Participants

clinical study
participants

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XELJANZ was tested
with and without
methotrexate

Safety studies

Efficacy and safety
evaluated in
multiple studies

Patients in 5 of the 6 clinical trials had moderate to severe RA, which is defined as having:

  • At least 6 tender/painful joints
  • At least 6 swollen joints
  • Lab test results that indicated inflammation in joints

Two of the clinical trials required patients to have 3 or more joint erosions or a lab test result indicating RA.

These studies measured if XELJANZ:

  • Reduced joint pain and swelling
  • Improved the ability to accomplish certain daily activities. Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses the ability to complete different activities, such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping.
  • The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses the following categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Its scale is 0-1 = mild disability; 1-2 = moderate to severe disability; 2+ = greater disability. The studies measured if there was an improvement of ≥0.22 on this scale.

  • Affected the progression of structural joint damage (in 2 of the studies)

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ/XELJANZ XR.

The ORAL Solo Study

ORAL Solo was a study that included adult patients with moderate to severe RA in whom biologic or nonbiologic DMARDs did not work well or could not be tolerated. Patients took either XELJANZ alone or a placebo alone. At 3 months, patients who received placebo were switched over to XELJANZ.

  • At 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) had an improvement in their RA signs and symptoms as measured by ACR20 response criteria.
  • A measuring standard created by the American College of Rheumatology (ACR). The "20" stands for 20% or greater reduction in the number of tender/painful and swollen joints as well as an improvement of 20% or more in at least three of the following measures:

    • Physician assessed overall health and progress information
    • Patient assessed overall health and progress information
    • Pain scale
    • Physical function (measured by the Health Assessment Questionnaire Disability Index, known as HAQ-DI)
    • Lab test results that measure the amount of inflammation in joints
  • At 3 months, 59% of XELJANZ patients (143 out of 243) and 25% of placebo patients (31 out of 122) experienced an improvement in their RA signs and symptoms as measured by ACR20.
  • At 6 months, 69% of XELJANZ patients (168 out of 243) had an improvement in their RA signs and symptoms as measured by ACR20.
  • At 3 months, 60% of XELJANZ patients (143 out of 240) and 39% of placebo patients (47 patients out of 120) experienced improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).

Results Of The Study

More than half (59%) of XELJANZ patients felt an improvement in their RA symptoms within 3 months.*

*Individual results may vary.
grip

At 3 months, more than half of XELJANZ patients could more easily complete common daily activities, such as getting dressed, walking down stairs, and gripping household items.

XELJANZ reduced further joint pain and swelling caused by RA, even without the use of methotrexate.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ/XELJANZ XR.

The ORAL Start & ORAL Scan Studies

Based on two studies, XELJANZ was shown on X-rays to help reduce further joint damage.

The ORAL Start Study

ORAL Start was a study that included adult patients with moderate to severe RA who hadn't taken methotrexate prior to the study. However, XELJANZ is only approved for use in patients for whom methotrexate did not work well. Patients took either XELJANZ alone or methotrexate alone.

At 6 months, patients who took XELJANZ had less progression of RA joint damage than patients who took methotrexate, as measured by the modified Total Sharp Score (mTSS).

Scores joint damage progression by grading erosion in the hands and feet, and the presence of joint space narrowing in the hands, wrists, and feet.

  • At 6 months, 73% of patients treated with XELJANZ 5 mg twice daily experienced no radiographic progression of joint damage compared to 55% of patients taking methotrexate.
  • X-ray is used to measure if there is a change from baseline in the mTSS score that grades erosion in the hands and feet, and the presence of joint space narrowing in the hands, wrists, and feet.

The ORAL Scan Study

ORAL Scan was a study of adult patients with moderate to severe RA in whom methotrexate did not work well. Patients took either XELJANZ and methotrexate or placebo and methotrexate.

At 6 months, patients who took XELJANZ and methotrexate had less progression of RA joint damage than patients who took placebo and methotrexate, as measured by the modified Total Sharp Score (mTSS).

  • At 6 months, 84% of patients treated with XELJANZ 5 mg twice daily plus methotrexate experienced no radiographic progression of joint damage compared to 74% of patients who took placebo plus methotrexate.

There is a possibility that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.

Results Of The Studies

Less Joint Damage

Arrow down

At 6 months, XELJANZ patients experienced less joint damage progression than methotrexate patients.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension). Learn more about the Most Important Information you should know about XELJANZ/XELJANZ XR.

Talking To Your Doctor

If your current treatment is not working well enough to manage your RA symptoms, it’s important to speak up with your doctor. Every appointment is an opportunity to discuss symptom concerns, different treatment options, and how your disease is affecting some aspects of your daily life. Use our list of questions to help start the conversation.

Get Helpful Questions
Indications Indaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active » Read More
Important Safety Information ISI Modal

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. 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 (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

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 can get tears in their stomach or intestine. 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, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ/XELJANZ XR?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: 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.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

IndicationsIndaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated...Read More

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active » Read More
Important Safety InformationISI Modal

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. 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 (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

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 can get tears in their stomach or intestine. 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, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ/XELJANZ XR?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: 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.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Indications

Close

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Important Safety Information

Close

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing is noted.

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include 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 and during treatment with XELJANZ.

Before and after starting XELJANZ, tell your doctor if you have an infection or symptoms of an infection, including:

  • Fever, sweating, or chills
  • Cough
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Burning when you urinate
  • Urinating more often than normal
  • Muscle aches
  • Shortness of breath
  • Weight loss
  • Diarrhea or stomach pain
  • Feeling very tired

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose.  People 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, shingles, or skin cancers.

Immune System Problem. 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 (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

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 can get tears in their stomach or intestine. 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, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ/XELJANZ XR?

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 starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: 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, or dark urine.

Common side effects in adults with rheumatoid arthritis and psoriatic arthritis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular juvenile idiopathic arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: 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.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.