Savings & Support

Pay as little as $0 per month for your XELJANZ prescription*

*Eligibility required. Annual savings up to $15,000. State and federal beneficiaries not eligible. Terms and conditions apply.

If you have a financial hardship and have been prescribed XELJANZ or XELJANZ XR, XELSOURCE may be able to help with access options. See below for details. Terms and conditions/eligibility requirements apply.


1-844-935-5269

MONDAY-FRIDAY, 8:00 AM8:00 PM ET

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Contacting XELSOURCE

To speak to someone at XELSOURCE about your insurance coverage and medication costs for XELJANZ or XELJANZ XR, Monday through Friday, 8:00 AM-8:00 PM ET, call 1-844-935-5269 and say “Representative.”

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Getting Started

After you have been prescribed XELJANZ or XELJANZ XR, our support program may help you by:

  • Contacting your insurance company on your behalf
  • Helping investigate and assess your eligibility for coverage when needed
  • Confirming what your out-of-pocket costs will be
  • Assisting you with obtaining Prior Authorization (PA) when needed

A process used by some health insurance companies to determine if they would cover a prescribed medication

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Activating Co-Pay Savings Card

Our Co-Pay Savings Program may reduce out-of-pocket cost for eligible, commercially insured patients prescribed XELJANZ or XELJANZ XR. Eligibility requirements apply.

To speak with someone about your insurance coverage and medication costs, call 1-844-935-5269 and say “Representative.”

Co-Pay Savings Card

Our Co-Pay Savings Card may reduce out-of-pocket cost for eligible, commercially insured patients prescribed XELJANZ or XELJANZ XR. Terms and conditions/eligibility requirements apply.

Sign Up To Receive A Co-Pay Savings Card Now

There are three ways you can get a Co-Pay Savings Card.*

ENVELOPE ICON

Receive one in the mail as part of your XELJANZ Welcome Kit.

SMS ICON

Elect to receive one via text message by texting “XPROGRAM” to 50336 and enrolling in the XSAVINGS Co-Pay Program for XELJANZ.

ARROW DOWN ICON

Follow the directions to print a card or save it to your digital wallet immediately after registering.

To activate your card, call 1-844-935-5269 and say “Activate.”

Renew/Replace Your Card

*For eligible underinsured or uninsured patients, XELSOURCE may offer financial assistance through the Pfizer Patient Assistance Program. Call XELSOURCE to learn more about these programs. Terms and conditions/eligibility requirements apply.

Mobile Terms and Conditions Apply. Msg and data rates may apply. Msg frequency varies. Text HELP for info, STOP to opt out.

Financial Support Questions

If I have been prescribed XELJANZ or XELJANZ XR, do I qualify for a Co-Pay Savings Card?

Commercial patients prescribed XELJANZ or XELJANZ XR should call XELSOURCE at 1-844-935-5269 to determine if they qualify for a Co-Pay Savings Card. Terms and conditions can be accessed here.

If I was originally prescribed XELJANZ and my doctor prescribes me XELJANZ XR, will I need additional insurance approvals?

When switching from XELJANZ to once-daily XELJANZ XR, additional approvals may not be required. For more information, check with your insurance provider.

What do I do if my insurance coverage changes?

Health plans can change—so can your health insurance and prescription benefits. Once your new plan begins, XELSOURCE can help review your plan information, verify your coverage if needed, and assist with the Prior Authorization (PA) process.

A process used by some health insurance companies to determine if they would cover a prescribed medication

What do I do if my claim for XELJANZ or once-daily XELJANZ XR is denied?

If your request is denied, you may able to appeal the decision. Call XELSOURCE to learn more about the support programs that may be available to you.

To speak with a XELSOURCE specialist, call 1-844-935-5269, Monday through Friday, 8:00 AM8:00 PM ET.

Learn About Savings Options

If you are running into financial challenges, Pfizer has programs in place that may be able to help. See below for details.

Calendar

If you have commercial insurance, you may qualify for a Co-Pay Savings Card. See limits, terms, and conditions. If your pharmacy does not accept the Co-Pay Savings Card, a rebate form is available. See limits, terms, and conditions. Eligibility is not based on income.

If you have government insurance, such as Medicare Part D, and you need financial assistance, we can also evaluate your eligibility for Medicare Extra Help for the Pfizer Patient Assistance Program.* If you are eligible, we will provide XELJANZ or XELJANZ XR at no cost to you. See limits, terms, and conditions.

If you have no insurance and need financial assistance, we will evaluate your eligibility for Medicaid and for the Pfizer Patient Assistance Program. If you are eligible, we will provide you XELJANZ or XELJANZ XR at no cost to you. See limits, terms, and conditions.

To speak with someone at XELSOURCE about your insurance coverage and medication costs for XELJANZ or XELJANZ XR, call 1-844-935-5269 and say “Representative.”


XELJANZ is covered for 98% of commercially-insured, moderate to severe rheumatoid arthritis patients with a prescription.‡§


*The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided through the Pfizer Patient Assistance Foundation. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

Covered: After trial and failure of methotrexate. Included on plan formulary as a preferred or non-preferred product. Non-preferred products are subject to a step edit and/or higher out-of-pocket cost to the patient. Not all covered lives are RA patients.

§Data on file. Pfizer Inc., New York, NY. Data are current as of January 2020. Because formularies are subject to change, and many health plans offer more than one formulary, please check directly with the health plan to confirm coverage for individual patients. The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. This communication is created by Pfizer. National commercial coverage updated as of January 2020. The number of covered lives does not represent the number of patients with RA. The information in this communication is valid until December 31, 2020 and is subject to change without notice. Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced herein.

Indications Indaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Adults with 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
  • Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

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

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

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active » Read More
Important Safety Information ISI Modal

XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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 and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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 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, 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; or 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 use XELJANZ/XELJANZ XR. 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, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

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 and immune system problems. 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 in patients taking XELJANZ/XELJANZ XR. 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 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 (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. 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. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ/XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot 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/XELJANZ XR 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 and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, 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 receive XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

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

  • have an infection
  • 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 ingredients in XELJANZ/XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
    • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. 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/XELJANZ XR, 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
  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.
  • 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.

Taking XELJANZ/XELJANZ XR

  • Take XELJANZ/XELJANZ XR 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/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

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

XELJANZ/XELJANZ XR may cause serious side effects, including 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 XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. 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, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic 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).

Common side effects of XELJANZ/XELJANZ XR in ulcerative colitis patients 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).

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

IndicationsIndaication Modal

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Adults with 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
  • Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

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

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

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor 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 a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active » Read More
Important Safety InformationISI Modal

XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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 and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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 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, 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; or 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 use XELJANZ/XELJANZ XR. 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, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

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 and immune system problems. 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 in patients taking XELJANZ/XELJANZ XR. 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 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 (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. 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. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ/XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot 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/XELJANZ XR 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 and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, 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 receive XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

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

  • have an infection
  • 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 ingredients in XELJANZ/XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
    • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. 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/XELJANZ XR, 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
  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.
  • 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.

Taking XELJANZ/XELJANZ XR

  • Take XELJANZ/XELJANZ XR 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/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

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

XELJANZ/XELJANZ XR may cause serious side effects, including 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 XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. 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, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic 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).

Common side effects of XELJANZ/XELJANZ XR in ulcerative colitis patients 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).

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

Indications

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What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
  • Adults with 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
  • Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

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

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

Important Safety Information

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XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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 and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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 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, 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; or 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 use XELJANZ/XELJANZ XR. 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, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

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 and immune system problems. 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 in patients taking XELJANZ/XELJANZ XR. 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 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 (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. 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. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ/XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot 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/XELJANZ XR 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 and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, 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 receive XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

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

  • have an infection
  • 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 ingredients in XELJANZ/XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
    • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. 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/XELJANZ XR, 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
  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.
  • 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.

Taking XELJANZ/XELJANZ XR

  • Take XELJANZ/XELJANZ XR 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/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

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

XELJANZ/XELJANZ XR may cause serious side effects, including 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 XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. 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, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic 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).

Common side effects of XELJANZ/XELJANZ XR in ulcerative colitis patients 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).

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