What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well.

  • It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C.
  • XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.
  • It is not known if XELJANZ/XELJANZ XR is safe and effective in children.

TRIAL Rx PROGRAM TERMS
AND CONDITIONS

  • This is not health insurance and is a one-time-only offer for eligible, commercially insured patients.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ® XR (tofacitinib citrate) extended release.
  • Patients who have already begun therapy with XELJANZ XR at the time of the request and patients under the age of eighteen (18) years of age are ineligible for participation in the Program.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party private payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare, or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts.
  • Available in a 14-day supply.
  • This offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Trial Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.

If you have questions or are in need of additional support, call 1-855-493-5526 or visit www.XELJANZ.com.

Pfizer Inc, 235 E. 42nd Street, New York, NY 10017

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

PATIENT ASSISTANCE PROGRAM/HARDSHIP
ASSISTANCE PROGRAM TERMS And CONDITIONS

  • The Patient Assistance Program/Hardship Assistance Program is not health insurance and is available for eligible patients with Medicaid insurance or eligible uninsured/underinsured patients only.
  • Offer is only available to patients who meet financial and other criteria.
  • This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
  • No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Offer good only in the US and Puerto Rico.
  • Patient must be a resident of the United States or Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.

If you have questions or are in need of additional support, call 1-855-493-5526 or visit www.XELJANZ.com.

Pfizer Inc, 235 E. 42nd Street, New York, NY 10017

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

Quick Facts

If moderate to severe rheumatoid arthritis (RA) pain is getting in the way of your normal activities, it may be time to ask if XELJANZ or the once-daily formulation, XELJANZ XR, could be right for you.

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1

Available by prescription, XELJANZ (pronounced zel-jans zel-janszel-jans) is a small pill that treats moderate to severe RA. XELJANZ is also available as a once-daily pill called XELJANZ XR. Learn more about once-daily XELJANZ XR here.

XELJANZ is proven to work alone—even without methotrexate.

2

XELJANZ is the first in a class of treatments for moderate to severe RA called Janus kinase (JAK) inhibitors. If methotrexate hasn’t done enough to help relieve your RA symptoms, and before you and your rheumatologist decide on a biologic, ask if XELJANZ is right for you.

3

X-rays have shown that XELJANZ helps stop further joint damage.

4

In some patients, XELJANZ began to work in as early as 2 weeks to reduce RA joint pain and swelling. In clinical trials, more than half of XELJANZ patients felt an improvement in RA symptoms at 3 months.

Everyone is different. Your results may vary.

5

XELJANZ is a pill proven to reduce RA pain, swelling, and joint damage—even without methotrexate.

6

The easy-to-open XELJANZ bottle cap was awarded the Arthritis Foundation’s Ease-of-Use Commendation.†

†The Arthritis Foundation’s Ease-of-Use Commendation recognizes products, such as the XELJANZ bottle cap, proven to make life easier for people who have arthritis and other physical limitations.

Quick Facts

If moderate to severe rheumatoid arthritis (RA) pain is getting in the way of your normal activities, it may be time to ask if XELJANZ could be right for you.
1A SMALL PILL

Available by prescription, XELJANZ (pronounced zel-jans zel-janszel-jans) is a small pill that treats moderate to severe RA. XELJANZ is also available as a once-daily pill called XELJANZ XR. Learn more about once-daily XELJANZ XR here.

XELJANZ is proven to work alone—even without methotrexate.

2A JAK INHIBITOR

XELJANZ is the first in a class of treatments for moderate to severe RA called Janus kinase (JAK) inhibitors. If methotrexate hasn’t done enough to help relieve your RA symptoms, and before you and your rheumatologist decide on a biologic, ask if XELJANZ is right for you.

3HELPS STOP FURTHER JOINT DAMAGE

X-rays have shown that XELJANZ helps stop further joint damage.

4REDUCES RA PAIN AND SYMPTOMS

In some patients, XELJANZ began to work in as early as 2 weeks to reduce RA joint pain and swelling. In clinical trials, more than half of XELJANZ patients felt an improvement in RA symptoms at 3 months.

Everyone is different. Your results may vary.

5CAN BE TAKEN ALONE

XELJANZ is a pill proven to reduce RA pain, swelling, and joint damage—even without methotrexate.

6EASY-TO-OPEN BOTTLE

The easy-to-open XELJANZ bottle cap was awarded the Arthritis Foundation’s Ease-of-Use Commendation.†

†The Arthritis Foundation’s Ease-of-Use Commendation recognizes products, such as the XELJANZ bottle cap, proven to make life easier for people who have arthritis and other physical limitations.

How XELJANZ Works

How Xeljanz Works
 
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XELJANZ is a Janus kinase (JAK) inhibitor that works deep inside the cell to disrupt activities occurring in signaling pathways. These JAK pathways are believed to play a role in the inflammation associated with RA. Watch to learn more about the science of XELJANZ and how it works to help disrupt the processes that can lead to inflammation.

Video description: 

Take a closer look at how XELJANZ works.

Clinical Trial Results

The effectiveness of XELJANZ, taken with and without a disease-modifying antirheumatic drug (DMARD), such as methotrexate, was tested in six studies that involved more than 4,200 adult patients with RA.

   

More Than Half Of XELJANZ Patients Felt An Improvement In RA Symptoms Within 3 Months.

In the ORAL Solo Study, at 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) experienced a 20% reduction in tender and swollen joint counts and 3 of these 5 indicators: blood test that measures inflammation, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.

At 3 months, 59% of XELJANZ patients (143 out of 243) and 26% of placebo patients (31 out of 122) experienced the same results. During this study, patients did not take methotrexate.

At 3 Months, More Than Half of XELJANZ Patients Could More Easily Complete Daily Activities, Such As Getting Dressed, Walking Down Stairs, And Gripping Household Items.

In the ORAL Solo Study, a scale was used that defines RA disability as: 0-1 = mild; 1-2 = moderate to severe; 2+ = greater disability. At the study start, XELJANZ patients had a mean baseline score of 1.53.

At 3 months, XELJANZ patients saw an improved score of 1.05 (a statistically important difference) and, overall, 60% (143 out of 240) of XELJANZ patients experienced an improvement ≥0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) that assesses the following categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. During this study, patients did not take methotrexate.

XELJANZ Reduced Joint Pain And Swelling Caused By RA, Even Without The Use Of Methotrexate.

In the ORAL Solo Study, at 2 weeks, 30% of XELJANZ patients (72 out of 240) and 12% of placebo patients (14 out of 120) experienced a 20% reduction in tender and swollen joint counts and 3 of these 5 indicators: blood test that measures inflammation, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.

At 3 months, 59% of XELJANZ patients (143 out of 243) and 26% of placebo patients (31 out of 122) experienced the same results. During this study, patients did not take methotrexate.

At 6 Months, XELJANZ Patients Experienced Less Joint Damage Progression Than Methotrexate Patients.

Based on two studies, XELJANZ was shown on X-rays to help reduce further structural joint damage. This included holes in the bones known as erosions and the narrowing of the space between the bones where cartilage has been lost.

In the ORAL Start Study, XELJANZ patients hadn't taken methotrexate prior to the study. However, XELJANZ is only approved for use in patients for whom methotrexate did not work well. At 6 months, XELJANZ patients got worse by 0.2 units of change on the modified Total Sharp Score (mTSS) scale, while patients taking methotrexate worsened by 0.8. mTSS measures joint damage progression in selected joints of the hands and feet. The higher the amount of change in the mTSS, the more joint damage has progressed.

In the ORAL Scan Study, patients who took XELJANZ and methotrexate had less progression of joint damage after 6 months (0.1) than those who took a placebo and methotrexate (0.5). However, the possibility was high enough that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.
       

    Safety & Side Effects

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    SERIOUS INFECTIONS

    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).

    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 in, 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.

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    CANCER AND IMMUNE SYSTEM PROBLEMS

    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, have happened in patients taking XELJANZ/XELJANZ XR. 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).

     

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    TEARS (PERFORATION) IN THE STOMACH OR INTESTINES

    Tears (perforation) in the 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.

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    CHANGES IN CERTAIN LAB TEST RESULTS

    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.

    Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.

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    WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING XELJANZ/XELJANZ XR?

    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 liver problems
    • have kidney problems
    • have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines, or narrowing within your digestive tract
    • 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. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. You should use effective birth control while you are taking XELJANZ/XELJANZ XR and for at least 4 weeks after you take your last dose.

    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

    Tell your healthcare provider about all of the medicines you take, especially any other medicines to treat your rheumatoid arthritis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ/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. 

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    WHAT ARE OTHER POSSIBLE SIDE EFFECTS OF XELJANZ/XELJANZ XR?

    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. Tell your healthcare provider if you have 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 include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).

    These are not all of the possible side effects of XELJANZ/XELJANZ XR. Please see the Prescribing Information, including BOXED WARNING and Medication Guide, for additional information and complete details about XELJANZ.

    REQUEST MORE INFO ABOUT XELJANZ.