Doctor Discussion Guide

Whether it’s a virtual appointment or an in-person visit, it’s important to have open and honest conversations with your doctor about how well your current treatment plan is working. And preparing ahead of time can help make the discussion more productive. Use our Doctor Discussion Guide to help track how you’re feeling, find helpful questions, and ensure you’re both speaking the same language.

  • Moderate to SevereRheumatoid Arthritis
  • ActivePsoriatic Arthritis
  • Moderate to SevereUlcerative Colitis

Tracking Your Rheumatoid Arthritis Symptoms

In three simple steps, we’ll help you prepare for a more productive conversation with your doctor about how your rheumatoid arthritis (RA) symptoms may be impacting you and whether XELJANZ/​XELJANZ XR could be an option for you.

Begin Tracking
Symptom tracking on tablet Symptom tracking on tablet

Iframe Step

Step 1 of 3

Is RA Impacting Your Daily Activities?

Of course, you may have good days and bad days. But your doctor needs to know if symptoms of your moderate to severe RA are affecting your ability to perform common daily activities.

Select any task (and pick a color) to rate how difficult it is for you to perform.

  • Easy
  • Medium
  • Hard/Unable
  • Getting Out Of Bed
  • Getting Dressed
  • Bathing
  • Grooming
  • Eating
  • Walking
  • Reaching
  • Gripping

Second Step

Step 2 of 3

Where Have You Noticed Any Symptoms?

If you’re experiencing RA symptoms that bother you or you notice symptoms in different parts of your body, talk to your doctor about your current treatment plan.

Select a symptom and mark an area of the body where you’ve been experiencing new joint pain, swelling, or both.

Joint pain

Joint swelling

Joint Pain

Third Step

Step 3 of 3

What Are Your RA Symptoms?

Tracking your RA symptoms and how these can impact your ability to do simple daily tasks is important. Share this information with your doctor.

Check any symptoms you may be experiencing.

Fourth Step

All Done. Here’s Your Recap.

Now that you’ve recorded your recent rheumatoid arthritis symptoms, share this self-assessment with your doctor to help you discuss your symptom management and treatment plan.

You’re all set. For more tools, tips, and support, sign up now.

This tracker is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. This is not intended to be used as a diagnostic tool. Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

This tracker is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. This is not intended to be used as a diagnostic tool. Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Talking To Your Doctor

To start a meaningful conversation with your doctor, it's helpful to come prepared with important questions about your treatment plan. Before your next appointment, consider the following questions and select ones to help you and your healthcare provider discuss the risks and benefits of treatment with XELJANZ/​XELJANZ XR for your moderate to severe RA.

You’re all set. For more tools, tips, and support, sign up now.

Speaking The Same Language

No matter where you are with your treatment, being able to clearly communicate your treatment goals, expectations—and even frustrations—is crucial to having an honest conversation with your doctor. Before your next appointment, use this glossary as a handy reference to help you and your doctor align on a treatment plan you both believe in.

Articular Cartilage

Joint Damage

Bony Ankylosis

Joint Inflammation

Synovium

Fibrous Ankylosis

Pannus

View Glossary You’re all set. For more tools, tips, and support, sign up now.

Hear From Real Patients

See how XELJANZ patients took a more active role in their treatment by starting an honest conversation with their doctor.

Watch Patient Stories
Family taking dog on a walk Family taking dog on a walk

Tracking Your Psoriatic Arthritis Symptoms

In three simple steps, we’ll help you prepare for a more productive conversation with your doctor about how your psoriatic arthritis symptoms may be impacting you and whether XELJANZ/​XELJANZ XR could be an option for you.

Begin Tracking

Iframe Step

Step 1 of 3

Is Psoriatic Arthritis Impacting Your Daily Activities?

Of course, you may have good days and bad days. But your doctor needs to know if symptoms of your active psoriatic arthritis are affecting your ability to perform common daily activities.

Select any task (and pick a color) to rate how difficult it is for you to perform.

  • Easy
  • Medium
  • Hard/Unable
  • Getting Out Of Bed
  • Getting Dressed
  • Bathing
  • Grooming
  • Eating
  • Walking
  • Reaching
  • Gripping

Second Step

Step 2 of 3

Where Have You Noticed Any Symptoms?

If you’re experiencing psoriatic arthritis symptoms that bother you or you notice symptoms in different parts of your body, talk to your doctor about your current treatment plan.

Select a symptom and mark an area of the body where you’ve been experiencing new joint pain, swelling, or both.

Joint pain

Joint swelling

Joint Pain

Third Step

Step 3 of 3

What Are Your Psoriatic Arthritis Symptoms?

Tracking your psoriatic arthritis symptoms and how these symptoms can impact your ability to do simple daily tasks is important. Share this information with your doctor.

Check any symptoms you may be experiencing.

Fourth Step

All Done. Here's Your Recap.

Now that you’ve recorded your recent psoriatic arthritis symptoms, share this self-assessment with your doctor to help you discuss your symptom management and treatment plan.

You’re all set. For more tools, tips, and support, sign up now.

This tracker is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. This is not intended to be used as a diagnostic tool. Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

This tracker is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. This is not intended to be used as a diagnostic tool. Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Talking To Your Doctor

To start a meaningful conversation with your doctor, it's helpful to come prepared with important questions about your treatment plan. Before your next appointment, consider the following questions. Then select ones to help you and your healthcare provider discuss the risks and benefits of treatment with XELJANZ/​XELJANZ XR for your active psoriatic arthritis.

You’re all set. For more tools, tips, and support, sign up now.

Speaking The Same Language

No matter where you are with your treatment, being able to clearly communicate your treatment goals, expectations—and even frustrations—is crucial to having an honest conversation with your doctor. Before your next appointment, use this glossary as a handy reference to help you and your doctor align on a treatment plan you both believe in.

Articular Cartilage

Enthesitis

Joint Inflammation

Bony Ankylosis

Fibrous Ankylosis

Pannus

Dactylitis

Joint Damage

Synovium

View Glossary You’re all set. For more tools, tips, and support, sign up now.

Is Your Approach To Life With UC All That It Can Be?

Have you resigned yourself to the idea that life with UC may be as good as it’s going to get? We’ve created this quiz to help you take a fresh look at your approach and think about how you discuss your disease and treatment plan with your gastroenterologist (GI).

Take The Quiz

 

I feel confident planning and attending social commitments despite my ulcerative colitis.

 

I’m open and honest when I talk with my GI about my ulcerative colitis symptoms.

 

I regularly research information about ulcerative colitis.

 

I actively try to connect with other people living with ulcerative colitis.

 

I worry about the impact of ulcerative colitis on my life.

 

I look for different ways to increase my level of activity that may help relieve tension and reduce stress.

 

I’d consider working with a dietitian.

 

I’d be open to talking to a counselor about my emotional well-being.

 

Don’t Let Ulcerative Colitis Discourage You.

You answered “Me” to 0 questions.

Living with ulcerative colitis can be challenging. You might feel worn down, but don't give up. You have options to help manage the impact of your condition. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Don’t Let Ulcerative Colitis Discourage You.

You answered “Me” to 1 question.

Living with ulcerative colitis can be challenging. You might feel worn down, but don't give up. You have options to help manage the impact of your condition. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Don’t Let Ulcerative Colitis Discourage You.

You answered “Me” to 2 questions.

Living with ulcerative colitis can be challenging. You might feel worn down, but don't give up. You have options to help manage the impact of your condition. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Gaining Knowledge Is Power.

You answered “Me” to 3 questions.

An open minded approach can sometimes help in making informed decisions. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Gaining Knowledge Is Power.

You answered “Me” to 4 questions.

An open minded approach can sometimes help in making informed decisions. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Gaining Knowledge Is Power.

You answered “Me” to 5 questions.

An open minded approach can sometimes help in making informed decisions. Talk to your GI about your UC symptoms, your current treatment plan, and what options may be available for you.

You’re all set. For more tools, tips, and support, sign up now.

Stay Proactive & Engaged.

You answered “Me” to 6 questions.

It sounds like you try not to let ulcerative colitis stop you from imagining a positive future as you manage your condition with your healthcare team. Talk to your GI to see if there are options you haven’t considered to help you live a fuller life with UC.

You’re all set. For more tools, tips, and support, sign up now.

Stay Proactive & Engaged.

You answered “Me” to 7 questions.

It sounds like you try not to let ulcerative colitis stop you from imagining a positive future as you manage your condition with your healthcare team. Talk to your GI to see if there are options you haven’t considered to help you live a fuller life with UC.

You’re all set. For more tools, tips, and support, sign up now.

Stay Proactive & Engaged.

You answered “Me” to 8 questions.

It sounds like you try not to let ulcerative colitis stop you from imagining a positive future as you manage your condition with your healthcare team. Talk to your GI to see if there are options you haven’t considered to help you live a fuller life with UC.

You’re all set. For more tools, tips, and support, sign up now.

All content on this website is for informational purposes only. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay seeking it because of something you have read on this website.

All content on this website is for informational purposes only. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay seeking it because of something you have read on this website.

Talking To Your Doctor

To start a meaningful conversation with your doctor, it's helpful to come prepared with important questions about your treatment plan. Before your next appointment, consider the following questions and select ones to help you and your healthcare provider discuss the risks and benefits of treatment with XELJANZ/​XELJANZ XR for your moderate to severe ulcerative colitis (UC).

You’re all set. For more tools, tips, and support, sign up now.

Speaking The Same Language

Before you speak with your doctor, it can be helpful to review some medical terms and definitions you may need when discussing your ulcerative colitis. Use this glossary tool as a handy reference as you prepare for your next appointment.

Anemia

Colonoscopy

Gastrointestinal Bleeding

Mucosa

Remission

Bowel Urgency

Flare

Gastrointestinal Tract (GI Tract)

Rectal Bleeding

Stool Frequency

Colon

Flexible Sigmoidoscopy

Inflammation

Rectum

Tenesmus

Ulcer

View Glossary You’re all set. For more tools, tips, and support, sign up now.
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.