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 used to treat adults with:

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

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

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

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

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

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

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

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

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

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ.

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

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

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

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

Higher dose.  People taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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

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

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

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

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

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

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

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

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

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

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

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

XELJANZ & Pregnancy

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

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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

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

IndicationsIndaication Modal

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

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

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

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

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

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

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

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

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

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

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

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

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ.

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

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

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

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

Higher dose.  People taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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

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

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

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

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

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

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

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

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

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

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

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

XELJANZ & Pregnancy

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

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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

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

Indications

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

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

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

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

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

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

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

Important Safety Information

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

Serious Infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious Infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ.

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

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

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

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

Higher dose.  People taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune System Problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

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

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

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

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

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

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

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

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

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

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

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

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

XELJANZ & Pregnancy

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

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

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

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