Important Safety Update for XELJANZ® (tofacitinib)
On Friday, December 3, 2021, the U.S. Food and Drug Administration (FDA) updated the XELJANZ full prescribing information. Pfizer issued a media statement announcing that the U.S. full prescribing information for XELJANZ® (tofacitinib) has been updated based on the U.S. FDA’s completed review of the ORAL Surveillance trial, a post-marketing required safety study. Talk to your healthcare provider if you have any questions or concerns about this safety update. Your healthcare provider should consider the benefits and risks of XELJANZ.
The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.
As a result of this review, an additional warning for Major Cardiovascular Events, and updated warnings for Mortality, Cancer, and Blood Clots were included in the Boxed Warning and related Warnings and Precautions section of the prescribing information and in the Most Important Information I Should Know section of the patient Medication Guide for XELJANZ.
The updated Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor taking recommended doses of XELJANZ.
The updated Boxed Warning regarding cancer discusses a higher risk of certain cancers, including lymphoma and lung cancer in patients taking XELJANZ, especially if you are a current or past smoker. Tell your healthcare provider if you are a current or past smoker or have had any type of cancer.
The new Boxed Warning includes information regarding increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking recommended doses of XELJANZ, especially if you are a current or past smoker.
Patients taking XELJANZ should seek medical attention right away or get emergency help if you have any symptoms of a heart attack or stroke, including:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
The updated Boxed Warning regarding blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) discusses that blood clots have happened more often in patients who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking recommended doses of XELJANZ. Patients should tell their healthcare provider if they have had blood clots in the veins of their legs, arms, or lungs or clots in arteries in the past. Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit https://www.fda.gov/MedWatch or call 1-800-FDA-1088.
The FDA approved use of XELJANZ for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and for children age 2 and over with polyarticular course juvenile idiopathic arthritis and now recommends use after one or more medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated.
If you have any questions about these updates talk to your healthcare provider.
The updated Important Safety Information and Indications for XELJANZ are included below for your review.
It is also important to read the patient Medication Guide you receive with your XELJANZ prescriptions, which explains the important things you need to know about the medicine. These include side effects, what the medicine is used for, how to take and store it properly, and other things to watch for when you’re taking the medicine.
Information about Post-Marketing Safety Study
When the FDA first approved XELJANZ for adults with moderate to severe rheumatoid arthritis in 2012, the agency required a clinical safety trial to examine the risk for heart-related problems, cancer, and serious infections in XELJANZ compared to another type of medicine called tumor necrosis factor (TNF) blockers. This trial, known as Oral Surveillance enrolled 4,369 participants who were required to be at least 50 years of age and have at least one cardiovascular risk factor.
IMPORTANT SAFETY INFORMATION
The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are 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. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.
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 who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.
Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.
Higher dose. People with ulcerative colitis 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).
Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
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 who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. 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
Are a current or past smoker
Have had any type of cancer
Have had a heart attack, other heart problems or stroke
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 course juvenile 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.
What is XELJANZ/XELJANZ XR/XELJANZ Oral Solution?
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:
Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and 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 course juvenile arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
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 course juvenile arthritis.
It is not known if XELJANZ XR is safe and effective in children.
Communicating openly and sharing with your doctor how your condition is affecting you from day to day is an important part of helping to assess your current treatment plan. Your appointment is an opportunity to share symptoms, ask questions, and discuss your goals. The tools and resources below may help you explore the impact of your condition, and share tips designed to encourage communication with your healthcare provider.
Moderate to SevereRheumatoid Arthritis
ActivePsoriatic Arthritis
Moderate to SevereUlcerative Colitis
For adults with moderate to severe rheumatoid arthritis when TNF blockers did not work well or could not be tolerated.
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Iframe Step
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey 30 seconds
Which of the activities below have been difficult to perform today due to your RA symptoms?
Select all that apply
Dressing
Rising
Grooming
Bathing
Walking
Eating
Reaching
Gripping
Second Step
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Which of your joints have had pain and/or swelling because of your condition today?
Select all that apply
Neck
Shoulders
Elbows
Wrists
Hands
Knees
Feet
Other
Third Step
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Because of your RA, are you feeling fatigued today?
Select one
Fourth Step
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Given your answers so far, how does today compare with how you’ve felt over the last month?
Select one
Fifth Step
Is RA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your moderate to severe RA is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey Completed
Here’s your recap: Overall, the way you’re feeling today is for you.
Today you had difficulty with:
Dressing
Rising
Grooming
You felt symptoms in these joints today:
Shoulders
Knees
Feet
Because of your RA, this is how you’re feeling today:
This is how today compares with the last month:
Did you know?
In one study, 54% of people with RA wanted to discuss pain control with their doctor but never got around to it.
Save Your Recap To Share With Your Doctor
Now that you have your results, be sure to save them and discuss it all with your doctor. It can help give your doctor a better sense of how you’ve been feeling lately.
You're all set! Your recap should be in your inbox soon. For more tools, tips and support, sign up now.
Send it to yourself
This survey 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.
Doctor Discussion Videos
Watch as experts share their thoughts on how to improve communication between you and your doctor.
Preparing for a Doctor Appointment Dr. Dana Lukin, MD
Being Your Own Best Advocate Dr. Grace Wright, MD, PhD, FACR
Supporting Good Communication Dr. Dana Lukin, MD
Minimizing Misunderstandings Dr. Grace Wright, MD, PhD, FACR
Tips For Your Appointment
Doctors may offer patients the option to schedule in-office or virtual visits. These tips may be helpful on your next appointment—whether you’ll be at the doctor’s office or on your device.
If you aren’t sure which telemedicine providers or services your insurance plan covers, call your insurance provider before scheduling your appointment.
Plan ahead
It’s important to be seen by your doctor regularly. Schedule in-office visits as far in advance as possible for the best choice of options that match your schedule.
Practice your conversation
Go over the topics you want to discuss with your doctor in advance. Practicing with a family member or friend may help you build confidence.
Bring a notebook
In addition to bringing the questions you want to ask your doctor, you may consider taking notes during your visit to help you remember the conversation after you leave.
Speak up
Don’t hesitate to advocate for yourself, especially if you're not feeling enough relief with your current treatment.
Test your tech
Set up and double-check the devices you plan to use for your appointment to make sure everything works. Consider asking a tech-savvy family member or caregiver for help.
Protect your privacy
Find a space where you can speak openly and consider using a headset or earbuds for extra privacy.
Get comfortable
Select an area where you feel at ease and can focus without too many distractions.
Prepare in advance
Think about what you’d like to share with your doctor. Have questions ready and take notes you can reference later.
We have more for you to explore. Where do you want to go next?
For adults with active psoriatic arthritis when TNF blockers did not work well or could not be tolerated.
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Iframe Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey 30 seconds
Which of the activities below have been difficult to perform today due to your PsA symptoms?
Select all that apply
Dressing
Rising
Grooming
Bathing
Walking
Eating
Reaching
Gripping
Second Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Which of your joints have had pain and/or swelling because of your condition today?
Select all that apply
Shoulders
Wrists
Hands
Lower back
Hips
Knees
Ankles
Feet
Other
Third Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Have you experienced any skin symptoms due to your condition lately? Skin symptoms can include thick, red skin with flaky white patches.
Select one
fourth Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Because of your PsA, are you feeling fatigued today?
Select one
fifth Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey
Given your answers so far, how does today compare with how you’ve felt over the last month?
Select one
sixth Step
Is PsA Impacting Your Daily Activities?
It can be helpful for your doctor to know how your active psoriatic arthritis is affecting you. Answer the questions below so you can get a sense of how you’re feeling today and share them with your doctor.
Symptom Survey Completed
Here’s your recap: Overall, the way you’re feeling today is for you.
Today you had difficulty with:
Dressing
Rising
Grooming
You felt symptoms in these joints today:
Shoulders
Knees
Feet
This is how you responded to having skin symptoms due to your condition:
Because of your PsA, this is how you’re feeling today:
This is how today compares with the last month:
Did you know?
In, one study, 41% of people with PsA have not met their therapy goals with their current treatment.
Save Your Recap To Share With Your Doctor
Now that you have your results, be sure to save them and discuss it all with your doctor. It can help give your doctor a better sense of how you’ve been feeling lately.
You're all set! Your recap should be in your inbox soon. For more tools, tips and support, sign up now.
Send it to yourself
This survey 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.
Doctor Discussion Videos
Watch as experts share their thoughts on how to improve communication between you and your doctor.
Preparing for a Doctor Appointment Dr. Dana Lukin, MD
Being Your Own Best Advocate Dr. Grace Wright, MD, PhD, FACR
Supporting Good Communication Dr. Dana Lukin, MD
Minimizing Misunderstandings Dr. Grace Wright, MD, PhD, FACR
Tips For Your Appointment
Doctors may offer patients the option to schedule in-office or virtual visits. These tips may be helpful on your next appointment—whether you’ll be at the doctor’s office or on your device.
If you aren’t sure which telemedicine providers or services your insurance plan covers, call your insurance provider before scheduling your appointment.
Plan ahead
It’s important to be seen by your doctor regularly. Schedule in-office visits as far in advance as possible for the best choice of options that match your schedule.
Practice your conversation
Go over the topics you want to discuss with your doctor in advance. Practicing with a family member or friend may help you build confidence.
Bring a notebook
In addition to bringing the questions you want to ask your doctor, you may consider taking notes during your visit to help you remember the conversation after you leave.
Speak up
Don’t hesitate to advocate for yourself, especially if you're not feeling enough relief with your current treatment.
Test your tech
Set up and double-check the devices you plan to use for your appointment to make sure everything works. Consider asking a tech-savvy family member or caregiver for help.
Protect your privacy
Find a space where you can speak openly and consider using a headset or earbuds for extra privacy.
Get comfortable
Select an area where you feel at ease and can focus without too many distractions.
Prepare in advance
Think about what you’d like to share with your doctor. Have questions ready and take notes you can reference later.
We have more for you to explore. Where do you want to go next?
For adults with moderate to severe ulcerative colitis when TNF blockers did not work well or could not be tolerated.
Is Your Approach To Life With UC All That It Can Be?
Living with UC isn’t easy, but don’t be discouraged. There are things you can do to help manage your condition. Answer a few questions about how UC is impacting your life and then discuss your disease and treatment plan with your gastroenterologist (GI).
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 me.
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.
Doctor Discussion Videos
Watch as experts share their thoughts on how to improve communication between you and your doctor.
Preparing for a Doctor Appointment Dr. Dana Lukin, MD
Being Your Own Best Advocate Dr. Grace Wright, MD, PhD, FACR
Supporting Good Communication Dr. Dana Lukin, MD
Minimizing Misunderstandings Dr. Grace Wright, MD, PhD, FACR
Tips For Your Appointment
Doctors may offer patients the option to schedule in-office or virtual visits. These tips may be helpful on your next appointment—whether you’ll be at the doctor’s office or on your device.
If you aren’t sure which telemedicine providers or services your insurance plan covers, call your insurance provider before scheduling your appointment.
Plan ahead
It’s important to be seen by your doctor regularly. Schedule in-office visits as far in advance as possible for the best choice of options that match your schedule.
Practice your conversation
Go over the topics you want to discuss with your doctor in advance. Practicing with a family member or friend may help you build confidence.
Bring a notebook
In addition to bringing the questions you want to ask your doctor, you may consider taking notes during your visit to help you remember the conversation after you leave.
Speak up
Don’t hesitate to advocate for yourself, especially if you're not feeling enough relief with your current treatment.
Test your tech
Set up and double-check the devices you plan to use for your appointment to make sure everything works. Consider asking a tech-savvy family member or caregiver for help.
Protect your privacy
Find a space where you can speak openly and consider using a headset or earbuds for extra privacy.
Get comfortable
Select an area where you feel at ease and can focus without too many distractions.
Prepare in advance
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XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and 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 course juvenile arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
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 course juvenile arthritis.
It is not known if XELJANZ XR is safe and effective in children.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid » Read More
Important Safety Information
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. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.
Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have 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 who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.
Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.
Higher dose. People with ulcerative colitis 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).
Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
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 people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people 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 starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take 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
Are a current or past smoker
Have had any type of cancer
Have had a heart attack, other heart problems or stroke
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®)
ixekizumab (Taltz®)
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 people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis 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 people 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 course juvenile 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.
The safety information above applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and 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 course juvenile arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
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 course juvenile arthritis.
It is not known if XELJANZ XR is safe and effective in children.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have...Read More
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid » Read More
Important Safety Information
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. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.
Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have 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 who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.
Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.
Higher dose. People with ulcerative colitis 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).
Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
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 people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people 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 starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take 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
Are a current or past smoker
Have had any type of cancer
Have had a heart attack, other heart problems or stroke
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®)
ixekizumab (Taltz®)
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 people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis 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 people 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 course juvenile 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.
The safety information above applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.
If you have questions, concerns, or comments, please call our XELJANZ Information Center toll-free at 1-844-935-5269 Monday through Friday, 8:00 AM–8:00 PM ET.
Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events or product quality complaints related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088. By clicking on this link, you will be leaving XELJANZ.com. This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content and services of this site.
You Are Now Leaving This Pfizer Site
Links to other sites are provided as a convenience to the visitor. Pfizer accepts no responsibility for the content of linked sites.
PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA
The Pfizer Patient Assistance Program is not health insurance and is available for eligible uninsured/underinsured patients only.
Offer is only available to patients who meet financial and other criteria.
This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
Offer good only in the US and Puerto Rico.
Patient must be a resident of the US or Puerto Rico.
Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
Patient must be treated in the outpatient setting of care.
Additional eligibility criteria may apply. Contact XELSOURCE for details.
INTERIM CARE Rx PROGRAM TERMS & CONDITIONS
Interim Care Rx is not health insurance and is available for eligible, commercially insured patients only.
Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ.
No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, or Rhode Island.
Available in 30-day supply. Refills are subject to limitations.
Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
Offer good only in the U.S. and Puerto Rico.
Prescription must be provided by a healthcare provider licensed in the U.S. or Puerto Rico.
Continued eligibility for the program requires the submission of two appeals within 180 days of
enrollment. After 12 months of program enrollment an updated prescription and benefits investigation is
required to confirm continued eligibility.
The Interim Care Rx Program is applicable to all XELJANZ formulations.
Additional eligibility criteria may apply. Contact XELSOURCE for details.
VOUCHER TERMS AND CONDITIONS
By redeeming this voucher, you acknowledge that you currently meet the eligibility criteria and will comply with the terms & conditions described below:
You will receive a one-time, 30-day supply of XELJANZ.
Only new patients may use this voucher. By redeeming this voucher, you certify that you are not currently using XELJANZ.
An original voucher and a valid prescription must be presented to the pharmacy.
The voucher will be accepted only at participating pharmacies.*
You must not submit any claim for reimbursement for product dispensed pursuant to this voucher to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. You cannot apply the value of the free product received through this voucher toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D True Out-of-Pocket Costs (TrOOP).
This voucher is not valid where prohibited by law.
This voucher cannot be combined with any other savings, free trial or similar offer for the specified prescription. This voucher should not be combined with samples for the specified prescription.
This free trial voucher is not health insurance.
This free trial voucher is not intended to address delays or gaps in health insurance coverage for the specified prescription.
Offer good only in the U.S. and Puerto Rico.
No purchase is necessary.
Patients have no obligation to continue to use XELJANZ.
Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
The voucher is applicable to all XELJANZ formulations.
This voucher expires 12/31/2023.
*MA residents may select their pharmacy. Otherwise, this free trial will be supplied through XELSOURCE.
CO-PAY CARD TERMS AND CONDITIONS
By using the XELJANZ Co-Pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
Patients are not eligible to use the Card if they are enrolled in a state- or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
Patient must have private insurance. Offer is not valid for cash-paying patients.
You will receive a maximum benefit of $6,000–$15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year. After a maximum is reached, you will be responsible for paying the remaining monthly out-of-pocket costs.
This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
You must deduct the value of this Card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
The Card is not valid where prohibited by law.
The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
The Card will be accepted only at participating pharmacies.
If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. The rebate form can be found at xeljanzrebate.com.
The Card is not health insurance.
Offer good only in the U.S. and Puerto Rico.
The Card is limited to 1 per person during this offering period and is not transferable.
The Card may not be redeemed more than once per 30 days per patient.
No other purchase is necessary.
Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
Pfizer reserves the right to rescind, revoke, or amend the program without notice.
The Card is applicable to all XELJANZ formulations.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and 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 course juvenile arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
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 course juvenile arthritis.
It is not known if XELJANZ XR is safe and effective in children.
Important Safety Information
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. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.
Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have 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 who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.
Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.
Higher dose. People with ulcerative colitis 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).
Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
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 people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people 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 starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take 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
Are a current or past smoker
Have had any type of cancer
Have had a heart attack, other heart problems or stroke
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®)
ixekizumab (Taltz®)
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 people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis 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 people 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 course juvenile 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.
The safety information above applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.
PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA
The Pfizer Patient Assistance Program is not health insurance and is available for eligible uninsured/underinsured patients only.
Offer is only available to patients who meet financial and other criteria.
This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
Offer good only in the US and Puerto Rico.
Patient must be a resident of the US or Puerto Rico.
Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
Patient must be treated in the outpatient setting of care.
Additional eligibility criteria may apply. Contact XELSOURCE for details.
INTERIM CARE Rx PROGRAM TERMS & CONDITIONS
Interim Care Rx is not health insurance and is available for eligible, commercially insured patients only.
Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ.
No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, or Rhode Island.
Available in 30-day supply. Refills are subject to limitations.
Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
Offer good only in the U.S. and Puerto Rico.
Prescription must be provided by a healthcare provider licensed in the U.S. or Puerto Rico.
Continued eligibility for the program requires the submission of two appeals within 180 days of enrollment. After 12 months of program enrollment an updated prescription and benefits investigation is required to confirm continued eligibility.
The Interim Care Rx Program is applicable to all XELJANZ formulations.
Additional eligibility criteria may apply. Contact XELSOURCE for details.
VOUCHER TERMS AND CONDITIONS
By redeeming this voucher, you acknowledge that you currently meet the eligibility criteria and will comply with the terms & conditions described below:
You will receive a one-time, 30-day supply of XELJANZ.
Only new patients may use this voucher. By redeeming this voucher, you certify that you are not currently using XELJANZ.
An original voucher and a valid prescription must be presented to the pharmacy.
The voucher will be accepted only at participating pharmacies.*
You must not submit any claim for reimbursement for product dispensed pursuant to this voucher to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. You cannot apply the value of the free product received through this voucher toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D True Out-of-Pocket Costs (TrOOP).
This voucher is not valid where prohibited by law.
This voucher cannot be combined with any other savings, free trial or similar offer for the specified prescription. This voucher should not be combined with samples for the specified prescription.
This free trial voucher is not health insurance.
This free trial voucher is not intended to address delays or gaps in health insurance coverage for the specified prescription.
Offer good only in the U.S. and Puerto Rico.
No purchase is necessary.
Patients have no obligation to continue to use XELJANZ.
Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
This voucher is applicable to all XELJANZ formulations.
This voucher expires 12/31/2023.
*MA residents may select their pharmacy. Otherwise, this free trial will be supplied through XELSOURCE.
CO-PAY CARD TERMS AND CONDITIONS
By using the XELJANZ Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
Patients are not eligible to use the Card if they are enrolled in a state- or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
Patient must have private insurance. Offer is not valid for cash-paying patients.
You will receive a maximum benefit of $6,000–$15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year. After a maximum is reached, you will be responsible for paying the remaining monthly out-of-pocket costs.
This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
You must deduct the value of this Card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
The Card is not valid where prohibited by law.
The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
The Card will be accepted only at participating pharmacies.
If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. The rebate form can be found at xeljanzrebate.com.
The Card is not health insurance.
Offer good only in the U.S. and Puerto Rico.
The Card is limited to 1 per person during this offering period and is not transferable.
The Card may not be redeemed more than once per 30 days per patient.
No other purchase is necessary.
Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
Pfizer reserves the right to rescind, revoke, or amend the program without notice.
The Card is applicable to all XELJANZ formulations.
By using the XELJANZ Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
Patients are not eligible to use the Card if they are enrolled in a state- or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
Patient must have private insurance. Offer is not valid for cash-paying patients.
You will receive a maximum benefit of $6,000–$15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year. After a maximum is reached, you will be responsible for paying the remaining monthly out-of-pocket costs.
This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
You must deduct the value of this Card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
The Card is not valid where prohibited by law.
The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
The Card will be accepted only at participating pharmacies.
If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. The rebate form can be found at xeljanzrebate.com.
The Card is not health insurance.
Offer good only in the U.S. and Puerto Rico.
The Card is limited to 1 per person during this offering period and is not transferable.
The Card may not be redeemed more than once per 30 days per patient.
No other purchase is necessary.
Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
Pfizer reserves the right to rescind, revoke, or amend the program without notice.
The Card is applicable to all XELJANZ formulations.
Pfizer Inc. is providing this tool with a third party, Doctor.com, to help patients find physicians in their area who have experience with prescription treatments for rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. While the directory is updated regularly, the search results may not include current physician information or a comprehensive list of all rheumatologists and gastroenterologists. If you are a rheumatologist or gastroenterologist and would like your listing to be added, updated, or removed, please contact Doctor.com
No fees have been received by Pfizer Inc. or paid to physicians for inclusion in this directory. Inclusion of a physician in this directory does not represent an endorsement by or a recommendation from Pfizer Inc., nor does it imply that the physicians on the list will determine that XELJANZ® (tofacitinib) is right for you. You are ultimately responsible for the selection of a physician and it is an important decision that you should consider carefully. This tool is just one source of information available to you.
Doctor.com may have its own terms of service and privacy policy for which Pfizer Inc. has no responsibility. Pfizer Inc. and Doctor.com do not collect patient- or physician-level data from this tool.
Pay as little as $0 per month
for your XELJANZ prescription*
Eligibility required. Annual savings of $6,000–$15,000. Federal and state healthcare beneficiaries ineligible. No membership fee. Offer not valid for cash paying patients. Terms and conditions apply.
Eligibility required. Annual savings of $6,000–$15,000. Federal and state healthcare beneficiaries ineligible. No membership fee. Offer not valid for cash paying patients. Terms and conditions apply.
Sign up for the XELJANZ Co-Pay Savings Program, if eligible.
Our Co-Pay Savings Program* may reduce out-of-pocket cost for eligible, commercially insured patients who have been prescribed XELJANZ. Eligibility requirements apply. If you haven't registered already, sign up now.
If you are unable to confirm your eligibility or have additional questions, call XELSOURCE at 1-844-935-5269.
*For eligible underinsured or uninsured patients, XELSOURCE may offer financial assistance through the Pfizer Patient Assistance Program. Call XELSOURCE to learn more about these programs. Terms and conditions/eligibility requirements apply.
