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:
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
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:
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
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:
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.
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:
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.
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:
XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with:
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.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Share your story and help other adults learn about XELJANZ. Learning about your experience with XELJANZ may be helpful for patients who are considering treatment or have already started. If selected, your story may appear on XELJANZ.com and/or in other marketing materials.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with:
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:
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:
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
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:
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.
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:
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.
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.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with:
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:
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
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:
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
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:
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.
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:
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.
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.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
If you have questions, concerns, or comments, please call our XELJANZ Information Center toll-free at
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
PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA
INTERIM CARE Rx PROGRAM TERMS & CONDITIONS
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:
*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:
If you have questions or are in need of additional support, call
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:
XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with:
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.
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:
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
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:
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.
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:
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.
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.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA
INTERIM CARE Rx PROGRAM TERMS & CONDITIONS
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:
*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:
If you have questions or are in need of additional support, call
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:
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
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.
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.
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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.
Sign UpIf 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.
