
XELJANZ IS A PILL,
NOT AN INJECTION
XELJANZ is also used to treat:
It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis
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/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
XSAVINGS MOBILE TEXT PROGRAM TERMS & CONDITIONS
User texts "XPROGRAM" to short code 50336. Text HELP for help, STOP to opt out. Patients may receive up to 10 messages per month. Message and data rates may apply.
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.
XELJANZ is also used to treat:
It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis
XELJANZ/XELJANZ XR may cause serious side effects, including:
Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
You should not start taking XELJANZ/XELJANZ XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.
Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you:
After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.
Cancer and immune system problems. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.
Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to check for the following side effects:
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ/XELJANZ XR if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?
Before taking XELJANZ/XELJANZ XR, tell your healthcare provider about all of your medical conditions, including if you:
Taking XELJANZ/XELJANZ XR
What are other possible side effects of XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.
Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and 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).
XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:
XELJANZ is also used to treat:
It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C.
XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.
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/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
XSAVINGS MOBILE TEXT PROGRAM TERMS & CONDITIONS
User texts "XPROGRAM" to short code 50336. Text HELP for help, STOP to opt out. Patients may receive up to 10 messages per month. Message and data rates may apply.
By using the XELJANZ/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.
If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.
On Friday July 26, 2019, the US FDA updated the XELJANZ full prescribing information and posted a statement. Pfizer also issued a media statement announcing that the U.S. full prescribing information for XELJANZ® (tofacitinib)/XELJANZ XR has been updated based on the U.S. Food and Drug Administration’s (FDA) review of data from an ongoing post-marketing safety study.
As a result of this review, two additional warnings for Mortality and Thrombosis 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/XELJANZ XR. Additionally, changes to the ulcerative colitis (UC) approved use and recommended dosing were made.
The new Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The FDA recommended dose in adult patients with rheumatoid arthritis or psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.
The new Boxed Warning information regarding Thrombosis includes information on the risk of blood clots. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.
Patients should stop taking XELJANZ/XELJANZ XR and seek medical attention immediately if they experience any signs or symptoms of a blood clot such as:
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 ulcerative colitis (UC) now recommends use after medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated. Healthcare providers are advised to use the lowest effective dose to maintain response in patients with UC.
If you have any questions about these updates talk to your healthcare provider.
The updated Important Safety Information and Indications for XELJANZ/XELJANZ XR are included on the following pages for your review.
It is also important to read the patient Medication Guide you receive with your XELJANZ/XELJANZ XR 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 Ongoing Post-Marketing Safety Study
This safety study is being conducted in patients 50 years of age and older with rheumatoid arthritis (RA) with at least one heart disease (cardiovascular) risk factor to evaluate the risk of heart-related events and cancer using XELJANZ at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor in combination with methotrexate. The FDA recommended dose in adult patients with rheumatoid arthritis or psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. XELJANZ/XELJANZ XR 10 mg twice daily is not approved for adult patients with rheumatoid arthritis or psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
XELJANZ/XELJANZ XR may cause serious side effects, including:
Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
You should not start taking XELJANZ/XELJANZ XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.
Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you:
After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.
Cancer and immune system problems. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.
Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to check for the following side effects:
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ/XELJANZ XR if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?
Before taking XELJANZ/XELJANZ XR, tell your healthcare provider about all of your medical conditions, including if you:
Taking XELJANZ/XELJANZ XR
What are other possible side effects of XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.
Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and 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).
What is XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:
XELJANZ is also used to treat:
It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C.
XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
The key changes were to the BOXED WARNING, Warnings and Precautions section, UC indication, and UC recommended dosage.1
Two new BOXED WARNINGS were added to the Warnings and Precautions section:
MORTALITY
THROMBOSIS
Additional language was included in the Warnings and Precautions section for Mortality and/or Thrombosis:
The UC indication has been modified:
The UC recommended dosage was also updated for both induction and maintenance therapy:
Induction
Maintenance
5 mg twice daily. Use of
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Reference: 1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc; July 2019.
Ask your doctor about XELJANZ,
a pill to treat adults with:
*When certain medicines no longer work well enough or cannot be tolerated.
XELJANZ IS A PILL,
NOT AN INJECTION
XELJANZ/XELJANZ XR may cause serious side effects, including:
Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
You should not start taking XELJANZ/XELJANZ XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.
Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you:
After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.
Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.
Cancer and immune system problems. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.
Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).
Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.
Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.
Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.
Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to check for the following side effects:
Your healthcare provider should routinely check certain liver tests.
You should not receive XELJANZ/XELJANZ XR if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?
Before taking XELJANZ/XELJANZ XR, tell your healthcare provider about all of your medical conditions, including if you:
Taking XELJANZ/XELJANZ XR
What are other possible side effects of XELJANZ/XELJANZ XR?
XELJANZ/XELJANZ XR may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.
Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).
Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and 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).
XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:
XELJANZ is also used to treat:
It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C.
XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.