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CLICK FOR IMPORTANT SAFETY UPDATE
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 http://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.
Please see full Prescribing Information, including BOXED WARNING and Medication
Guide.
* Indications
* Important Safety Information
* Prescribing Information
* Medication Guide
* For Healthcare Professionals
Indications
Important Safety Information
* Rheumatoid Arthritis
* Moderate to Severe Rheumatoid Arthritis
* ActivePsoriatic Arthritis
* Moderate to Severe Ulcerative Colitis
* Active Ankylosing Spondylitis
* Active Polyarticular Course Juvenile Idiopathic
Arthritis
* Doctor Discussion Guide
* Safety / Side Effects
* Savings & Support
* Sign Up
Sign Up
SAVINGS & SUPPORT
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.
Savings may be just a phone call away. If you have a financial hardship and
you’ve been prescribed XELJANZ, call XELSOURCE to learn how you may be able to
save on your XELJANZ prescription. See below for details. Terms and
conditions/eligibility requirements apply.
LEARN HOW TO CONNECT WITH XELSOURCE.
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1-844-935-5269
MONDAY-FRIDAY, 8:00 AM–8:00 PM ET
CALL XELSOURCE
To speak to someone at XELSOURCE about your insurance coverage and medication
costs for XELJANZ, Monday through Friday, 8:00 AM-8:00 PM ET, call
1-844-935-5269 and say “Representative.”
GET STARTED
After you have been prescribed XELJANZ, our support program may help you by:
* Contacting your insurance company on your behalf
* Helping investigate and assess your eligibility for coverage when needed
* Confirming what your out-of-pocket costs will be
* Assisting you with obtaining Prior Authorization (PA) when needed
* Ready to fill your XELJANZ prescription? See where you are in the process.
A process used by some health insurance companies to determine if they would
cover a prescribed medication
OBTAIN A CO-PAY SAVINGS CARD
Our Co-Pay Savings Program may reduce out-of-pocket cost for eligible,
commercially insured patients prescribed XELJANZ. Eligibility requirements
apply. Once you have a Co-Pay Savings Card, call XELSOURCE at 1-844-935-5269 and
say “Activate” to activate your Card. Eligibility requirements apply.
To speak with someone about your insurance coverage and medication costs, call
1-844-935-5269 and say “Representative.”
CO-PAY SAVINGS CARD FOR ELIGIBLE PATIENTS
Our Co-Pay Savings Card may reduce out-of-pocket cost for eligible, commercially
insured patients prescribed XELJANZ. Terms and conditions/eligibility
requirements apply.
SIGN UP TO RECEIVE A CO-PAY SAVINGS CARD NOW
There are two ways you can get a Co-Pay Savings Card.†
Receive one in the mail as part of your XELJANZ Welcome Kit.
Follow the directions to print a card or save it to your digital wallet
immediately after registering.
To activate your card, call 1-844-935-5269 and say “Activate.”
Sign Up For A Card Renew/Replace Your Card
Sign Up For A Card Renew/Replace Your Card
†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.
FINANCIAL SUPPORT QUESTIONS
If I have been prescribed XELJANZ or XELJANZ XR, do I qualify for a Co-Pay
Savings Card?
Commercial patients prescribed XELJANZ or XELJANZ XR should call XELSOURCE at
1-844-935-5269 to determine if they qualify for a Co-Pay Savings Card. Terms and
conditions can be accessed here.
If I was originally prescribed XELJANZ and my doctor prescribes me XELJANZ XR,
will I need additional insurance approvals?
When switching from XELJANZ to once-daily XELJANZ XR, additional approvals may
not be required. For more information, check with your insurance provider.
What do I do if my insurance coverage changes?
Health plans can change—so can your health insurance and prescription benefits.
Once your new plan begins, XELSOURCE can help review your plan information,
verify your coverage if needed, and assist with the Prior Authorization (PA)
process.
A process used by some health insurance companies to determine if they would
cover a prescribed medication
What do I do if my claim for XELJANZ or once-daily XELJANZ XR is denied?
If your request is denied, you may be able to appeal the decision. Call
XELSOURCE to learn more about the support programs that may be available to you.
To speak with a XELSOURCE specialist, call 1-844-935-5269, Monday through
Friday, 8:00 AM–8:00 PM ET.
How much should I expect to pay for XELJANZ?
For more information about pricing, including what out-of-pocket costs may be
for your XELJANZ prescription, please visit XELJANZpricing.com.
LEARN ABOUT SAVINGS OPTIONS
Pfizer has programs in place designed to help eligible patients afford their
treatment. Keep reading for ways you may be able to save on your XELJANZ
prescription.
If you have commercial insurance, you may qualify for a Co-Pay Savings Card. See
limits, terms, and conditions. If your pharmacy does not accept the Co-Pay
Savings Card, a rebate form is available. See limits, terms, and conditions.
Eligibility is not based on income.
If you have government insurance and need financial assistance, we will refer
you to Medicare Extra Help if you appear to be eligible. If turned down, we will
evaluate you for the Pfizer Patient Assistance Program.‡ If you are eligible, we
will provide XELJANZ at no cost to you. See limits, terms, and conditions.
If you have no insurance and need financial assistance, we will refer you to
Medicaid if you appear to be eligible. If turned down, we will evaluate you for
the Pfizer Patient Assistance Program. If you are eligible, we will provide you
XELJANZ at no cost to you. See limits, terms, and conditions.
To speak with someone at XELSOURCE about your insurance coverage and medication
costs for XELJANZ or XELJANZ XR, call 1-844-935-5269 and say “Representative.”
--------------------------------------------------------------------------------
XELJANZ IS COVERED FOR 99% OF COMMERCIALLY-INSURED, MODERATE TO SEVERE
RHEUMATOID ARTHRITIS PATIENTS WITH A PRESCRIPTION.§‖
--------------------------------------------------------------------------------
‡The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the
Pfizer Patient Assistance Foundation™. Free medicines from Pfizer are provided
through the Pfizer Patient Assistance Foundation. The Pfizer Patient Assistance
Foundation is a separate legal entity from Pfizer Inc. with distinct legal
restrictions.
§Covered: After trial and failure of methotrexate. Included on plan formulary as
a preferred or non-preferred product. Non-preferred products are subject to a
step edit and/or higher out-of-pocket cost to the patient. Not all covered lives
are RA patients.
‖Data on file. Pfizer Inc., New York, NY.
XELJANZ can be filled by both retail and specialty pharmacies. Find out more
about the process.
Get Started
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* Contact Us
Please see full Prescribing Information, including BOXED WARNING and Medication
Guide.
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 http://fda.gov/MedWatch or call
1-800-FDA-1088.
If your doctor has prescribed XELJANZ and you need help paying for it, XELSOURCE
may be able to assist, depending on eligibility, terms and conditions.
Call 1-844-935-5269 Monday through Friday, 8:00 AM–8:00 PM ET, for more
information.
This site is intended only for U.S. residents. The products discussed in this
site may have different product labeling in different countries. The information
provided is for educational purposes only and is not intended to replace
discussions with a healthcare provider.
XELJANZ is a registered trademark of Pfizer Inc. The brand names included
throughout are the properties of their respective owners.
XELJANZ (tofacitinib) is available in 5 mg and 10 mg tablets.
XELJANZ XR (tofacitinib) is available in 11 mg and 22 mg extended-release
tablets.
XELJANZ Oral Solution (tofacitinib) is available in 1 mg/mL oral solution.
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Indications
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
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 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.
Please see full Prescribing Information, including BOXED WARNING and Medication
Guide.
Indications
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
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 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.
Please see full Prescribing Information, including BOXED WARNING and Medication
Guide.
CONTACT US
×
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.
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YOU ARE NOW LEAVING XELJANZ.COM
The information provided on xeljanzpro.com is intended only for healthcare
professionals in the United States.
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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.
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NO
XELSOURCE & XELJANZ ACCESS TERMS & CONDITIONS
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, Missouri, Ohio,
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.
* Card and Program expires 12/31/2023.
If you have questions or are in need of additional support, call 1-844-935-5269
or visit www.XELJANZ.com.
INDICATIONS
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
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 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.
Please see full Prescribing Information, including BOXED WARNING and Medication
Guide.
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