|
IMPORTANT SAFETY INFORMATION AND INDICATIONS
|
|
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).
|
|
XELJANZ & Pregnancy
|
|
XELJANZ may affect the ability of females to get pregnant. It is not
known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn
baby.
|
|
• |
Pregnancy Registry: Pfizer
has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check
the health of the pregnant mother and her baby. If you are pregnant or become pregnant while
taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy
registry or you may contact the registry at 1‑877‑311‑8972
to enroll.
|
|
|
You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should
not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18
hours after your last dose of XELJANZ or 36 hours after your last dose of
XELJANZ XR.
|
|
The safety information above applies to all marketed formulations of XELJANZ. Specific risks
associated with certain dosing are noted.
|
|
What is
XELJANZ/XELJANZ XR?
|
|
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
|
|
| |
|
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.
|
|
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.
|
|
|
|
If you no longer wish to receive promotional email communications from
XELJANZ, unsubscribe here.
|
|
Please do not reply, as this email address cannot accept replies. If you
wish to contact Pfizer, click here.
|
|
View the Pfizer Privacy Policy here.
|
|
Pfizer, XELJANZ
P.O. Box 29387
Mission, KS
66201
|
|
|
|
This advertisement is intended for U.S. residents only. The information
provided is for educational purposes only and is not intended to replace discussions with a
healthcare provider.
|
|
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 www.fda.gov/MedWatch
or
call 1‑800‑FDA‑1088.
|
|
|
|
|
