IMPORTANT
SAFETY INFORMATION AND INDICATION
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CIBINQO
may cause serious side effects, including:
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Serious infections. CIBINQO can lower your immune system’s ability to fight
infections. Do not start CIBINQO if you have any kind of infection unless your healthcare provider
tells you it is okay. Serious infections, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body, have occurred in people taking
CIBINQO or other similar medicines. Some people have been hospitalized or died from these
infections. Your risk of developing shingles may increase while taking CIBINQO.
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Your healthcare provider should test you for TB before treatment with CIBINQO and monitor you
closely for signs and symptoms of TB infection during treatment.
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Before and after starting CIBINQO, tell your doctor right away if you have an
infection, are being treated for one, or have symptoms of an infection, including:
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- fever, sweating, or chills
- muscle aches
- cough or shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinating more often than usual
- feeling very tired
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CIBINQO can make you more likely to get infections or worsen infections you have. If you get a
serious infection, your healthcare provider may stop treatment with CIBINQO until your infection
is controlled.
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There is an increased risk of death in people 50 years and older who have at least one
heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK) inhibitor (such
as CIBINQO).
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Cancer and immune system problems. CIBINQO 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, especially current or past smokers, have a higher risk of certain
cancers, including lymphoma and lung cancers, while taking a JAK inhibitor. Follow your healthcare
provider’s advice about having your skin checked for skin cancer during treatment. Limit the
amount of time you spend in sunlight and avoid using tanning beds or sunlamps. When in the sun,
wear protective clothing and use SPF 30+ sunscreen. This is especially important if you have very
fair skin or a family history of skin cancer. Tell your healthcare provider if you have ever had
any type of cancer.
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There is an increased risk of major cardiovascular (CV) events such as heart attack,
stroke or death in people 50 years and older who have at least one heart disease (CV) risk
factor and are taking a JAK inhibitor, especially for current or past smokers.
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Some people taking CIBINQO have had major cardiovascular events.
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Get emergency
help right away if you develop any symptoms of a heart attack or stroke while taking
CIBINQO, including:
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- 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
- weakness in one part or on one side of your body
- slurred speech
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
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Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or
lungs (pulmonary embolism, PE) can happen in some people taking CIBINQO. This may be
life-threatening. Blood clots in the veins of the legs and lungs have happened more often in
people 50 years and older, with at least one heart disease (CV) risk factor, taking a JAK
inhibitor. Tell your healthcare provider if you have had blood clots in the veins of your legs or
lungs in the past.
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Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood
clots including swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or
upper back pain; shortness of breath or difficulty breathing.
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Changes in certain laboratory test results. Your doctor should do blood tests
before and during treatment with CIBINQO to check your lymphocyte, neutrophil, red blood cell, and
platelet counts. You should not take CIBINQO if these counts are too low. Your healthcare provider
may stop treatment for a period of time if there are changes in these blood test
results. Increased cholesterol levels. You may also have increases in the
amount of fat found in your blood. Your doctor should check your cholesterol about 4 weeks after
you start CIBINQO and then as needed.
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Do not take CIBINQO with medicines that prevent blood clots (antiplatelet medicines) during the first 3 months of treatment. You can take low-dose aspirin (≤81 mg daily) during this time, if prescribed.
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Before taking CIBINQO, tell your healthcare provider if you:
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- have an infection, are being treated for one, or have one that won't
go away or keeps returning
- have diabetes, chronic lung disease, HIV, or a weak immune system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have had hepatitis B or hepatitis C
- live, have lived, or traveled to certain areas (such as Ohio &
Mississippi River Valleys and the Southwest) where there is an increased chance for getting
certain kinds of fungal infections. These infections may happen or worsen when taking CIBINQO.
Ask your healthcare provider if you're unsure if you have lived in an area where these
infections are common
- have had any type of cancer
- have had blood clots in the veins of your legs or lungs
- are a current or past smoker
- have had a heart attack, other heart problems, or stroke
- have kidney or liver problems
- have abnormal blood tests (low platelet count or white blood cell
count)
- have high levels of fat in your blood (high cholesterol)
- have any eye problems, including cataracts or retinal detachment
- have recently received or are scheduled to receive any vaccinations.
People who take CIBINQO should not receive live vaccines
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are or plan to become pregnant. It is not known if CIBINQO will harm your unborn baby. Pfizer
has a Pregnancy Exposure Registry for pregnant women who take CIBINQO to check
your health and the health of your baby. If you are pregnant or become pregnant while taking
CIBINQO, ask your healthcare provider how you can join this pregnancy registry, call 1-877-311-3770,
or visit www.CIBINQOPregnancyRegistry.com to
enroll
- are breastfeeding or plan to breastfeed. It is not known if CIBINQO
passes into your breast milk. You should not take CIBINQO while breastfeeding
- are taking other medicines, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. CIBINQO and other medicines may
affect each other, causing side effects. Especially tell your healthcare provider if you
take aspirin or any antiplatelet therapies. Ask your healthcare provider if you are
unsure
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The most common side effects of CIBINQO include common cold, nausea, headache,
herpes simplex including cold sores, increased blood level of creatine phosphokinase, dizziness,
urinary tract infection, tiredness, acne, vomiting, mouth and throat pain, flu, stomach flu,
bacterial skin infection, high blood pressure, allergic skin rash to something you contacted,
stomach pain, shingles, and low platelet count.
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Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in
people treated with CIBINQO. Call your healthcare provider right away if you have any sudden
changes in your vision.
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CIBINQO may cause fertility problems in females, which may affect the ability of females to get
pregnant. Talk to your healthcare provider if you have concerns about fertility.
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These are not all of the possible side effects of CIBINQO.
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What
is CIBINQO?
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CIBINQO (abrocitinib) is a prescription medicine to treat adults and children 12 years of age and older with
moderate-to-severe eczema (atopic dermatitis) that did not respond to other treatment and is not
well controlled with prescription medicines, including biologics, or when they cannot be
tolerated.
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It is not known if CIBINQO is safe and effective in children under 12 years of age.
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Please see full Prescribing
Information, including BOXED WARNING, and Medication
Guide.
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CIBINQO (abrocitinib) is available in 50 mg, 100 mg, and 200 mg pills.
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Pfizer, CIBINQO
P.O. Box 29387
Mission, KS 66201
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Eligibility required for financial assistance.
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This information 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.
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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.
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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.
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