to your PfizerFlex
Patient Support Program
for
CIBINQO®
Welcome to your PfizerFlex Patient Support
Program for CIBINQO
®
Safety information you should know about
This page contains important safety information that you need to be aware of before and during treatment with CIBINQO. For complete safety information, please consult the Patient Medication Information leaflet contained in your product package.
You can also check out the
CIBINQO Patient Safety Information Leaflet. It summarizes the important safety information to help you better understand CIBINQO and minimize potential risks associated with your treatment.
Do not use CIBINQO if you’re allergic to abrocitinib or any of the other ingredients in CIBINQO. If you’re not sure about this, talk to your healthcare professional before taking CIBINQO.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CIBINQO. Be sure to discuss any health conditions or problems you may having, including if you:
Are taking other immunosuppressant medicines such as methotrexate and cyclosporine or other JAK inhibitor medicines
Have an infection or get infections that often come back
Have hepatitis virus B or C infection
Have liver problems
Have kidney problems
Have a low platelet count or white blood cell count
Have or have had cancer
Serious warnings and precautions
CIBINQO may cause serious side effects, including:
Serious infections
CIBINQO is a medicine that affects your immune system. CIBINQO can lower the ability of your immune system to fight infections. This can cause serious infections that can lead to hospitalization or death. The most common type of infections were caused by viruses. Before you take CIBINQO, tell your healthcare professional if you have an infection or get infections that often come back. Your healthcare professional will assess the risks before you begin treatment with CIBINQO if you have a chronic and reoccurring infection. They will closely monitor you for symptoms of an infection during and after your treatment with CIBINQO. This includes monitoring you for symptoms of tuberculosis. Your healthcare professional may suspend your treatment if you develop a serious infection.
Cancer
CIBINQO may increase your risk of getting cancer, by changing the way your immune system works. Before you take CIBINQO, tell your healthcare professional if you have ever had cancer. People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors may have a higher risk of certain cancers including lymphoma.
Blood clots
CIBINQO may increase your risk of getting blood clots in the veins of your legs (
deep vein thrombosis), lungs (
pulmonary embolism), or arteries (
arterial thrombosis). These blood clots can be serious or life threatening. Your healthcare professional will assess your risk of getting blood clots and tell you if it is safe to take CIBINQO. Blood clots in the veins of the legs and lungs have happened more often in people who are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors.
Heart problems, stroke and death
JAK inhibitors may increase your risk of heart problems including heart attack or your risk of stroke. These can lead to death.
See “Other warnings you should know about” for more information on these serious side effects.
Other warnings you should know about
CIBINQO may cause serious side effects, including:
Serious infections
Tell your healthcare professional if you have an infection or get infections that often come back. Taking CIBINQO increases your risk of developing serious infections such as herpes simplex, shingles (herpes zoster) and pneumonia. CIBINQO may also make infections such as shingles and herpes simplex come back. Your healthcare professional will closely monitor you for infection during and after your treatment. They may put you on antimicrobial therapy if you develop a new infection during treatment. They might also stop your treatment with CIBINQO. They will also screen you for the following infections before and during treatment with CIBINQO:
Tuberculosis (TB): You should not take CIBINQO if you have an active TB infection. Your healthcare professional may put you on preventative medication before beginning treatment with CIBINQO. You will be given this if you are newly diagnosed with inactive TB or had an untreated previous diagnosis of inactive TB.
Viral hepatitis: Tell your healthcare professional if you have hepatitis virus B or C infection. They will also screen you for these infections before you start treatment with CIBINQO.
Talk to your healthcare professional if you get any symptoms of an infection, including shingles, herpes simplex, pneumonia or other infection while you are taking CIBINQO. See
Serious side effects and what to do about them for more information.
Cancer
Before you take CIBINQO, tell your healthcare professional if you have or have had cancer:
CIBINQO may increase your risk of getting certain cancers
If you smoke, this might further increase your risk of getting certain cancers while taking CIBINQO
Your healthcare professional may want to examine your skin regularly for any sign of cancer
Blood clots
CIBINQO may increase your risk of getting blood clots in the veins of your legs or lungs. Your healthcare professional will assess your risk of getting blood clots and tell you if it is safe to take CIBINQO. You are more likely to get blood clots while taking CIBINQO if you:
Are immobile for a long time
Have major surgery
Are older
Are obese
Have had blood clots in the veins of your legs or lungs in the past
Have an inherited blood clotting disorder
Take hormone therapy or birth control pills
Stop taking CIBINQO and talk to your healthcare professional right away if you get any symptoms of blood clots in the veins of your legs (
deep vein thrombosis) or lungs (
pulmonary embolism) while you are taking CIBINQO. See
Serious side effects and what to do about them for more information.
Heart problems, stroke and death
CIBINQO may increase your risk of heart attacks and stroke:
You are more likely to get these if you have certain risk factors, including if you smoke
Talk to your healthcare professional about these risk factors
Stop taking CIBINQO and get immediate medical help if you develop any symptoms of a heart attack during treatment with CIBINQO
Talk to your healthcare professional before starting CIBINQO if you are planning to receive a vaccine:
You should not receive live or attenuated vaccines while receiving CIBINQO or immediately before you start treatment
Your immunizations should be up to date before taking CIBINQO. This includes vaccines for shingles
Pregnancy
If you’re able to get pregnant:
Tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant before taking CIBINQO
Avoid becoming pregnant while taking CIBINQO and for at least 1 month after stopping treatment. It may harm your unborn baby
Use effective birth control during treatment and for at least 1 month after your last dose of CIBINQO. Your healthcare professional can advise which birth control methods may be right for you during this time
Your healthcare professional will have you take a pregnancy test before you can start treatment with CIBINQO
If you become pregnant or think you might be pregnant, talk to your healthcare professional right away.
Breastfeeding
Before you take CIBINQO, tell your healthcare professional if you’re breastfeeding or plan to breastfeed:
You should not breastfeed during treatment with CIBINQO because it may pass into your breastmilk and harm your baby
Talk to your healthcare professional about the best way to feed your baby if you are taking CIBINQO
Monitoring and tests
Blood tests should be performed before you start taking CIBINQO, as well as during your treatment with CIBINQO.
You should not take CIBINQO if your white blood cell or platelet count is too low
Your healthcare professional may interrupt or stop your treatment for a period of time depending on your blood test results
Your healthcare professional will also monitor your blood lipid levels while you are taking CIBINQO
Driving and using machines
CIBINQO may cause dizziness. Do NOT drive or use dangerous machines until you know how CIBINQO affects you.
What are the possible side effects from using CIBINQO?
Side effects with CIBINQO may include:
acne
cold sores (also known as oral herpes simplex)
dizziness
headache
nausea
upper abdominal pain
vomiting
CIBINQO may also cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
Talk to your healthcare professional if you experience any of the following serious side effects:
COMMON
Herpes simplex (infection of the genitals, eyes or skin caused by the herpes simplex virus)
Symptoms include tingling, pain or itching in genital area, small red blisters or sores on penis, scrotum or vaginal area, redness, pain or swelling around the eye, blurred vision, watery eyes, small red blisters or sores on any skin area.
Infections
Symptoms include fever, chills, muscle aches, flu-like symptoms, cough, sore throat, diarrhea or stomach pain, feeling tired
UNCOMMON
Cancer including skin cancer
Symptoms may be variable
Lymphopenia (low white blood cells)
Symptoms include getting infections more easily
Pneumonia (lung infection)
Symptoms include chest pain when you breathe or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking, chills, nausea, vomiting or diarrhea, shortness of breath
Shingles, also known as herpes zoster (skin infection)
Symptoms include a painful skin rash of fluid-filled blisters, blisters appear along a strip of skin, itching or tingling of the skin
Thrombocytopenia (low blood platelets)
Symptoms include bruising or bleeding
Stop taking CIBINQO and get immediate medical help if you experience any of the following serious side effects:
COMMON
Herpes simplex (infection of the genitals, eyes or skin caused by the herpes simplex virus)
Symptoms include tingling, pain or itching in genital area, small red blisters or sores on penis, scrotum or vaginal area, redness, pain or swelling around the eye, blurred vision, watery eyes, tingling, pain or itching in genital area, small red blisters or sores on any skin area
UNCOMMON
Myocardial infarction (heart attack)
Symptoms include pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, lightheadedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat
Blood clots
•
Deep vein thrombosis (blood clot in the legs) Symptoms include swelling, and pain; leg may be warm to the touch and may appear red
•
Pulmonary embolism (blood clot in the lungs) Symptoms include chest pain that may increase with deep breathing, cough, coughing up bloody sputum, shortness of breath
There are other possible side effects that you could experience when taking CIBINQO. If you have a troublesome symptom or side effect that isn’t listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
