IMPORTANT SAFETY INFORMATION
It is not known if CIBINQO (abrocitinib) is safe and effective in children.
CIBINQO may cause serious side effects, including:
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 died from these infections. Your risk of developing shingles may increase while taking CIBINQO.
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.
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: 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; or feeling very tired. CIBINQO can make you more likely to get infections or worsen infections you have.
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). 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.
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.
Some people taking CIBINQO have had major cardiovascular events. Get emergency help right away if you develop any symptoms of a heart attack or stroke while taking CIBINQO, 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; 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; or feeling lightheaded.
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.
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.
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. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your doctor should do blood tests about 4 weeks after you start treatment and 4 weeks after any increase in dose to check blood cell counts and as often as needed for other laboratory tests.
During the first 3 months of treatment with CIBINQO, do not take medicines that prevent blood clots except low-dose aspirin (≤81 mg daily), if prescribed.
Before taking CIBINQO, tell your healthcare provider if you: 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 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; 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 or call 1-877-311-3770 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; or are taking other medications, 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.
The most common side effects of CIBINQO include common cold, nausea, headache, herpes simplex including cold sores, increased blood level of creatinine 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.
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.
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.
These are not all of the possible side effects of CIBINQO.
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.
CIBINQO is available in 50 mg, 100 mg and 200 mg pills.
© 2022 Pfizer Inc. All rights reserved. May 2022. PP-ABR-USA-0921
Please see Important Facts, including BOXED WARNING, on the next pages or visit CIBINQOPI.com for full Prescribing Information.
This brief summary outlines important information about CIBINQO (abrocitinib) and is not comprehensive. If you would like more information, talk to your healthcare provider or visit www.CIBINQOPI.com.
What is CIBINQO?
CIBINQO is a prescription medicine that is a Janus kinase (JAK) inhibitor. CIBINQO is used to treat adults with moderate-to-severe atopic dermatitis (eczema) that did not respond to other treatment and is not well controlled with prescription therapies, including biologic medicines or in adults who cannot tolerate these therapies.
It is not known if CIBINQO is safe and effective in children.
What is the most important information I should know about CIBINQO? CIBINQO may cause serious side effects, including: 1. Serious infections
CIBINQO is a medicine that affects your immune system. CIBINQO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking CIBINQO or other similar medicines, including 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 treatment with CIBINQO.
• Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with CIBINQO.
You should not start taking CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay.
You may be at a higher risk of developing shingles (herpes zoster).
Before starting CIBINQO, tell your healthcare provider if you:
• are being treated for an infection.
• have had an infection that does not go away or that keeps coming back.
• 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 or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use CIBINQO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• think you have an infection or have symptoms of an infection such as: − 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
After starting CIBINQO, call your healthcare provider right away if you have any symptoms of an infection. CIBINQO can make you more likely to get infections or make any infections that you have worse.
2. 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 a medicine in the class of medicines called Janus kinase (JAK) inhibitors. CIBINQO is a JAK inhibitor medicine.
3. 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 in people taking CIBINQO.
• People taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. • Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment with CIBINQO. Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if your skin is very fair or if you have a family history of skin cancer.
Tell your healthcare provider if you have ever had any type of cancer.
4. 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 taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.
Some people taking CIBINQO have had major cardiovascular events.
Get emergency help right away if you develop any symptoms of a heart attack or stroke during treatment with CIBINQO, 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
• 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
5. 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 (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) 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 a medicine in the class of medicines called Janus kinase (JAK) inhibitors.
• Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past.
• Get medical help right away if you have any signs and symptoms of blood clots during treatment with CIBINQO, including:
− swelling, pain or tenderness in one or both legs
− sudden, unexplained chest or upper back pain
− shortness of breath or difficulty breathing
6. Changes in certain laboratory test results
Your healthcare provider should do blood tests before you start taking CIBINQO and during treatment with CIBINQO to check for the following:
• low lymphocyte count. Lymphocytes are white blood cells that help the body fight off infections.
• low neutrophil count. Neutrophils are white blood cells that help the body fight off infections.
• low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.
• low platelet count. Platelets help form clots and stop or prevent bleeding.
You should not take CIBINQO if your lymphocyte counts, neutrophil counts, red blood cell counts, or platelet counts are too low. Your healthcare provider may stop your CIBINQO treatment for a period of time if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels.
Your healthcare provider should do blood tests about 4 weeks after you start taking CIBINQO, and 4 weeks after any increase in your dose of CIBINQO to check your blood cell counts, and as often as needed for your other laboratory tests.
See “What are the possible side effects of CIBINQO?” for more information about side effects.
What medicines should I avoid while taking CIBINQO?
During the first 3 months of treatment with CIBINQO, do not take CIBINQO with other medicines that prevent blood clots. You can take low-dose aspirin up to a dose of 81 mg each day during this time if prescribed by your healthcare provider.
What should I tell my healthcare provider before taking CIBINQO?
Tell your healthcare provider about all of your medical conditions, including if you:
• See “What is the most important information I should know about CIBINQO?”
• have an infection.
• are a current or past smoker.
• have had a heart attack, other heart problems, or stroke.
• have kidney problems or liver problems.
• have low platelet counts or white blood cell counts.
• have any eye problems, including cataracts or retinal detachment.
• have recently received or are scheduled to receive an immunization (vaccine). People who take CIBINQO should not receive live vaccines.
• are pregnant or plan to become pregnant. It is not known if CIBINQO will harm your unborn baby.
− Pregnancy Exposure Registry. Pfizer has a registry for women who take CIBINQO during pregnancy. The purpose of this registry is to check the health of you and your baby. If you are pregnant or become pregnant during treatment with CIBINQO, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-877-311-3770 or www.CIBINQOPregnancyRegistry.com.
• are breastfeeding or plan to breastfeed. It is not known if CIBINQO passes into your breast milk. You and your healthcare provider should decide if you will take CIBINQO or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, 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. See “Do not take CIBINQO if you.” Ask your healthcare provider if you are unsure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist whenever you get a new medicine.
How should I take CIBINQO?
• Take CIBINQO exactly as your healthcare provider tells you to take it.
• Take CIBINQO 1 time each day, at about the same time each day.
• Swallow CIBINQO tablets whole with water. Do not split, crush, or chew the tablets.
• You can take CIBINQO with or without food.
• CIBINQO can be used with or without prescribed topical medicines for atopic dermatitis. Prescribed topical medicine are lotions, creams, or ointments applied to your skin.
• If you miss a dose, take the dose as soon as possible. If it is less than 12 hours before the next dose, skip the dose. Take the next dose at your usually scheduled time.
• If you take too much CIBINQO, call the Poison Control Center at 1-800-222-1222 right away.
What are the possible side effects of CIBINQO?
CIBINQO may cause serious side effects, including:
• See “What is the most important information I should know about CIBINQO?”
The most common side effects of CIBINQO include:
See “What is the most important information I should know about CIBINQO.”
• common cold
• nausea
• headache
• herpes simplex including cold sores
• increased blood level of creatinine phosphokinase
• dizziness
• urinary tract infection
• tiredness
• acne
• vomiting
• mouth and throat pain
• flu
• stomach flu
• bacterial skin infection (impetigo)
• high blood pressure
• allergic skin rash to something you came into contact with
• stomach-area pain
• shingles
• low platelet count
CIBINQO may cause fertility problems in females, which may affect your ability to get pregnant. Talk to your healthcare provider if you have concerns about fertility.
Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with CIBINQO. Call your healthcare provider right away if you have any sudden changes in your vision during treatment with CIBINQO.
These are not all the possible side effects of CIBINQO.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer at 1-800-438-1985.
General information about the safe and effective use of CIBINQO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIBINQO for a condition for which it was not prescribed. Do not give CIBINQO to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about CIBINQO that is written for health professionals.
What are the ingredients in CIBINQO?
Active ingredient: abrocitinib
Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.
CIBINQO is available in 50 mg, 100 mg, and 200 mg pills.