CIBINQO What is the most important information I should know about CIBINQO?

(abrocitinib)

What is the most important information I should know about CIBINQO?


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 been hospitalized or 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:
o
fever, sweating, or chills
o
muscle aches
o
cough or shortness of breath
o
blood in your phlegm
o
weight loss
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinating more often than usual
o
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. If you get a serious infection, your healthcare provider may stop treatment with CIBINQO until your infection is controlled.


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 of 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.
•
Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood clots during treatment with CIBINQO, including:
o
swelling, pain or tenderness in one or both legs
o
sudden, unexplained chest or upper back pain
o
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.

Increased cholesterol levels. You may also have increases in the amount of fat found in your blood. Your healthcare provider should check your cholesterol about 4 weeks after you start CIBINQO, and then as needed.

See "What are the possible side effects of CIBINQO?" for more information about side effects.

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Health Professional Information

What is the most important information I should know about CIBINQO?

What is the most important information I should know about CIBINQO?


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 been hospitalized or 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:
o
fever, sweating, or chills
o
muscle aches
o
cough or shortness of breath
o
blood in your phlegm
o
weight loss
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinating more often than usual
o
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. If you get a serious infection, your healthcare provider may stop treatment with CIBINQO until your infection is controlled.


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 of 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.
•
Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood clots during treatment with CIBINQO, including:
o
swelling, pain or tenderness in one or both legs
o
sudden, unexplained chest or upper back pain
o
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.

Increased cholesterol levels. You may also have increases in the amount of fat found in your blood. Your healthcare provider should check your cholesterol about 4 weeks after you start CIBINQO, and then as needed.

See "What are the possible side effects of CIBINQO?" for more information about side effects.
Prescribing Information
Download Prescribing Information

Health Professional Information

What is the most important information I should know about CIBINQO?

What is the most important information I should know about CIBINQO?


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 been hospitalized or 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:
o
fever, sweating, or chills
o
muscle aches
o
cough or shortness of breath
o
blood in your phlegm
o
weight loss
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinating more often than usual
o
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. If you get a serious infection, your healthcare provider may stop treatment with CIBINQO until your infection is controlled.


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 of 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.
•
Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood clots during treatment with CIBINQO, including:
o
swelling, pain or tenderness in one or both legs
o
sudden, unexplained chest or upper back pain
o
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.

Increased cholesterol levels. You may also have increases in the amount of fat found in your blood. Your healthcare provider should check your cholesterol about 4 weeks after you start CIBINQO, and then as needed.

See "What are the possible side effects of CIBINQO?" for more information about side effects.

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