GET IN FRONT OF IT WITH CIBINQO
IMPORTANT FACTS ABOUT CIBINQO
This brief summary outlines important information and BOXED WARNING for CIBINQO (abrocitinib) and is not comprehensive. If you would like more information, talk to your healthcare provider or visit www.CIBINQOPI.com.
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; or 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.