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 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: