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

CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

  • Your doctor should test you for TB before starting CIMZIA
  • Your doctor should monitor you closely for signs and symptoms of TB during treatment with CIMZIA

Certain Types of Cancer
There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. CIMZIA is not approved for use in pediatric patients. For people taking TNF-blocker medicines, including CIMZIA, the chances for getting lymphoma or other cancers may increase. People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

What are the possible side effects of CIMZIA?
CIMZIA can cause serious side effects including:

  • Heart Failure including new heart failure or worsening of heart failure you already have
  • Nervous System Problems such as Multiple Sclerosis, seizures, or inflammation of the nerves of the eyes
  • Allergic Reactions. Signs of an allergic reaction include a skin rash, swollen face, or trouble breathing
  • Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with CIMZIA if you carry the hepatitis B virus in your blood.
  • Blood Problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding
  • Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.

Call your doctor right away if you develop any of the above side effects or symptoms.

The most common side effects of CIMZIA are: upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).

Other side effects have happened in some people including new psoriasis or worsening of psoriasis you already have and injection site reactions.

You are encouraged to report negative side effects to FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.