Important Safety Information you should know about CIMZIA® (certolizumab pegol). 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, including 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 tumor necrosis factor (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 rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

What is CIMZIA?

CIMZIA is a medicine called a TNF blocker. CIMZIA is used in adult patients to:

• Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in adults who have not been helped enough by usual treatments
• Treat moderately to severely active RA

Before starting CIMZIA, tell your doctor about all of your medical conditions, including if you:

You should not take CIMZIA while you take one of these medicines.

how should I use CIMZIA?

CIMZIA is available as a lyophilized powder for reconstitution or in a prefilled syringe. if your doctor prescribes the lyophilized pack, CIMZIA should be injected by a healthcare provider. if your doctor prescribes the prefilled syringe, see the section “Patient Instructions for Use” at the end of the Medication Guide for complete instructions for use. Do not give yourself an injection of CIMZIA unless you have been shown how by your doctor or nurse–or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your doctor will tell you how much CIMZIA to inject and how often, based on your condition to be treated. Make sure to keep all of your injection and follow-up appointments with your doctor.

After starting CIMZIA,if you get an infection; any sign of an infection including a fever, cough, or flu-like symptoms; or have open cuts or sores on your body, call your doctor right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.

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. Symptoms may include shortness of breath or swelling of your ankles or feet
• Nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Symptoms include dizziness, numbness or tingling, problems with your vision, and weakness in your arms or legs
• 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 the 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. Tell your doctor if you have any of the following symptoms: feel unwell, poor appetite, tiredness (fatigue), fever, skin rash, or joint pain
• Blood problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that doesn’t go away, bruising or bleeding very easily, or looking very pale
• 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. Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with CIMZIA. ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the Medication Guide for CIMZIA and discuss it with your doctor.

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

Important Safety Information Regarding Fungal Infections