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Brand Names: Cimzia

Generic Name: certolizumab (Pronunciation: SER toe LIZ oo mab)

• What is certolizumab (Cimzia)?
• What are the possible side effects of certolizumab (Cimzia)?
• What is the most important information I should know about certolizumab (Cimzia)?
• What should I discuss with my healthcare provider before I receive certolizumab (Cimzia)?
• How is certolizumab given (Cimzia)?
• What happens if I miss a dose (Cimzia)?
• What happens if I overdose (Cimzia)?
• What should I avoid while receiving certolizumab (Cimzia)?
• What other drugs will affect certolizumab (Cimzia)?
• Where can I get more information?

What is certolizumab (Cimzia)?

Certolizumab reduces the effects of a substance in the body that can cause inflammation.

Certolizumab is used to treat the symptoms of Crohn's disease after other drugs have been tried without successful treatment of symptoms. Certolizumab is also used to treat moderate to severe rheumatoid arthritis in adults.

Certolizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of certolizumab (Cimzia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat; or
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling of your ankles or feet;
• chest pain, ongoing cough, coughing up blood or mucus;
• swollen glands in your neck, armpits, or groin;
• easy bruising or bleeding, pale skin, unusual weakness;
• fast or slow heart rate;
• pain or burning when you urinate;
• seizure (convulsions);
• jaundice (yellowing of the skin or eyes);
• severe blistering, peeling, and red skin rash;
• vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
• joint pain or swelling with fever, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions); or
• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

• stuffy nose, sinus pain;
• stomach pain, diarrhea, constipation; or
• pain, redness, itching, swelling, or bleeding where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about certolizumab (Cimzia)?

Before you start treatment with certolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Tell your doctor if you have any signs of infection or if you have recently received any vaccines.

Tell your doctor if you are allergic to any drugs, or if you have lupus, diabetes, HIV/AIDS, hepatitis B, a seizure disorder, congestive heart failure, a history of cancer, or a disease that affects the nerves or muscles (such as multiple sclerosis or myasthenia gravis).

Certolizumab can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses.

Serious and sometimes fatal infections may occur during treatment with certolizumab. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a "live" vaccine while you are being treated with certolizumab.

Treatment with certolizumab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.