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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 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.

• fever, night sweats, weight loss, tiredness;
• feeling full after eating only a small amount;
• pain in your upper stomach that may spread to your shoulder;
• easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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

• signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
• 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;
• fast or slow heart rate;
• pain or burning when you urinate;
• confusion, neck stiffness, seizure (convulsions);
• 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, mild 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)?

Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Certolizumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. 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.

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).

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.

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