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

Using certolizumab may increase your risk of developing infections or certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal.

What is certolizumab?

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 success. 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 should I discuss with my healthcare provider before using certolizumab?

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

To make sure certolizumab is safe for you, tell your doctor if you have ever had:

• a chronic infection;
• diabetes;
• HIV or a weak immune system;
• hepatitis B (or if you are a carrier of the virus);
• cancer (especially skin cancer);
• congestive heart failure;
• epilepsy or seizure disorder;
• numbness or tingling, or a disease that affects your nerves or muscles (such as multiple sclerosis); or
• if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of certolizumab on the baby.

How is certolizumab given?

Before you start treatment with certolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Certolizumab is given as two injections under the skin of your stomach or thigh. This medication is usually given every 2 to 4 weeks. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Certolizumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Your blood may need to be tested often. Your skin may also need to be checked for signs of skin cancer.

If you have ever had hepatitis B, certolizumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving certolizumab?

Ask your doctor before receiving any vaccine while you are being treated with certolizumab.

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of certolizumab?

• chest pain, cough, feeling short of breath;
• swelling in your neck, underarm, or groin (this swelling may come and go);
• fever, night sweats, itching, weight loss, feeling tired;
• feeling full after eating only a small amount; or
• pain in your upper stomach that may spread to your back or shoulder.

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• pale skin, easy bruising or bleeding;
• a new growth on your skin (may be red or purple), or any change in the size or color of a mole, freckle, or bump on your skin;
• nerve problems --vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
• liver problems --loss of appetite, right-sided stomach pain, tiredness, jaundice (yellowing of the skin or eyes); or
• lupus-like syndrome --joint pain or swelling, trouble breathing, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Common side effects may include:

• pain or burning when you urinate;
• rash; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 other drugs will affect certolizumab?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• abatacept;
• adalimumab;
• anakinra;
• etanercept;
• golimumab;
• infliximab;
• natalizumab; or
• rituximab.

This list is not complete. Other drugs may interact with certolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about certolizumab.