certolizumab

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

Your risk of infection may be higher if you have diabetes, HIV, a weak immune system, hepatitis B, chronic infections, if you use certain medications, or if you live in or travel to certain areas.

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

What is certolizumab?

Certolizumab is used to treat the symptoms of Crohn's disease after other treatments have failed.

Certolizumab is also used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

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

What should I discuss with my healthcare provider before using certolizumab?

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• a chronic infection;
• hepatitis B (or if you are a carrier of the virus);
• lymphoma or other types of cancer;
• a blood cell disorder;
• congestive heart failure;
• a seizure;
• an allergy to latex;
• numbness or tingling, or a nervous system disorder such as multiple sclerosis or Guillain-Barré syndrome; or
• if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

How is certolizumab given?

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Certolizumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Certolizumab is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Certolizumab can increase your risk of bleeding or infection. You will need frequent medical tests.

Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you've ever had hepatitis B, using certolizumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving certolizumab?

Avoid injecting certolizumab into scars or stretch marks, or into skin that is red, bruised, swollen, hard, or tender.

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.

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
• new or worsening symptoms of lupus --joint pain, and a skin rash on your cheeks or arms that 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 other medicines, especially:

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

This list is not complete. Other drugs may affect certolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about certolizumab.