Certolizumab (Patient information)

What is certolizumab?

Certolizumab is in a group of drugs called tumor necrosis factor blockers. 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 may also be used for other purposes not listed in this medication guide.

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

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, hepatitis B, a seizure disorder, congestive heart failure, any signs of infection, 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, chills, sore throat, flu symptoms, easy bruising or bleeding, pale skin, or unusual weakness.

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 with your doctor about your individual risk.

What should I discuss with my healthcare provider before I receive certolizumab? You should not receive this medication if you have active but untreated tuberculosis. Tell your doctor if you have a history of tuberculosis, if you have close contact with a person who has active tuberculosis, or if you have recently traveled to countries or locations where tuberculosis is common.

Before you start treatment with certolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. If you are found to have tuberculosis, you should start treatment for the infection before you receive your first dose of certolizumab.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. Before you receive certolizumab, tell your doctor if you are allergic to any drugs, or if you have:

• an active or recent infection;

• signs of infection such as fever, chills, cough, or flu symptoms;

• open sores or skin wounds;

• lupus;

• diabetes;

• HIV;

• hepatitis B (or if you are a carrier of the virus);

• a history of cancer;

• epilepsy or seizure disorder;

• congestive heart failure;

• a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;

• if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or

• if you are scheduled to receive any vaccines.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether certolizumab passes into breast milk. Before you receive certolizumab, tell your doctor if you are breast-feeding a baby.

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

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.

Certolizumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Contact your doctor at once if you develop signs of infection.

It is important to use certolizumab regularly to get the most benefit. For best results, stay on your injection schedule and do not miss any appointments.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are receiving certolizumab.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your certolizumab injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. An overdose of certolizumab is not expected to produce life-threatening symptoms.

What should I avoid while receiving certolizumab?

Do not receive a "live" vaccine while you are being treated with certolizumab. The live vaccine may not work as well during this time, and may not fully protect you from disease. Also avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Avoid contact with people who have colds, the flu, or other contagious illnesses.

Certolizumab side effects

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. Call your doctor at once if you have a serious side effect such as:

• feeling short of breath (even with mild exertion), swelling of your ankles or feet;

• vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;

• chest pain, fast or slow heart rate;

• pain or burning when you urinate;

• seizure (convulsions);

• jaundice (yellowing of the skin or eyes); or

• severe blistering, peeling, and red skin rash.

• Rare but serious side effects may include:

• chest pain, ongoing cough, coughing up blood or mucus;

• fever, chills, sore throat, flu symptoms, night sweats, weight loss;

• swollen glands in your neck, armpits, or groin;

• easy bruising or bleeding, pale skin, unusual weakness;

• 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. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect certolizumab?

Tell your doctor about all other medications you use, especially:

• anakinra (Kineret); or

• other drugs that weaken your immune system (such as cancer medicine or steroids).

This list is not complete and there may be other drugs that can interact with certolizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about certolizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.