Certolizumab Pegol Solution for injection

What is this medicine?

CERTOLIZUMAB (SER toe LIZ oo mab) is used to treat Crohn's disease or rheumatoid arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• heart disease
• hepatitis B or history of hepatitis B infection
• immune system problems
• infection or history of infections
• low blood counts, like low white cell, platelet, or red cell counts
• multiple sclerosis
• recently received or scheduled to receive a vaccine
• scheduled to have surgery
• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis
• an unusual or allergic reaction to certolizumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• abatacept
• adalimumab
• anakinra
• etanercept
• infliximab
• live virus vaccines
• rilonacept

This medicine may also interact with the following medications:

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Your condition will be monitored carefully while you are receiving this medicine.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional for advice if you get a fever, chills, sore throat, or other symptoms of an infection. Do not treat yourself. This medicine may decrease your body's ability to fight infection. Try to avoid being around people who are sick.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain or palpitations
• fever or chills, sore throat
• pain, tingling, numbness in the hands or feet
• red, scaly patches or raised bumps on the skin
• seizures
• swelling of the ankles, feet, hands
• swollen lymph nodes in the neck, underarm, or groin areas
• unexplained weight loss
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.