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Certolizumab

Generic Name: certolizumab (SER-toe-LIZ-ue-mab)
Brand Name: Cimzia

Patients who use certolizumab have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, or fungal infections; tuberculosis [TB]). Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).

TB may be caused by a new infection or by reactivation of a previous infection. Patients should receive a TB skin test before using certolizumab. Patients who test positive for TB should begin treatment for TB before starting certolizumab. All patients should also be monitored for signs of TB while using certolizumab, even if their TB test is negative.

Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle aches or weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; diarrhea or stomach pain; increased or painful urination).

Certolizumab is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Certolizumab is not approved for use in children or teenagers. Talk with your doctor for more information.


Certolizumab is used for:

Reducing signs and symptoms of Crohn disease in certain patients. It is also used to treat active rheumatoid arthritis or psoriatic arthritis. It may be used alone or in combination with other medicine.

Certolizumab is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body's immune system that causes inflammation.

Do NOT use certolizumab if:

  • you are allergic to any ingredient in certolizumab
  • you have an active infection
  • you are using certain biologic medicines (eg, abatacept, adalimumab, anakinra, etanercept, golimumab, infliximab, natalizumab, rituximab, tocilizumab)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using certolizumab:

Some medical conditions may interact with certolizumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to another TNF blocker (eg, infliximab)
  • if you have any type of infection, including bacterial, viral, or protozoal infection; fungal infection (eg, coccidiomycosis, histoplasmosis); TB infection; skin infection; flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin); open cuts or sores on your body, or are using medicine to treat an infection
  • if you have a history of chronic or recurring infections, a positive TB skin test, or if you have recently been around someone who might have TB
  • if you have ever lived in or traveled to an area where TB is common
  • if you live in, have lived in, or have traveled to certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
  • if you have a risk for skin cancer or a history of cancer (eg, lymphoma, skin cancer); hepatitis B infection or other liver problems; diabetes; heart problems (eg, heart failure); high blood pressure; blood problems (eg, anemia); bone marrow problems; autoimmune problems (eg, lupus); or numbness, tingling, or other nervous system problems (eg, Guillain-Barré syndrome, multiple sclerosis [MS], seizures)
  • if you have a weakened immune system, HIV, or any other immune system problems, or if you have any condition that may increase your risk of infection
  • if you have recently received or are scheduled to receive a vaccine

Some MEDICINES MAY INTERACT with certolizumab. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain biologic medicines (eg, abatacept, adalimumab , anakinra, etanercept, golimumab, infliximab, natalizumab, rituximab, tocilizumab), corticosteroids (eg, prednisone), methotrexate, or another medicine that may weaken the immune system because the risk of severe infection may be increased
  • Nonsteroidal anti-inflammatory drugs (NSAIDS) (eg, ibuprofen) because the risk of high blood pressure may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if certolizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use certolizumab:

Use certolizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Certolizumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get certolizumab refilled.
  • Certolizumab is usually given as an injection under the skin at your doctor's office, hospital, or clinic. If you will be using it at home, a health care provider will teach you how to use it. Be sure you understand how to use certolizumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Certolizumab should be a clear, colorless to yellow liquid. Do not use certolizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Let certolizumab come to room temperature before you inject it, as directed by your doctor.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
  • Certolizumab may be injected in your stomach or thigh area. If your dose requires 2 injections, be sure to use separate injection sites for each injection. Be sure to rotate injection sites.
  • Do not inject into areas of the skin that are sore, bruised, red, or hard.
  • Discard any unused medicine remaining in the syringe or vial after use.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of certolizumab, use it as soon as possible. Then go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use certolizumab.

Important safety information:

  • Certolizumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Certolizumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.
  • Certolizumab may increase the risk of developing blood cancer (eg, leukemia, lymphoma) and other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop any unusual symptoms, such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, unexplained cough or shortness of breath, persistent unexplained itching, or unexplained weight loss.
  • A rare type of cancer called HSTCL has been reported in patients using TNF blockers. These cases have been fatal. Most of these cases occurred in teenagers or young adults. Most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using certolizumab along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer. Tell your doctor right away if you develop stomach pain or tenderness, fever, night sweats, or unexplained weight loss.
  • Some patients who use certolizumab have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches; raised bumps filled with pus).
  • New or worsening nervous system problems (eg, MS, Guillain-Barré syndrome, seizures, inflammation of the nerves of the eyes) have occurred with TNF blockers. Tell your doctor if you have a condition that affects your nervous system. Discuss any questions or concerns with your doctor.
  • Tell your doctor or dentist that you take certolizumab before you receive any medical or dental care, emergency care, or surgery.
  • Do not receive a live vaccine (eg, measles, mumps) or treatment with a weakened bacteria (eg, BCG for bladder cancer) while you are taking certolizumab. Talk with your doctor before you receive any vaccine.
  • If you used certolizumab while you were pregnant, tell your baby's doctor.
  • Certolizumab may interfere with certain lab tests, including blood clotting tests and TB tests. Be sure your doctor and lab personnel know you are using certolizumab.
  • Lab or medical tests, including TB, complete blood cell counts, liver function, and skin examinations, may be performed while you use certolizumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use certolizumab with caution in the ELDERLY; they may be more sensitive to its side effects, especially infection.
  • Certolizumab should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. Certolizumab is not approved for use in children. Children and teenagers may be at increased risk for developing certain types of cancer with certolizumab, which may be fatal.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using certolizumab while you are pregnant. It is not known if certolizumab is found in breast milk. Do not breast-feed while taking certolizumab.

Possible side effects of certolizumab:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Minor pain, redness, or swelling at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; flushing; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; butterfly-shaped rash on the nose and cheeks; chest pain; confusion; dizziness; fainting; irregular heartbeat; joint pain; mental or mood changes (eg, anxiety, depression, suicidal thoughts or actions); muscle weakness; one-sided weakness; red, swollen, blistered, or peeling skin; seizure; severe or persistent headache; severe or persistent pain, swelling, or redness at the injection site; shortness of breath; slurred speech; sudden, unusual weight gain; swelling of the hands, ankles, or feet; symptoms of infection (eg, chills, fever, painful or frequent urination, persistent cough or sore throat, persistent feeling of being unwell, unusual vaginal discharge or odor, unusual weight loss, white patches in the mouth); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, decreased appetite, nausea or stomach pain); unusual bruising or bleeding; unusual lumps (eg, in the armpits, groin, neck); unusual sweating; unusual tiredness or weakness; unusually pale skin; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of certolizumab:

Store certolizumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not use certolizumab past the expiration date on the label. Do not store in the bathroom. Keep certolizumab out of the reach of children and away from pets.

General information:

  • If you have any questions about certolizumab, please talk with your doctor, pharmacist, or other health care provider.
  • Certolizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take certolizumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about certolizumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to certolizumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using certolizumab.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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