certolizumab

Pronunciation: SER toe LIZ oo mab

Brand: Cimzia

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

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Some people using certolizumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using certolizumab or similar medicines to treat Crohn's disease or ulcerative colitis.

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Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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Serious and sometimes fatal infections may occur during treatment with certolizumab. Contact your doctor right away if you have open sores or skin wounds, or signs of infection such as: fever, cough, or flu symptoms.

Do not receive a "live" vaccine while you are being treated with certolizumab.

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 successful treatment of symptoms. 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 I receive certolizumab?

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You should not receive this medication if you have active but untreated tuberculosis. 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 tuberculosis is common.

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Some people using certolizumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using certolizumab or similar medicines to treat Crohn's disease or ulcerative colitis.

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.

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

  • an active or recent infection;
  • signs of infection such as fever, cough, or flu symptoms;
  • open sores or skin wounds;
  • lupus;
  • HIV or AIDS;
  • hepatitis B (or if you are a carrier of the virus);
  • a history of cancer (especially skin cancer);
  • epilepsy or seizure disorder;
  • congestive heart failure;
  • numbness or tingling, or a disease that affects your nerves or muscles (such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome); or
  • if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

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.

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It is not known whether certolizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a 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. Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

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 self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Certolizumab comes in a prefilled syringe, or as a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

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.

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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, cough, sweating, tired feeling, or if you feel short of breath.

While using certolizumab, you may need frequent blood tests at your doctor's office. Your skin may also need to be checked for signs of skin cancer.

Use certolizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using certolizumab.

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Store in the refrigerator. Protect from light and do not freeze. Take the medication and diluent out of the refrigerator and allow them to reach room temperature before preparing your dose.

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After mixing certolizumab powder with a diluent, store in the refrigerator and use within 24 hours. Do not freeze. Take the mixture out of the refrigerator and allow it to reach room temperature for up to 2 hours before giving the injection. Do not heat this medicine before using.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using certolizumab.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of certolizumab.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving certolizumab?

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Do not receive a "live" vaccine while using certolizumab, and 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. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, yellow fever, varicella (chickenpox), zoster (shingles), oral typhoid vaccine, and nasal flu (influenza) vaccine.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with certolizumab.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

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?

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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.

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Call your doctor right away if you have any of these symptoms of lymphoma:

  • 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.
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Stop using certolizumab and call your doctor at once if you have:

  • signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
  • swelling of your ankles or feet;
  • fast or slow heart rate;
  • pain or burning when you urinate;
  • confusion, neck stiffness, seizure (convulsions);
  • severe blistering, peeling, and red skin rash;
  • vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
  • joint pain or swelling with fever, muscle aches, nausea, 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).

Common side effects may include:

  • stuffy nose, sinus pain;
  • stomach pain, mild 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. 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 medicines you use, and those you start or stop using during your treatment with certolizumab, especially:

  • abatacept;
  • anakinra;
  • natalizumab;
  • rituximab;
  • NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
  • other drugs that weaken your immune system (such as cancer medicine, methotrexate, or steroids).

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.


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.

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