certolizumab

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certolizumab

Pronunciation:SER toe LIZ oo mab
Brand:Cimzia

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

emtSome 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.
donotCall 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).
emtCertolizumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. 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.

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/AIDS, hepatitis B, a seizure disorder, congestive heart failure, a history of cancer, or a disease that affects the nerves or muscles (such as multiple sclerosis or myasthenia gravis).

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.

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?

donotYou 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.
emtSome 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 you can safely use certolizumab, tell your doctor if you have any of these other conditions:

  • an active or recent infection;
  • signs of infection such as fever, chills, cough, or flu symptoms;
  • open sores or skin wounds;
  • lupus;
  • diabetes;
  • HIV or AIDS;
  • 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.

nobrfeedIt is not known whether certolizumab passes into breast milk. Before you receive certolizumab, 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.

donotSome 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.

emtCertolizumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. 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.

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

emtIf you need surgery, tell the surgeon ahead of time that you are using certolizumab.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using 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?

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

What should I avoid while receiving certolizumab?

donotDo 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, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

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

What are the possible side effects of certolizumab?

emtGet 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.
donotCall your doctor right away if you have any of these symptoms of lymphoma:
  • fever, night sweats, weight loss, tiredness;
  • feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
donotCall your doctor at once if you have any of these other serious side effects:
  • signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up blood or mucus;
  • swollen glands in your neck, armpits, or groin;
  • 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, 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, 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 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 other drugs may interact with certolizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start 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.

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