Consumer Information

Cimzia

Generic Name: certolizumab (Ser toe LIZ oo mab)
Brand Names: Cimzia

What is Cimzia?

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Cimzia 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.

Cimzia is used to treat the symptoms of Crohn's disease after other drugs have been tried without successful treatment of symptoms.

Cimzia may also be used for other purposes not listed in this medication guide.

Important information about Cimzia

Before you start treatment with Cimzia, 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).).

Cimzia 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 Cimzia. 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.

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 Cimzia.

Treatment with Cimzia may increase your risk of developing certain types of cancer or autoimmune disorder. 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 Cimzia?

You should not receive Cimzia 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.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. Before you receive Cimzia, 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 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. Cimzia 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 Cimzia passes into breast milk. Before you receive Cimzia, tell your doctor if you are breast-feeding a baby.

Treatment with Cimzia may increase your risk of developing certain types of cancer or autoimmune disorder. This risk may be greater in children and young adults. Talk with your doctor about your individual risk.



How is Cimzia given?

Before you start treatment with Cimzia, 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.

Cimzia is given as two injections under the skin of your stomach or thigh.

This medication is usually given every 2 to 4 weeks.

Cimzia 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 Cimzia regularly to get the most benefit. For best results, stay on your injection schedule and do not miss any appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Cimzia.

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

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving Cimzia?

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

Cimzia side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Cimzia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with this medicine. Stop using Cimzia and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;

  • feeling short of breath;

  • cough, sore throat; or

  • flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:
  • 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;

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

  • fast or slow heart rate;

  • pain or burning when you urinate;

  • seizure (convulsions);

  • jaundice (yellowing of the skin or eyes);

  • 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 Cimzia 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. 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 Cimzia?

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 Cimzia. 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 Cimzia.
  • 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.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 3.02. Revision Date: 4/12/2009 4:46:25 PM.








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