Certolizumab Injection: MedlinePlus Drug Information

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Certolizumab Injection

(ser'' toe liz' oo mab)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

[UPDATED 08/31/2009] Supplemental Q&As added

[Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

IMPORTANT WARNING: Return to top

Certolizumab injection may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection including sepsis (infection that affects the entire body). Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, hepatitis B (a viral infection that affects the liver), human immunodeficiency virus (HIV), or any condition that affects your immune system. Tell your doctor if you are taking medications that slow the activity of the immune system such as abatacept (Orencia), anakinra (Kineret), azathioprine (Imuran), cancer chemotherapy medications, cyclophosphamide (Cytoxan), cyclosporine (Neoral, Sandimmune), oral corticosteroids, 6-mercaptopurine (Purinethol), methotrexate (Rheumatrex), sirolimus (Rapamune), sulfasalazine (Azulfidine), and tacrolimus (Prograf). If you experience any of the following symptoms during or shortly after your treatment with certolizumab, call your doctor immediately: sore throat; cough; fever; flu-like symptoms; open cuts or sores; weight loss; difficult, frequent, or painful urination; or other signs of infection.

Using certolizumab injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using certolizumab. Your doctor will monitor you for signs of TB during your treatment even if you did not have an inactive infection before you began to receive certolizumab.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with certolizumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using certolizumab injection.

Why is this medication prescribed? Return to top

Certolizumab injection is used to relieve the symptoms of Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in people who can no longer be helped by other medications. Certolizumab injection is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes inflammation.

How should this medicine be used? Return to top

Certolizumab injection comes as a powder to be mixed with sterile water and injected subcutaneously (under the skin) by a doctor or nurse. Each dose is given as two separate injections in the stomach area or thigh. It is usually given every two weeks for the first three doses and then every four weeks for as long as your treatment continues.

Certolizumab injection controls Crohn's disease but does not cure it. Your doctor will watch you carefully to see how well certolizumab works for you. It is important to tell your doctor how you are feeling during your treatment.

Other uses for this medicine Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before using certolizumab injection,

tell your doctor and pharmacist if you are allergic to certolizumab injection; other TNF inhibitors such as adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade); or any other medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had a disease that affects your nervous system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage) or optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); numbness, burning, or tingling in any part of your body; seizures; heart failure; any type of cancer; or bleeding problems or diseases that affect your blood.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using certolizumab injection, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using certolizumab injection.
do not have any vaccinations without talking to your doctor.

What special dietary instructions should I follow? Return to top

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose? Return to top

If you miss an appointment to receive a dose of certolizumab injection, call your doctor as soon as possible.

What side effects can this medication cause? Return to top

Certolizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

redness, itching, pain, or swelling at the site of injection

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
shortness of breath
difficulty swallowing or breathing
chest pain
sudden weight gain
hives
rash, especially on the cheeks or arms that worsens in the sun
pale skin
blistering skin
dizziness
extreme tiredness
numbness or tingling
problems with vision
weakness in the arms or legs
joint pain
unusual bruising or bleeding
loss of appetite

Some adults who received certolizumab injection during clinical trials and some adults and children 18 years of age or younger who received similar medications developed lymphoma (cancer that begins in the cells of the immune system) and other types of cancer. There is not enough information to tell whether people who receive certolizumab are more likely to develop cancer than people who do not receive the medication. Patients who have Crohn's disease or other diseases that require taking immunosuppressants for a long time may be more likely to develop certain types of cancer than people who do not have these conditions. Talk to your doctor about the risks of using certolizumab injection.

Certolizumab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to certolizumab injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving certolizumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Cimzia®

Last Revised - 09/01/2009

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.