Certolizumab Injection

Conditions Treated

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.

Possible Side Effects

What Side Effects Can This Cause?

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
• loss of appetite
• red scaly patches and/or pus-filled bumps on the skin

Receiving certolizumab injection may increase the risk of developing leukemia (cancer that begins in the white blood cells) and other types of cancer in adults and children. Talk to your doctor about the risks of receiving 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].

Usage Instructions

How Should This Medication Be Used

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.

What Dietary Instructions Should I Follow

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

Are There Any Special Instructions

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. 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.