U.S. Brand Names

Cimzia®

Pharmacologic Category

Gastrointestinal Agent, Miscellaneous; Tumor Necrosis Factor (TNF) Blocking Agent

What key warnings should I know about before taking this medicine?

Tuberculosis has been seen in patients started on certolizumab pegol. These patients were exposed to tuberculosis in the past, but never had the infection. You should be tested to see if you have been exposed to tuberculosis.

Serious infections have occurred in patients who take these types of medicine.

Please read medication guide given to you.

Reasons not to take this medicine

• If you have an allergy to certolizumab pegol or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you are breast-feeding.

What is this medicine used for?

• This medicine is used to treat Crohn's disease.

How does it work?

• Certolizumab pegol decreases the body's harmful response to diseases affecting the immune system.

• It reduces gastrointestinal inflammation and helps reduce symptoms.

How is it best taken?

• This medicine is given as a shot into the fatty part of the skin.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Call your healthcare provider for instructions.

What are the precautions when taking this medicine?

• Hepatitis B testing may be suggested. Unrecognized hepatitis B infection may worsen during treatment.

• Long-term use may increase your risk of cancer.

• Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider.

• Talk with healthcare provider before receiving any vaccinations. Use with this medicine may either increase the risk of serious infection or make the vaccination less effective.

• If you have diabetes, talk with healthcare provider. You may be more likely to develop infections.

• If you have heart disease, talk with healthcare provider.

• If you have multiple sclerosis or other nerve disease, talk with healthcare provider.

• If you are taking anakinra, talk with healthcare provider.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Tell dentists, surgeons, and other healthcare providers that you use this medicine.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

What are some possible side effects of this medicine?

• Risk of infection. Avoid people with infections, colds, or flu.

• Headache.

• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.

• Irritation where the shot is given.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• You will need a tuberculosis test before starting this medicine.

• Check blood work. Talk with healthcare provider.

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain.

• Severe headache.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• This medicine will be given to you in a healthcare setting. You will not store it at home.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2008-04-30 11:15:35.0

Modified: 2008-05-02 11:08:58.0

Lexi-PALS^TM © (1977)-(2008) Lexi-Comp, Inc. All rights reserved.