Cimzia (Certolizumab Pegol) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Cimzia

Crohn's Disease »

What is Crohn's disease?

Crohn's disease (also spelled Crohn disease) is a chronic inflammatory disease of the intestines. It primarily causes ulcerations (breaks in the lining) of the small and large intestines, but can affect the digestive system anywhere from the mouth to the anus. It is named after the physician who described the disease in 1932. It also is called granulomatous enteritis or colitis, regional enteritis, ileitis, or terminal ileitis.

Crohn's disease is related closely to another chronic inflammatory condition that involves only the colon called ulcerative colitis. Together, Crohn's disease and ulcerative colitis are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's disease have no medical cure. Once the diseases begin, they tend to fluctuate between periods of inactivity (remission) and activity (relapse).

Inflammatory bowel disease affects approximately 500,000 to two million peop...

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Cimzia

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CIMZIA
(certolizumab pegol) Lyophilzed Powder for Solution and Solution for Subcutaneous Injection

WARNINGS

SERIOUS INFECTIONS

Patients treated with CIMZIA (certolizumab pegol) are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

CIMZIA (certolizumab pegol) should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA (certolizumab pegol) use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA (certolizumab pegol) use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with CIMZIA (certolizumab pegol) should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA (certolizumab pegol) , including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member [see WARNINGS AND PRECAUTIONS]. CIMZIA (certolizumab pegol) is not indicated for use in pediatric patients.

DRUG DESCRIPTION

CIMZIA (certolizumab pegol) is a TNF blocker. CIMZIA (certolizumab pegol) is a recombinant, humanized antibody Fab' fragment, with specificity for human tumor necrosis factor alpha (TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K). The Fab' fragment is manufactured in E. coli and is subsequently subjected to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol. The Fab' fragment is composed of a light chain with 214 amino acids and a heavy chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately 91 kiloDaltons.

CIMZIA (certolizumab pegol) is supplied as either a sterile, white, lyophilized powder for solution or as a sterile, solution in a single-use prefilled 1 mL glass syringe for subcutaneous injection. After reconstitution of the lyophilized powder with 1 mL sterile Water for Injection, USP, the resulting pH is approximately 5.2.

Each single-use vial provides approximately 200 mg certolizumab pegol, 100 mg sucrose, 0.9 mg lactic acid, and 0.1 mg polysorbate. Each prefilled syringe delivers 1 mL (200 mg) of drug product with a pH of approximately 4.7. Each 1 mL syringe of CIMZIA contains 200 mg of certolizumab pegol, 1.36 mg of sodium acetate, 7.31 mg sodium chloride, and Water for Injection, USP.

CIMZIA (certolizumab pegol) is a clear to opalescent solution that is colorless to pale yellow and essentially free from particulates. No preservatives are present.

What are the possible side effects of certolizumab (Cimzia)?

Get 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.

Serious and sometimes fatal infections may occur during treatment with certolizumab. Stop using certolizumab 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...

Read All Potential Side Effects and See Pictures of Cimzia »

What are the precautions when taking certolizumab pegol (Cimzia)?

Before using certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any infection that keeps coming back, hepatitis B infection, HIV infection, tuberculosis (TB), cuts or open sores, cancer, diabetes, heart failure, blood/bone marrow disorders, history of cancer (such as lymphoma), brain/nervous system disorders...

Read All Potential Precautions of Cimzia »

Last reviewed on RxList: 8/27/2010
This monograph has been modified to include the generic and brand name in many instances.