GENERIC NAME: certolizumab

BRAND NAME: Cimzia

DRUG CLASS AND MECHANISM: Certolizumab is an injectable synthetic (man-made) protein antibody that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis and Crohn's disease. Adalimumab (Humira) and etanercept (Enbrel) are two other injectable drugs that block TNFα. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation. Certolizumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented. The FDA approved Certolizumab in April 2008.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Injection (powder): 200 mg. Injection (prefilled syringe): 200 mg STORAGE: Certolizumab should be stored refrigerated at 2 to 8 C (36 to 46 F). Reconstituted certolizumab should be used within two hours if kept at room temperature or within 24 hours if refrigerated.

PRESCRIBED FOR: Certolizumab is used for treating signs and symptoms of moderate to severe Crohn's disease and maintaining response in adults unresponsive to usual treatment. It is also used for treating rheumatoid arthritis. It may be used alone or combined with methotrexate (Rheumatrex, Trexall) or other drugs used for treating rheumatoid arthritis.

DOSING: Certolizumab is injected under the skin (thigh or abdomen). Injection sites should be rotated. The recommended dose for treating Crohn�s disease is 400 mg initially (2 injections of 200 mg), followed by 400 mg at weeks 2 and 4. For those who respond, the recommended maintenance dose is 400 mg every 4 weeks. The recommended dose for treating rheumatoid arthritis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.

DRUG INTERACTIONS: Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) or natalizumab (Tysabri) with certolizumab may result in reduced white blood cells in the blood (neutropenia), serious infections and no additional benefit. Certolizumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with certolizumab. Certolizumab may interfere with tests of coagulation in patients receiving blood thinners.

PREGNANCY: There are no adequate studies of certolizumab in pregnant women. NURSING MOTHERS: It is not known whether certolizumab is excreted in breast milk.

SIDE EFFECTS: The most common adverse effects in clinical studies were respiratory tract infections, urinary tract infections, and arthralgia (pain in the joints). Abdominal pain, diarrhea, and intestinal obstruction also may occur. Certolizumab may cause swelling, redness, pain and itching at the site of injection. Like other drugs that block TNFα, use of certolizumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with certolizumab. Certolizumab may worsen or cause new diseases of the nervous system. Certolizumab also may cause or worsen congestive heart failure. In studies, some patients who used certolizumab or other TNFα blocking drugs developed cancer. Since patients with Crohn's disease have a higher risk of cancers than the general population, the connection between cancer and use of certolizumab is unclear. Other side effects of certolizumab include hypersensitivity (allergic) reactions (including anaphylaxis) and reduced levels in the blood of platelets and red blood cells (aplastic anemia). Certolizumab may increase the risk of reactivating hepatitis B virus in chronic careers of the virus.