The FDA ( Food and Drug Administration ) has approved a new drug for treating Crohn's disease.
Cimzia ( Certolizumab pegol ) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies.
This product was approved with a Medication Guide.
Crohn's disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to fistulas leading from the intestine to the skin or internal organs.
Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.
The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.
Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death.
Because Cimzia affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections.
Cimzia is a blocker of TNF and may cause lymphomas and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion.
Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.
Source: FDA, 2008
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