WEDNESDAY, April 23 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) announced this week the approval of Cimzia (certolizumab pegol) for the treatment of moderate to severe Crohn's disease in patients who have not responded to conventional therapies.
Cimzia, which is manufactured by UCB Inc. of Smyrna, Ga., is a pegylated anti-tumor necrosis factor drug. Patients receive an injection every two weeks for the first three doses and then injections every four weeks. The most common side effects include headache, upper respiratory infections and abdominal pain.
Because Cimzia affects the immune system, patients taking the drug are at increased risk for serious infections, including tuberculosis and other opportunistic infections. Patients taking Cimzia should be educated so they can recognize signs of infection and instructed to contact their health care providers should these signs develop. They may also be at increased risk of lymphomas and other malignancies.
"Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research, said in a statement. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."
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