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| |  Remicade (Infliximab) Prescribing Information Updated by FDA/Drug Maker MALVERN, PA -- August 15, 2001 -- Centocor, Inc. announced today that it is updating the prescribing information for Remicade® (infliximab), a biologic drug used in the treatment of rheumatoid arthritis (RA) and Crohn's disease. Developed with the U.S. Food and Drug Administration (FDA), the revised label instructs that patients should be evaluated for latent tuberculosis (TB) with a tuberculin skin test in reference to current American Thoracic Society/Centers for Disease Control and Prevention guidelines, and that treatment for latent tuberculosis should be initiated prior to therapy with Remicade. In addition, the revised label strengthens the warnings about the risk of serious infections in general, and has drawn attention to this important safety information through a boxed warning. "The very mechanism of action that makes TNF-blocking agents effective is believed to be the reason why these therapeutics may increase the risk of infection, including the reactivation of latent tuberculosis," said E. William St. Clair, MD, Duke University Medical Center. "All health care professionals should take the appropriate precautions, including evaluating patients for latent TB with a tuberculin skin test, prior to starting treatment with any therapy that suppresses the immune system." Many of the serious infections associated with Remicade have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn's disease or rheumatoid arthritis, could further hinder their infection-fighting capabilities. To announce the updated safety information, Centocor has begun an outreach program to Remicade-prescribing physicians. To date, Centocor has initiated direct communication with U.S. physicians to provide information that may ensure appropriate patient management. In addition, a "dear healthcare professional" letter will be sent to U.S. physicians treating patients with RA and Crohn's disease. Moreover, a patient information leaflet will be sent to all prescribing physicians to assist in educating patients on the benefits and risks of Remicade treatment. Remicade has a well-demonstrated benefit-to-risk ratio. It was the first biologic approved by the FDA for short-term use in patients with Crohn's disease that have had inadequate response to conventional therapy. Remicade is also indicated, in combination with methotrexate, for reducing the signs and symptoms and inhibiting progression of joint damage in patients with moderately to severely active rheumatoid arthritis that have had an inadequate response to methotrexate alone. As of June 30, 2001, more than 170,000 patients worldwide have been treated with Remicade in commercial experience, with 84 cases of tuberculosis reported from post-marketing surveillance and clinical trials of Remicade. The vast majority of cases (52) occurred in Europe, where latent tuberculosis is more prevalent. Twenty cases occurred in the United States and twelve in other parts of the world. Among the 84 cases, 14 were fatal. Most of the cases of TB reported in association with Remicade have occurred within the first three to six months of treatment, a pattern consistent with reactivation of latent -- or dormant -- tuberculosis, rather than a newly acquired infection. The incidence of latent TB in the U.S. is estimated to be four to six percent in the general population. The new label also addresses the risk of opportunistic infections, including histoplasmosis, listeriosis and pneumocystis. With respect to the risk for histoplasmosis infection, the revised labeling instructs that the benefits and risks of Remicade therapy should be carefully considered for patients who have resided in a region where histoplasmosis is endemic.
SOURCE: Centocor Inc. Related Links: Remicade (infliximab) and Centocor Inc.
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