Remicade
Remicade (also known as Infliximab), is manufactured by the Johnson & Johnson subsidiary, Centocor. Remicade is used to treat Crohn's Disease and Rheumatoid Arthritis. Remicade was first approved by the FDA on August 24, 1998. Remicade was specifically approved for Rheumatoid Arthritis on November 10, 1999. Remicade is made from a combination of mouse and human substances and is administered intravenously, at a doctor's office or hospital. The patient is given 3 mg/kg as a single dose. The initial dose should be followed by additional 3 mg/kg doses two and six weeks after the first dose. The maintenance dose is 3 mg/kg every eight weeks. Patients often take Methotrexate simultaneously with Remicade treatments.
Tumor necrosis factor (TNF) plays a key role in the response of the body's immune system to infections. The action of blocking TNF may worsen or increase the occurrence of infections. Remicade blocks the effects of TNF-alpha.
A "black box warning" is the strongest consumer warning available to drug manufacturers. On August 15, 2001, Centocor announced that a "black box warning" had been added to Remicade's label in order to better inform doctors and patients of the increased chance of developing tuberculosis while receiving Remicade treatments. This increased warning followed allegations that Remicade has been associated with 84 cases of tuberculosis and at least 14 deaths.
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