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The Pharmaceutical Journal Vol 265 No 7103 p33
July 1, 2000 Products

Prescription products

New indication for Remicade

The licensed indications for Schering-Plough's Remicade infusion have been extended. Remicade is now additionally indicated for the "reduction of signs and symptoms in patients with active rheumatoid arthritis disease when the response to disease-modifying drugs, including methotrexate, has been inadequate." Efficacy and safety have been demonstrated only in combination with methotrexate. A dose of 3mg/kg should be given as an intravenous infusion over a two hour period, followed by additional 3mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter. Safety and efficacy of repeated administration, given every eight weeks, have been established. Remicade must be given concomitantly with methotrexate. Remicade can be readministered within 14 weeks following the last infusion. The risk of delayed hypersensitivity following readministration after a drug-free interval of 15 weeks to two years is unknown and therefore readministration after 15 weeks cannot be recommended.