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Myelodysplastic Diseases News

FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)

Posted 15 Mar 2010 by Drugs.com

WOODCLIFF LAKE, N.J., March 11 /PRNewswire-FirstCall/ – Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells. The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m2 continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks. The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m2 continuous IV ... Read more

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