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FDA Approves Five-Day Dosing Regimen for Dacogen(R) (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Date:3/11/2010

termediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups.

Dacogen is currently approved in the treatment of MDS in more than 20 countries outside of the United States.

Important Safety Information

Dacogen may cause fetal harm when administered to a pregnant woman.  Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Dacogen.  Men should be advised to not to father a child while receiving treatment with Dacogen, and for two months afterwards.

In the previous Dacogen Phase III studies, the highest incidences of Grade 3 or Grade 4 adverse events in the Dacogen arm were neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia (22%).  Bone marrow suppression was the most frequent cause of dose reduction, delay and discontinuation.  Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia, and thrombocytopenia) that were considered at least possibly related to drug treatment.


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