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Otsuka America Pharmaceutical, Inc.

INDICATION:

DACOGEN is a prescription medicine indicated for treatment of patients with myelodysplastic syndromes (MDS), including:

Previously treated and untreated MDS
De novo (cause unknown) and secondary (treatment-related) MDS:
  • All French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia)
  • Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups

IMPORTANT SAFETY INFORMATION:

Treatment with DACOGEN is associated with serious, sometimes fatal, blood disorders including:
  • fewer white blood cells (neutropenia and leukopenia), platelets (thrombocytopenia), and/or red blood cells (anemia)
  • fever associated with low white blood cell counts (febrile neutropenia)
  • bone marrow suppression
  • infections
Your doctor will test and monitor your blood cells before and during treatment with DACOGEN. Your doctor may prescribe medicine to help manage your blood cell counts and/or medicines to prevent or treat infections. Your doctor may need to delay your treatment and/or reduce your dose if you experience certain side effects. Patients should monitor and report any symptoms or fever to their doctor as soon as possible
Harm to a fetus when administered to a pregnant woman: Women of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy while taking DACOGEN
Other common side effects including:
  • feeling tired (fatigue)
  • fever (pyrexia)
  • nausea
  • cough
  • reddish or purplish spots (petechiae)
  • constipation
  • diarrhea
  • high blood sugar (hyperglycemia)
DACOGEN should be used with caution if you have kidney or liver problems

You are encouraged to report side effects of DACOGEN® (decitabine), please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION