How Is DACOGEN (decitabine) Given?

  • Your doctor may perform blood tests before treatment to determine if DACOGEN is right for you. Blood tests may be performed during treatment with DACOGEN to see how well the drug is working and to look for any potential side effects
  • DACOGEN is given as an intravenous (IV) infusion [in-FYOO-shun]
  • In an infusion, the medicine is in a plastic bag and flows through a tube into a vein in the body. The flow of the medicine may be controlled by a machine called an IV pump
  • There are 2 dosing regimens for DACOGEN:
3-day dosing includes:
  • A 3-hour infusion

  • Every 8 hours for 3 days

  • Repeat every 6 weeks

5-day dosing includes:
  • A 1-hour infusion

  • Every day for 5 days

  • Repeat every 4 weeks

  • Your healthcare provider will determine the dosing regimen that is right for you
  • Your healthcare provider may need to delay your treatment and/or reduce your dose if you experience certain side effects. Be sure to tell your healthcare provider how you are feeling during your treatment with DACOGEN
  • With either regimen it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles
  • To get the most out of your DACOGEN treatment, it is important to stay on treatment as long as your healthcare provider recommends

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