Dacogen is a nucleoside metabolic inhibitor indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
DOSAGE AND ADMINISTRATION

There are two regimens for Dacogen administration. 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.  (2)

• Treatment Regimen – Option 1
  Administer Dacogen at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days.  Repeat cycle every 6 weeks.  (2.1)
• Treatment Regimen – Option 2
  Administer Dacogen at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days.  Repeat cycle every 4 weeks. (2.2)

Lyophilized powder in a single-dose vial, 50 mg/vial. (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

• Neutropenia and thrombocytopenia: Perform complete blood counts and platelet counts. (5.1)
• Pregnancy: Can cause fetal harm. Advise women of potential risk to the fetus (5.2, 8.1)
• Women of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy (5.3, 5.4)

Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eisai, Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.