INDICATIONS AND USAGE（适应症）

DACOGEN is indicated for treatment of adult 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.

DOSAGE（服用剂量）

Pre-Medications and Baseline Testing

Consider pre-medicating for nausea with antiemetics.

Conduct baseline laboratory testing: complete blood count (CBC) with platelets, serum hepatic panel, and serum creatinine.

DACOGEN Regimen Options

Three Day Regimen

Administer DACOGEN at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/µL and platelets at least 50,000/µL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles. Delay and reduce dose for hematologic toxicity.

Five Day Regimen

Administer DACOGEN at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days. Delay and reduce dose for hematologic toxicity. Repeat cycles every 4 weeks upon hematologic recovery (ANC at least 1,000/µL and platelets at least 50,000/µL) for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles.

Patients with Renal or Severe Hepatic Impairment

Treatment with DACOGEN has not been studied in patients with pre-existing renal or hepatic impairment. For patients with pre-existing renal or hepatic impairment, consider the potential risks and benefits before initiating treatment with DACOGEN.

ADVERSE REACTIONS（不良反应）

Neutropenia

Thrombocytopenia

Anemia

Fatigue

Pyrexia

Nausea

Cough

Petechiae

Constipation

Diarrhea

Hyperglycemia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/deb4a13c-855b-4372-9778-6e81da598df6/spl-doc?hl=Dacogen

Dacogeninformation