Drug Detail:Dacogen (Decitabine [ de-sit-a-been ])
Generic Name: DECITABINE 50mg in 20mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: Antimetabolites
Recommended Dosage
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 [see Dosage and Administration (2.2)].
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 [see Dosage and Administration (2.2)]. 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.
Dosage Modifications for Adverse Reactions
Hematologic Toxicity
If hematologic recovery from a previous DACOGEN treatment cycle requires more than 6 weeks, delay the next cycle of DACOGEN therapy and reduce DACOGEN dose temporarily by following this algorithm:
- Recovery requiring more than 6, but less than 8 weeks: delay DACOGEN dosing for up to 2 weeks and reduce the dose temporarily to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy.
- Recovery requiring more than 8, but less than 10 weeks: Perform bone marrow aspirate to assess for disease progression. In the absence of progression, delay DACOGEN dosing for up to 2 more weeks and reduce the dose to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintain or increase dose in subsequent cycles as clinically indicated.
Non-hematologic Toxicity
Delay subsequent DACOGEN treatment for any the following nonhematologic toxicities and do not restart until toxicities resolve:
- Serum creatinine greater than or equal to 2 mg/dL
- Alanine transaminase (ALT), total bilirubin greater than or equal to 2 times upper limit of normal (ULN)
- Active or uncontrolled infection
Preparation and Administration
DACOGEN is a cytotoxic drug. Follow special handling and disposal procedures.1
Aseptically reconstitute DACOGEN with room temperature (20°C to 25°C) 10 mL of Sterile Water for Injection, USP. Upon reconstitution, the final concentration of the reconstituted DACOGEN solution is 5 mg/mL. You must dilute the reconstituted solution with 0.9% Sodium Chloride Injection or 5% Dextrose Injection prior to administration. Temperature of the diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) depends on time of administration after preparation.
For Administration Within 15 Minutes of Preparation
If DACOGEN is intended to be administered within 15 minutes from the time of preparation, dilute the reconstituted solution with room temperature (20°C to 25°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg/mL to 1 mg/mL. Discard unused portion.
For Delayed Administration
If DACOGEN is intended to be administered after 15 minutes of preparation, dilute the reconstituted solution with cold (2°C to 8°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg/mL to 1 mg/mL. Store at 2°C to 8°C for up to 4 hours. Diluted stored solution must be used within 4 hours from the time of preparation. Discard unused portion.
Use the diluted, refrigerated solution within 4 hours from the time of preparation or discard.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.
