Decitabine - Dacogen™
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|NS, D5W, LR|
DOSAGE AND ADMINISTRATION Summary:
• Treatment Regimen - Option 2
|Stability / Miscellaneous|
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
Complete blood counts and platelet counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of treatment.
2.1 Treatment Regimen - Option 1
If hematologic recovery (ANC ≥ 1,000/µL and platelets ≥ 50,000/µL) from a previous Dacogen treatment cycle requires more than 6 weeks, then the next cycle of Dacogen therapy should be delayed and dosing temporarily reduced by following this algorithm:
Recovery requiring more than 6, but less than 8 weeks - Dacogen dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy.
2.2 Treatment Regimen - Option 2
If myelo-suppression is present, subsequent treatment cycles of Dacogen should be delayed until there is hematologic recovery (ANC ≥ 1,000/µL platelets ≥ 50,000/µL ).
2.3 Patients with Non-hematologic Toxicity
2.4 Instructions for Intravenous Administration
Dacogen should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5.0 mg of decitabine at pH 6.7-7.3. Immediately after reconstitution, the solution should be further diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection to a final drug concentration of 0.1 - 1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2°C - 8°C) infusion fluids and stored at 2°C - 8°C (36°F - 46°F) for up to a maximum of 4 hours until administration.
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.
3. DOSAGE FORMS AND STRENGTHS
HOW SUPPLIED / STORAGE AND HANDLING
Dacogen® is a registered trademark of SuperGen, Inc., Dublin, CA, U.S.A. used under license
1) [PACKAGE INSERT DATA] : DACOGEN (decitabine) injection, powder, lyophilized, for solution. Eisai Inc., Woodcliff Lake, NJ 07677. Revision Date 03/2010.
2) Solimando, Dominic A. Drug Information Handbook for Oncology: A Complete Guide to Combination Chemotherapy Regimens, 8th ed. Hudson, OH: Lexi-Comp, Inc.; 2010.