Dosage and Administration

It is recommended that patients receive DACOGEN^® (decitabine) for Injection for a minimum of 4 cycles. A complete or partial response may take longer than 4 cycles, so treatment should continue as long as the patient continues to benefit from DACOGEN.¹

Recommended Dosage and Administration

• The recommended DACOGEN dose is 15 mg/m², administered by continuous intravenous infusion over 3 hours, every 8 hours for 3 days. This cycle should be repeated every 6 weeks.
• The DACOGEN dose may need to be delayed or reduced based on hematologic laboratory values.

  If hematologic recovery (ANC ≥ 1,000/pL 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.
  • Recovery requiring more than 8, but less than 10 weeks - Patient should be assessed for disease progression (by bone marrow aspirates); in the absence of progression, the DACOGEN dose should be delayed up to 2 more weeks and the dose reduced to 11 mg/m² every 8 hours (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy, then maintained or increased in subsequent cycles as clinically indicated.

If any of the following non-hermatologic toxicities are present, DACOGEN treatment should not be restarted until the toxicity is resolved: 1) serum creatinine ≥ 2 mg/dL; 2) SGPT, total bilirubin ≥ 2 times ULN; and 3) active or uncontrolled infection.

Preparation Instructions

• DACOGEN is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing DACOGEN. Please refer to Handling and Disposal section.
• 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 7 hours until administration.

DACOGEN Doses and Final Concentration of Admixture³

Please view the DACOGEN prescribing information for more information about dosage and administration.

Read more about the DACOGEN Safety Profile

References

IMPORTANT SAFETY INFORMATION

DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using DACOGEN. Men should be advised not to father a child while receiving treatment with DACOGEN, and for 2 months afterwards. The most commonly occurring adverse reactions include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

DACOGEN is available by prescription only. Please see the important product information for DACOGEN for more information. This site does not contain everything that is known about DACOGEN. If you would like to know more, talk to your healthcare professional.

This web site contains information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. Individual responses to DACOGEN treatment may vary.

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