Decitabine Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Myelodysplastic Syndrome

Treatment Regimen - Option 1
First Treatment Cycle: 15 mg/m2 administered by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Patients may be premedicated with standard antiemetic therapy.

Subsequent Treatment Cycles: The above cycle should be repeated every 6 weeks. 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. Treatment may be continued as long as the patient continues to benefit.

If hematologic recovery (absolute neutrophil count (ANC) greater than or equal to 1000/microliter and platelets greater than or equal to 50,000/microliter) from a previous treatment cycle requires more than 6 weeks, then the next cycle of decitabine therapy should be delayed and dosing temporarily reduced by following this algorithm: Recovery requiring more than 6, but less than 8 weeks - decitabine 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 decitabine 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.

Treatment Regimen - Option 2
20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks. Patients may be premedicated with standard antiemetic therapy.

If myelosuppression is present, subsequent treatment cycles of decitabine should be delayed until there is hematologic recovery (ANC greater than or equal to 1,000/mcL platelets greater than or equal to 50,000/mcL ).

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

If any of the following nonhematologic toxicities are present, decitabine treatment should not be restarted until the toxicity is resolved: 1) serum creatinine greater than or equal to 2 mg/dL; 2) SGPT, total bilirubin greater than or equal to 2 times ULN; and 3) active or uncontrolled infection.

Geriatric patients were generally dosed at the same level as younger adult patients. Dose adjustments for toxicity should be conducted as specified for the general population.

Precautions

No overall differences in safety, effectiveness, or responses have been reported between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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