Usual Adult Dose for Myelodysplastic Syndrome

TREATMENT REGIMEN OPTION 1:
15 mg/m2 IV over 3 hours; repeat every 8 hours for 3 days; repeat this cycle every 6 weeks; patients may be premedicated with standard antiemetic therapy

If hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater) from a previous treatment cycle requires more than 6 weeks, then the next cycle should be delayed and dosing temporarily reduced by following this algorithm:

• Recovery requiring more than 6, but less than 8 weeks: Delay dosing for up to 2 weeks and temporarily reduce the dose to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy
• Recovery requiring more than 8, but less than 10 weeks: Assess patient for disease progression (by bone marrow aspirates); in the absence of progression, the dose should be delayed up to 2 more weeks and then reduced to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy, then maintained or increased in subsequent cycles as clinically indicated

TREATMENT REGIMEN OPTION 2:
20 mg/m2 IV over 1 hour; repeat daily for 5 days; repeat this cycle every 4 weeks; patients may be premedicated with standard antiemetic therapy

If myelosuppression is present, subsequent treatment cycles should be delayed until there is hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater)

Comments:

• With either regimen, 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.
• Perform complete blood and platelet counts prior to each cycle and as needed to monitor response and toxicity.
• Perform liver chemistries and serum creatinine prior to initiation of therapy.

Use: For the treatment of 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

Renal Dose Adjustments

Caution recommended.

Liver Dose Adjustments

Caution recommended.

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

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Once prepared, the final product should be given as a continuous IV infusion over one hour; a central venous catheter is not required.
• Premedication for prevention of nausea and vomiting is not typically required, but may be administered if necessary.

Storage requirements: The manufacturer's product information should be consulted.

Reconstitution/preparation techniques: The manufacturer's product information should be consulted.

Patient advice:

• Decitabine may cause adverse effects such as anemia during treatment; therefore, caution should be exercised if you are driving or operating machinery.