Adult Dosing
Myelodysplastic syndrome
- 3 day regimen
- 15 mg/m2 IV over 3 hrs; repeat q8 hrs x3 days. Repeat cycle q6 wks for minimum of 4 cycles. Premedicate patients with standard anti-emetic therapy
- If hematologic recovery (ANC = 1,000/µL and platelets = 50,000/µL) from a previous treatment cycle requires >6 wks, then delay the next cycle and temporarily reduce dose
- Recovery requiring >6, but <8 wks: Delay dosing for up to 2 wks and temporarily reduce dose to 11 mg/m2 IV q8 hrs (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy
- Recovery requiring >8, but <10 wks: Assess patients for disease progression (by bone marrow aspirates); in the absence of progression delay dose up to 2 more wks and decrease dose to 11 mg/m2 q8 hrs (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintain or increase in subsequent cycles as clinically indicated
- 5 day regimen
- 20 mg/m2 IV over 1 hr x5 days. Repeat cycle q4 wks for minimum of 4 cycles. Premedicate patients with standard anti-emetic therapy
- On presence of myelosuppression delay subsequent treatment cycles until there is hematologic recovery (ANC = 1,000/µL platelets = 50,000/µL )
Note: Avoid restarting of therapy until resolution of non-hematologic toxicities
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Neutropenia and thrombocytopenia have occurred in association with therapy. Perform CBC and platelet counts as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle
- Adjust treatment for subsequent cycles after administration of the recommended dosage for the first cycle. Consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS
- Myelosuppression and worsening of neutropenia have occurred more frequently in the first or second treatment cycles, and may not necessarily indicate progression of underlying MDS
- Fetal harm has occurred on administration to a pregnant woman. Apprise patients of the potential hazard to the fetus if this drug is used during pregnancy, or if a patient becomes pregnant while receiving this therapy. Advise women of childbearing potential to avoid becoming pregnant while taking this drug and for 1 month following completion of therapy
- Advise men not to father a child while receiving treatment and for 2 months following completion of therapy; also advise men with female partners of childbearing potential to use effective contraception during this time
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
Supplemental Patient Information
- Advise women of childbearing potential to avoid becoming pregnant while taking this drug and for 1 month following completion of therapy
- Advise men not to father a child while receiving treatment and for 2 months following completion of therapy; also advise men with female partners of childbearing potential to use effective contraception during this time
Pregnancy Category:D
Breastfeeding: Unknown whether decitabine or its metabolites are excreted in human milk. Potential for serious adverse reactions in nursing infants exists. Manufacturer advises to make a decision for discontinuing nursing or discontinue the drug, taking into account the importance of the drug to the mother.
