DECITABINE INJECTION IS INDICATED FOR TREATMENT OF PATIENTS WITH 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.
THERE ARE TWO REGIMENS FOR DECITABINE INJECTION & 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.
REGIMEN 1:
DECITABINE IS ADMINISTERED AT A DOSE OF 15 MG/MΒ² BY CONTINUOUS INTRAVENOUS INFUSION OVER 3 HOURS REPEATED EVERY 8 HOURS FOR 3 DAYS. THIS CYCLE SHOULD BE REPEATED EVERY 6 WEEKS. PATIENTS MAY BE PREMEDICATED WITH STANDARD ANTI-EMETIC THERAPY.
REGIMEN 2:
DECITABINE IS ADMINISTERED AT A DOSE OF 20 MG/MΒ² 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 ANTI-EMETIC THERAPY.
IF MYELOSUPPRESSION IS PRESENT, SUBSEQUENT TREATMENT CYCLES OF DECITABINE SHOULD BE DELAYED UNTIL THERE IS HEMATOLOGIC RECOVERY (ANC = 1,000/?L PLATELETS = 50,000/?L ).