Decita

Myelodysplastic syndromes (MDS) including previously treated & untreated, de novo & secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia w/ ringed sideroblasts, refractory anemia w/ excess blasts, refractory anemia w/ excess blasts in transformation, & chronic myelomonocytic leukemia) & intermediate-1, intermediate-2, & high-risk International Prognostic Scoring System groups.

Treat patient for min of 4 cycles; complete or partial response may take longer than 4 cycles. Patient may be premedicated w/ standard anti-emetic therapy. Treatment regimen option 1: 15 mg/m² by continuous IV infusion over 3 hr repeated every 8 hr for 3 days. Repeat cycle every 6 wk. If hematologic recovery (ANC ≥1,000/microliter & platelets ≥50,000/microliter) from previous treatment cycle requires >6 wk, delay next cycle & reduce dose as follows: Recovery requiring >6 wk, but <8 wk: Delay dose for up to 2 wk & reduce dose to 11 mg/m² every 8 hr (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy. Recovery requiring >8 wk, but <10 wk: In absence of disease progression, delay dose for up to 2 more wk & reduce dose to 11 mg/m² every 8 hr (33 mg/m²/day, 99 mg/m²/cycle) upon restarting therapy, then maintain or increase in subsequent cycles as clinically indicated. Treatment regimen option 2: 20 mg/m² by continuous IV infusion over 1 hr repeated daily for 5 days. Repeat cycle every 4 wk. If myelosuppression is present, delay subsequent cycles until there is hematologic recovery (ANC ≥1,000/microliter & platelets ≥50,000/microliter).

May exacerbate myelosuppression & complications of myelosuppression, including infections & bleeding that occur in patients w/ MDS. Cases of ILD (including pulmonary infiltrates, organising pneumonia & pulmonary fibrosis) w/o signs of infectious aetiology. Safety & efficacy have not been established in patients w/ history of severe CHF or clinically unstable cardiac disease. Patients on controlled Na diet. Perform complete blood & platelet counts regularly, as clinically indicated & prior to each cycle. Closely monitor patients w/ hepatic & severe renal (CrCl 30 mL/min) impairment. Use w/ hormonal contraceptives has not been studied. Women of childbearing potential must use effective contraception & avoid becoming pregnant during treatment. Men should use effective contraception & be advised to not father a child during treatment & for 3 mth following completion of treatment. Possibility of infertility. Not to be used during pregnancy. Discontinue breast-feeding during treatment.

Neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, & hyperglycemia.

Cytotoxic Chemotherapy

L01BC08 - decitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

Rx