Monotherapy or in combination w/ other antiblastic drugs for acute myeloblastic leukemia. Promyelocytic & acute lymphoblastic leukemia, neuroblastoma & rhabdomyosarcoma.
0.5-3 mg/kg single dose. Repeat doses 0.5-1 mg/kg at ≥1-day intervals, doses 2 mg/kg at ≥4-day intervals & doses 2.5-3 mg/kg at 7-14 day intervals. Adult & childn Max dose: Not to exceed 20 mg/kg. Max cumulative dose: Childn >2 yr 300 mg/m2, <2 yr, <0.5 m2 10 mg/kg.
Hypersensitivity to daunorubicin, other anthracyclines or anthracenediones. Persistent myelosuppression; severe infections & arrhythmias; myocardial insufficiency, recent MI. Previous treatments w/ max cumulative doses of daunorubicin, other anthracyclines &/or anthracenediones. Severe hepatic [Child-Pugh grade C (total score 10-15)] or renal (GFR <10 mL/min or serum creatinine >7.9 mg/dL) impairment.
Not to be given IM or intrathecal. Severe & febrile neutropenia; secondary leukemia; early & delayed cardiotoxicity; active or dormant CV disease; nausea & vomiting, mucositis/stomatitis; tumour lysis syndrome; alopecia. Inj site effects; extravasation. Assess hematologic profiles, cardiac function prior to & during therapy. Evaluate bilirubin, renal function, blood uric acid levels, K, Ca phosphate & creatinine prior to & during therapy. Not to be mixed w/ heparin. Avoid use w/ live vaccines. Prior or concomitant RT to mediastinal/pericardial area, previous therapy w/ other anthracyclines or anthracenediones, concomitant use of drugs w/ ability to suppress cardiac contractility or cardiotoxic drugs eg, trastuzumab. Not to be used in severe hepatic impairment. Renal impairment. Mild to moderate hepatic impairment. May affect male fertility. Women of childbearing potential. Not to be used during pregnancy & lactation.
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