Zuellig Pharma
Concise Prescribing Info
Daunorubicin HCl
Monotherapy or in combination w/ other antiblastic drugs for acute myeloblastic leukemia. Promyelocytic & acute lymphoblastic leukemia, neuroblastoma & rhabdomyosarcoma.
Dosage/Direction for Use
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.
Special Precautions
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.
Adverse Reactions
Sepsis/septicemia, infection; bone marrow failure, leukopenia, granulocytopenia, neutropenia, thrombocytopenia, anemia; cardiomyopathy; hemorrhage; nausea, vomiting, diarrhoea, oesophagitis, mucositis/stomatitis; alopecia, erythema, rash; pyrexia, pain; increased blood bilirubin, alkaline phosphatase & AST. Abdominal pain; infusion site phlebitis; abnormal ECG.
Drug Interactions
Additive toxicity w/ other cytotoxic drugs. Monitor cardiac function w/ other potentially cardiotoxic drugs, other cardioactive compd eg, Ca-channel blockers. Precipitation w/ heparin & Al.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB02 - daunorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Daunoblastina powd for inj 20 mg
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