Zuellig Pharma


Concise Prescribing Info
Daunorubicin HCl
Monotherapy or in combination w/ other antiblastic 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.
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; tumour lysis syndrome; alopecia. Inj site effects; extravasation. Evaluate bilirubin, renal function, blood uric acid levels, K, Ca phosphate & creatinine prior to & during therapy. Assess hematologic profiles, cardiac function prior to & during therapy. Prior or concomitant radiotherapy 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. Avoid use w/ live vaccines. Renal impairment. Not to be used in severe hepatic impairment. May cause infertility in men. 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 & aspartate aminotransferase. Abdominal pain; infusion site phlebitis; abnormal ECG.
Drug Interactions
Additive toxicity w/ other cytotoxic drugs. Other potentially cardiotoxic drugs, other cardioactive compd (eg, Ca-channel blockers). Precipitation w/ heparin & Al.
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 (vial) 20 mg
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