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Daunoblastina

Daunoblastina

daunorubicin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Daunorubicin HCl
Indications/Uses
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, BSA <0.5 m2 10 mg/kg.
Contraindications
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; tumor lysis syndrome; alopecia. Inj site effects; extravasation. Assess hematologic profiles, cardiac function prior to & during therapy. Evaluate serum total bilirubin, renal function, blood uric acid levels, K, Ca phosphate & creatinine prior to & during therapy. Not to be mixed w/ heparin. Not to be used in combination w/ other cardiotoxic agents. 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 & mild to moderate hepatic impairment. May affect fertility. Women of childbearing potential & male partners should use effective contraception during & for a period after treatment. Not to be used during pregnancy; lactation & for at least 6 days after last dose.
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. Incompatibility w/ dexamethasone Na phosphate, aztreonam, allopurinol Na, fludarabine, piperacillin/tazobactam, aminophylline.
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.
Presentation/Packing
Form
Daunoblastina powd for inj 20 mg
Packing/Price
1's
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