Adult: For remission induction: 45 mg/m2 on alternate days for a course of up to 3 inj. Alternatively, 45 mg/m2 on Days 1, 2 and 3. Administer doses over 5-10 minutes through a rapidly flowing IV infusion of NaCl 0.9% solution or dextrose 5% inj. Max cumulative dose: 550 mg/m2 in patients without risk factors for cardiotoxicity and 400 mg/m2 in patients who have received chest radiotherapy. Treatment recommendations may vary among countries (refer to local treatment guidelines). Elderly: Dose reduction may be required. Child: For remission induction: 25 mg/m2 on Day 1 every week for 4 weeks in combination with other regimens. Max cumulative dose: <2 years 10 mg/kg; >2 years 300 mg/m2. Treatment recommendations may vary among countries (refer to local treatment guidelines).
Intravenous Acute myeloid leukaemia
Adult: For induction of remission: 45 mg/m2 on alternate days for a course of up to 3 inj. Alternatively, 45 mg/m2 on Days 1, 2 and 3 of the 1st course, then on Days 1 and 2 of subsequent courses. Administer doses through a rapidly flowing IV infusion of NaCl 0.9% solution or dextrose 5% inj. Max cumulative dose: 550 mg/m2 in patients without risk factors for cardiotoxicity and 400 mg/m2 in patients who have received chest radiotherapy. Treatment recommendations may vary among countries (refer to local treatment guidelines). Elderly: Dose reduction may be required.
What are the brands available for Daunorubicin in Hong Kong?
Daunoblastina
Renal Impairment
Patient on haemodialysis: Administer 50% of the usual dose.
CrCl (mL/min)
Dosage
<30
Administer 50% of the usual dose.
30-50
Administer 75% of the usual dose.
Hepatic Impairment
Serum bilirubin 1.2-3 mg/dL: Administer 75% of the usual dose. Serum bilirubin >3 mg/dL: Administer 50% of the usual dose.
Reconstitution
Reconstitute vial with 4 mL of sterile water for inj to make a concentration of 5 mg/mL. Further dilute the reconstituted solution to make a final concentration of 1 mg/mL.
Incompatibility
Incompatible with heparin inj, dexamethasone, aztreonam, allopurinol, piperacillin/tazobactam, fludarabine.
Contraindications
Persistent myelosuppression, severe infection, severe arrhythmia, myocardial insufficiency, recent MI. Recent exposure or with existing chickenpox or herpes zoster. Concomitant use with live or live-attenuated vaccines. Severe renal and hepatic impairment. Lactation.
Special Precautions
Patient with pre-existing drug-induced bone marrow suppression, history of CV disease; previous or concurrent radiotherapy to mediastinal or pericardial area. Avoid extravasation. Mild to moderate renal and hepatic impairment. Children and elderly. Pregnancy.
Adverse Reactions
Significant: Severe bone marrow suppression (e.g. leucopenia, neutropenia, thrombocytopenia), anaemia, secondary leukaemia; supraventricular arrhythmias (e.g. sinus tachycardia, premature ventricular contractions, AV block), non-specific ECG abnormalities (e.g. ST-T wave changes, low voltage QRS complex, T waves), angina pectoris, MI, endomyocardial fibrosis, pericarditis/myocarditis, congestive cardiomyopathy; hyperuricaemia, tumour lysis syndrome, uric acid nephropathy. Gastrointestinal disorders: Nausea, vomiting, mucositis, stomatitis, colitis, enterocolitis, neutropenic enterocolitis (typhlitis), abdominal pain, diarrhoea. General disorders and administration site conditions: Pain, pyrexia, infusion site phlebitis. Investigations: Increased blood bilirubin, AST or alkaline phosphatase. Renal and urinary disorders: Red urine discolouration. Skin and subcutaneous tissue disorders: Alopecia, rash, erythema. Vascular disorders: Haemorrhage. Potentially Fatal: CHF, sepsis/septicaemia, infection.
This drug may cause confusion, and visual disturbances, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor CBC with differential, LFTs (ALT, AST, total bilirubin), serum creatinine; cardiac function (LVEF using ECG or multi-gated radionuclide angiography [MUGA]) before and periodically during and after treatment, serum uric acid; cumulative anthracycline or daunorubicin dose. Monitor for signs of extravasation or infusion-related reactions, tumour lysis syndrome, and secondary malignancies.
Increased risk of cardiotoxicity with other cardiotoxic drugs (e.g. cyclophosphamide) or radiation therapy of the mediastinum. Increased risk of significant haematopoiesis disorder with drugs affecting the bone marrow function (e.g. amidopyrine derivatives, antiretrovirals, cytostatics, sulfonamides, chloramphenicol, diphenylhydantoin). Increased risk of hepatotoxicity with hepatotoxic drugs (e.g. methotrexate). Increased risk of potentiated hyperuricaemia with drugs that delays uric acid secretion (e.g. sulfonamides, certain diuretics). Potentially Fatal: Serious vaccine-associated infections with live and live-attenuated vaccines.
Action
Description: Mechanism of Action: Daunorubicin is an antineoplastic anthracycline antibiotic. Its exact mechanism of action is unclear, but it is believed to inhibit DNA and RNA synthesis by intercalation between DNA base pairs and by template disordering and steric obstruction. Additionally, it may inhibit polymerase activity, affect gene expression regulation, and produce free radical damage to DNA. Synonym(s): Daunomycin. Pharmacokinetics: Distribution: Widely distributed into tissues (particularly the lung, liver, kidneys, spleen and heart). Crosses the placenta. Metabolism: Mainly metabolised in the liver into daunorubicinol (active) and into inactive aglycones, conjugated sulfates and glucuronides. Excretion: Via faeces (40%); urine (approx 25% as unchanged drug and metabolites). Elimination half-life: 45 minutes (initial); 18.5 hours (terminal).
Chemical Structure
Daunorubicin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 30323, Daunorubicin. https://pubchem.ncbi.nlm.nih.gov/compound/Daunorubicin. Accessed Apr. 26, 2024.
Storage
Powder for inj: Store below 25°C. Protect from light. Reconstituted solution: Store between 2-8°C. Protect from light. Solution for inj: Store between 2-8°C. Protect from light. Do not freeze. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01DB02 - daunorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
References
Buckingham R (ed). Daunorubicin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/04/2024.Daunorubicin (Conventional). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/04/2024.Daunorubicin 20 mg Powder for I.V. Injection (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2024.Daunorubicin Hydrochloride Injection (Hikma Pharmaceuticals USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2024.Joint Formulary Committee. Daunorubicin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/04/2024.Pfizer New Zealand Limited. Daunorubicin Solution for Injection data sheet 03 November 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2024.Zavedos CS Injection Vials (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2024.
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