1. Clinical & Scientific Overview
Daunorubicin Hydrochloride (TIP-MED-000558, Reference Code [ONC-09]) is classified under
Oncology & Antineoplastic Medicines as a Anthracycline Cytotoxic Antibiotic • Anthracycline Antileukaemic Antibiotic.
Within the Indian regulatory and compendial framework, it is governed under Schedule H (Prescription Only — Specialist Oncology Supervision).
Daunocin (Neon Laboratories), Cerubidine Reference, Daunotec (Cipla Ltd)
Lyophilised Powder / Solution for IV Injection: 20 mg vial
Oncology Specialisation & Cytotoxic Safety Protocol
Anthracycline Cytotoxic Antibiotic
Antineoplastic Cytotoxic (Vesicant)
Standard Regimen & Cycle Context: AML Induction (7+3): 60–90 mg/m2 IV on Days 1, 2, and 3; maximum lifetime cumulative dose: 550 mg/m2 in adults (450 mg/m2 if prior chest radiation).
Signature Dose-Limiting Toxicities & Organ Monitoring: Acute arrhythmias and chronic cumulative cardiomyopathy (LVEF decline), severe vesicant extravasation ulceration, profound bone marrow aplasia (expected therapeutic goal in leukaemia induction), and red discolouration of urine, tears, and sweat.
Extravasation, Premedication & Safe Cytotoxic Handling: NEVER administer intrathecally (fatal ascending myeloencephalopathy); confirm baseline LVEF >=50% and reduce dose by 25–50% if serum bilirubin >1.2–3.0 mg/dL.
3. Mechanism of Action & Pharmacodynamics
Intercalates between DNA base pairs, inhibits Topoisomerase II alpha, and generates semiquinone free radicals that trigger apoptosis in rapidly dividing myeloid and lymphoid blasts.
4. Therapeutic Indications & Evidence-Supported Uses
- Acute Myeloid Leukaemia (AML — 7+3 induction with Cytarabine)
- Acute Lymphoblastic Leukaemia (ALL)
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Educational Oncology Regimen Context (Specialist Reference Only): AML Induction (7+3): 60–90 mg/m2 IV on Days 1, 2, and 3; maximum lifetime cumulative dose: 550 mg/m2 in adults (450 mg/m2 if prior chest radiation).
Administration & Meal Timing: AML Induction (7+3): 60–90 mg/m2 IV on Days 1, 2, and 3; maximum lifetime cumulative dose: 550 mg/m2 in adults (450 mg/m2 if prior chest radiation).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Specialist oncology pharmacokinetic profile; dosing depends on Body Surface Area (BSA in m2), Calvert GFR formula, or flat targeted dosing with strict organ-function adjustments.
Hepatic enzymatic activation/inactivation or proteolytic degradation (for monoclonal antibodies); see specific polymorphism and interaction notes.
Verify serum creatinine and eGFR before every cycle; see drug-specific renal dosing and uroprotection rules.
Check total bilirubin, AST, and ALT prior to each cycle; taxanes, anthracyclines, and TKIs require strict hepatic dose modification.
7. Contraindications, Precautions & High-Risk Warnings
- Severe hypersensitivity to Daunorubicin or formulation vehicle
- Pregnancy and lactation (potent teratogen/embryotoxic class warning unless explicitly evaluated by oncology specialist)
- Severe unrecovered bone marrow aplasia or decompensated organ failure per protocol thresholds
Key Clinical Precautions: Acute arrhythmias and chronic cumulative cardiomyopathy (LVEF decline), severe vesicant extravasation ulceration, profound bone marrow aplasia (expected therapeutic goal in leukaemia induction), and red discolouration of urine, tears, and sweat.
8. Adverse Effects Profile
- Acute arrhythmias and chronic cumulative cardiomyopathy (LVEF decline), severe vesicant extravasation ulceration, profound bone marrow aplasia (expected therapeutic goal in leukaemia induction), and red discolouration of urine, tears, and sweat.
- Acute arrhythmias and chronic cumulative cardiomyopathy (LVEF decline), severe vesicant extravasation ulceration, profound bone marrow aplasia (expected therapeutic goal in leukaemia induction), and red discolouration of urine, tears, and sweat.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Acute arrhythmias and chronic cumulative cardiomyopathy (LVEF decline), severe vesicant extravasation ulceration, profound bone marrow aplasia (expected therapeutic goal in leukaemia induction), and red discolouration of urine, tears, and sweat.
- Avoid live-attenuated vaccines during immunosuppressive chemotherapy; verify CYP3A4, UGT1A1, DPD, and QTc interactions before each cycle.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: NEVER administer intrathecally (fatal ascending myeloencephalopathy); confirm baseline LVEF >=50% and reduce dose by 25–50% if serum bilirubin >1.2–3.0 mg/dL.
Pharmacist Patient Counselling Points:
- NEVER administer intrathecally (fatal ascending myeloencephalopathy); confirm baseline LVEF >=50% and reduce dose by 25–50% if serum bilirubin >1.2–3.0 mg/dL.
- Report fever >=38.0°C (100.4°F) immediately (medical emergency: possible febrile neutropenia).
- Follow strict reproductive contraception and safe cytotoxic oral handling instructions.
Storage, Stability & Dispensing Safeguards: NEVER administer intrathecally (fatal ascending myeloencephalopathy); confirm baseline LVEF >=50% and reduce dose by 25–50% if serum bilirubin >1.2–3.0 mg/dL.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: National Cancer Grid (NCG) India Consensus Guidelines; NLEM 2022 Antineoplastic Section; Indian Pharmacopoeia (IP) & CDSCO Approved Oncology Prescribing Information.
Official Verification Portals: National Cancer Grid (NCG) India — Evidence-Based Oncology Guidelines • CDSCO — Central Drugs Standard Control Organization Approved Drug Data • Indian Pharmacopoeia Commission (IPC)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
13. Related Reference Monographs, Educational Guides & Visual Concept
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