Daunorubicin Hikma
Anthracycline chemotherapy for acute leukaemia — solution for infusion 5 mg/ml
Quick Facts About Daunorubicin Hikma
Key Takeaways About Daunorubicin Hikma
- Hospital-only chemotherapy: Daunorubicin is always given as an intravenous infusion under the supervision of experienced oncology specialists in a hospital setting
- Cardiotoxicity is the major risk: Cumulative doses must be tracked carefully; the maximum recommended lifetime dose is 550 mg/m² (reduced to 400–450 mg/m² with prior chest radiation)
- Severe bone marrow suppression: Regular blood count monitoring is essential as daunorubicin significantly reduces white blood cells, red blood cells, and platelets
- Vesicant drug: Extravasation (leakage from the vein) can cause severe tissue damage; administration requires careful IV access
- Part of combination regimens: Daunorubicin is almost always used alongside other chemotherapy drugs such as cytarabine for AML or vincristine and prednisone for ALL
What Is Daunorubicin Hikma and What Is It Used For?
Daunorubicin Hikma is an anthracycline antibiotic chemotherapy drug used to induce remission in acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). It works by intercalating into DNA, inhibiting topoisomerase II, and generating free radicals that destroy cancer cells.
Daunorubicin belongs to the anthracycline class of cytotoxic antibiotics, a group of drugs originally derived from the bacterium Streptomyces peucetius. It was one of the first anthracyclines to be developed and has been a cornerstone of acute leukaemia treatment since the 1960s. The drug is included on the World Health Organization (WHO) Model List of Essential Medicines, reflecting its fundamental importance in cancer treatment worldwide.
The primary mechanism of action involves intercalation between DNA base pairs, which physically disrupts the structure of the DNA double helix. Additionally, daunorubicin inhibits the enzyme topoisomerase II, which is critical for DNA replication and repair. This dual action prevents cancer cells from dividing and ultimately leads to programmed cell death (apoptosis). The drug also generates oxygen free radicals that cause further damage to DNA, RNA, and cell membranes.
Daunorubicin Hikma is specifically formulated as a solution for infusion at a concentration of 5 mg/ml, designed for intravenous administration in hospital settings. Unlike some other anthracyclines, daunorubicin is not used for solid tumours; its primary indications are restricted to acute leukaemias. The drug is manufactured by Hikma Pharmaceuticals and is available in many countries as a generic form of daunorubicin.
Acute myeloid leukaemia (AML)
In AML, daunorubicin is a key component of the standard induction chemotherapy regimen known as "3+7" or "7+3". This involves three days of daunorubicin combined with seven days of continuous cytarabine infusion. This regimen achieves complete remission rates of approximately 60–80% in younger adults, according to large-scale randomised controlled trials published in the New England Journal of Medicine and Blood. The European LeukemiaNet (ELN) and National Comprehensive Cancer Network (NCCN) guidelines both recommend daunorubicin-based induction as standard of care for fit patients with newly diagnosed AML.
Acute lymphoblastic leukaemia (ALL)
For ALL, daunorubicin is used as part of multi-agent induction regimens that typically also include vincristine, corticosteroids (prednisone or dexamethasone), and asparaginase. In adult ALL, daunorubicin-containing regimens achieve complete remission rates of approximately 80–90%. The drug is used in both paediatric and adult ALL treatment protocols, although dosing and scheduling differ between age groups.
Daunorubicin is listed on the WHO Model List of Essential Medicines (2023) under Section 8.2 – Cytotoxic and Adjuvant Medicines. This designation recognises it as one of the most important medications needed in a basic health system, reflecting decades of clinical evidence supporting its efficacy in acute leukaemia treatment.
What Should You Know Before Receiving Daunorubicin Hikma?
Before receiving daunorubicin, your oncologist must evaluate your cardiac function, blood counts, liver and kidney function. The drug is contraindicated in patients with severe cardiac disease, active infection, or severe bone marrow failure not caused by leukaemia.
Daunorubicin is a powerful chemotherapy drug with significant potential for serious and sometimes life-threatening side effects. Before starting treatment, your medical team will conduct a thorough assessment to determine whether the drug is appropriate for you and to establish baseline measurements for monitoring throughout your treatment course. Open and honest communication with your healthcare team about your complete medical history is essential for safe treatment.
Contraindications
Daunorubicin should not be given if you have:
- Hypersensitivity to daunorubicin, other anthracyclines, or any of the excipients
- Severe cardiac disease including heart failure, recent myocardial infarction, severe arrhythmias, or significantly reduced left ventricular ejection fraction (LVEF)
- Previous treatment with maximum cumulative doses of daunorubicin or other anthracyclines/anthracenediones
- Severe bone marrow suppression not caused by the leukaemia being treated
- Active systemic infection that is not adequately controlled
- Severe hepatic impairment (bilirubin greater than 5 mg/dL)
- Severe renal impairment
Warnings and Precautions
Several important warnings apply to daunorubicin treatment. Your healthcare team will carefully consider these factors before and during therapy:
Cardiotoxicity: This is the most significant long-term risk associated with daunorubicin. Cardiac damage can manifest as acute effects (arrhythmias, ECG changes) during or shortly after infusion, or as delayed cardiomyopathy and congestive heart failure that may develop weeks, months, or even years after completing treatment. The risk of cardiotoxicity increases significantly with cumulative doses exceeding 550 mg/m² (or 400–450 mg/m² in patients who have received prior mediastinal/cardiac radiation or concurrent cardiotoxic agents). Cardiac function must be assessed by echocardiography or MUGA (multigated acquisition) scan before and regularly during treatment.
Myelosuppression: Daunorubicin causes severe bone marrow suppression, with the nadir (lowest point) of white blood cell counts typically occurring 10–14 days after administration. This places patients at significant risk of serious infections, bleeding, and anaemia. Complete blood counts must be performed frequently, and treatment may need to be delayed if blood counts have not adequately recovered.
Extravasation: Daunorubicin is classified as a vesicant, meaning that leakage from the vein during administration can cause severe local tissue damage, including necrosis (tissue death). If extravasation is suspected during infusion, the administration must be stopped immediately and appropriate measures taken, which may include local application of dimethyl sulfoxide (DMSO) or administration of dexrazoxane.
The risk of irreversible heart damage increases with the cumulative dose. The maximum recommended lifetime dose is 550 mg/m². If you have previously received other anthracyclines (such as doxorubicin or epirubicin), mediastinal radiation, or concurrent cardiotoxic drugs, the maximum cumulative dose is reduced to 400–450 mg/m². Cardiac monitoring with echocardiography or MUGA scan is mandatory before and during treatment.
Pregnancy and Breastfeeding
Daunorubicin is classified as Category D in pregnancy – there is positive evidence of human foetal risk based on adverse reaction data. The drug can cause foetal harm when administered to a pregnant woman. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Men should also use effective contraception during treatment and for at least 3 months following the last dose, as daunorubicin may damage sperm.
Breastfeeding is contraindicated during daunorubicin treatment and for at least 14 days after the final dose, as the drug and its metabolites may be excreted in breast milk and could cause serious adverse effects in the nursing infant.
Patients who wish to have children in the future should discuss fertility preservation options (such as sperm banking or oocyte cryopreservation) with their healthcare team before starting treatment, as daunorubicin can cause permanent infertility in both men and women.
How Does Daunorubicin Hikma Interact with Other Drugs?
Daunorubicin interacts with several drug classes including other cardiotoxic agents, hepatotoxic drugs, and live vaccines. The most clinically significant interactions involve drugs that increase the risk of heart damage or suppress the immune system further.
Drug interactions with daunorubicin are of particular clinical importance because many patients receiving this chemotherapy will also be receiving other medications as part of multi-agent treatment protocols or for supportive care. Your oncologist and clinical pharmacist will review all your current medications, including over-the-counter medicines and supplements, to identify and manage potential interactions.
Daunorubicin is metabolised primarily in the liver by cytochrome P450 enzymes and aldo-keto reductases to its principal active metabolite, daunorubicinol. Drugs that interfere with hepatic metabolism can significantly alter daunorubicin levels and toxicity. The drug is also a substrate for P-glycoprotein (P-gp), so P-gp inhibitors and inducers may affect its distribution and elimination.
| Interacting Drug | Type | Effect | Clinical Management |
|---|---|---|---|
| Trastuzumab (Herceptin) | Major | Greatly increased risk of cardiotoxicity and heart failure | Avoid concurrent use; wait at least 7 months after stopping trastuzumab |
| Cyclophosphamide | Major | Increased cardiotoxicity risk; enhanced myelosuppression | Monitor cardiac function closely; reduce cumulative dose limits |
| Live vaccines | Major | Risk of disseminated vaccine infection due to immunosuppression | Contraindicated; avoid live vaccines during and after treatment |
| Cytarabine | Moderate | Additive myelosuppression (used therapeutically in combination) | Monitor blood counts; dose adjustments per protocol |
| Hepatotoxic drugs | Moderate | Impaired daunorubicin metabolism leading to increased toxicity | Monitor liver function; consider dose reduction |
| Ciclosporin | Moderate | May increase daunorubicin exposure via P-gp inhibition | Monitor for increased toxicity |
| Dexrazoxane | Beneficial | Cardioprotective effect; reduces anthracycline-related cardiac damage | May be used when cumulative doses approach limits |
Major Interactions
The most dangerous interactions involve other cardiotoxic drugs. When daunorubicin is combined with agents such as trastuzumab, cyclophosphamide, or other anthracyclines, the risk of irreversible cardiac damage is substantially increased. These combinations require particularly careful cardiac monitoring and may necessitate dose adjustments or alternative treatment strategies. Live vaccines are absolutely contraindicated in patients receiving daunorubicin, as the severe immunosuppression caused by the drug can lead to disseminated vaccine infection.
Minor Interactions
Drugs that inhibit P-glycoprotein (such as verapamil and ciclosporin) may increase daunorubicin levels in certain tissues, potentially increasing both efficacy and toxicity. Concurrent use of nephrotoxic agents may impair daunorubicin elimination, as approximately 25% of the drug is excreted renally. Herbal supplements, particularly St John's wort, should be avoided as it is a potent CYP enzyme inducer that may reduce daunorubicin efficacy.
What Is the Correct Dosage of Daunorubicin Hikma?
Daunorubicin dosage is calculated based on body surface area (BSA) and varies according to the specific treatment protocol, disease type, and patient factors. Typical adult doses range from 30–60 mg/m²/day given intravenously for 1–3 days per treatment cycle.
Daunorubicin dosing is highly individualised and determined by the treating oncologist based on the specific chemotherapy protocol being used, the type and stage of leukaemia, the patient's body surface area, age, organ function, and overall performance status. The drug is never self-administered; all doses are prepared by specialised pharmacy staff and given by trained healthcare professionals in a hospital setting.
| Indication | Patient Group | Typical Dose | Schedule |
|---|---|---|---|
| AML Induction | Adults (<60 years) | 60 mg/m²/day IV | Days 1–3 of 7+3 regimen with cytarabine |
| AML Induction | Adults (≥60 years) | 30–45 mg/m²/day IV | Days 1–3; reduced due to increased toxicity risk |
| ALL Induction | Adults | 45 mg/m²/day IV | Days 1–3 of induction; with vincristine + prednisone |
| ALL Induction | Children | 25–45 mg/m² IV | Per protocol (varies by risk group) |
Adults
For adult patients with AML under 60 years of age, the standard induction regimen (known as "7+3") uses daunorubicin at 60 mg/m²/day administered intravenously on days 1, 2, and 3, combined with continuous cytarabine infusion at 100–200 mg/m²/day on days 1 through 7. This dosing is supported by the landmark randomised trial published in the New England Journal of Medicine (Fernandez et al., 2009) which demonstrated superior outcomes with 90 mg/m² compared to 45 mg/m² in younger patients, though 60 mg/m² is more commonly used in current practice.
For adult ALL, daunorubicin is typically given at 45 mg/m²/day IV on days 1–3 of the induction phase, as part of a multi-agent regimen including vincristine, prednisone or dexamethasone, and asparaginase.
Children
Paediatric dosing follows specific treatment protocols established by cooperative groups such as the Children's Oncology Group (COG) or the International BFM Study Group. Doses typically range from 25 to 45 mg/m², and children generally tolerate anthracyclines somewhat better than adults in the short term. However, children are at higher risk for late cardiotoxicity because their hearts are still developing. Careful cardiac monitoring and cumulative dose tracking are essential in the paediatric population. The maximum recommended cumulative dose is generally the same as for adults (550 mg/m²).
Elderly
Patients aged 60 years and older are at increased risk of daunorubicin toxicity, particularly cardiotoxicity and prolonged myelosuppression. Reduced doses of 30–45 mg/m²/day are typically used for elderly patients. Age-related declines in cardiac, hepatic, and renal function must be taken into account. Some treatment protocols use alternative anthracyclines (such as idarubicin) or different dosing schedules for older patients. Geriatric assessment tools may be used to help determine the most appropriate treatment intensity.
Dose Adjustments
Dose reductions are required in patients with impaired liver function, as daunorubicin is primarily metabolised hepatically. Standard recommendations include: reduce dose by 25% if bilirubin is 1.2–3.0 mg/dL; reduce by 50% if bilirubin is 3.1–5.0 mg/dL; and withhold the drug if bilirubin exceeds 5.0 mg/dL. Renal impairment may also require dose adjustment, with a 50% dose reduction recommended if serum creatinine exceeds 3.0 mg/dL.
Missed Dose
As daunorubicin is administered by healthcare professionals in a hospital setting, missed doses are managed by the treating oncologist. If a dose is missed or delayed due to insufficient blood count recovery or other medical reasons, the treatment schedule will be adjusted according to clinical judgement. Patients should never attempt to make up for missed doses on their own.
Overdose
Overdose of daunorubicin is extremely serious and can be life-threatening. Acute overdose enhances the toxic effects on the bone marrow and gastrointestinal tract, and may cause acute cardiac failure. There is no specific antidote for daunorubicin overdose. Treatment is supportive and may include blood transfusions, antibiotics for infection, and intensive care monitoring. The patient should remain hospitalised for close observation of cardiac function. Dexrazoxane may potentially provide some cardioprotection in the overdose setting.
What Are the Side Effects of Daunorubicin Hikma?
Daunorubicin causes significant side effects including severe bone marrow suppression, nausea, vomiting, hair loss, mouth sores, and red urine discolouration. The most serious long-term risk is cardiotoxicity, which can lead to heart failure. Most acute side effects are manageable with supportive care.
As with all cytotoxic chemotherapy drugs, daunorubicin causes a wide range of side effects. The severity and pattern of side effects depend on the dose, schedule, and the patient's individual factors. Your healthcare team will provide detailed information about what to expect and how to manage side effects. It is essential to report any new or worsening symptoms to your medical team promptly, as some side effects require immediate medical intervention.
The following frequency categories are based on data from clinical trials and post-marketing surveillance, following the European Medicines Agency (EMA) standard classification:
Very Common (affects more than 1 in 10 patients)
- Myelosuppression – severe decrease in white blood cells (neutropenia), red blood cells (anaemia), and platelets (thrombocytopenia)
- Nausea and vomiting – usually begins within hours of infusion
- Alopecia (hair loss) – usually complete; hair typically regrows after treatment ends
- Mucositis/stomatitis – painful inflammation of the mouth and throat lining
- Red discolouration of urine – harmless, due to the drug's red colour; may last 1–2 days after each dose
- Diarrhoea – can range from mild to severe
- Fatigue – often profound and may persist throughout the treatment course
Common (affects 1 in 10 to 1 in 100 patients)
- Cardiotoxicity – ECG changes, arrhythmias, reduced left ventricular function
- Abdominal pain
- Fever (pyrexia) – may indicate infection in the context of neutropenia
- Infection – due to immunosuppression; can be severe or life-threatening
- Skin rash – may appear as generalised erythema or urticaria
- Hyperuricaemia – elevated uric acid from tumour lysis
- Transient liver enzyme elevation
Uncommon (affects 1 in 100 to 1 in 1,000 patients)
- Congestive heart failure – may be delayed weeks to months after treatment
- Extravasation injury – severe tissue damage if drug leaks from vein
- Anaphylaxis – severe allergic reaction (rare but potentially life-threatening)
- Secondary leukaemia – treatment-related AML or myelodysplastic syndrome years after therapy
- Nail hyperpigmentation – darkening of the nails
Rare (affects fewer than 1 in 1,000 patients)
- Severe cardiomyopathy – irreversible heart muscle damage, particularly at high cumulative doses
- Tumour lysis syndrome – metabolic emergency from rapid cancer cell breakdown
- Radiation recall – inflammatory reaction in previously irradiated areas
- Permanent infertility – especially with high cumulative doses
Seek immediate medical attention if you experience: fever above 38°C (100.4°F) especially if your blood counts are low, signs of bleeding (unusual bruising, blood in urine or stool), chest pain or shortness of breath, rapid or irregular heartbeat, signs of severe infection (chills, rigors, confusion), or severe mouth sores preventing eating or drinking. Do not wait for your next scheduled appointment – contact your oncology team or go to the emergency department.
How Should You Store Daunorubicin Hikma?
Daunorubicin Hikma solution for infusion should be stored at 2–8°C (36–46°F) protected from light. Once opened or diluted, it should be used within the timeframe specified by the manufacturer, typically within 24 hours when stored at 2–8°C.
As a hospital-administered chemotherapy drug, storage of daunorubicin is handled by the hospital pharmacy and is not typically a concern for patients. However, understanding proper storage conditions is important for healthcare professionals and for general knowledge.
The unopened vials of Daunorubicin Hikma 5 mg/ml solution for infusion should be stored in a refrigerator at 2–8°C and protected from light. The vials should be kept in the outer carton to protect from light exposure, as daunorubicin is photosensitive and degrades when exposed to prolonged light. Do not freeze the product.
After opening or dilution, the solution should be used promptly. If not used immediately, in-use storage times and conditions are the responsibility of the user and are normally not longer than 24 hours at 2–8°C, unless dilution has taken place in controlled and validated aseptic conditions. The diluted solution should be protected from light during storage and administration.
Daunorubicin is classified as a cytotoxic substance and must be handled according to local guidelines for hazardous pharmaceutical agents. Unused product or waste material should be disposed of in accordance with local regulations for cytotoxic drug disposal. Accidental exposure should be managed according to institutional protocols, which typically involve immediate thorough washing of the affected area.
What Does Daunorubicin Hikma Contain?
Each millilitre of Daunorubicin Hikma contains 5 mg of daunorubicin (as daunorubicin hydrochloride). Excipients include mannitol, hydrochloric acid for pH adjustment, and water for injections.
Daunorubicin Hikma is supplied as a clear, red solution ready for dilution and intravenous administration. The active substance is daunorubicin hydrochloride, which is the water-soluble salt form of the anthracycline antibiotic daunorubicin. The molecular formula is C27H29NO10·HCl, with a molecular weight of approximately 563.98 g/mol.
The inactive ingredients (excipients) serve important functions in maintaining the stability, solubility, and compatibility of the solution:
- Mannitol: Acts as a tonicity agent to make the solution isotonic with blood, ensuring comfortable and safe intravenous administration
- Hydrochloric acid: Used for pH adjustment to maintain the solution at an appropriate pH (typically pH 4.5–6.5) for stability and compatibility
- Water for injections: The vehicle (solvent) for the solution, meeting pharmacopoeial standards for purity and sterility
The solution appears as a clear, orange-red liquid. Before administration, the solution is further diluted in sodium chloride 0.9% or glucose 5% solution. Healthcare professionals should inspect the solution visually before use and discard it if there are any signs of precipitation, discolouration beyond the expected red colour, or particulate matter.
Daunorubicin Hikma does not contain preservatives, and each vial is intended for single use only. Any unused portion remaining in the vial after the required dose has been withdrawn must be discarded according to local cytotoxic waste disposal protocols.
Frequently Asked Questions About Daunorubicin Hikma
Daunorubicin Hikma is an anthracycline chemotherapy drug used to treat acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). It is given as an intravenous infusion in hospital settings as part of combination chemotherapy regimens. The drug works by intercalating into DNA and inhibiting topoisomerase II, which prevents cancer cells from dividing and leads to their death.
The most common side effects include severe bone marrow suppression (leading to low blood cell counts and increased infection risk), nausea and vomiting, complete hair loss (which is reversible), mouth sores (mucositis), diarrhoea, fatigue, and temporary red discolouration of the urine. Cardiotoxicity is a serious concern, especially at higher cumulative doses. Most acute side effects can be managed with supportive medications.
No, daunorubicin and doxorubicin are both anthracycline chemotherapy drugs but they are different medications with different primary indications. Daunorubicin is primarily used for acute leukaemias (ALL and AML), while doxorubicin has a broader range of indications including solid tumours such as breast cancer, lymphomas, and sarcomas. They have different chemical structures, different dosing schedules, and slightly different toxicity profiles, though both carry a risk of cardiotoxicity.
The maximum recommended cumulative lifetime dose of daunorubicin is 550 mg/m² body surface area. For patients who have received prior mediastinal radiation therapy or concurrent cardiotoxic agents such as cyclophosphamide or trastuzumab, the maximum is reduced to 400–450 mg/m². Exceeding these limits significantly increases the risk of irreversible cardiotoxicity and heart failure. Your oncologist will carefully track your cumulative dose throughout treatment.
Yes, cardiotoxicity is one of the most serious risks of daunorubicin treatment. It can cause both acute effects (arrhythmias, ECG changes) during or shortly after infusion, and delayed cardiomyopathy that may develop months to years after treatment has ended. The risk increases with higher cumulative doses, age over 70, prior cardiac disease, previous chest radiation, and concurrent use of other cardiotoxic drugs. Regular cardiac monitoring with echocardiography or MUGA scans is mandatory throughout treatment. If signs of cardiac impairment develop, treatment may need to be modified or stopped.
Yes, hair loss (alopecia) from daunorubicin is almost always reversible. Hair typically begins to regrow 2–3 months after the completion of chemotherapy. When hair grows back, it may initially be a different texture or colour than before, but it usually returns to its normal state over time. While hair loss can be distressing, it is a temporary side effect. Wigs, head coverings, and other options are available and can be discussed with your healthcare team.
References
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- Döhner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1312-1377.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. Version 3.2024.
- Zamorano JL, Lancellotti P, Rodriguez Muñoz D, et al. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity. Eur Heart J. 2016;37(36):2768-2801.
- Armenian SH, Lacchetti C, Barac A, et al. Prevention and monitoring of cardiac dysfunction in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2017;35(8):893-911.
- Hunger SP, Mullighan CG. Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2015;373(16):1541-1552.
- British National Formulary (BNF). Daunorubicin. Available at: bnf.nice.org.uk
- Cardinale D, Colombo A, Bacchiani G, et al. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015;131(22):1981-1988.
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