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Idarubicin hydrochloride parenteral


Injections of idarubicin.

Drugs List

  • idarubicin 10mg powder for solution for injection
  • idarubicin 5mg powder for solution for injection
  • idarubicin hydrochloride 10mg/10ml injection solution
  • idarubicin hydrochloride 5mg/5ml injection solution
  • ZAVEDOS 10mg powder for solution for injection
  • ZAVEDOS 10mg/10ml injection solution
  • ZAVEDOS 5mg powder for solution for injection
  • ZAVEDOS 5mg/5ml injection solution
  • Therapeutic Indications


    Leukaemia - acute lymphoblastic
    Leukaemia - acute myeloid

    Treatment of acute myeloid leukaemia (AML) in adults, for remission induction in untreated patients or for remission induction in relapsed or refractory patients.

    Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.

    First line treatment of acute myeloid leukaemia (AML), in combination with cytarabine for remission induction.

    Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.

    Doses may vary significantly if this agent is used as monotherapy or different combinations.

    When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.

    Patients with Renal Impairment

    Dose recommendations in patients with renal impairment:

    Renal impairment with GFR 20 to 50ml/minute: Use 75% of dose.
    Renal impairment with GFR 10 to 20ml/minute: Use 75% of dose with caution.
    Renal impairment with GFR less than 10ml/minute: Use 50% of dose with caution.

    Patients with Hepatic Impairment

    The manufacturers state that in a number of phase III clinical trials, treatment was not given if serum bilirubin and/or creatinine serum levels exceeded 2mg%. With other anthracyclines a 50% dose reduction is generally employed if bilirubin levels are in the range 1.2 to 2.0mg%.

    Additional Dosage Information

    Severe mucositis: Administration of a second course should be delayed until recovery from the mucositis. A dose reduction of 25% is recommended following severe mucositis.


    For intravenous administration only.


    Uncontrolled systemic infection
    Recent myocardial infarction
    Serious cardiac arrhythmias
    Severe cardiac disorder
    Severe hepatic impairment
    Severe myelosuppression
    Severe renal impairment

    Precautions and Warnings

    Children under 18 years
    Concurrent radiotherapy
    History of anthracycline therapy
    History of cardiotoxic drug therapy
    History of mediastinal radiotherapy
    History of pericardial irradiation
    Within 7 months of discontinuing trastuzumab
    Cardiovascular disorder
    Gastrointestinal disorder
    Hepatic impairment
    Renal impairment

    Administration of live vaccines is not recommended
    Reduce dose in patients with glomerular filtration rate below 50ml/min
    Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration during therapy
    Consult local policy on the safe use of anti-cancer drugs
    Febrile neutropenia should be treated with broad spectrum IV antibiotics
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Treatment to be administered by or under supervision of specialist
    Baseline & follow-up ECGs during & immediately after administration advised
    Measurement of LV ejection fraction recommended before and during treatment
    Monitor haematological parameters before and during treatment
    Monitor hepatic function before treatment and regularly during treatment
    Monitor renal function before treatment and regularly during treatment
    Monitor patients for signs of tumour lysis syndrome
    Monitor serum creatinine
    Monitor serum phosphate levels
    Monitor serum potassium and calcium
    Monitor uric acid levels
    Consider treatments to prevent hyperuricaemia
    Delayed myocardial toxicity may occur
    If mucositis/stomatitis occurs, delay next treatment until recovery
    Risk of cardiomyopathy increases with high cumulative dosage
    May colour urine red
    Discontinue if cardiomyopathy occurs
    Discontinue or review if symptoms of congestive heart failure occur
    Not licensed for all indications in all age groups
    Female: Ensure adequate contraception during treatment
    Male: Contraception required during and for 3 months after treatment

    Acute cardiotoxicity is usually a transient disturbance of cardiac function marked by ECG abnormalities (including severe arrhythmias) and does not usually predict subsequent development of delayed cardiomyopathy or require treatment discontinuation.

    Delayed cardiotoxicity may manifest towards the end of therapy, within 2 to 3 months of finishing treatment or even years following the completion of treatment. This risk rises with increasing exposure to anthracyclines. Delayed cardiotoxicity is usually irreversible dose related cardiomyopathy, which may result in cardiac failure. Severe cardiac failure may occur precipitously without ECG changes. Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF). Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

    Cardiotoxicity may occur at doses lower than the recommended cumulative limit of anthracyclines.

    Infants and children appear to be more susceptible to anthracycline induced cardiac toxicity and long term periodic evaluation of cardiac function has to be performed.

    Pregnancy and Lactation


    Idarubicin is contraindicated during pregnancy.

    The manufacturer recommends that idarubicin is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Studies in rat have shown embryotoxicity and teratogenicity. Studies in rabbits only showed embryotoxicity. At the time of writing there is limited human data available. Idarubicin is less likely to cause cardiac abnormalities than other anthracyclines but the lipophilicity of idarubicin means that it will pass through the placenta more easily. Risks are unknown.

    The effect of concurrent therapies must also be considered.


    Idarubicin is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking idarubicin. At the time of writing there are no published reports concerning the use of idarubicin while breastfeeding. The molecular weight of idarubicin is low enough that it should be expected to be present in the breast milk.

    The effect of concurrent therapies must also be considered.

    Side Effects

    Abdominal pain
    Acute myeloid leukaemia
    Atrioventricular block
    Bundle branch block
    Burning sensation
    Cerebral haemorrhage
    Congestive cardiac failure
    Decreased ejection fraction
    ECG changes
    Febrile neutropenia
    Gastric erosions
    Gastro-intestinal perforation
    Gastro-intestinal ulceration
    Gastrointestinal bleeding
    Hyperpigmentation of skin
    Hypersensitivity reactions
    Increases in hepatic enzymes
    Local reaction at injection site
    Myelodysplastic syndrome
    Myocardial infarction
    Neutropenic colitis
    Pigmentation of nails
    Radiation recall dermatitis
    Red urine
    Secondary leukaemia
    Septic shock
    Serum bilirubin increased
    Sinus tachycardia
    Skin necrosis
    Tumour lysis syndrome


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

    Summary of Product Characteristics: Idarubicin 5mg/5ml solution for injection. Accord Healthcare Ltd. Revised August 2017.

    Summary of Product Characteristics: Idarubicin 10mg/10ml solution for injection. Accord Healthcare Ltd. Revised August 2017.

    Summary of Product Characteristics: Idarubicin solution for injection 1 mg/ml. Teva UK Limited. Revised July 2014.

    Summary of Product Characteristics: Zavedos 1mg/ml Solution for Injection. Pfizer Ltd. Revised April 2020.

    Summary of Product Characteristics: Zavedos 5 mg powder solution for injection. Pfizer Ltd. Revised December 2014.

    Summary of Product Characteristics: Zavedos 10 mg powder solution for injection. Pfizer Ltd. Revised December 2014.

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