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Mitoxantrone parenteral


Concentrate for solution for infusion containing mitoxantrone.

Drugs List

  • mitoxantrone 20mg/10ml concentrate for solution for infusion
  • mitoxantrone 25mg/12.5ml concentrate for solution for infusion
  • ONKOTRONE 20mg/10ml concentrate for solution for infusion
  • ONKOTRONE 25mg/12.5ml concentrate for solution for infusion
  • Therapeutic Indications


    Adult acute non-lymphocytic leukaemia
    Carcinoma - prostate (adjunct to other treatment)
    Hepatocellular carcinoma
    Leukaemia - chronic myeloid
    Lymphoma - non-Hodgkin's
    Metastatic breast cancer
    Treatment of Multiple Sclerosis


    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.

    Additional Dosage Information

    Nadir after Prior Dose
    WBC greater than 1500/cubic millimetre AND platelets greater than 50,000/cubic millimetre, time to recovery, equal to or less than 21 days - Repeat previous dose after recovery or increase by 2mg/square metre if myelosuppression not considered adequate.

    WBC greater than 1500/cubic millimetre AND platelets greater than 50,000/cubic millimetre, time to recovery, more than 21 days - Withhold until recovery, then repeat previous dose.

    WBC less than 1500/cubic millimetre OR platelets less than 50,000/cubic millimetre, time to recovery, any duration - Decrease by 2mg/square metre from previous dose after recovery.

    WBC less than 1000/cubic millimetre OR platelets less than 25,000/cubic millimetre, time to recovery, any duration - Decrease by 4mg/square metre from previous dose after recovery.


    For administration by intravenous infusion only.

    Mitoxantrone should be administered as an intravenous infusion via the tubing of fast running infusion.

    Some manufacturers advise administration as an intravenous infusion.


    Severe hepatic impairment

    Precautions and Warnings

    Allergic disposition
    Children under 18 years
    History of mediastinal radiotherapy
    History of thoracic radiotherapy
    History of treatment with anthracyclines
    Risk factors for cardiovascular disorder
    Within 7 months of discontinuing trastuzumab
    Cardiac disorder
    Hepatic impairment
    History of asthma
    Renal impairment

    Administration of live vaccines is not recommended
    Live virus vaccine should not be given for 3 months after treatment
    Monitor cardiac function when a history of exposure to cardiotoxic agents
    Advise ability to drive/operate machinery may be affected by side effects
    Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Not all available brands are licensed for all indications
    Treatment to be prescribed under the supervision of a specialist
    Some brands contain metabisulfite, may cause bronchospasm/allergies
    Consult local policy on the safe use of anti-cancer drugs
    Dilute and use as an infusion
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Monitor haematological parameters before and during treatment
    Monitor cardiac function during prolonged treatment
    Monitor cardiac function in patients with cardiac disease
    Monitor cardiac function when a history of chest radiotherapy
    Monitor patients for signs of tumour lysis syndrome
    Monitor serum biochemistry regularly
    Advise patient that blue discolouration of skin, nails & sclera may occur
    Advise patient to expect blue-green discolouration of the urine
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Not licensed for use in children under 18 years
    Lifetime cumulative dose should be limited to 160mg/metre squared
    Male & female: Contraception required during & for 6 months after treatment

    Functional cardiac changes, including potentially fatal congestive heart failure and decreases in left ventricular ejection fraction have been reported during therapy or months to years after therapy stopped. In the majority of cases, patients had previously received treatment with anthracyclines, had mediastinal/thoracic radiotherapy or had pre-existing heart disease. It is recommended that such patients are treated with mitoxantrone at full cytotoxic doses but added caution is required and careful regular cardiac examinations are recommended from the start of treatment. Some manufacturers advise all cancer patients should have an echocardiogram or multi-gated acquisition to evaluate left-ventricular function before the initial dose of mitoxantrone.

    Multiple sclerosis patients should have an echocardiogram or multi-gated acquisition to evaluate left-ventricular function before the initial dose of mitoxantrone. This should be repeated prior to each dose of mitoxantrone and every year for 5 years after cessation of therapy. It is recommended that patients with multiple sclerosis should not receive a lifetime cumulative dose greater than 72mg per metre squared. Mitoxantrone should not be used if left-ventricular ejection fraction is less than 50 percent or if a clinically significant reduction in left-ventricular ejection fraction.

    Ensuring a negative pregnancy test prior to each dose is recommended by some manufacturers.

    Some manufacturers advise women treated with mitoxantrone have an increased risk of transient or persistent amenorrhoea. Preservation of gametes should be discussed prior to commencing treatment.

    Pregnancy and Lactation


    Contraindicated in pregnancy.

    Mitoxantrone has a cytocidal effect on both proliferating and non-proliferating human cells.

    The effect of concurrent therapies must also be considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Contraindicated in nursing mothers.

    Mitoxantrone is excreted in breast milk and significant concentrations (18 nanogram/ml) have been detected 28 days after the last administration. There is the potential for serious adverse reactions in infants.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute leukaemia
    Blue discoloration of skin and nails
    Blue discoloration of the sclera (reversible)
    Blue-green discoloration of urine
    Bone marrow failure
    Burning pain at injection site
    Cardiovascular effects
    Congestive cardiac failure
    Discolouration (injection site)
    ECG changes
    Erythema at injection site
    Gastrointestinal bleeding
    Hepatic impairment
    Hypersensitivity reactions
    Increase in blood urea nitrogen
    Increases in hepatic enzymes
    Myelodysplastic syndrome
    Myocardial infarction
    Nail dystrophy
    Necrosis (injection site)
    Phlebitis (injection site)
    Reduced left ventricular output
    Serum creatinine increased
    Sinus bradycardia
    Swelling (injection site)
    Taste disturbances
    Tumour lysis syndrome
    Upper respiratory tract infection
    Urinary tract infections
    Weight changes
    White blood cell count decreased


    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.

    Summary of Product Characteristics: Mitoxantrone 2mg/ml Sterile Concentrate. Hospira UK Ltd. Revised February 2016.

    Summary of Product Characteristics: Mitoxantrone 2mg/ml concentrate for solution for infusion. Accord Heathcare Limited. Revised November 2016.

    Summary of Product Characteristics: Onkotrone Injection 2mg/ml concentrate for solution for infusion. Baxter Healthcare Ltd. Revised September 2010.

    NICE Evidence Services Available at: Last accessed: 13 March 2018

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