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Generic Name: Mitozantrone hydrochloride
Product Name: Novantrone


Mitozantrone is indicated in the treatment of:

  • metastatic breast cancer
  • non-Hodgkin’s lymphoma
  • adult acute non-lymphocytic leukaemia
  • chronic myelogenous leukaemia in blast crisis (acute advanced stage)


Mitozantrone is from the family of chemotherapy drugs known as anthracyclines. Anthracyclines act directly on DNA, blocking its production and inhibiting the enzyme responsible for DNA repair. Cells do not have to be actively dividing to be affected by Mitozantrone, as is the case with some chemotherapy drugs. Mitozantrone causes slightly less damage to the heart than other anthracyclines.

Dose advice

Single doses greater than 140mg/m2 are not recommended, particularly as a single bolus injection. This may result in fatal overdose.

Breast cancer and lymphoma

Single agent therapy:

  • 14mg/m2 initially, as a single intravenous dose
  • repeat at 21 day intervals
  • 12mg/m2 may be more suitable for patients with residual myelosuppression from previous treatments
  • individual observation and clinical monitoring is important in determining future doses

Combination therapy:

  • may be used in combination with cyclophosphamide, fluorouracil, vincristine, vinblastine, bleomycin, methotrexate or glucocorticoids
  • initial dose of Mitozantrone should be reduced by 2-4mg/m2
  • subsequent doses should depend on degree and duration of myelosuppression


Single agent therapy:

  • 12mg/m2 given as a single intravenous dose daily for five days
  • patients who achieve remission usually do so as a result of the first induction course
  • repeat dosage following relapse is the same

Combination therapy:

  • use in combination with cytosine arabinoside
  • 10-12mg/m2 of Mitozantrone and 100mg/m2 of cytosine arabinoside for seven consecutive days
  • if a second course is indicated, the same dose should be used but Mitozantrone for only two days and cytosine arabinoside for five


  • contents of vial should be diluted in 50ml sodium chloride or glucose 5% for injection
  • introduce slowly into tubing of free running infusion of the above agents
  • follow with flush of appropriate diluent
  • if extravasation occurs, stop infusion immediately and recommence in another vein
  • care should be taken to avoid contact with skin, mucous membranes and eyes
  • diluted solutions should be used as soon as possible, as Mitozantrone contains no antimicrobial agent
  • pregnant staff should not handle Mitozantrone



Common side effects

  • nausea
  • vomiting
  • hair loss (reversible on cessation of therapy)
  • mouth ulcers (especially in leukaemia patients)
  • bone marrow suppression, which most commonly results in decreased numbers of white blood cells (therefore increased risk of infection)
  • blue-green colouration of urine for 24 hours

Uncommon side effects

  • diarrhoea
  • loss of appetite
  • gastrointestinal bleeding
  • abdominal pain
  • altered taste
  • shortness of breath
  • inflammation of vein used for injection
  • rash
  • decrease in platelets and red blood cells (resulting in bleeding and anaemia)
  • change in colour of nails
  • changes in liver enzymes
  • increased serum bilirubin
  • changes in kidney function tests
  • blue colouration of sclera (whites of eyes)

For further information talk to your doctor.

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Posted On: 22 July, 2003
Modified On: 20 November, 2015


Created by: myVMC