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Antineoplastic (cancer/cell-growth inhibitor)

Mitoxantrone is a chemotherapy-style drug used to treat certain types of multiple sclerosis, advanced prostate cancer, and acute nonlymphocytic leukemia. It works by interfering with DNA to stop cells from growing. Because it can cause serious side effects like severe blood cell reduction and heart issues, it must be given by a specialist through an IV infusion. It is not for use in people with certain types of multiple sclerosis or those with existing heart problems.

How it worksMitoxantrone works by entering the cell's DNA and causing breaks or crosslinks, which prevents the cell from replicating. It also stops an enzyme called topoisomerase II from repairing damaged DNA, ultimately killing the cells.

Brand names:NOVANTRONE

Used for
Reducing disability and relapse frequency in secondary progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis.Initial chemotherapy for pain related to advanced hormone-refractory prostate cancer (used with corticosteroids).Initial therapy for acute nonlymphocytic leukemia (ANLL) in adults.
Conditions
Secondary progressive multiple sclerosisProgressive relapsing multiple sclerosisWorsening relapsing-remitting multiple sclerosisAdvanced hormone-refractory prostate cancerAcute nonlymphocytic leukemia (ANLL)
Class
ChemotherapyDNA inhibitorAntineoplasticAntineoplastic (cancer/cell-growth inhibitor)Immune SystemHematologicCardiovascularNervous System

How to take

FormsInjectable solution (concentrate)
RoutesIntravenous (IV) infusion

For multiple sclerosis, the typical dose is 12 mg/m² given as a short IV infusion every 3 months. For leukemia, higher doses may be used under strict medical supervision.

The concentrate must be diluted before it is injected. It must never be injected into the skin, muscle, or arteries.

Key warnings

Mitoxantrone must be given by a doctor experienced in chemotherapy. It must be given slowly through a flowing IV; if it leaks into the surrounding tissue (extravasation), it can cause severe damage. It must never be injected into the spinal fluid (intrathecal).

  • ·Mitoxantrone must be given by a doctor experienced in chemotherapy. It must be given slowly through a flowing IV; if it leaks into the surrounding tissue (extravasation), it can cause severe damage. It must never be injected into the spinal fluid (intrathecal).
  • ·Can cause severe drops in blood cell counts, which may require blood transfusions or antibiotics.
  • ·Can cause heart-related problems; heart function must be checked before and during treatment.
  • ·Contains sodium metabisulfite, which can cause life-threatening allergic reactions or asthma in sensitive people.
  • ·Should not be used in patients with certain types of multiple sclerosis (primary progressive) or those with significant heart issues.

Do not use if

  • ·People who have had an allergic reaction to Mitoxantrone in the past.

Side effects

Common

NauseaHair thinningUrinary tract infectionsMenstrual changes (such as loss of periods)Low white blood cell counts

Serious

  • ·Severe reduction in blood cell counts (myelosuppression)
  • ·Heart muscle weakness or failure (decreased LVEF)
  • ·Severe local tissue damage if the drug leaks from the vein
  • ·Allergic reactions or asthma-like symptoms from sulfites
  • ·Increased risk of certain leukemias

Seek help if

  • ·Mitoxantrone is a cytotoxic agent and requires specialized handling.

Interactions

  • ·No significant interactions have been found with other drugs in cancer patients, but information is limited for those using it for multiple sclerosis.
  • ·No significant interactions were observed when used with corticosteroids.

Special populations

PregnancyMitoxantrone should not be used during pregnancy. Women who are able to become pregnant should use effective birth control during treatment.

BreastfeedingBreastfeeding should be stopped before starting Mitoxantrone because the drug is passed into human milk and could cause serious harm to the infant.

PediatricThe safety and effectiveness of Mitoxantrone in children have not been established.

GeriatricThere is limited data on use in patients over 65 for multiple sclerosis, but studies in prostate cancer patients aged 65 and older have been conducted.

Talk to your doctor

Monitor

  • ·Left ventricular ejection fraction (LVEF)
  • ·Complete blood counts (including platelets and neutrophils)
  • ·Liver function tests

Questions to ask

  • ·How will my heart function be monitored during treatment?
  • ·What are the signs of a sulfite allergic reaction I should watch for?
  • ·How often will my blood counts be checked?
  • ·What precautions should I take regarding pregnancy or breastfeeding?

Pharmacokinetics

Half-lifeAlpha half-life is 6 to 12 minutes; beta half-life is 1.1 to 3.1 hours; terminal half-life is 23 to 215 hours.
MetabolismExcreted in bile and urine.
ExcretionExcreted in bile and urine.

Practical

OverdoseThere is no specific antidote for an overdose. Severe overdose can lead to death from infection caused by extremely low blood cell counts.

StorageStore between 20° to 25°C (68° to 77°F). Do not freeze. Store upright.

Ingredients

Allergens

sulfite

Inactive

Sodium chlorideSodium metabisulfiteSodium acetateAcetic acidWater for Injection

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.