Metastatic breast cancer

Active Ingredient: Mitoxantrone

Indication for Mitoxantrone

Population group: only adults (18 years old or older)

Mitoxantrone is indicated in the treatment of metastatic breast cancer.

For this indication, competent medicine agencies globally authorize below treatments:

10-14 mg/m² once every 3 weeks

Route of admnistration


Defined daily dose

10 - 14 mg per m² of body surface area (BSA)

Dosage regimen

From 10 To 14 mg per m² of body surface area (BSA) once every 21 day(s)

Detailed description

Single Agent Therapy

The recommended initial dosage of mitoxantrone used as a single agent is 14 mg/m² of body surface area, given as a single intravenous dose, which may be repeated at 21-day intervals. A lower initial dosage (12 mg/m² or less) is recommended in patients with inadequate bone marrow reserves e.g. due to prior chemotherapy or poor general condition.

Dosage modification and the timing of subsequent dosing should be determined by clinical judgement depending on the degree and duration of myelosuppression. For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to normal levels after 21 days.

The following table is suggested as a guide to dosage adjustment in the treatment of metastatic breast cancer and non-Hodgkin’s lymphoma according to haematological nadir (which usually occurs about 10 days after dosing).

WBC and platelet nadirTime to recoverySubsequent dosing
If WBC nadir >1,500 µl and platelet nadir >50,000 µlRecovery ≤21 daysRepeat prior dose
If WBC nadir >1,500 µl and platelet nadir >50,000 µlRecovery >21 daysWithhold until recovery, then repeat prior dose.
If WBC nadir <1,500 µl or platelet nadir <50,000 µlAny durationDecrease by 2 mg/m² from prior dose, after recovery.
If WBC nadir <1,000 µl or platelet nadir <25,000 µlAny durationDecrease by 4 mg/m² from prior dose, after recovery.

Combination Therapy

Mitoxantrone has been given as part of combination therapy. In metastatic breast cancer, combinations of mitoxantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.

Mitoxantrone has also been used in various combinations for non-Hodgkin’s lymphoma; however, data are presently limited and specific regimens cannot be recommended.

In combination regimens mitoxantrone, in starting doses ranging from 7 to 8 to 10 to 12 mg/m², dependent on the combination and frequency used, has shown effectiveness.

As a guide, when mitoxantrone is used in combination chemotherapy with another myelosuppressive agent, the initial dose of mitoxantrone should be reduced by 2 to 4 mg/m² below the doses recommended for single agent usage; subsequent dosing, as outlined in the table above, depends on the degree and duration of myelosuppression.

Dosage considerations

Mitoxantrone concentrate should be slowly injected into a free flow lowing intravenous infusion of isotonic saline or 5% glucose solution over a period of not less than 3 to 5 minutes. The tubing should be inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.

Active ingredient


Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.

Read more about Mitoxantrone

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