Mitoxantrone

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Ebexantron, Mitoxantron, Novantron; Belgium: Mitoxantrone, Xantrosin; Bulgaria: Mitoxantron, Oncotrone; Cyprus: Mitoxantron, Novantrone; Czech Republic: Refador; Denmark: Mitoxantron; Estonia: Onkotrone; Finland: Mitoxantron; France: Elsep, Mitoxantrone, Novantrone; Germany: Mitoxantron, Novantron, Onkotrone, Oxan, Ralenova; Greece: Genefadrone, Mitoxan, Mitoxantrone, Novantrone, Zyneva; Hungary: Onkotrone; Ireland: Mitoxantrone; Italy: Mitoxantrone, Novantrone, Onkotrone; Latvia: Novantrone, Oncotrone; Luxembourg: Mitoxantron, Novantrone; Netherlands: Mitoxantron, Mitoxantrone; Poland: Mitoxantrone; Portugal: Mitoxantrona, Mitoxantrone, Novantrone; Romania: Mitoxantrone, Novantrone, Onkotrone; Slovakia: Onkotrone, Refador; Slovenia: Novantrone, Onkotrone; Spain: Mitoxantrona, Novantrone, Pralifán; Sweden: Mitoxantron, Novantrone; UK: Mitoxantrone, Onkotrone.

North America

Canada: Mitoxantrone; USA: Mitoxantrone, Novantrone.

Latin America

Argentina: Micraleve, Mitoxantrona, Mitoxgen; Brazil: Misostol, Mitoxal; Mexico: Formyxan, Mitoxantrona, Mitoxgen, Neotalem.

Asia

Japan: Novantron.

Drug combinations

Chemistry

Mitoxantrone Hydrochloride: C~22~H~28~N~4~O~6~ 2HCl. Mw: 517.40. (1) 9,10-Anthracenedione, 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-, dihydrochloride; (2) 1,4-Dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthraquinone dihydrochloride. CAS-70476-82-3; CAS-65271-80-9 (mitoxantrone)(1980).

Pharmacologic Category

Antineoplastic Agents; Cytotoxic Antibiotics and Related Substances; Anthracenedione. (ATC-Code: L01DB07).

Mechanism of action

Binds to nucleic acids and inhibits DNA and RNA synthesis by template disordering and steric obstruction.

Therapeutic use

Treatment of acute nonlymphocytic leukemias, prostate cancer, lymphoma, secondary progressive or relapsing-remitting multiple sclerosis.

Pregnancy and lactiation implications

Adverse effects noted in animal studies. May cause fetal harm if administered to a pregnant woman. Contraindicated during lactation.

Unlabeled use

Treatment of pediatric acute leukemias, pediatric sarcoma.

Contraindications

Hypersensitivity to mitoxantrone or any component of the formulation. Multiple sclerosis with left ventricular ejection fraction (LVEF) <50% or clinically significant decrease in LVEF.

Warnings and precautions

Hazardous agent. Severe myelosuppression possible (use with caution in pre-existing myelosuppression). May cause myocardial toxicity and potentially fatal heart failure. Associated with development of secondary acute myelogenous leukemia and myelodysplasia. Use with caution in hepatic impairment (not for treatment of multiple sclerosis in concurrent hepatic impairment). Not for treatment of primary progressive multiple sclerosis. For intravenous administration only (may cause severe local tissue damage if extravasation occurs). May cause urine, saliva, tears, and sweat to turn blue-green for 24 hours postinfusion. Whites of eyes may have blue-green tinge.

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