mitoxantrone hydrochloride: clinical use

Prescribing considerations

• Restrict administration to clinicians experienced with cytotoxic chemotherapy.
• Assess cardiac history, previous anthracycline or anthracenedione exposure, chest radiotherapy and concurrent cardiotoxic treatments.
• Consider reduced marrow reserve following previous chemotherapy or radiotherapy and the patient's general condition.
• Use caution in hepatic or renal impairment; clearance may be reduced in hepatic impairment.
• Discuss possible amenorrhoea, impaired fertility and gamete preservation before treatment where appropriate.
• Minimise extravasation risk and stop administration immediately if it is suspected.

Contraindications and cautions

• Hypersensitivity to mitoxantrone, any excipient or manufacturing-related sulphites
• Breastfeeding

Monitoring

• Full blood count, including platelets, before and during treatment and whenever infection is suspected
• Clinical and laboratory assessment for bone-marrow suppression and infection
• Baseline and periodic left-ventricular ejection fraction, with reassessment if heart-failure symptoms develop
• Uric acid, electrolytes and urea for tumour lysis syndrome
• Relevant chemical laboratory parameters and clinical assessment for hepatic or renal toxicity
• Pregnancy testing in patients who could become pregnant

Clinical pharmacology

Mitoxantrone is a synthetic anthracenedione and topoisomerase II inhibitor. It intercalates into DNA, promotes cross-links and strand breaks, and disrupts RNA and cell-cycle processes. Tissue distribution is extensive, elimination is slow through urine and faeces, and hepatic impairment may reduce clearance.

Formulation and product differences

• The selected product is a sterile dark-blue aqueous concentrate supplied in glass vials and requiring dilution before intravenous infusion.
• It may be diluted with isotonic saline or glucose infusion solution.
• It must not be mixed with other medicines in the infusion solution; adding heparin may cause precipitation.

Solution for infusion

Route: Intravenous

Strengths: 2 mg/mL