pixantrone dimaleate: clinical use

Prescribing considerations

• Treatment should be supervised by clinicians experienced with antineoplastic agents and appropriate monitoring facilities.
• Assess previous anthracycline exposure, cardiovascular disease, active or recurrent infection, performance status and risk of tumour lysis syndrome.
• Use caution with renal impairment, mild-to-moderate hepatic impairment and controlled-sodium diets.
• Consider fertility counselling and sperm preservation before treatment.

Contraindications and cautions

• Hypersensitivity to pixantrone dimaleate or an excipient
• Live-virus vaccination
• Profound bone-marrow suppression
• Severe abnormal hepatic function

Monitoring

• Baseline full blood count, bilirubin, creatinine and left-ventricular ejection fraction
• Frequent differential blood counts, including neutrophils and platelets
• Cardiac symptoms and repeat ejection-fraction assessment where risk factors or clinical concerns exist
• Urate, potassium, calcium, phosphate and creatinine in patients at high risk of tumour lysis
• Relevant interacting-medicine monitoring, including INR or theophylline concentrations

Clinical pharmacology

Pixantrone is a cytotoxic aza-anthracenedione that directly damages DNA through stable adducts and cross-strand breaks and has topoisomerase II activity. It is widely distributed, approximately half is protein-bound, and elimination is mainly non-renal, probably involving hepatic or biliary pathways.

Formulation and product differences

• The selected product is a dark-blue powder for concentrate that requires reconstitution, further dilution and administration through an in-line filter.
• The prepared infusion contains a substantial sodium load and should be considered in people following a controlled-sodium diet.
• The product is cytotoxic, single-use and requires appropriate protective handling and disposal.