mifamurtide: clinical use

Prescribing considerations

• Initiation and supervision require clinicians experienced in osteosarcoma treatment.
• Evidence is insufficient for routine use in adults older than the studied young-adult population or in children younger than the licensed population.
• Use caution in moderate hepatic impairment and in severe renal or hepatic impairment because clinical data are limited.
• Consider respiratory risk and possible preventive bronchodilator therapy in patients with asthma or chronic obstructive pulmonary disease.
• Use caution with autoimmune, inflammatory or collagen disorders and with venous thrombosis, vasculitis or unstable cardiovascular disease.

Contraindications and cautions

• Hypersensitivity to mifamurtide or any excipient.
• Concurrent ciclosporin or another calcineurin inhibitor.
• Concurrent high-dose non-steroidal anti-inflammatory drugs.

Monitoring

• Assess persistent fever or chills for infection or sepsis, particularly during neutropenia.
• Monitor for respiratory distress, allergic reactions and excessive inflammatory responses.
• Monitor blood counts and manage febrile neutropenia appropriately.
• Monitor renal and hepatic function when treatment continues after chemotherapy.
• Consider clotting assessment early in treatment and again later, particularly where clinically indicated.
• Closely observe patients with relevant cardiovascular or thrombotic history.

Clinical pharmacology

Mifamurtide is liposomal muramyl tripeptide phosphatidylethanolamine, a synthetic muramyl-dipeptide derivative and NOD2 ligand. It activates monocytes and macrophages and promotes cytokine and adhesion-molecule production. Serum concentrations decline rapidly, and accumulation was not observed in the available pharmacokinetic study.

Formulation and product differences

• The selected product is a liposomal powder for concentrate for dispersion for infusion.
• It requires reconstitution, filtration with the supplied product filter and further dilution using aseptic technique.
• An in-line filter is not recommended during administration because of the liposomal formulation.
• The prepared dispersion is intended for intravenous infusion and must not be given as a bolus.

Dispersion for infusion

Route: Intravenous

Strengths: 4 mg