loncastuximab tesirine: clinical use

Prescribing considerations

• Restrict use to specialist supervision in adults meeting the licensed lymphoma indication.
• Use corticosteroid premedication unless contraindicated.
• Assess active or recent infection, hepatic disease, pregnancy potential and fertility-preservation needs before treatment.
• Safety and efficacy are not established in people under 18.
• Evidence is limited in severe renal impairment and moderate or severe hepatic impairment.
• Record product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to loncastuximab tesirine or any excipient.
• Exercise particular caution with active infection, significant hepatic impairment, severe renal impairment, pre-existing effusion or oedema, cytopenias and serious skin disease.

Monitoring

• Full blood count before each administration and more frequently if cytopenias develop.
• Liver function tests and clinical toxicity, particularly with hepatic impairment.
• New or worsening infection, oedema, weight gain, ascites, pleural or pericardial effusion and possible capillary leak syndrome.
• Skin reactions and photosensitivity.
• Infusion site for extravasation or subcutaneous infiltration.
• Pregnancy status where relevant.

Clinical pharmacology

A humanised IgG1 kappa antibody–drug conjugate binds CD19 and is internalised. Proteolytic cleavage releases the pyrrolobenzodiazepine dimer SG3199, which forms cytotoxic DNA interstrand crosslinks. The antibody is expected to undergo protein catabolism; SG3199 is metabolised by CYP3A4/5 in vitro.

Formulation and product differences

• The selected product is a single-use, preservative-free powder for concentrate requiring aseptic reconstitution and dilution before intravenous infusion.
• It contains histidine compounds, sucrose and polysorbate 20; polysorbates may cause allergic reactions.
• The vial must be refrigerated, protected from light and not frozen.

Solution for infusion

Route: Intravenous

Strengths: 10 mg