lumasiran sodium: clinical use

Prescribing considerations

• Initiate and supervise treatment through a clinician experienced in hyperoxaluria.
• Establish renal and dialysis status, hepatic function and history of hypersensitivity before treatment.
• Data are limited in infants younger than one year and in people with end-stage renal disease or receiving dialysis.

Contraindications and cautions

• Severe hypersensitivity to lumasiran sodium or any excipient.
• Use caution in severe or end-stage renal impairment because increased glycolate may contribute to metabolic acidosis.
• Moderate or severe hepatic impairment may reduce efficacy.

Monitoring

• Monitor treatment efficacy in moderate or severe hepatic impairment.
• In severe or end-stage renal disease, monitor for new or worsening metabolic acidosis.
• Assess injection sites and investigate suspected hypersensitivity.

Clinical pharmacology

A liver-targeted, double-stranded siRNA that engages RNA interference to degrade HAO1 messenger RNA, reducing glycolate oxidase, glyoxylate availability and oxalate production. It is metabolised by nucleases rather than CYP450 enzymes and is predominantly cleared from plasma by hepatic uptake.

Formulation and product differences

• The selected product is a clear, colourless-to-yellow, ready-to-use solution in a single-use vial for subcutaneous administration.
• It is essentially sodium-free and must not be mixed with other medicinal products.

Injection

Route: Parenteral

Strengths: 94.5 mg/0.5 mL