eliglustat tartrate: clinical use

Prescribing considerations

• Initiation and supervision should be by a clinician experienced in Gaucher disease.
• Obtain CYP2D6 genotype before initiation; do not use when metaboliser status is ultra-rapid or indeterminate.
• Reconcile prescription, non-prescription and herbal products because suitability depends on CYP2D6 status, interacting medicines and liver function.
• Avoid use in significant cardiac disease, long-QT syndrome and with Class IA or III antiarrhythmics.
• Consider renal and hepatic function; evidence is limited for several metaboliser-status and impairment combinations.
• The capsule contains lactose.

Contraindications and cautions

• Hypersensitivity to eliglustat or an excipient.
• CYP2D6 intermediate or extensive metabolisers taking both a strong or moderate CYP2D6 inhibitor and a strong or moderate CYP3A inhibitor.
• CYP2D6 poor metabolisers taking a strong CYP3A inhibitor.
• CYP2D6 extensive metabolisers with severe hepatic impairment.
• CYP2D6 extensive metabolisers with mild or moderate hepatic impairment who are taking a strong or moderate CYP2D6 inhibitor.

Monitoring

• Assess response across relevant Gaucher disease domains.
• After switching from enzyme-replacement therapy, monitor for disease progression and stability across disease domains.
• Review treatment if response is suboptimal.
• Repeat interaction and organ-function review whenever medicines or clinical circumstances change.

Clinical pharmacology

Eliglustat selectively inhibits glucosylceramide synthase. It is extensively metabolised, mainly through CYP2D6 and less through CYP3A4, and inhibits CYP2D6 and P-glycoprotein in vitro; CYP2D6 phenotype is the main determinant of exposure variability.

Formulation and product differences

• The selected product is a gelatin hard capsule containing lactose and must be swallowed intact; opening, crushing, dissolving or mixing its contents with food or drink is unsupported.

Capsule

Route: Oral

Strengths: 84 mg