CERDELGA

What it is

Cerdelga contains 84 mg eliglustat (equivalent to 100 mg eliglustat tartrate) . Cerdelga is formulated as a hard capsule for oral administration .

Approved indications

— Long-term treatment of adult patients with Gaucher disease type 1 .

Dosing overview

Before initiation of treatment with eliglustat, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status . The recommended dose of Cerdelga in CYP2D6 intermediate metabolisers and extensive metabolisers is 84 mg twice daily taken orally . The recommended dose in CYP2D6 poor metabolisers is 84 mg once daily taken orally . Eliglustat should not be used in patients who are CYP2D6 ultra-rapid or indeterminate metabolisers .

Key safety warnings

Use of eliglustat should be avoided in patients with cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia and structural heart disease associated with arrhythmia), long QT syndrome, and in combination with Class IA (e.g. quinidine) and Class III (e.g. amiodarone, sotalol) antiarrhythmic medications . Grapefruit or grapefruit juice should be avoided with eliglustat because grapefruit is a strong CYP3A inhibitor . Use of Cerdelga with strong CYP3A inducers substantially decreases the exposure to eliglustat, which may reduce the therapeutic effectiveness of Cerdelga; therefore co-administration is not recommended . Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine .

Contraindications

Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers or extensive metabolisers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in CYP2D6 poor metabolisers who are taking a strong CYP3A inhibitor . Cerdelga is contraindicated in CYP2D6 intermediate metabolisers or poor metabolisers with any degree of hepatic impairment and in CYP2D6 extensive metabolisers with moderate or severe hepatic impairment .

Regulatory history

Cerdelga (eliglustat 84 mg capsule) was first listed on the Australian Register of Therapeutic Goods on 17 February 2015 . In July 2025, the PBAC deferred a submission for Cerdelga for Gaucher disease type 1 under the Life Saving Drugs Program .