To avoid any misinterpretation and to ensure the terms contained within the prescriber guide are aligned with HSE Code of Practice requirements, Sanofi Genzyme have amended the prescriber guide to remove reference to “QD” throughout and replace this with the wording “Once daily”.

To avoid any misinterpretation and to ensure the terms contained within the prescriber guide are aligned with HSE Code of Practice requirements, Sanofi Genzyme have amended the prescriber guide to remove reference to “QD” throughout and replace this with the wording “Once daily”.

5.2     Pharmacokinetic properties

Absorption

Median time to reach maximum plasma concentrations occurs between 1.5 to 36 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism. Eliglustat is a substrate of the efflux transporter P-gp. Food does not have a clinically relevant effect on eliglustat pharmacokinetics. Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.  Oral dosing of 84 mg eliglustat once daily has not been studied in CYP2D6 poor metabolisers (PMs).

Characteristics in specific groups

CYP2D 6 phenotype

4.9     Overdose

The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients. At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.

In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.

7.       MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands