Posology : מינונים

4.2    Posology and method of administration

Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease.

Posology
The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs). The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).

Missed dose
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.

Special populations
CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4).

Patients with hepatic impairment
In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).

In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment (Child-Pugh class A), no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily.

In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, eliglustat is not recommended (see sections 4.4 and 5.2).
In CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor, Cerdelga is contraindicated (see sections 4.3 and 5.2).

In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered (see sections 4.4 and 5.2).

Patients with renal impairment
In CYP2D6 extensive metabolisers (EMs) with mild, moderate or severe renal impairment, no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily (see sections 4.4 and 5.2).

In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).

In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate or severe renal impairment or ESRD, eliglustat is not recommended (see sections 4.4 and 5.2).

Elderly
There is limited experience in the treatment of elderly with eliglustat. Limited data indicates that no dosage adjustment is considered necessary (see sections 5.1 and 5.2).

Paediatric population
The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established. No data are available.

Method of administration
Cerdelga is to be taken orally. The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
The capsules may be taken with or without food. Consumption of grapefruit or its juice should be avoided (see section 4.5).