CERDELGA Hard capsule Ref.[8493] Active ingredients: Eliglustat

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. 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).

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.

3 years.

This medicinal product does not require any special storage conditions.

PETG/COC.PETG/PCTFE-aluminium blister.

Each blister wallets contains 14 hard capsules.

Each pack contains 14, 56 or 196 hard capsules.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.