Eliglustat

Chemical formula: C₂₃H₃₆N₂O₄  Molecular mass: 404.551 g/mol  PubChem compound: 23652731

Therapeutic indications

Eliglustat is indicated for:

Gaucher disease type 1 (GD1)

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Adults

Eliglustat is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).

Paediatric population (from 6 to <18 years of age) weighing ≥15 kg

Eliglustat is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Eliglustat is contraindicated in the following cases:

Lactation

Lactation

CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment

at least one of
Cytochrome P450 family 2 subfamily D member 6 rapid metabolizer
Cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer
and additionally Hepatic failure stage IV

CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor

at least one of
Cytochrome P450 family 2 subfamily D member 6 rapid metabolizer
Cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer
and additionally at least one of
Hepatic failure stage II
Hepatic failure stage III
and additionally at least one of
Strong CYP2D6 inhibitors
Moderate CYP2D6 inhibitors

CYP2D6 intermediate (IMs) or extensive metabolisers (EMs) taking strong or moderate CYP2D6 or CYP3A inhibitors

at least one of
Cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer
Cytochrome P450 family 2 subfamily D member 6 high intermediate metaboliser
and additionally at least one of
Strong CYP2D6 inhibitors
Moderate CYP2D6 inhibitors
and additionally at least one of
Strong CYP3A4 inhibitors
Moderate CYP3A4 inhibitors
Cytochrome P-450 CYP3A5 strong inhibitors
Cytochrome P-450 CYP3A5 moderate inhibitors

CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor

Cytochrome P450 family 2 subfamily D member 6 poor metabolizer and additionally CYP2D6 (cytochrome P450 family 2 subfamily D member 6) low normal metabolizer
and additionally at least one of
Strong CYP3A4 inhibitors
Cytochrome P-450 CYP3A5 strong inhibitors

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Factors such as age, gender, and health history are evaluated to create a personalized medication regimen.

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