Active Ingredient: Eliglustat
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).
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:
For:
Regimen A: In case that there is cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer, oral, 84 milligrams eliglustat, 2 times daily.
Regimen B: In case that there is cytochrome P450 family 2 subfamily D member 6 rapid metabolizer, oral, 84 milligrams eliglustat, 2 times daily.
Regimen C: In case that there is cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer, oral, 84 milligrams eliglustat, 2 times daily.
Regimen D: In case that there is cytochrome P450 family 2 subfamily D member 6 poor metabolizer, oral, 84 milligrams eliglustat, 2 times daily.
Before initiation of treatment with eliglustat, patients must be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status.
Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers.
The recommended dose is 84 mg eliglustat twice daily in CYP2D6 IMs and EMs.
The recommended dose is 84 mg eliglustat once daily in CYP2D6 PMs.
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
There is limited experience in the treatment of elderly with eliglustat. Data indicates that no dose adjustment is considered necessary.
Eliglustat may be taken with or without food. Consumption of grapefruit or its juice should be avoided.
For:
Regimen A: In case that there is cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer and patient weight is ≥ 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen B: In case that there is cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer and patient weight is > 25 kg and patient weight is < 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen C: In case that there is cytochrome P450 family 2 subfamily D member 6 intermediate metabolizer and patient weight is > 15 kg and patient weight is < 25 kg, oral, 42 milligrams eliglustat, 2 times daily.
Regimen D: In case that there is cytochrome P450 family 2 subfamily D member 6 rapid metabolizer and patient weight is ≥ 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen E: In case that there is cytochrome P450 family 2 subfamily D member 6 rapid metabolizer and patient weight is > 25 kg and patient weight is < 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen F: In case that there is cytochrome P450 family 2 subfamily D member 6 rapid metabolizer and patient weight is > 15 kg and patient weight is < 25 kg, oral, 42 milligrams eliglustat, 2 times daily.
Regimen G: In case that there is cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer and patient weight is ≥ 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen H: In case that there is cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer and patient weight is > 25 kg and patient weight is < 50 kg, oral, 84 milligrams eliglustat, 2 times daily.
Regimen I: In case that there is cytochrome P450 family 2 subfamily D member 6 ultra-rapid metabolizer and patient weight is > 15 kg and patient weight is < 25 kg, oral, 42 milligrams eliglustat, 2 times daily.
Regimen J: In case that there is cytochrome P450 family 2 subfamily D member 6 poor metabolizer and patient weight is ≥ 50 kg, oral, 84 milligrams eliglustat, once daily.
Regimen K: In case that there is cytochrome P450 family 2 subfamily D member 6 poor metabolizer and patient weight is > 25 kg and patient weight is < 50 kg, oral, 42 milligrams eliglustat, once daily.
Regimen L: In case that there is cytochrome P450 family 2 subfamily D member 6 poor metabolizer and patient weight is > 15 kg and patient weight is < 25 kg, oral, 21 milligrams eliglustat, once daily.
Before initiation of treatment with eliglustat, patients must be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status.
Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers.
Table 1. Paediatric population (from 6 to <18 years of age) weighing ≥15 kg:
| Weight | CYP2D6 EMs and IMs | CYP2D6 PMs |
|---|---|---|
| ≥50 kg | 84 mg twice daily | 84 mg once daily |
| 25 to <50 kg | 84 mg twice daily | 42 mg once daily |
| 15 to <25 kg | 42 mg twice daily | 21 mg once daily |
Cerdelga is to be taken orally in children who can swallow intact capsule.
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Eliglustat may be taken with or without food. Consumption of grapefruit or its juice should be avoided.
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