Active Ingredient: Levacetylleucine
Levacetylleucine is indicated for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease, in combination with miglustat, or as a monotherapy in patients where miglustat is not tolerated, in adults and children aged 6 years and older and weighing at least 20 kg.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is ≤ 24 kg
Oral, 1 milligrams levacetylleucine, 2 times daily.
Regimen B, in case that patient age in years is ≥ 6 and patient weight is ≥ 25 kg and patient weight is ≤ 34 kg
Oral, 1 milligrams levacetylleucine, 3 times daily.
Regimen C, in case that patient age in years is ≥ 6 and patient weight is ≥ 35 kg
Oral, 4 milligrams levacetylleucine, divided 3 times daily.
The recommended dose is based on the patient's body weight in kg according to the following table. Food and drink should be avoided 0.5 hours before and 2 hours after administration.
Recommended dose:
| Patient's body weight | Morning dose | Afternoon dose | Evening dose |
| 20 to 24 kg | 1 g | No dose | 1 g |
| 25 to 34 kg | 1 g | 1 g | 1 g |
| 35 kg or more | 2 g | 1 g | 1 g |
If a dose is missed, it should be skipped, and the next dose should be taken as scheduled.
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