Posology : מינונים

4.2       Posology and method of administration

Fintepla should be initiated by a neurologist with experience treating epilepsy and overseen by a clinician with experience treating epilepsy.


Posology
Paediatric (children aged 2 years and older) and adult populations


Table 1: Dosage recommendations for Dravet Syndrome
without stiripentol                 with stiripentol
Starting dose – first week                 0.1 mg/kg taken twice daily (0.2 mg/kg/day) 
Maintenance dose
0.2 mg/kg twice daily
Day 7 - second week*                                                   0.2 mg/kg twice daily (0.4 mg/kg/day)
(0.4 mg/kg/day)

Day 14 - Further titration as
0.35 mg/kg twice daily applicable*                                                           Not applicable (0.7 mg/kg/day)

26 mg                              17 mg
Maximal recommended dose               (13 mg twice daily i.e.           (8.6 mg twice daily i.e.
6.0 mL twice daily)                4.0 mL twice daily)

* For patients who are tolerating fenfluramine and require a further reduction of seizures. For patients requiring more rapid titration, the dose may be increased every 4 days.

If the calculated dose is 3.0 mL or less, the green printed 3 mL syringe should be used.
If the calculated dose is more than 3.0 mL, the purple printed 6 mL syringe should be used.
The calculated dose should be rounded to the nearest graduated increment.

Table 2. Dosage recommendations for Lennox-Gastaut Syndrome
0.1 mg/kg taken twice daily
Starting dose – first week
(0.2 mg/kg/day)
0.2 mg/kg twice daily
Day 7 - second week**
(0.4 mg/kg/day)
0.35 mg/kg twice daily
Day 14 - maintenance dose**
(0.7 mg/kg/day)
26 mg
Maximal recommended dose
(13 mg twice daily i.e. 6.0 mL twice daily)
**The dosage should be increased as tolerated to the recommended maintenance dosage (i.e., Day 14).

If the calculated dose is 3.0 mL or less, the green printed 3 mL syringe should be used.
If the calculated dose is more than 3.0 mL, the purple printed 6 mL syringe should be used.
The calculated dose should be rounded to the nearest graduated increment.

Discontinuation of treatment

When discontinuing treatment, the dose should be decreased gradually. As with all anti-epileptic medicines, abrupt discontinuation should be avoided when possible to minimize the risk of increased seizure frequency and status epilepticus.

Special populations

Patients with renal impairment
There are no clinical data available in subjects with renal impairment.


Patients with hepatic impairment
There are no clinical data available in subjects with hepatic impairment.
Administration to patients with moderate or severe liver impairment is not recommended.
Elderly
There are no data on the use of Fintepla in elderly patients.

Paediatric population
The safety and efficacy of Fintepla in children below 2 years of age has not yet been established. No data are available.

Method of administration

Fintepla is to be administered orally.
Fintepla may be taken with or without food.
Fintepla is compatible with commercially available gastric and nasogastric feeding tubes (see section 6.6).
Fintepla contains a very limited amount of digestible carbohydrates and is compatible with a ketogenic diet.