Fintepla Dosage/Direction for Use

Fintepla should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Fintepla is prescribed and dispensed according to the Fintepla controlled access programme (see Precautions).
Posology: Paediatric (children aged 2 years and older) and adult populations: See Table 5.

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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. (See Table 6.)

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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. A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine.
Special populations: Patients with renal impairment: Generally, no dose adjustment is recommended when Fintepla is administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are reported, a dose reduction may be needed (see Pharmacology: Pharmacokinetics under Actions).
Fintepla has not been studied in patients with end-stage renal disease. It is not known if fenfluramine or its active metabolite, norfenfluramine, is dialyzable.
There are no specific clinical data on the use of Fintepla with stiripentol in patients with impaired renal function. Fintepla is therefore not recommended for use in patients with impaired renal function treated with stiripentol.
Patients with hepatic impairment: Generally, no dose adjustment is recommended when Fintepla is administered without concomitant stiripentol to patients with mild and moderate hepatic impairment (Child-Pugh Class A and B).
In patients with severe hepatic impairment (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage for these patients is 0.2 mg/kg twice daily, and the maximal total daily dose is 17 mg.
There are limited clinical data on the use of Fintepla with stiripentol in patients with mild impaired hepatic function (see Pharmacology: Pharmacokinetics under Actions).
A slower titration may be considered in patients with hepatic impairment. If adverse reactions are reported, a dose reduction may be needed (see Pharmacology: Pharmacokinetics under Actions).
There are no clinical data on the use of Fintepla with stiripentol in patients with moderate and severe impaired hepatic function. Fintepla is therefore not recommended for use in patients with moderate and severe hepatic impairment treated with stiripentol.
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 Special precautions for disposal and other handling under Cautions for Usage).
Fintepla contains a very limited amount of digestible carbohydrates and is compatible with a ketogenic diet.