FINTEPLA Oral solution Ref.[27912] Active ingredients: Fenfluramine

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 section 4.4).

Posology

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

Table 1. Dosage recommendations for Dravet Syndrome:

^* 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:

^** 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. 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 section 5.2).

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 section 5.2).

A slower titration may be considered in patients with hepatic impairment. If adverse reactions are reported, a dose reduction may be needed (see section 5.2).

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 section 6.6).

Fintepla contains a very limited amount of digestible carbohydrates and is compatible with a ketogenic diet.

Only limited data have been reported concerning clinical effects and management of overdose of fenfluramine. Agitation, drowsiness, confusion, flushing, tremor (or shivering), fever, sweating, abdominal pain, hyperventilation, and dilated non-reactive pupils were reported at much higher doses of fenfluramine than those included in the clinical trial program.

Reportedly, the treatment of fenfluramine intoxication should include gastric lavage. Vital functions should be monitored closely, and supportive treatment administered in case of convulsions, arrhythmias, or respiratory difficulties.

4 years.

Shelf life after first opening: This medicinal product should be used within 3 months of first opening the bottle.

This medicinal product does not require any special storage conditions. Do not refrigerate or freeze.

Fintepla is presented in a white High Density Polyethylene (HDPE) bottle with a child-resistant, tamper-evident cap packaged in a carton, a Low Density Polyethylene (LDPE) press-in bottle adaptor, and Polypropylene (PP)/HDPE oral syringes. The oral syringe included in the pack should be used to administer the prescribed dose.

Presentations:

Bottle containing 60 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.

Bottle containing 120 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.

Bottle containing 250 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.

Bottle containing 360 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Inserting the bottle adaptor:

When the bottle is first opened the bottle adaptor must be pushed into the bottle.

Wash and dry hands.

Remove the bottle adaptor packaging.

Place the bottle on a flat, firm surface.

Open the bottle.

Hold the bottle firmly.

Align the bottle adaptor with the open top of the bottle.

Push the bottle adaptor into the bottle using the palm of the hand.

The bottle adaptor should be flush with the top of the bottle.

The bottle adaptor should not be removed after each use.

The bottle cap can be screwed onto the bottle with the bottle adaptor in place.

Cleaning the syringe:

Separate the plunger from the syringe to rinse each part.

Rinse the oral syringe with clean water and allow it to air dry after each use.

Rinse the inside of the syringe and the plunger.

The syringe and plunger can be cleaned in a dishwasher.

Clean water can be pulled into the syringe with the plunger and pushed out several times to clean the syringe.

The syringe and plunger must be completely dry before the next use.

Feeding tubes:

Fintepla oral solution is compatible with most enteral feeding tubes.

To flush the feeding tube, fill the syringe used for dosing with water and flush the tube. Do this 3 times.