A new standard in seizure control
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.1
Dr. Nicola Specchio is Head of the Epilepsy Unit in the Department of Neuroscience at Bambino Gesù Children's Hospital, Rome, Italy. He is also a representative of the International League Against Epilepsy (ILAE) Europe and of the Italian Chapter of the ILAE.
Dr. Specchio was a lead investigator of the "Efficacy and safety of Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: A real-world study", in which 52 people (aged between 2.1y and 28.6y) with Dravet syndrome were treated with add-on Fintepla as part of an Early Access Programme which included 4 Italian paediatric epilepsy centres.2
In this video Dr. Specchio provides practical advice on how to initiate your patient with Dravet syndrome on Fintepla and answers questions on how to prescribe. You can either jump to specific sections or watch the whole video by selecting 'Watch all'.
Which patients could benefit from Fintepla?
8 mins 25 secs
Fintepla should be initiated and supervised by healthcare professionals with experience in the treatment of epilepsy.
Steps to initiation for your patient with Dravet syndrome with treatment-resistant seizures
*Please refer to contraindications in the Summary of Product Characteristics.
**Echocardiogram monitoring should be conducted every 6 months for the first 2 years and annually thereafter.
Fintepla is prescribed and dispensed according to the Fintepla Controlled Access Programme.
Because of the potential risk of developing regurgitant aortic or mitral valvular heart disease, cardiac monitoring must be performed using echocardiography. In clinical trials of more than 1 year in duration, no patient with Dravet syndrome receiving Fintepla developed regurgitant valvular heart disease.
Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline prior to initiating treatment and exclude any pre-existing valvular heart disease or pulmonary arterial hypertension (PAH).
Echocardiograms should be performed at baseline, every 6 months for the first 2 years, and annually thereafter.
If an echocardiogram indicates pathological valvular changes, a follow-up echocardiogram should be considered at an earlier timeframe to evaluate whether the abnormality is persistent. If pathological abnormalities on the echocardiogram are observed, it is recommended to evaluate benefit versus risk of continuing Fintepla treatment with the prescriber, caregiver and cardiologist.
If echocardiogram findings are suggestive of PAH*, a repeat echocardiogram should be performed as soon as possible and within 3 months to confirm these findings. If the echocardiogram finding is confirmed suggestive of an increased probability of PAH*, it should lead to a benefit versus risk evaluation of continuation of Fintepla by the prescriber, carer, and cardiologist. If the echocardiogram finding, after confirmation, suggests a high probability of PAH*, it is recommended fenfluramine treatment should be stopped.
Dosing without stiripentol1
For patients not receiving stiripentol: based on effectiveness and tolerability, the dose can be increased to a maximum of 0.35mg/kg twice daily (0.7mg/kg/day) which is the recommended maintenance dose. The maximum daily dose of 26mg (13mg twice daily i.e. 6.0mL twice daily) should not be exceeded.
Dosing with concomitant stiripentol1
For patients who are receiving stiripentol: based on effectiveness and tolerability, the dose can be increased to a maximum of 0.2mg/kg twice daily (0.4mg/kg/day) which is the recommended maintenance dose. The maximum daily dose of 17mg (8.6mg twice daily i.e. 4.0mL twice daily) should not be exceeded.
Fintepla has a well-characterised safety profile.1 No worsening of cognition* and a low discontinuation rate was observed in
add-on Fintepla clinical trials in patients with Dravet syndrome.4,5
Adverse reactions reported with Fintepla in placebo-controlled clinical studies are listed in the table below by MedDRA System organ class and frequency:1
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10).
Most commonly reported adverse reactions are shown in bold.
*As assessed by the Behavior Rating Inventory of Executive Function® (BRIEF®) or BRIEF®—Preschool Version (BRIEF®-P), tools used to determine if there were any negative effects of Fintepla on executive function, a construct of cognition.
- Fintepla Summary of Product Characteristics. Accessed May 2021.
- Specchio N, Pietrafusa N, Doccini V, et al. Efficacy and safety of Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: A real‐world study. Epilepsia. 2020;61(11):2405-2414.
- Fintepla Package leaflet. Accessed May 2021.
- Lagae L, Sullivan J, Knupp K, et al; FAiRE DS Study Group. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019;394(10216):2243-2254.
- Nabbout R, Mistry A, Zuberi S, et al. Fenfluramine for treatment-resistant seizures in patients with Dravet syndrome receiving stiripentol-inclusive regimens: a randomized clinical trial. JAMA Neurol. 2020;77(3):300-308.