Prescribing Fintepla

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

View the European Summary of Product Characteristics for Fintepla here

Prescribing advice from Dr. Nicola Specchio

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'.

Patient selection

Which patients could benefit from Fintepla?

Watch all
8 mins 25 secs
Patient selection - 1 min 15 secs
How to initiate - 1 min 25 secs
Contraindications - 1 min 26 secs
Cardiac monitoring - 1 min 18 secs
Controlled Access Programme - 1 min 10 secs
Side effects - 51 secs
Summary - 1 min

How to prescribe

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.

Controlled Access Programme (CAP)

Four quick and easy steps

CAP process

If you are a healthcare professional in Germany and wish to prescribe Fintepla, you can obtain your CAP ID here

IMPORTANT: In order for Fintepla prescriptions to be fulfilled and dispensed in pharmacy, the prescriber must 

add their CAP ID to the prescription. The pharmacy will be unable to dispense Fintepla without it

Contraindications


  • Hypersensitivity to the active substance or any of the excipients listed in section 6.1 of the Summary of Product Characteristics
  • Aortic or mitral valvular heart disease
  • Pulmonary arterial hypertension
  • Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome
Echocardiograms1

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.

*As defined by the 2015 European Society of Cardiology (ESC) and European Respiratory Society (ERS) Guidelines.

PAH, pulmonary arterial hypertension.

Dosing and titration for children (aged 2 years and older) and adults1

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 table without stiripentol

* For patients requiring more rapid titration, the dose may be increased every 4 days

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.

Dosing table with stiripentol

* For patients requiring more rapid titration, the dose may be increased every 4 days

Safety

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

Safety data adverse events

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.

View references

  1. Fintepla Summary of Product Characteristics. Accessed May 2021.
  2. 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.
  3. Fintepla Package leaflet. Accessed May 2021.
  4. 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.
  5. 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.

Adverse events should be reported.

Please refer to section 4.8 of the SmPC for national reporting requirements in your country.

Adverse events should also be reported to Zogenix International Limited on +44 (0)800 060 8767 or email medinfo.eu@zogenix.com