FINTEPLA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENFLURAMINE AS HYDROCHLORIDE

Available from:

MEDISON PHARMA LTD

ATC code:

A08AA02

Pharmaceutical form:

ORAL SOLUTION

Composition:

FENFLURAMINE AS HYDROCHLORIDE 2.2 MG / 1 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ZOGENIX INC, USA

Therapeutic area:

FENFLURAMINE

Therapeutic indications:

Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older

Authorization date:

2022-03-29

Patient Information leaflet

Important information
about Fintepla for patients
and their parents
This guide has been prepared in coordination with the Ministry
of Health as an additional measure for the minimization of risks;
it is designed to ensure that patients and their parents become
familiar with the characteristics of Fintepla (fenfluramine),
thereby reducing the potential risk of certain side effects.
FINTEPLA
® (FENFLURAMINE)
Please read the Patient Information leaflet before use.
This medication is subject to additional monitoring. This enables the
rapid
identification of new safety findings.
You can help by reporting any side effects that occur. Please read the
last page for
information regarding reporting of side effects.
This guide is designed for patients and their parents.
FIN0030
INTRODUCTION
Fintepla (fenfluramine) has been prescribed for you or for your child
for the treatment of
seizures associated with Dravet syndrome or Lennox-Gastaut syndrome.
This guide includes
information about the risks associated with fenfluramine as well as
the tests and follow ups
required during the treatment with fenfluramine.
The attending physician will speak with you about this guide. Use the
conversation to ask any
questions you may have.
Keep this guide in a safe place so that you will be able to look at it
later.
In addition, please read the Patient Information leaflet for more
information about fenfluramine.
WHAT ARE THE RISKS ASSOCIATED WITH FENFLURAMINE?
There are two potential risks associated with fenfluramine treatment,
which require regular
follow up:
•
Development of valvular heart disease
•
Development of pulmonary arterial hypertension (PAH)
However, no patient has developed valvular heart disease or pulmonary
arterial hypertension
in any of the clinical trials conducted in patients with Dravet
syndrome or Lennox-Gastaut
syndrome under treatment with Fintepla. These are not the only risks
associated with
fenfluramine. Additional risks are described in the Patient
Information leaflet.
WHAT IS VALVULAR HEART DISEASE, AND WHY

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Fintepla
Patient and patient's parent safety information guide
The marketing of Fintepla is subject to a Risk management plan (RMP)
including a "patient and patient's
parent safety information guide". The "patient and patient's safety
information guide", emphasizes important
safety information that the patient or his parent should be aware of
before and during the treatment. Please
explain to the patient or his parent the need to review the guide
before starting treatment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 2.2 mg of fenfluramine (as fenfluramine
hydrochloride).
Excipient(s) with known effect
Glucose (maize): 0.627 mg/mL
Sodium ethyl para-hydroxybenzoate (E 215): 0.23 mg/mL
Sodium methyl para-hydroxybenzoate (E 219): 2.3 mg/mL
Sulfur dioxide (E 220): 0.000009 mg/mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless, slightly viscous liquid, with a pH of 5.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Fintepla is indicated for the treatment of seizures associated with
Dravet syndrome and Lennox-
Gastaut syndrome as an add-on therapy to other anti-epileptic
medicines for patients 2 years of
age and older.
Fintepla is not indicated for the treatment of obesity
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
2
without
stiripentol
with
stiripentol
Starting dose – first week
0.1 mg/kg taken twice daily (0.2 mg/kg/day)
Day 7 - second week*
0.2 mg/kg twice daily
(0.4 mg/kg/day)
Maintenance dose
0.2 mg/kg twice daily
(0.4 mg/kg/day)
Day 14 - Further titration as
applicable*
0.35 mg/kg twice daily
(0.7 mg/kg/day)
Not applicable
Maximal recommended dose
26 mg
(13 mg twice daily i.e.
6.0 mL twice daily)
17 mg
(8.6 mg twice daily i.