FINTEPLA

What it is

Fintepla is an oral solution containing fenfluramine hydrochloride 2.2 mg per millilitre. The solution is a clear, colourless, slightly viscous liquid. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Seizures associated with Dravet syndrome in patients 2 years of age and older, as add-on therapy. — Seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older, as add-on therapy.

Dosing overview

Fintepla should be initiated and supervised by physicians with experience in the treatment of epilepsy. All patients are started at 0.1 mg/kg twice daily and may be titrated every 7 days based on clinical response and tolerability, to an appropriate maintenance dose. The maximum daily maintenance dosage of Fintepla is based on whether patients are taking stiripentol concomitantly. For patients without stiripentol, the starting dose is 0.1 mg/kg twice daily with a maximum daily dose of 26 mg. For patients with stiripentol, the starting dose is 0.1 mg/kg twice daily with a maximum daily dose of 17 mg. Fintepla is to be administered orally and may be taken with or without food.

Key safety warnings

There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine, and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during and after treatment with Fintepla. Prior to starting treatment, patients must undergo an echocardiogram to assess the patient for the risk of valvular heart disease and pulmonary arterial hypertension to establish a baseline prior to initiating treatment and exclude any pre-existing valvular heart disease or pulmonary hypertension. Echocardiograms should be conducted every 6 months for the first 2 years and then annually. Fenfluramine can cause decreased appetite and weight loss. An additive effect on decreased appetite can occur when fenfluramine is combined with other anti-epileptic medicines, for example stiripentol. A benefit risk evaluation should be undertaken prior to commencing treatment with fenfluramine in patients with a history of anorexia nervosa or bulimia nervosa or who are significantly underweight or likely to be adversely impacted by further weight loss. Fenfluramine can cause somnolence. Other central nervous system depressants, including alcohol, could potentiate the somnolence effect of fenfluramine. Serotonin syndrome, a potentially life-threatening condition, may occur with fenfluramine treatment, particularly with concomitant use of other serotonergic agents; with agents that impair metabolism of serotonin such as monoamine oxidase inhibitors; or with antipsychotics that may affect serotonergic neurotransmitter systems.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Aortic or mitral valvular heart disease. Pulmonary arterial hypertension. Concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

PBS listing

Fintepla oral solution 2.2 mg (as hydrochloride) per mL is listed on the PBS in 360 mL bottles. There is 1 PBS item with authority required restriction at an ex-manufacturer price of A$4474.84.

Regulatory history

Fintepla (fenfluramine 2.2 mg/mL oral solution) was first registered on the ARTG on 28 November 2024. In November 2024, the PBAC recommended Fintepla as additional therapy for seizures associated with Dravet Syndrome on the General Schedule with authority required listing, noting effective therapy with significant improvement in efficacy over cannabidiol and acceptable cost-effectiveness at the proposed price.