Fintepla 2.2 mg/mL oral solution

Fintepla (Fenfluramine) 2.2 mg/mL Oral Solution is a prescription medication used to treat seizures associated with Dravet syndrome in patients aged 2 years and older. Dravet syndrome is a rare, severe form of epilepsy that begins in infancy. Fintepla works by reducing the frequency and severity of seizures, offering hope to patients and families dealing with this challenging condition.

How Fintepla Works

Mechanism of Action:

Fintepla contains fenfluramine, a drug that was originally used as an appetite suppressant. However, it has been repurposed for the treatment of epilepsy due to its effects on serotonin levels in the brain. Here’s how it works:

1. Serotonin Release: Fenfluramine increases the release of serotonin, a neurotransmitter that plays a crucial role in regulating mood, appetite, and seizures. It stimulates the release of serotonin from nerve terminals and inhibits its reuptake, leading to increased serotonin levels in the brain.
2. Serotonin Receptor Activation: The elevated serotonin levels activate specific serotonin receptors, particularly the 5-HT2A and 5-HT2C receptors. This activation is believed to reduce neuronal excitability and inhibit the spread of seizure activity in the brain.
3. Reduction in Seizures: By modulating serotonin levels and receptor activity, Fintepla helps to stabilize neuronal firing, reducing the frequency and severity of seizures in patients with Dravet syndrome.
4. Neuroprotective Effects: There is also evidence suggesting that fenfluramine may have neuroprotective properties, potentially safeguarding neurons from damage due to excessive excitation during seizures.

Side Effects

Like all medications, Fintepla can cause side effects. Patients and caregivers should be aware of these potential risks and monitor for any signs of adverse reactions.

Common Side Effects:

• Decreased Appetite: Loss of appetite is a common side effect, which can lead to weight loss in some patients.
• Fatigue: Patients may experience tiredness or lethargy, which can affect daily activities.
• Diarrhea: Gastrointestinal discomfort, including diarrhea, can occur with Fintepla use.
• Sleepiness (Somnolence): Some patients may feel unusually sleepy or drowsy.
• Irritability: Changes in mood, including irritability or agitation, have been reported.

Serious Side Effects:

• Cardiac Valve Disease: Fenfluramine has been associated with an increased risk of heart valve problems. Regular cardiac monitoring is recommended during treatment.
• Pulmonary Arterial Hypertension (PAH): A rare but serious condition where the blood pressure in the arteries of the lungs becomes elevated, leading to heart problems.
• Increased Blood Pressure: Monitoring of blood pressure is advised as Fintepla may cause elevations in blood pressure.
• Depression and Suicidal Thoughts: As with many medications affecting the central nervous system, there is a risk of depression and suicidal ideation, particularly in patients with a history of mental health disorders.

Indications

Fintepla is specifically indicated for the treatment of seizures associated with Dravet syndrome, a condition that is notoriously difficult to manage with standard antiepileptic drugs.

Approved Indications:

• Seizures Associated with Dravet Syndrome: Fintepla is approved for the treatment of seizures in patients aged 2 years and older with Dravet syndrome.

Contraindications

There are several conditions and situations in which Fintepla should not be used.

Contraindications:

• Hypersensitivity: Fintepla is contraindicated in patients with a known hypersensitivity to fenfluramine or any of the ingredients in the oral solution.
• History of Cardiac Valve Disease: Due to the risk of cardiac valve disease, Fintepla should not be used in patients with a history of valvular heart disease.
• History of Pulmonary Arterial Hypertension (PAH): Patients with a history of PAH should not use Fintepla due to the risk of exacerbating this condition.
• Concurrent Use with MAO Inhibitors: Fintepla should not be used in patients taking monoamine oxidase inhibitors (MAOIs), as this combination can lead to dangerously high serotonin levels (serotonin syndrome).

Price in Different Countries

The cost of Fintepla varies across different countries depending on factors such as healthcare system, insurance coverage, and local pricing regulations. Below is a table showing the approximate cost of Fintepla in various countries.

Country	Price (Per Unit)	Reference
United States	$1,200 – $1,500	GoodRx
United Kingdom	£900 – £1,100	NHS UK
Canada	CAD $1,500 – $1,800	DrugBank
Australia	AUD $1,600 – $1,900	PBS Australia
Germany	€1,000 – €1,200	G-BA Germany

Top 5 Global Brands

While Fintepla is a unique product for treating Dravet syndrome, there are other pharmaceutical companies known for producing antiepileptic medications and managing rare diseases.

1. Zogenix

• Zogenix is the developer of Fintepla and is focused on therapies for rare diseases, particularly severe forms of epilepsy.

2. Eisai Co., Ltd.

• Eisai is known for its portfolio of antiepileptic drugs, including Fycompa (perampanel) and Zonegran (zonisamide).

3. UCB Pharma

• UCB is a leader in epilepsy treatment with drugs like Keppra (levetiracetam) and Vimpat (lacosamide).

4. GW Pharmaceuticals

• Known for Epidiolex (cannabidiol), GW Pharmaceuticals focuses on innovative treatments for rare and severe forms of epilepsy.

5. Biogen

• Biogen specializes in neurological disorders, including multiple sclerosis and spinal muscular atrophy, and is involved in research for new epilepsy treatments.