| Common Brands | Fintepla |
|---|---|
|
Drug Class |
Fenfluramine Hydrochloride |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
Lower-cost generic available |
|
Availability |
Prescription only under REMS |
Fintepla (generic name: fenfluramine) is a prescription medicine used to treat seizures in people with rare types of epilepsy, specifically:
These are severe forms of epilepsy that usually begin in early childhood and are difficult to treat with standard anti-seizure medicines.
Fintepla is not a cure for epilepsy, but it helps reduce the number and severity of seizures in patients when other treatments have not worked well. It is taken by mouth in the form of a liquid solution.
Fintepla comes as a liquid solution that you take by mouth using a special measuring syringe provided with the medicine.
Instructions for use:
Important: Patients on Fintepla must be enrolled in the Fintepla REMS program, a safety program that monitors for heart problems (explained below).
Fintepla works in the brain by increasing the activity of serotonin, a chemical that helps regulate mood and brain activity. It is thought that by affecting serotonin, Fintepla can reduce the electrical signals in the brain that cause seizures.
While the exact way it works is still being studied, it has been shown to lower the frequency of seizures in children and adults with Dravet and Lennox-Gastaut syndromes.
Fintepla also has other actions in the nervous system that may help control excessive brain activity, making it useful for certain epilepsy syndromes that do not respond to traditional treatments.
Like all medicines, Fintepla may cause side effects. Some are mild, but others may be serious and require close monitoring.
Because of the risk of heart-related side effects, regular heart checks (echocardiograms) are required during treatment.
Fintepla comes with important safety warnings. Before starting, patients must go through a screening process and follow specific guidelines.
Patients who are pregnant or breastfeeding should speak to their doctor, as the safety of Fintepla in pregnancy is not well known.
Fintepla can interact with other medicines, especially:
Always inform your doctor of all medications and supplements you’re taking before starting Fintepla.
Your doctor will decide the best dose based on your weight, age, and other medications you are taking.
Regular follow-ups are needed to check:
Never increase or decrease your dose without your doctor’s advice.
Fintepla is a controlled substance and can only be prescribed by doctors enrolled in the Fintepla REMS program. This is a special program in the U.S. and other countries to ensure patient safety.
To receive Fintepla:
It cannot be bought over the counter or online without a prescription and REMS enrollment.
What is Fintepla used for?
It is used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years and older.
What is the brand name?
Fintepla® (U.S. and worldwide).
What is the active ingredient?
Fenfluramine hydrochloride, a serotonin-releasing agent.
How does Fintepla work?
It increases serotonin levels in the brain.
This helps stabilize abnormal electrical activity that causes seizures.
The exact anti-seizure mechanism is not fully understood but differs from traditional anti-epileptic drugs.
What type of medication is it?
An anti-epileptic (anticonvulsant) and serotonergic agent.
How is Fintepla taken?
By mouth as an oral solution (liquid).
Usually taken twice daily, with or without food.
Dosing is individualized and based on weight and response.
What are the available strengths?
Oral solution: 2.2 mg/mL (contains fenfluramine hydrochloride).
How long does it take to work?
Some patients notice fewer seizures within weeks, though full effect may take a few months.
What are the common side effects?
Decreased appetite or weight loss
Fatigue or sleepiness
Diarrhea
Constipation
Drooling
Increased blood pressure
Are there serious side effects?
Yes — Fintepla carries serious warnings for:
Valvular heart disease and pulmonary arterial hypertension (PAH)
Depression and suicidal thoughts (rare)
Sleepiness or fatigue affecting alertness
Low appetite and weight loss in children
Why does Fintepla require monitoring?
Because of its heart-related risks, patients must:
Have echocardiograms (heart ultrasound) before, during, and after treatment.
Be enrolled in a REMS (Risk Evaluation and Mitigation Strategy) program in the U.S.
Who should not take Fintepla?
Patients with a history of heart valve disease or pulmonary hypertension.
Those allergic to fenfluramine or similar compounds.
Avoid with MAO inhibitors (risk of serotonin syndrome).
Can Fintepla cause weight loss?
Yes — appetite loss and weight reduction are very common, especially in children.
Growth and nutrition should be regularly monitored.
Can it be used during pregnancy?
Not recommended — potential risk to the fetus; discuss with your doctor before use.
Can it be taken while breastfeeding?
Not advised — uncertain if it passes into breast milk.
Does Fintepla interact with other medications?
Yes — avoid or use caution with:
SSRIs, SNRIs, or MAO inhibitors (risk of serotonin syndrome)
CYP1A2, CYP2D6, and CYP2B6 inhibitors (may alter drug levels)
Stiripentol — requires lower Fintepla doses
How should I store Fintepla?
Store at room temperature (20 °C–25 °C / 68 °F–77 °F).
Keep tightly closed and discard any unused portion after 3 months of opening.
Is there a generic available?
No — Fintepla® is brand only.
Where can I get it?
Available by prescription only, through certified pharmacies under the Fintepla REMS program.
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