Fintepla (fenfluramine)
An approved treatment for Dravet Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Fenfluramine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Fenfluramine
- Brand name
- Fintepla
- Drug class
- Serotonergic anticonvulsant
- Manufacturer
- UCB Pharma (originally Zogenix)
- How it's taken
- Taken by mouth as an oral solution, typically twice daily.
A low-dose serotonin medication that reduces seizure frequency by activating specific brain receptors involved in seizure control. Has a boxed warning because it can cause heart valve disease and pulmonary arterial hypertension, so heart ultrasounds are required before, during, and after treatment.
We'll email you when Fintepla's FDA label changes, when the FDA acts on it, and when new trials for Dravet Syndrome open. Unsubscribe anytime.
Where Fenfluramine fits
Treatment for seizures associated with Dravet syndrome in people 2 years and older, usually used alongside other seizure medicines. Requires cardiac monitoring through a REMS program.
How Fenfluramine works
Fenfluramine increases serotonin activity in the brain by releasing stored serotonin and activating serotonin 5-HT2 receptors. It also works through sigma-1 receptors.
These combined serotonergic pathways strengthen the brain's natural seizure-suppressing circuits. The low doses used for Dravet (much lower than the weight-loss doses that caused heart problems in the 1990s) have a different safety profile.
Mechanism: Serotonin-releasing agent and 5-HT2 receptor agonist with sigma-1 receptor positive modulation, reducing seizure activity through multiple serotonergic pathways
Side effects and safety
Common side effects include decreased appetite, diarrhea, fatigue, fever, weight loss, drowsiness, coordination problems, drooling, and constipation. Fintepla has a boxed warning: it can cause heart valve disease and pulmonary arterial hypertension (high blood pressure in the lungs). No cases were seen in clinical trials of up to 3 years, but cases have been reported since the drug came on the market. Echocardiograms (heart ultrasounds) are required before starting, every 6 months during treatment, and once 3 to 6 months after stopping. The label also warns about suicidal thoughts or behavior and serotonin syndrome (a possibly life-threatening reaction, especially with other serotonin drugs; do not use within 14 days of an MAOI). Other warnings are raised blood pressure (blood pressure should be checked), sudden eye pain or vision loss from glaucoma, and more seizures if it is stopped suddenly.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Fenfluramine
Taken by mouth as an oral solution, typically twice daily. Dosing starts low (0.2 mg/kg/day) and is gradually increased based on tolerability. Available only through a restricted distribution program (REMS) that requires cardiac monitoring.
Availability and cost
Only available as the brand-name product.
Serotonergic anti-seizure medication requiring enrollment in a REMS program due to historical cardiac valve concerns. Specialty pricing with risk management overhead.
Help paying for Fintepla
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 and no more than $25 per refill; limits apply. Not for Medicare, Medicaid or other government plans.
For: private insurance · source - Free medicine program
If you have no insurance or your plan does not cover FINTEPLA, ONWARD may be able to help you get access. Call ONWARD to check eligibility.
For: no insurance · source - Insurance and case manager help
A dedicated Care Coordinator reviews insurance coverage and approval status, helps find echocardiogram locations, and connects families with the program pharmacy for refills.
The official page does not say who qualifies. Ask the program. · source - Other support
At-Home Echo Program: a sonographer can come to your home for required heart echocardiograms if you cannot reach an echo facility because of location or disability.
The official page does not say who qualifies. Ask the program. · source
Good to know: UCB's pricing page says the copay program can also cover the echocardiograms FINTEPLA requires. UCB also runs a general UCB Patient Assistance Program (1-844-599-2273) that gives some UCB medicines at no cost to eligible uninsured or underinsured patients; that page does not list which medicines are included.
- From a charity · Dravet Syndrome FoundationPatient Assistance Grant (PAG) Program fundOpen
Pays for: Medical equipment, therapy devices and educational aids, up to $1,500 per year.
The foundation says: “Our grant application period runs from January 1st – November 30th each year. We cannot accept applications during the month of December.”
Clinical trial results
Two Phase 3 trials in 202 Dravet patients aged 2-18 showed fenfluramine significantly reduced seizure frequency vs. placebo, with reductions evident within 3-4 weeks. Also approved for Lennox-Gastaut syndrome.
Development history
Fenfluramine (Pondimin) was originally marketed for weight loss but was withdrawn in 1997 due to heart valve damage at high doses. Zogenix reformulated it at much lower doses for Dravet syndrome and demonstrated safety with cardiac monitoring. FDA approval came in June 2020. UCB acquired Zogenix in 2022.
Explore Dravet Syndrome trials
Other Dravet Syndrome treatments
Fenfluramine in Trial Friend News and Guides
Common questions about Fenfluramine
▸What is Fenfluramine (Fintepla)?
A low-dose serotonin medication that reduces seizure frequency by activating specific brain receptors involved in seizure control. Has a boxed warning because it can cause heart valve disease and pulmonary arterial hypertension, so heart ultrasounds are required before, during, and after treatment.
▸How does Fenfluramine work?
Fenfluramine increases serotonin activity in the brain by releasing stored serotonin and activating serotonin 5-HT2 receptors. It also works through sigma-1 receptors.
These combined serotonergic pathways strengthen the brain's natural seizure-suppressing circuits. The low doses used for Dravet (much lower than the weight-loss doses that caused heart problems in the 1990s) have a different safety profile.
▸What are the side effects of Fenfluramine?
Common side effects include decreased appetite, diarrhea, fatigue, fever, weight loss, drowsiness, coordination problems, drooling, and constipation. Fintepla has a boxed warning: it can cause heart valve disease and pulmonary arterial hypertension (high blood pressure in the lungs). No cases were seen in clinical trials of up to 3 years, but cases have been reported since the drug came on the market. Echocardiograms (heart ultrasounds) are required before starting, every 6 months during treatment, and once 3 to 6 months after stopping. The label also warns about suicidal thoughts or behavior and serotonin syndrome (a possibly life-threatening reaction, especially with other serotonin drugs; do not use within 14 days of an MAOI). Other warnings are raised blood pressure (blood pressure should be checked), sudden eye pain or vision loss from glaucoma, and more seizures if it is stopped suddenly.
▸How is Fenfluramine taken?
Taken by mouth as an oral solution, typically twice daily. Dosing starts low (0.2 mg/kg/day) and is gradually increased based on tolerability. Available only through a restricted distribution program (REMS) that requires cardiac monitoring.
▸Is Fenfluramine FDA approved?
Yes, Fenfluramine (Fintepla) is FDA approved (2020) for the treatment of Dravet Syndrome.
▸Is fenfluramine the same drug that caused heart problems in the 1990s?
It is the same molecule, but at a much lower dose and for a completely different purpose. In the 1990s, fenfluramine was used at high doses (60-120 mg/day) for weight loss in combination with phentermine (fen-phen), which caused heart valve damage. Fintepla uses dramatically lower doses (0.2-0.7 mg/kg/day, typically under 30 mg/day) for seizure control. In clinical trials of up to 3 years, no patients taking Fintepla developed heart valve disease or pulmonary arterial hypertension, but cases have since been reported in people taking Fintepla, so the label carries a boxed warning and regular echocardiograms are required.
▸Why does fenfluramine require heart monitoring?
Because of the historical association with heart valve damage at higher weight-loss doses, the FDA requires patients on Fintepla to undergo echocardiograms (heart ultrasounds) before starting treatment, every 6 months during treatment, and once 3 to 6 months after the final dose. This monitoring is part of the mandatory REMS program. No patients in the Dravet and Lennox-Gastaut clinical trials (up to 3 years) developed heart valve disease or pulmonary arterial hypertension, but cases have been reported since Fintepla came on the market, which is why this monitoring matters.
▸How effective is fenfluramine for Dravet seizures?
In Phase 3 trials, fenfluramine reduced convulsive seizure frequency by about 60% to 70% more than placebo at the higher doses (70% at 0.7 mg/kg/day, and 59.5% at 0.4 mg/kg/day with stiripentol). The lowest dose, 0.2 mg/kg/day, reduced seizures by about 32% more than placebo. Some patients achieved seizure-free periods. No head-to-head trial has compared fenfluramine with the other approved Dravet medicines. Long-term extension data shows sustained benefit over multiple years.
▸Can fenfluramine be used with other Dravet medications?
Yes. Fenfluramine is approved to treat seizures associated with Dravet syndrome and is typically used alongside other anti-seizure medications. It was studied in combination with stiripentol-containing regimens and without stiripentol, showing benefit in both settings. However, the maximum dose differs depending on whether stiripentol is part of the regimen, because stiripentol inhibits the enzymes that metabolize fenfluramine.
▸What is the REMS program for Fintepla?
Fintepla is available only through a Risk Evaluation and Mitigation Strategy (REMS) program because of the cardiac monitoring requirement. The REMS requires that prescribers, pharmacies, and patients are all enrolled. Patients must undergo echocardiograms before starting and every 6 months during treatment. Only certified pharmacies can dispense the drug. This program ensures appropriate cardiac surveillance throughout treatment.