Fintepla: Uses, Dosage & Side Effects
A serotonergic antiepileptic oral solution used as add-on therapy for seizure reduction in patients aged 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome
Fintepla (fenfluramine) is a serotonergic antiepileptic medication approved as add-on therapy for the treatment of seizures in patients aged 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome. Fenfluramine works primarily by increasing serotonin activity in the brain and by acting as a positive modulator of the sigma-1 receptor, which together help reduce seizure frequency and severity. Fintepla is available as an oral solution (2.2 mg/mL) taken twice daily, with doses carefully titrated based on body weight and whether the patient is also taking stiripentol. Due to historical associations of fenfluramine with cardiac valvulopathy at higher doses, all patients require regular cardiac monitoring with echocardiography before, during, and after treatment.
Quick Facts: Fintepla
Key Takeaways
- Fintepla (fenfluramine) is an add-on antiepileptic medication specifically approved for patients aged 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome – two severe, treatment-resistant forms of childhood-onset epilepsy.
- Regular cardiac monitoring with echocardiography is mandatory: before starting treatment, every 6 months for the first 2 years, annually thereafter, and 3–6 months after stopping. Fintepla must not be used in patients with heart valve disease or pulmonary arterial hypertension.
- Dosing is weight-based and administered twice daily. The maximum dose without stiripentol is 13.2 mg (6 mL) twice daily, reduced to 8.8 mg (4 mL) twice daily when taken with stiripentol due to metabolic interaction.
- Fintepla carries a risk of serotonin syndrome when combined with other serotonergic medications such as SSRIs, SNRIs, triptans, or MAO inhibitors. MAO inhibitors are absolutely contraindicated within 2 weeks of Fintepla use.
- Treatment should not be stopped abruptly due to the risk of rebound seizures and status epilepticus. Doses must be gradually tapered under medical supervision, and a follow-up echocardiogram is required after discontinuation.
What Is Fintepla and What Is It Used For?
Fintepla contains the active substance fenfluramine, a compound that enhances serotonergic neurotransmission in the central nervous system. Fenfluramine was originally developed and marketed as an appetite suppressant in the 1970s and 1980s, but was withdrawn from worldwide markets in 1997 due to an association with heart valve disease and pulmonary arterial hypertension when used at high doses (60–120 mg daily) for weight loss. However, subsequent research revealed that at substantially lower doses, fenfluramine possesses remarkable anticonvulsant properties, particularly in the severe developmental and epileptic encephalopathies of childhood.
The rediscovery of fenfluramine as an antiepileptic agent arose from a remarkable observation in Belgium, where a physician documented dramatic seizure reduction in patients with Dravet syndrome who were treated with low-dose fenfluramine as part of a compounding pharmacy preparation. This clinical observation led to formal clinical trials that eventually resulted in regulatory approval. The doses used for epilepsy (typically 0.2–0.7 mg/kg/day) are far below the doses that were previously associated with cardiac adverse effects (up to 120 mg/day for obesity), although cardiac monitoring remains a mandatory safety precaution.
Fenfluramine’s antiepileptic mechanism of action is believed to involve two main pathways. First, it increases the release of serotonin (5-hydroxytryptamine, or 5-HT) from presynaptic neurons and inhibits its reuptake, thereby raising serotonin levels in the synaptic cleft. Serotonin plays a complex role in modulating neuronal excitability, and enhanced serotonergic signaling has been shown to suppress seizure activity in multiple experimental models of epilepsy. Second, fenfluramine acts as a positive modulator of the sigma-1 receptor, a chaperone protein located on the endoplasmic reticulum that is involved in regulating ion channel activity, neuroplasticity, and cellular stress responses. The combination of these two mechanisms is thought to provide the potent anticonvulsant effect observed in clinical practice.
Fintepla is specifically indicated for two severe forms of epilepsy. Dravet syndrome (previously known as severe myoclonic epilepsy of infancy) is a rare genetic epilepsy syndrome that typically begins in the first year of life and is most commonly caused by loss-of-function mutations in the SCN1A gene, which encodes a voltage-gated sodium channel subunit. Patients with Dravet syndrome experience frequent, prolonged, and often treatment-resistant seizures, along with developmental delays, behavioral difficulties, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Lennox-Gastaut syndrome (LGS) is another severe epileptic encephalopathy characterized by multiple seizure types (including tonic, atonic, and atypical absence seizures), an abnormal electroencephalogram (EEG) pattern with slow spike-and-wave complexes, and cognitive impairment. Both conditions are notoriously difficult to treat with conventional antiepileptic drugs, making the addition of Fintepla a significant therapeutic advance.
In clinical trials, Fintepla demonstrated impressive efficacy. In the pivotal Study 1504 for Dravet syndrome, patients receiving fenfluramine experienced a median reduction in monthly convulsive seizure frequency of approximately 62–75% compared to baseline, with a significant proportion of patients achieving greater than 50% seizure reduction. Similar meaningful reductions in seizure frequency have been observed in Lennox-Gastaut syndrome trials, where Fintepla reduced the frequency of drop seizures (tonic and atonic seizures that cause falls) by a clinically significant margin compared to placebo.
Dravet syndrome affects approximately 1 in 15,000–40,000 births and is one of the most severe childhood-onset epilepsies. Lennox-Gastaut syndrome accounts for approximately 1–10% of all childhood epilepsies and typically develops between ages 3 and 5 years, often after other epilepsy syndromes such as West syndrome. Both conditions require lifelong multidisciplinary management involving neurologists, developmental specialists, physiotherapists, and psychologists. Fintepla represents one of only a handful of medications specifically approved for these devastating conditions.
What Should You Know Before Taking Fintepla?
Contraindications
There are specific situations in which Fintepla must absolutely not be used. These contraindications exist to protect patients from potentially serious or life-threatening adverse effects.
- Hypersensitivity: Do not take Fintepla if you or your child are allergic to fenfluramine or any of the other ingredients in the formulation, including sodium ethyl para-hydroxybenzoate (E215), sodium methyl para-hydroxybenzoate (E219), sucralose (E955), hydroxyethylcellulose (E1525), sulfur dioxide (E220), or any other excipient.
- Heart valve disease: Fintepla is contraindicated in patients with aortic or mitral valvulopathy (heart valve disease), as fenfluramine has a historical association with valvular heart damage when used at higher doses.
- Pulmonary arterial hypertension: Patients with pulmonary arterial hypertension (high blood pressure in the arteries between the heart and lungs) must not take Fintepla, as fenfluramine has been linked to this potentially fatal condition.
- MAO inhibitors: Do not take Fintepla if you or your child have taken a monoamine oxidase inhibitor (MAOI) within the previous 2 weeks. The combination of fenfluramine with MAOIs can lead to dangerous elevations in serotonin levels, potentially causing serotonin syndrome.
Warnings and Precautions
Before starting Fintepla, your doctor must perform an echocardiogram (cardiac ultrasound) to confirm that the heart valves are functioning normally and that the pressure in the pulmonary arteries is not elevated. Once treatment begins, echocardiography must be repeated every 6 months for the first 2 years, then once a year for the duration of treatment. If Fintepla is discontinued, a follow-up echocardiogram must be performed 3 to 6 months after the last dose. This monitoring is essential to detect any potential drug-related cardiac changes at the earliest possible stage.
Talk to your doctor, pharmacist, or nurse before taking Fintepla if any of the following apply:
- Glaucoma: If you or your child have glaucoma (increased pressure in the eye), inform your doctor, as fenfluramine may affect intraocular pressure.
- Suicidal thoughts: If you or your child have had thoughts of self-harm or suicide, discuss this with your doctor before starting Fintepla, as antiepileptic medications may be associated with an increased risk of suicidal ideation in some patients.
- Cyproheptadine use: If you or your child are taking cyproheptadine (an antihistamine used for allergies or appetite stimulation), tell your doctor. Cyproheptadine is a serotonin antagonist and may reduce the effectiveness of Fintepla.
- Increased seizure frequency: If you or your child experience an increase in seizure frequency after starting Fintepla, contact your doctor promptly.
- Increased drowsiness: If you or your child experience excessive sleepiness, inform your doctor as dose adjustment may be necessary.
- Weight monitoring: Your doctor should monitor weight before and during treatment, as Fintepla can cause decreased appetite and weight loss.
Serotonin syndrome is a potentially life-threatening condition that can occur when Fintepla is taken together with other medications that increase serotonin levels. These include triptans (e.g., sumatriptan for migraine), MAO inhibitors (for depression), SSRIs (selective serotonin reuptake inhibitors), and SNRIs (serotonin-norepinephrine reuptake inhibitors). Watch for symptoms including agitation, hallucinations, fainting, rapid heartbeat, fluctuating blood pressure, high body temperature, sweating, muscle twitching, poor coordination, nausea, vomiting, and diarrhea. Seek immediate medical attention if any of these symptoms develop.
Pregnancy and Breastfeeding
If you or your child are pregnant, think you may be pregnant, are planning to have a baby, or are breastfeeding, ask your doctor for advice before taking Fintepla. There are limited data on the use of fenfluramine during pregnancy. Based on the mechanism of action and potential risks, the decision to use Fintepla during pregnancy should involve a careful assessment of the benefits of seizure control against the potential risks to the fetus. Women of childbearing potential should discuss contraception and family planning with their healthcare provider.
It is not known whether fenfluramine passes into breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue Fintepla therapy, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Consult your doctor for individualized guidance.
Driving and Operating Machinery
Fintepla can cause drowsiness and fatigue, which may impair the ability to drive, operate machinery, or participate in activities such as cycling or other sports. Talk to your doctor about whether these activities are safe for you or your child during treatment. Do not drive or use machines until you understand how Fintepla affects you.
Important Information About Ingredients
Fintepla oral solution contains several excipients that patients should be aware of. It contains sodium ethyl para-hydroxybenzoate (E215) and sodium methyl para-hydroxybenzoate (E219), which may cause allergic reactions (potentially delayed). It also contains sulfur dioxide (E220), which may rarely cause hypersensitivity reactions and bronchospasm. The formulation contains glucose (from corn), which may be harmful to teeth; patients with sugar intolerances should consult their doctor. Fintepla contains less than 1 mmol (23 mg) sodium per 12 mL dose, meaning it is essentially sodium-free.
How Does Fintepla Interact with Other Drugs?
Drug interactions with Fintepla are clinically important because many patients with Dravet syndrome and Lennox-Gastaut syndrome are already on multiple antiepileptic medications. Fenfluramine is metabolized primarily by the hepatic cytochrome P450 enzyme system, and its blood levels can be significantly affected by drugs that induce or inhibit these enzymes. Additionally, the serotonergic mechanism of action means that combining Fintepla with other serotonin-active drugs carries specific risks. It is essential to provide your healthcare team with a complete list of all medications, supplements, and herbal products being used.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Stiripentol (antiepileptic) | Inhibits fenfluramine metabolism; increases blood levels | Maximum Fintepla dose reduced to 4 mL (8.8 mg) twice daily; shorter titration schedule |
| MAO inhibitors (antidepressants) | Dangerous serotonin accumulation; life-threatening serotonin syndrome | Absolutely contraindicated – do not use within 2 weeks of MAOIs |
| SSRIs (e.g., fluoxetine, sertraline) | Additive serotonergic effects; risk of serotonin syndrome | Use with extreme caution; monitor closely for serotonin syndrome symptoms |
| SNRIs (e.g., venlafaxine, duloxetine) | Additive serotonergic effects; risk of serotonin syndrome | Use with extreme caution; monitor closely for serotonin syndrome symptoms |
| Triptans (e.g., sumatriptan) | Serotonin agonists; additive serotonergic effects | Risk of serotonin syndrome; discuss migraine alternatives with your doctor |
Other Important Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Carbamazepine, Phenobarbital, Phenytoin, Primidone | CYP enzyme inducers; decrease fenfluramine blood levels | Fintepla dose may need to be increased; monitor seizure control |
| Rifampicin, Efavirenz | Potent CYP inducers; significantly reduce fenfluramine levels | Fintepla dose may need to be increased substantially |
| Clobazam (antiepileptic) | Pharmacokinetic interaction; may alter clobazam levels | Monitor for changes in clobazam effectiveness or side effects |
| Valproate (antiepileptic) | Commonly co-prescribed; monitor for additive sedation | Dose adjustments may be necessary; watch for increased drowsiness |
| Cannabidiol (Epidiolex) | Often used concomitantly in refractory epilepsy; potential interaction | Monitor therapeutic response and side effects; dose adjustment may be needed |
| Cyproheptadine (antihistamine) | Serotonin antagonist; may reduce Fintepla antiepileptic effect | Avoid combination if possible; monitor seizure frequency closely |
Fintepla may cause increased drowsiness when combined with other medications that affect the central nervous system, including other antiepileptics, sedatives, anxiolytics, and opioid analgesics. Alcohol should also be avoided or minimized during treatment, as it can intensify sedation and drowsiness. Patients and caregivers should be alert to any unusual changes in alertness or behavior when starting new medications alongside Fintepla.
Because patients with Dravet syndrome and Lennox-Gastaut syndrome are typically on polytherapy involving multiple antiepileptic medications, a thorough medication review by a specialized neurologist or epileptologist is essential before initiating Fintepla. Your healthcare team will consider the overall drug regimen, potential interactions, and the therapeutic goals when planning Fintepla treatment and monitoring.
What Is the Correct Dosage of Fintepla?
Always take Fintepla exactly as prescribed by your doctor, pharmacist, or nurse. The dose is carefully calculated based on body weight, and the titration schedule differs depending on whether the patient is also taking stiripentol. Do not adjust the dose or stop treatment without medical advice.
Dosing Without Stiripentol
Patients NOT Taking Stiripentol
Starting dose (Day 1–6): 0.1 mg/kg twice daily
Day 7–13: 0.2 mg/kg twice daily
Day 14 onwards (maintenance): 0.35 mg/kg twice daily
Maximum dose: 6 mL (13.2 mg) twice daily, regardless of body weight
Dosing With Stiripentol
Patients Taking Stiripentol Concurrently
Starting dose (Day 1–6): 0.1 mg/kg twice daily
Day 7 onwards (maintenance): 0.2 mg/kg twice daily
Maximum dose: 4 mL (8.8 mg) twice daily, regardless of body weight
The dose volume is calculated using the formula: Weight (kg) × weight-based dose (mg/kg) ÷ 2.2 mg/mL = mL dose, taken twice daily. The calculated volume should be rounded to the nearest graduation mark on the provided oral syringe. The green 3 mL syringe (with 0.1 mL graduations) is used for doses up to 3 mL, while the purple 6 mL syringe (with 0.2 mL graduations) is used for doses between 3.2 mL and 6 mL.
Dose Volume Reference by Weight
| Weight | Starting Dose (0.1 mg/kg) | Maintenance Without STP (0.35 mg/kg) | Maintenance With STP (0.2 mg/kg) |
|---|---|---|---|
| 10–15 kg | 0.5–0.7 mL | 1.6–2.4 mL | 0.9–1.4 mL |
| 15–20 kg | 0.7–0.9 mL | 2.4–3.2 mL | 1.4–1.8 mL |
| 20–30 kg | 0.9–1.4 mL | 3.2–4.8 mL | 1.8–2.7 mL |
| 30–43 kg | 1.4–2.0 mL | 4.8–6.0 mL (max) | 2.7–4.0 mL (max) |
| 43–65 kg | 2.0–3.0 mL | 6.0 mL (max) | 4.0 mL (max) |
| >65 kg | 3.0–6.0 mL | 6.0 mL (max) | 4.0 mL (max) |
How to Take Fintepla
Fintepla is taken by mouth as an oral solution. It can be taken with or without food and is compatible with a ketogenic diet, which is commonly used in patients with refractory epilepsy. The solution can also be administered via most enteral feeding tubes (nasogastric or gastrostomy tubes). After administration via feeding tube, flush the tube with water using the dosing syringe three times to ensure the full dose is delivered.
When opening a new bottle for the first time, note the date on the carton. The bottle adapter must be pressed firmly into the bottle opening and left in place permanently. To measure each dose, insert the appropriate oral syringe into the bottle adapter, invert the bottle, slowly pull the plunger to the correct graduation mark, then return the bottle upright and carefully remove the syringe. Place the syringe tip against the inside of the cheek and slowly push the plunger to dispense the medication. Do not squirt the solution into the back of the throat, as this may cause it to enter the airway. After each use, rinse the syringe with cold water and allow it to dry completely before the next use. Do not wash the syringe in a dishwasher or with cleaning agents.
Missed Dose
If you or your child miss a dose, take it as soon as you remember. However, if it is nearly time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a forgotten dose. If you are unsure what to do, contact your doctor or pharmacist for advice.
Overdose
If too much Fintepla has been taken, contact your doctor or go to a hospital emergency department immediately. Bring the medication package with you. Symptoms of overdose may include agitation, drowsiness or confusion, flushing or a feeling of warmth, tremors, and sweating. There is no specific antidote for fenfluramine overdose, and treatment is supportive and symptomatic.
Stopping Treatment
Do not stop taking Fintepla without first talking to your doctor. If the doctor decides to discontinue treatment, the daily dose should be reduced gradually over a period of time. Abruptly stopping Fintepla may increase the risk of seizure recurrence and potentially life-threatening status epilepticus (prolonged seizures). After the last dose, an echocardiogram must be performed 3 to 6 months later to assess cardiac valve function.
What Are the Side Effects of Fintepla?
Like all medicines, Fintepla can cause side effects, although not everybody gets them. The side effects listed below have been observed during clinical trials and post-marketing surveillance. If you experience any of these symptoms, particularly the serious ones, contact your healthcare provider promptly.
Very Common
May affect more than 1 in 10 patients
- Decreased appetite
- Somnolence (drowsiness)
- Diarrhea
- Fatigue
Common
May affect up to 1 in 10 patients
- Bronchitis
- Abnormal behavior
- Rapid mood swings
- Aggression
- Agitation
- Insomnia (sleep difficulties)
- Tremor (shaking of hands, arms, or legs)
- Problems with coordination, gait, and balance (ataxia)
- Decreased muscle tone (hypotonia)
- Seizures (including status epilepticus)
- Lethargy
- Weight loss
- Constipation
- Increased saliva production (hypersalivation)
- Vomiting
- Skin rash
- Low blood sugar (hypoglycemia)
- Elevated prolactin levels in the blood
Not Known
Frequency cannot be estimated from available data
- Irritability
- Serotonin syndrome
- Pulmonary arterial hypertension (high blood pressure in the lung arteries)
- Heart valve disease (valvulopathy)
The side effect profile of Fintepla reflects both its serotonergic mechanism of action and the characteristics of the patient populations being treated. Decreased appetite and weight loss are among the most frequently reported effects and are particularly important to monitor in pediatric patients who need adequate nutrition for growth and development. Your doctor should regularly assess weight and nutritional status during treatment, and dietary counseling may be recommended.
Behavioral side effects such as aggression, irritability, abnormal behavior, and mood swings should be carefully monitored, particularly because patients with Dravet syndrome and Lennox-Gastaut syndrome may already exhibit behavioral challenges as part of their underlying condition. It can sometimes be difficult to distinguish drug-related behavioral effects from symptoms of the underlying epilepsy syndrome, making careful clinical observation and communication between caregivers and healthcare providers essential.
The somnolence (drowsiness) and fatigue reported with Fintepla can be additive with the sedating effects of other antiepileptic medications that patients may be taking. If excessive drowsiness occurs, your doctor may consider adjusting the overall antiepileptic medication regimen to optimize the balance between seizure control and alertness.
Seek emergency medical care immediately if you or your child experience: symptoms of serotonin syndrome (agitation, hallucinations, rapid heartbeat, high temperature, muscle rigidity, loss of coordination); signs of heart problems (unusual shortness of breath, chest pain, swelling of the legs, or exercise intolerance); or prolonged seizures (status epilepticus) that do not stop as expected.
It is important to report any suspected side effects to your doctor. Reporting helps regulatory agencies continuously monitor the benefit-risk balance of Fintepla and can identify previously unknown adverse reactions. In the EU, suspected side effects can be reported through the national adverse drug reaction reporting systems. In the US, reports can be submitted through the FDA MedWatch program.
How Should You Store Fintepla?
Proper storage of Fintepla is essential to maintain the stability and effectiveness of the medication. The oral solution should be stored at room temperature, protected from cold temperatures. Under no circumstances should Fintepla be frozen, as this may alter the chemical composition and pharmacological properties of the solution.
Once the bottle has been opened for the first time, the solution must be used within 3 months. It is recommended to write the date of first opening on the carton to ensure timely disposal. Always check the expiration date (marked “EXP” on the bottle and carton) before each dose – do not use the medicine after the last day of the stated month.
Keep Fintepla out of the sight and reach of children. Although the bottle has a child-resistant and tamper-evident cap, additional precautions should be taken given that the medication is often used in households with young children. If an oral syringe is lost, damaged, or the graduations become unreadable, use a replacement syringe from the package or contact your pharmacist.
Do not dispose of Fintepla by pouring it down the drain or placing it in household waste. Ask your pharmacist about proper medication disposal methods. These measures help protect the environment and prevent accidental exposure.
What Does Fintepla Contain?
The active substance in Fintepla is fenfluramine. Each milliliter of the oral solution contains 2.2 milligrams of fenfluramine, present as 2.5 mg of fenfluramine hydrochloride (the salt form). Fenfluramine hydrochloride is a white to off-white crystalline powder that is freely soluble in water.
The other (inactive) ingredients in Fintepla include:
- Sodium ethyl para-hydroxybenzoate (E215) – preservative
- Sodium methyl para-hydroxybenzoate (E219) – preservative
- Sucralose (E955) – sweetener
- Hydroxyethylcellulose (E1525) – thickening agent
- Monosodium phosphate (E339) – buffering agent
- Disodium phosphate (E339) – buffering agent
- Cherry flavor powder containing acacia gum (E414), glucose (corn), ethyl benzoate, natural flavoring preparations, natural flavoring substances, flavoring substances, maltodextrin (corn), sulfur dioxide (E220), potassium citrate (E332), and citric acid monohydrate (E330)
- Water for injections
Fintepla oral solution is a clear, colorless, slightly viscous liquid with a pleasant cherry flavor, designed to be palatable for pediatric patients. The solution is supplied in white bottles with child-resistant and tamper-evident closures. Each carton contains one bottle, one bottle adapter, two green 3 mL oral syringes with 0.1 mL graduations, and two purple 6 mL oral syringes with 0.2 mL graduations. Available pack sizes are 60 mL, 120 mL, 250 mL, and 360 mL, though not all sizes may be marketed in every country.
The marketing authorization holder is UCB Pharma S.A., Allee de la Recherche 60, B-1070 Brussels, Belgium. The manufacturer is UCB Pharma SA, Chemin du Foriest, 1420 Braine-l’Alleud, Belgium. Additional information about Fintepla is available from the European Medicines Agency (EMA) website and the FDA prescribing information.
Frequently Asked Questions About Fintepla
Fintepla (fenfluramine) is used as add-on therapy to treat seizures in patients aged 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome. These are severe forms of childhood-onset epilepsy that are often resistant to standard antiepileptic medications. In clinical trials, Fintepla has been shown to significantly reduce the frequency and severity of seizures when added to existing antiepileptic therapy.
Fenfluramine was historically associated with heart valve disease and pulmonary arterial hypertension when used at much higher doses as a weight-loss drug in the 1990s. Although Fintepla uses substantially lower doses for epilepsy, regular echocardiography (heart ultrasound) is required as a safety precaution. Patients must have an echocardiogram before starting treatment, every 6 months for the first 2 years, then annually, and 3–6 months after stopping treatment. This monitoring ensures any potential cardiac changes are detected early.
Serotonin syndrome is a potentially life-threatening condition caused by excessive serotonin activity in the nervous system. Because Fintepla works by increasing serotonin levels, combining it with other serotonergic medications (such as SSRIs, SNRIs, triptans, or MAO inhibitors) can trigger this syndrome. Symptoms include agitation, hallucinations, rapid heartbeat, fluctuating blood pressure, high body temperature, sweating, muscle twitching, poor coordination, nausea, vomiting, and diarrhea. If you notice any of these symptoms, seek immediate medical attention.
Yes, Fintepla oral solution is compatible with a ketogenic diet, which is a high-fat, low-carbohydrate dietary therapy commonly used alongside medications to help control seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome. There are no known interactions between Fintepla and the ketogenic diet. However, because Fintepla can decrease appetite and cause weight loss, your doctor and dietitian should monitor nutritional intake carefully, especially in growing children.
When Fintepla is taken together with stiripentol (another antiepileptic drug commonly used in Dravet syndrome), the maximum dose is reduced from 6 mL (13.2 mg) twice daily to 4 mL (8.8 mg) twice daily. This reduction is necessary because stiripentol inhibits the enzymes that metabolize fenfluramine, leading to higher blood levels. The dose titration schedule is also shorter: without stiripentol, the dose is increased over 14 days in three steps; with stiripentol, it is increased over just 7 days in two steps.
No, you should not stop taking Fintepla suddenly without consulting your doctor. Abrupt discontinuation may increase the risk of rebound seizures or status epilepticus (prolonged, potentially life-threatening seizures). If your doctor decides to stop Fintepla, the dose will be gradually reduced over time. Additionally, an echocardiogram must be performed 3 to 6 months after the last dose to check heart valve function and pulmonary arterial pressure.
References
- European Medicines Agency (EMA). Fintepla (fenfluramine) – Summary of Product Characteristics. Available at: EMA – Fintepla EPAR. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Fintepla (fenfluramine) oral solution – Prescribing Information. Approved June 2020 (Dravet syndrome), March 2022 (Lennox-Gastaut syndrome). Available at: FDA Drugs Database.
- Lagae L, Sullivan J, Knupp K, et al. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019;394(10216):2243–2254. doi:10.1016/S0140-6736(19)32500-0
- Knupp KG, Scheffer IE, Engel J Jr, et al. Fenfluramine provides clinically meaningful reduction in frequency of drop seizures in patients with Lennox-Gastaut syndrome: interim analysis of an open-label extension study. Epilepsia. 2023;64(1):139–151. doi:10.1111/epi.17448
- Nabbout R, Mistry A, Zuberi S, et al. Fenfluramine for treatment-resistant seizures in patients with Dravet syndrome receiving stiripentol-inclusive regimens: a randomized clinical trial. JAMA Neurology. 2020;77(3):300–308. doi:10.1001/jamaneurol.2019.4113
- Scheffer IE, Nabbout R, et al. Dravet syndrome: treatment options, management, and new therapies. Epilepsy & Behavior. 2024;150:109539.
- Cross JH, Auvin S, Falip M, et al. Expert Opinion on the Management of Lennox-Gastaut Syndrome: Treatment Algorithms and Practical Considerations. Frontiers in Neurology. 2024;15:1270.
- World Health Organization (WHO). Epilepsy Fact Sheet. Available at: WHO Epilepsy. Accessed January 2026.
- International League Against Epilepsy (ILAE). Treatment Guidelines for Epilepsy Syndromes. Updated 2024. Available at: ILAE Guidelines.
Medical Editorial Team
Medical Content
Written by iMedic Medical Editorial Team – specialists in neurology, epileptology, and clinical pharmacology
Medical Review
Reviewed by iMedic Medical Review Board – independent panel following WHO, EMA, FDA, and ILAE guidelines
Evidence Standard
Level 1A evidence – based on systematic reviews and meta-analyses of randomized controlled trials
Editorial Policy
No commercial funding or pharmaceutical sponsorship. Independent medical editorial content following GRADE evidence framework
Last medically reviewed: . All medical information undergoes rigorous fact-checking and is reviewed by board-certified physicians according to international guidelines.