Fenfluramine is a prescription medicine indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. It is available as oral solution. MedsAcross supplies Fenfluramine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
Source: US FDA prescribing information
The precise mechanism by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome is unknown. Fenfluramine and the metabolite, norfenfluramine, exhibit agonist activity at serotonin 5-HT2 receptors. There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine and norfenfluramine, and valvular heart disease and pulmonary arterial hypertension.
Source: US FDA prescribing information
FINTEPLA is to be administered orally and may be taken with or without food. Dravet Syndrome The initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. The maximum daily maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). Lennox-Gastaut Syndrome The initial starting dosage is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability. The recommended maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). Dravet Syndrome and Lennox-Gastaut Syndrome Dose adjustment is required in patients taking concomitant stiripentol plus clobazam: the maximum daily maintenance dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg).
Source: US FDA prescribing information
FINTEPLA is contraindicated in patients with: Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA Concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome
Source: US FDA prescribing information
Boxed warning (valvular heart disease and pulmonary arterial hypertension fintepla): can cause valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings. Decreased Appetite and Decreased Weight: Advise patients that FINTEPLA can cause decreased appetite and decreased weight. Somnolence, Sedation, and Lethargy: Monitor for somnolence and sedation. Advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA. Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in labeling: Valvular Heart Disease and Pulmonary Arterial Hypertension Decreased Appetite and Decreased Weight Somnolence, Sedation, and Lethargy Suicidal Behavior and Ideation Withdrawal of Antiepileptic Drugs Serotonin Syndrome Increase in Blood Pressure Glaucoma The most common adverse reactions (incidence at least 10% and greater than placebo) in patients with Dravet syndrome were decreased appetite, somnolence, sedation, lethargy, diarrhea, constipation, abnormal echocardiogram, fatigue, malaise, asthenia, ataxia, balance disorder, gait disturbance, blood pressure increased, drooling, salivary hypersecretion, pyrexia, upper respiratory tract infection, vomiting, decreased weight, fall, status epilepticus.
Source: US FDA prescribing information
Dose adjustment is required for patients taking stiripentol plus clobazam. Strong CYP1A2 or CYP2D6 inhibitors: a dose adjustment is recommended. Strong CYP1A2, CYP2B6, or CYP3A4 inducers: it is recommended to avoid coadministration with FINTEPLA. If coadministration is necessary, consider a FINTEPLA dosage increase.
Source: US FDA prescribing information
Store FINTEPLA at room temperature between 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Do not refrigerate or freeze. Store the bottle and syringe together.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Fenfluramine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fintepla 2.2 mg/mL oral solutionOral | UCB | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Fenfluramine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Fenfluramine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fenfluramine, including Fintepla.
Yes. The US FDA first approved Fenfluramine on 25 June 2020, according to Drugs@FDA.
Yes. Fenfluramine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Fenfluramine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fenfluramine is classified under ATC code A08AA02 (Fenfluramine).
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