What Is Fintepla? Uses, Dosage, and What You Need to Know in 2026

Fintepla (fenfluramine) is a prescription antiseizure medication approved by the FDA for two rare and serious forms of childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. Here's what patients and caregivers need to know about this medication in 2026.

What Is Fintepla?

Fintepla is the brand name for fenfluramine oral solution. It comes as a cherry-flavored liquid at a concentration of 2.2 mg/mL. It is a Schedule IV controlled substance (the same schedule as drugs like Xanax or Valium), meaning it has recognized potential for dependence and is subject to controlled substance regulations.

Fintepla is manufactured and marketed by UCB, a global biopharmaceutical company, which acquired it from Zogenix in 2022. It is available exclusively through the FINTEPLA REMS (Risk Evaluation and Mitigation Strategy) program, which requires cardiac monitoring before and during treatment.

What Is Fintepla Approved to Treat?

Fintepla is FDA-approved as an add-on treatment for:

Dravet syndrome (DS): Approved June 25, 2020 for patients 2 years of age and older. Dravet syndrome is a rare, severe form of epilepsy typically caused by a mutation in the SCN1A gene. Seizures are frequent, prolonged, and often difficult to control with standard medications.

Lennox-Gastaut syndrome (LGS): Approved March 28, 2022 for patients 2 years of age and older. LGS is a severe form of childhood-onset epilepsy characterized by multiple seizure types and intellectual disability.

Fintepla is not approved as a standalone medication for these conditions — it is used in addition to other antiseizure drugs (hence "add-on" or "adjunctive" therapy). It is also an Orphan Drug, meaning it was developed for a rare disease affecting fewer than 200,000 people in the U.S.

How Is Fintepla Dosed?

Fintepla dosing is weight-based and individualized. The key dosing information:

Starting dose: 0.1 mg/kg twice daily (given morning and evening)

Titration: Dose increased weekly based on seizure response and tolerability

Maximum without stiripentol: 0.35 mg/kg twice daily, max 26 mg/day

Maximum with stiripentol + clobazam: 0.2 mg/kg twice daily, max 17 mg/day

Fintepla can be taken with or without food. It should not be stopped abruptly — the dose should be gradually reduced under medical supervision to avoid triggering increased seizures.

What's the Evidence That Fintepla Works?

Fintepla's FDA approval for Dravet syndrome was based on data from two randomized, double-blind, placebo-controlled Phase 3 clinical trials in 117+ patients ages 2-18. Patients treated with fenfluramine at 0.7 mg/kg/day showed significantly greater reductions in convulsive seizure frequency compared to placebo — with reductions often seen within 3-4 weeks. Many patients achieved a greater than 50% reduction in seizures.

For LGS, the Phase 3 trial (Study 1601) showed fenfluramine at 0.7 mg/kg/day was superior to placebo in reducing monthly drop seizure frequency. In the 12-month open-label extension, patients continued to show a 39.4% reduction in seizure frequency at month 3, improving to 51.8% for patients assessed at months 10-12.

Long-term follow-up data published in Epilepsia in 2025 confirmed that these benefits were sustained over multiple years, with no patients developing valvular heart disease or pulmonary arterial hypertension.

Who Should NOT Take Fintepla?

Fintepla is contraindicated (should not be taken) in patients who:

Are allergic to fenfluramine or any ingredient in Fintepla

Are currently taking or have taken MAOIs in the past 14 days (risk of serotonin syndrome)

Have moderate or severe kidney disease (not recommended)

Have liver disease (not recommended)

Are children under 2 years of age (safety and effectiveness not established)

How Does Fintepla Get to Patients?

Fintepla is only available through the FINTEPLA REMS program. This means: prescribers must be REMS-certified, pharmacies must be REMS-certified specialty pharmacies, patients must have a baseline echocardiogram before starting, and ongoing echocardiograms every 6 months are required.

If you're struggling to access Fintepla, medfinder can help you locate certified specialty pharmacies. See also: Why Is Fintepla So Hard to Find?.