Fenfluramine

FINTEPLA

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What it isSerotonin releaser with 5-HT2C and sigma-1 activity; Dravet and Lennox-Gastaut seizures.

Why this oneIt reduces convulsive seizures more than most adjuncts in Dravet syndrome.

What limits itValvular heart disease and pulmonary hypertension require echocardiography under a REMS — the toxicity that withdrew fen-phen. Appetite suppression.

FDA-approved for

Dravet/Lennox-Gastaut seizures (2020)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Valvular heart disease and pulmonary arterial hypertension; echocardiogram required before, during, and after treatment; available only through FINTEPLA REMS.

FDA dosing	Population	Start	Target	Max
Dravet syndrome	≥2 yr	0.1 mg/kg BID	0.35 mg/kg BID	0.35 mg/kg BID (26 mg/day)
Lennox-Gastaut syndrome	≥2 yr	0.1 mg/kg BID	0.35 mg/kg BID	0.35 mg/kg BID (26 mg/day)
DS or LGS with concomitant stiripentol + clobazam	≥2 yr	0.1 mg/kg BID	0.2 mg/kg BID	0.2 mg/kg BID (17 mg/day)

Titration May increase weekly based on efficacy and tolerability.

Renal Dosage adjustment required in severe renal impairment.

Hepatic Dosage adjustment required in mild, moderate, and severe hepatic impairment.

Instructions

Administer orally with or without food.
Obtain echocardiogram before treatment, every 6 months during, and 3–6 months after stopping.
Withdraw gradually to minimize risk of increased seizure frequency and status epilepticus.

Contraindications

MAOIs (concurrently or within 14 days) due to risk of serotonin syndrome

Cautions

Valvular heart disease and pulmonary arterial hypertension (cardiac monitoring required)
Decreased appetite and weight
Somnolence, sedation, lethargy
Suicidal behavior and ideation
Serotonin syndrome with serotonergic drugs
Increased blood pressure
Glaucoma

Adverse reactions

Decreased appetite
Somnolence/sedation/lethargy
Diarrhea
Constipation
Fatigue
Ataxia/balance disorder
Increased blood pressure
Pyrexia
Vomiting
Decreased weight

Pregnancy No human data; animal studies show fetal malformations and mortality; may cause fetal harm.

Lactation No data on presence in human milk or effects on the breastfed infant.

⚠ BOXED WARNING

Valvular heart disease and pulmonary arterial hypertension

Cost, est. cash$300–$2,500/month

Generic entry2038 est.

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability1 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilitySedation, dizziness and agent-specific rash, behavioral, hepatic, hematologic or teratogenic toxicity.

Mechanism of action: Fenfluramine ballicule

Fenfluramine ballicule: receptor binding, kinetics and half-life diagram

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Memory aids: mascots and interaction avatars

Fenfluramine FINTEPLA mascot mnemonic cartoon — **“Fin flower (on) Fin tip”**
blue → serotonergic

Open Fenfluramine in the interactive console ↗