FDA Approves Fintepla (fenfluramine) for Seizures in Dravet and Lennox-Gastaut Syndromes
The FDA has approved Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. The approval provides a new oral option for these rare, severe epilepsies that often do not respond adequately to existing therapies. Clinicians should note that Fintepla requires careful dosing adjustments based on weight and concomitant medications, particularly stiripentol plus clobazam, and mandates an echocardiogram before starting treatment to evaluate for valvular heart disease and pulmonary arterial hypertension. The maximum daily dosage varies from 17 mg to 26 mg depending on concomitant therapy and patient factors.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
Fintepla is administered orally with or without food. For Dravet syndrome, the initial dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability up to a maximum of 0.35 mg/kg twice daily (26 mg daily). For Lennox-Gastaut syndrome, the initial dosage is 0.1 mg/kg twice daily, titrated weekly to a recommended maintenance of 0.35 mg/kg twice daily (26 mg daily). In patients taking concomitant stiripentol plus clobazam, the maximum maintenance dosage is 0.2 mg/kg twice daily (17 mg daily). Dose adjustments are recommended for patients taking strong CYP1A2 or CYP2D6 inhibitors (max 20 mg daily without stiripentol, 17 mg with stiripentol plus clobazam), those with severe renal impairment (eGFR 15-29 mL/min/1.73m2; max 20 mg daily without stiripentol, 17 mg with stiripentol plus clobazam), and those with hepatic impairment (mild Child-Pugh A: max 20 mg without stiripentol, 13 mg with stiripentol plus clobazam; moderate Child-Pugh B: max 20 mg without stiripentol; severe: use not recommended with stiripentol plus clobazam). Prior to initiation, obtain an echocardiogram to assess for valvular heart disease and pulmonary arterial hypertension.
Trial data not available in label.
Prior to starting Fintepla, obtain an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Dose adjustments are required for patients taking concomitant stiripentol plus clobazam, strong CYP1A2 or CYP2D6 inhibitors, and those with severe renal or hepatic impairment.
Fintepla is indicated for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years and older, offering a treatment option for these refractory epilepsies. Its use requires careful patient selection and monitoring due to potential cardiac risks.
View Original Abstract ↓
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