FDA approved Fintepla (fenfluramine) for Seizures in Dravet and Lennox-Gastaut SyndromesFDA approved new drug Fintepla for two rare seizure disorders.

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.