Fintepla Generic Name & Formulations
Fintepla Dosage and Administration
Adults and Children
<2yrs: not established. Use calibrated measuring device. ≥2yrs: DS: Initially 0.1mg/kg twice daily, may be increased weekly based on efficacy and tolerability. LGS: Initially 0.1mg/kg twice daily, should be increased weekly based on tolerability. Both: if further seizure reduction is required and 0.1mg/kg twice daily tolerated; may increase dose by titration schedule (see full labeling). For severe renal impairment (eGFR 15–29mL/min/1.73m2) or concomitant strong CYP1A2 or CYP2D6 inhibitors: max total dose of 20mg/day without concomitant stiripentol; and max total dose of 17mg/day with concomitant stiripentol plus clobazam. For mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: max total dose of 20mg/day without concomitant stiripentol; for severe (Child-Pugh C) hepatic impairment: max total dose of 17mg/day without concomitant stiripentol. For mild hepatic impairment: max total dose of 13mg/day with concomitant stiripentol plus clobazam; for moderate or severe hepatic impairment: use not recommended with concomitant stiripentol plus clobazam.
Fintepla Boxed Warnings
Risk of heart valvular heart disease and pulmonary arterial hypertension. Obtain echocardiogram prior to initiation, every 6 months during, and once 3–6 months after treatment. Consider treatment benefits vs risks if following seen via echocardiogram: valvular abnormality or new abnormality; VHD as indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional VHD characteristics; PAH as indicated by elevated right heart/pulmonary artery pressure (PASP >35mmHg). Increased risk of suicidal thoughts or behavior; monitor for clinical worsening or unusual changes. Monitor BP, weight regularly; consider dose adjustment if weight loss occurs. Monitor for serotonin syndrome; discontinue immediately if suspected. Glaucoma. Consider discontinuation if visual acuity impairment or ocular pain occurs. Avoid abrupt cessation. Hepatic impairment: see Adults and Children dose. Renal impairment (eGFR 15–29mL/min/1.73m2): see Adults and Children; (<15mL/min/1.73m2): not studied. Elderly. Pregnancy. Nursing mothers.
Fenfluramine has a time to maximum plasma concentration (Tmax) of 3 to 5 hours at steady state. The absolute bioavailability of fenfluramine is ~68-74%.
The geometric mean (CV%) apparent volume of distribution (Vz/F) of fenfluramine is 11.9 (16.5%) L/kg following oral administration of Fintepla in healthy subjects. Fenfluramine is 50% bound to human plasma proteins in vitro and binding is independent of drug concentrations.
Fintepla Adverse Reactions
Fintepla Clinical Trials
Fintepla Patient Counseling