Fenfluramine

No UK SPC (eMC) record was fetched in this bundle — figures are from the US prescribing information for FINTEPLA (UCB, label date 2025-10-27) and must be verified against the UK SPC before use. This is a WEIGHT-BASED dose applied across the whole licensed population; safety and effectiveness have been established in patients 2 years of age and older (the Lennox-Gastaut study enrolled patients aged 2 to 35 years). DRAVET SYNDROME: initial and maintenance dosage 0.1 mg/kg twice daily, which CAN be increased weekly based on efficacy and tolerability; patients not on concomitant stiripentol who tolerate 0.1 mg/kg twice daily and need further seizure reduction may benefit from an increase up to the maximum recommended maintenance dosage of 0.35 mg/kg twice daily (maximum 26 mg/day); patients taking concomitant stiripentol plus clobazam may be increased up to a maximum of 0.2 mg/kg twice daily (maximum 17 mg/day). LENNOX-GASTAUT SYNDROME: initial dosage 0.1 mg/kg twice daily, which SHOULD be increased weekly based on tolerability to the recommended maintenance dosage of 0.35 mg/kg twice daily (maximum 26 mg/day), or 0.2 mg/kg twice daily (maximum 17 mg/day) with concomitant stiripentol plus clobazam. TITRATION SCHEDULE (label Table 1): without concomitant stiripentol — initial 0.1 mg/kg twice daily, Day 7 0.2 mg/kg twice daily, Day 14 0.35 mg/kg twice daily (maximum total daily dosage 26 mg throughout); with concomitant stiripentol plus clobazam — initial 0.1 mg/kg twice daily, Day 7 0.15 mg/kg twice daily, Day 14 0.2 mg/kg twice daily (maximum total daily dosage 17 mg throughout). For patients not on concomitant stiripentol in whom a more rapid titration is warranted, the dose may be increased every 4 days. DOSE VOLUME CALCULATION (label): weight (kg) x weight-based dosage (mg/kg) / 2.2 mg/mL = mL dose to be taken twice daily. CARDIAC MONITORING: obtain an echocardiogram before starting treatment to evaluate for valvular heart disease and pulmonary arterial hypertension, then every 6 months during treatment and 3 to 6 months after the final dose. STRONG CYP1A2 OR CYP2D6 INHIBITORS: maximum total daily dosage 20 mg without concomitant stiripentol, or 17 mg with concomitant stiripentol plus clobazam. HEPATIC IMPAIRMENT (maximum total daily dosage): mild (Child-Pugh A) 20 mg without concomitant stiripentol or 13 mg with stiripentol plus clobazam; moderate (Child-Pugh B) 20 mg without stiripentol, use not recommended with stiripentol plus clobazam; severe (Child-Pugh C) 17 mg without stiripentol, use not recommended with stiripentol plus clobazam.

US labelling (FINTEPLA) — safety and effectiveness established in patients 2 YEARS OF AGE AND OLDER for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome; safety and effectiveness in patients less than 2 years of age have not been established. Starting dosage 0.1 mg/kg twice daily; titrate weekly (Day 7 0.2 mg/kg twice daily, Day 14 0.35 mg/kg twice daily) without concomitant stiripentol, or Day 7 0.15 mg/kg twice daily and Day 14 0.2 mg/kg twice daily with concomitant stiripentol plus clobazam. Dose volume = weight (kg) x mg/kg dosage / 2.2 mg/mL, taken twice daily. The product can cause decreases in appetite and weight, so the growth of paediatric patients should be carefully monitored. Echocardiogram required before starting, every 6 months during treatment and 3 to 6 months after the final dose. DRAFT ONLY, from US labelling — verify every paediatric figure against a children's formulary and the UK SPC before prescribing.