Brivaracetam

PRODUCT: Brivaracetam Cipla 100 mg film-coated tablets (UK SPC). The same adult regimen applies to adolescents and children weighing 50 kg or more. The physician should prescribe the most appropriate formulation and strength according to weight and dose. MISSED DOSES: if one or more doses are missed, take a single dose as soon as remembered and take the following dose at the usual morning or evening time. DISCONTINUATION: for patients from 16 years of age, reduce the dose gradually by 50 mg/day on a weekly basis; for patients below 16 years, reduce by a maximum of half the dose every week until 1 mg/kg/day (body weight under 50 kg) or 50 mg/day (50 kg or more) is reached, then after 1 week at 50 mg/day a final week of treatment at 20 mg/day is recommended. HEPATIC IMPAIRMENT: exposure is increased in adult patients with chronic liver disease - for all stages of hepatic impairment, adults and those weighing 50 kg or more should start at 50 mg/day with a recommended maximum daily dose of 150 mg/day, given in 2 divided doses approximately 12 hours apart. ELDERLY (65 years and above): no dose adjustment needed, though clinical experience is limited. RENAL: no dose adjustment needed; not recommended in end-stage renal disease patients undergoing dialysis. PAEDIATRIC UNDER 2 YEARS: efficacy has not yet been established and no recommendation on posology can be made. ALCOHOL: intake of brivaracetam with alcohol is not recommended.

The UK SPC gives WEIGHT-BANDED per-kg dosing for children from 2 years of age, so no single per-kg figure applies (dosePerKg deliberately left null). ADOLESCENTS AND CHILDREN WEIGHING 50 KG OR MORE: starting dose 50 mg/day (may also be initiated at 100 mg/day based on the physician's assessment of need for seizure control), maintenance 100 mg/day, therapeutic range 50-200 mg/day. WEIGHING 20 KG TO LESS THAN 50 KG: starting dose 1 mg/kg/day (may be initiated up to 2 mg/kg/day), maintenance 2 mg/kg/day, therapeutic range 1-4 mg/kg/day. WEIGHING 10 KG TO LESS THAN 20 KG: starting dose 1 mg/kg/day (may be initiated up to 2.5 mg/kg/day), maintenance 2.5 mg/kg/day, therapeutic range 1-5 mg/kg/day. HEPATIC IMPAIRMENT (all stages): 20 kg to less than 50 kg - starting dose 1 mg/kg/day, maximum 3 mg/kg/day; 10 kg to less than 20 kg - starting dose 1 mg/kg/day, maximum 4 mg/kg/day. No clinical data are available in paediatric patients with hepatic impairment. RENAL: based on adult data no dose adjustment is necessary in paediatric renal impairment, but no paediatric clinical data are available. UNDER 2 YEARS: efficacy has not yet been established and no recommendation on posology can be made. DISCONTINUATION UNDER 16 YEARS: reduce by a maximum of half the dose every week until 1 mg/kg/day (under 50 kg) or 50 mg/day (50 kg or more) is reached. Verify against a children's formulary before use.