Briviact

FC tab & oral soln: Adjunctive therapy in the treatment of partial-onset seizures w/ or w/o secondary generalisation in adults, adolescents & childn ≥2 yr w/ epilepsy. Soln for inj/infusion: Adjunctive therapy in the treatment of partial-onset seizures w/ or w/o secondary generalisation in adults & adolescents ≥16 yr w/ epilepsy.

FC tab & oral soln Administer dose in 2 equally divided doses, approx 12 hr apart. Round calculated dose of oral soln to the nearest graduated increment, & use larger graduated increment if equidistant between 2 graduated increments. Adult Initially 50 mg/day or 100 mg/day based on physician's assessment of required seizure reduction versus potential side effects. May be adjusted in the effective dose range of 50-200 mg/day based on individual patient response & tolerability. Adolescent & childn weighing ≥50 kg Initially 50 mg/day. May also be initiated at 100 mg/day based on physician's assessment of need for seizure control. Maintain dose at 100 mg/day. May be adjusted in the effective dose range of 50-200 mg/day based on individual patient response. Adolescent & childn weighing 20-<50 kg Initially 1 mg/kg/day. May also be initiated at doses up to 2 mg/kg/day based on physician's assessment of need for seizure control. Maintain dose at 2 mg/kg/day. May be adjusted in the effective dose range of 1-4 mg/kg/day based on individual patient response. Childn weighing 10-<20 kg Initially 1 mg/kg/day. May also be initiated at doses up to 2.5 mg/kg/day based on physician's assessment of need for seizure control. Maintain dose at 2.5 mg/kg/day. May be adjusted in the effective dose range of 1-5 mg/kg/day based on individual patient response. Adult, adolescent & childn weighing ≥50 kg w/ hepatic impairment Initially 50 mg/day. Max: 150 mg/day. Adolescent & childn weighing 20-<50 kg w/ hepatic impairment Initially 1 mg/kg/day. Max: 3 mg/kg/day. Childn weighing 10-<20 kg w/ hepatic impairment Initially 1 mg/kg/day. Max: 4 mg/kg/day. Soln for inj/infusion May be administered as IV bolus w/o dilution, or may be diluted in compatible diluent & administered as 15-min IV infusion. Initially 50 mg/day or 100 mg/day based on physician's assessment of required seizure reduction versus potential side effects. Administer dose in 2 equally divided doses, once in the morning & once in the evening. May be adjusted in the dose range of 50-200 mg/day based on individual patient response & tolerability. Patient w/ hepatic impairment Initially 50 mg/day. Max: 150 mg daily in 2 divided doses.

FC tab: May be taken with or without food: Swallow whole w/ liqd. Oral soln: May be taken with or without food: Can be diluted in water or juice shortly before swallowing. May be administered via nasogastric or gastrostomy tube.

Hypersensitivity to brivaracetam or other pyrrolidone derivatives.

Monitor for signs of suicidal ideation & behaviours. Minor or moderate influence on the ability to drive & use machines. Not recommended in ESRD patients undergoing dialysis. Increased exposure to brivaracetam in adults w/ chronic liver disease. Limited clinical data in patients w/ pre-existing hepatic impairment. Discuss family planning & contraception w/ women of childbearing potential taking brivaracetam. Do not use during pregnancy unless clinically necessary. Discontinue breastfeeding or discontinue brivaracetam therapy during lactation. Limited clinical experience in elderly ≥65 yr. FC tab: Contains lactose. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Efficacy in paed patients <2 yr has not yet been established. Oral soln: Contains sorbitol. Should not be taken by patients w/ hereditary fructose intolerance. Contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Contains propylene glycol. Efficacy in paed patients <2 yr has not yet been established. Soln for inj/infusion: Not recommended in acute conditions eg, status epilepticus. No experience w/ bd IV administration for >4 days. Do not mix w/ other medicinal products. Contains 19.1 mg Na per vial, equiv to 1% of WHO recommended max daily intake of 2 g Na for an adult. Safety & efficacy in childn <16 yr have not yet been established.

Dizziness, somnolence. Flu; decreased appetite; depression, anxiety, insomnia, irritability; convulsion, vertigo; URTI, cough; nausea, vomiting, constipation; fatigue.

Doubled effect of alcohol on psychomotor function, attention & memory. Increased plasma conc w/ strong CYP2C19 inhibitors (eg, fluconazole, fluvoxamine, cannabidiol). Decreased plasma conc w/ strong enzyme inducers (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort). Increased plasma conc of CYP2C19 substrates (eg, lansoprazole, omeprazole, diazepam); OAT3 substrates; carbamazepine epoxide. Decreased plasma conc of CYP2B6 substrates (eg, efavirenz). Reduced AUCs of oestrogen & progestin w/o impact on ovulation suppression when brivaracetam was co-administered w/ OC containing ethinylestradiol & levonorgestrel.

Anticonvulsants

N03AX23 - brivaracetam ; Belongs to the class of other antiepileptics.

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