Fycompa

Perampanel

Adjunctive treatment of partial-onset seizures (POS) w/ or w/o secondarily generalised seizures in patients ≥4 yr; primary generalised tonic-clonic seizures (PGTCS) in patients ≥7 yr w/ idiopathic generalised epilepsy.

Individualised dosing, once daily at bedtime. POS Adult, adolescent ≥12 yr & childn 4-11 yr weighing ≥30 kg Initially 2 mg (4 mL) daily, may be increased by 2-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 4-8 mg (8-16 mL) daily, may be increased by 2-mg increments based on clinical response & tolerability. Max: 12 mg (24 mL) daily. Childn 4-11 yr weighing 20 to <30 kg Initially 1 mg (2 mL) daily, may be increased by 1-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 4-6 mg (8-12 mL) daily, may be increased by 1-mg increments based on clinical response & tolerability. Max: 8 mg (16 mL) daily. Childn 4-11 yr weighing <20 kg Initially 1 mg (2 mL) daily, may be increased by 1-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 2-4 mg (4-8 mL) daily, may be increased by 0.5-mg (1 mL) increments based on clinical response & tolerability. Max: 6 mg (12 mL) daily. Patient w/ mild or moderate hepatic impairment Initially 2 mg (4 mL), up-titrate by 2-mg increments no faster than every 2 wk based on tolerability & effectiveness. Max: 8 mg. PGTCS Adult, adolescent ≥12 yr Initially 2 mg (4 mL) daily, may be increased by 2-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: Up to 8 mg (16 mL) daily, may be increased by 2-mg increments based on clinical response & tolerability. Max: 12 mg (24 mL) daily. Childn 7-11 yr weighing ≥30 kg Initially 2 mg (4 mL) daily, may be increased by 2-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 4-8 mg (8-16 mL) daily, may be increased by 2-mg increments based on clinical response & tolerability. Max: 12 mg (24 mL) daily. Childn 7-11 yr weighing 20 to <30 kg Initially 1 mg (2 mL) daily, may be increased by 1-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 4-6 mg (8-12 mL) daily, may be increased by 1-mg increments based on clinical response & tolerability. Max: 8 mg (16 mL) daily. Childn 7-11 yr weighing <20 kg Initially 1 mg (2 mL) daily, may be increased by 1-mg increments (wkly or every 2 wk) based on clinical response & tolerability. Maintenance dose: 2-4 mg (4-8 mL) daily, may be increased by 0.5-mg (1 mL) increments based on clinical response & tolerability. Max: 6 mg (12 mL) daily. Patient w/ mild or moderate hepatic impairment Initially 2 mg (4 mL), up-titrate by 2-mg increments no faster than every 2 wk based on tolerability & effectiveness. Max: 8 mg.

May be taken with or without food: Take at bedtime. Swallow whole, do not chew/crush/split.

Hypersensitivity.

Monitor for signs of suicidal ideation & behaviours. Reports of severe cutaneous adverse reactions, including DRESS & SJS. Monitor patients w/ myoclonic & absence seizures while on treatment. Increased risk of falls particularly in the elderly. Reports of aggressive & hostile behaviour. Abuse potential. May decrease effectiveness of progestative-containing hormonal contraceptives. Concomitant use w/ CYP3A-inducing antiepileptics & other (non-antiepileptic) CYP450 inducers or inhibitors. Hepatotoxicity (mainly increased hepatic enzyme) in combination w/ other antiepileptics. May cause dizziness & somnolence & therefore may influence ability to drive or use machines. Not recommended in patients w/ moderate or severe renal impairment, patients undergoing haemodialysis, & patients w/ severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Additional non-hormonal forms of contraception are recommended when using Fycompa. Lactation. Elderly ≥65 yr. Safety & efficacy have not yet been established in childn <4 yr (POS indication) or in childn <7 yr (PGTCS indication). FC tab: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Oral susp: Not to be taken by patients w/ rare hereditary problems of fructose intolerance. Concomitant use w/ other antiepileptic medications containing sorbitol.

Dizziness, somnolence. Increased/decreased appetite; aggression, anger, anxiety, confusional state; ataxia, dysarthria, balance disorder, irritability; diplopia, blurred vision; vertigo; nausea; back pain; gait disturbance, fatigue; increased wt; fall.

Decreased exposure of levonorgestrel; midazolam. Increased clearance w/ carbamazepine, phenytoin, oxcarbazepine. Decreased clearance of oxcarbazepine. Decreased conc w/ strong CYP450 inducers (eg, rifampicin, hypericum); felbamate. Increased AUC & prolonged t_½ w/ CYP3A4 inhibitors (eg, ketoconazole). Additive or supra-additive to alcohol effects on tasks involving alertness & vigilance.

Anticonvulsants

N03AX22 - perampanel ; Belongs to the class of other antiepileptics.

P₁S₁S₃