Fycompa

Perampanel

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

Individualized dosing; once daily at bedtime. POS: Monotherapy Adult, adolescent ≥12 yr & childn 4-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by 2 mg daily at intervals of 2 wk. Maintenance: 4-8 mg daily. Max: 8 mg daily, 20 to <30 kg Initially 1 mg daily, may be increased by 1 mg daily at intervals of 2 wk. Maintenance: 4-6 mg daily. Max: 6 mg daily, <20 kg Initially 1 mg daily, may be increased by 1 mg daily at intervals of 2 wk. Maintenance: 2-4 mg daily. Max: 4 mg daily. Adjunctive therapy Adult, adolescent ≥12 yr & childn 4-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by 2 mg daily at wkly intervals. Maintenance: 4-8 mg daily, may be increased by 2 mg daily at wkly intervals. Max: 12 mg daily, 20 to <30 kg Initially 1 mg daily, may be increased by 1 mg daily at wkly intervals. Maintenance: 4-6 mg daily, may be increased by 1 mg daily at wkly intervals. Max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by 1 mg daily at wkly intervals. Maintenance: 2-4 mg daily, may be increased by 0.5 mg daily at wkly intervals. Max: 6 mg daily. PGTC seizures Adult & adolescent ≥12 yr Initially 2 mg daily, may be increased by 2 mg daily at wkly intervals. Maintenance: Up to 8 mg daily, may be increased by 2 mg daily at wkly intervals. Max: 12 mg daily. Childn 7-11 yr weighing ≥30 kg Initially 2 mg daily, may be increased by 2 mg daily at wkly intervals. Maintenance: 4-8 mg daily, may be increased by 2 mg daily at wkly intervals. Max: 12 mg daily, 20 to <30 kg Initially 1 mg daily, may be increased by 1 mg daily at wkly intervals. Maintenance: 4-6 mg daily, may be increased by 1 mg daily at wkly intervals. Max: 8 mg daily, <20 kg Initially 1 mg daily, may be increased by 1 mg daily at wkly intervals. Maintenance: 2-4 mg daily, may be increased by 0.5 mg daily at wkly intervals. Max: 6 mg daily. Mild or moderate hepatic impairment Initially 2 mg daily, may be up-titrated using 2 mg doses no faster than every 2 wk based on tolerability & effectiveness. Max: 8 mg.

May be taken with or without food: FC tab: Swallow whole, do not chew/crush/split.

Hypersensitivity.

Monitor for signs of suicidal ideation & behaviors; aggressive, hostile & abnormal behaviors. Closely monitor for skin reactions; w/draw immediately if signs & symptoms of severe cutaneous AR including DRESS & SJS appear. Increased events related to dizziness, disturbance in gait or coordination & falls particularly in the elderly. Increased somnolence & fatigue-related events including fatigue, asthenia & lethargy. Monitor patients w/ myoclonic & absence seizures. Gradually discontinue use to minimize the potential for rebound seizures. Monitor patients w/ history of substance abuse & symptoms of perampanel abuse. Concomitant use w/ CYP3A enzyme-inducing anti-epileptics (eg, carbamazepine, phenytoin, oxcarbazepine) & other concomitant (non-anti-epileptic) cytochrome P450 inducers or inhibitors. May moderately influence ability to drive or use machines; may cause dizziness & somnolence. Not recommended in patients w/ moderate or severe renal impairment or those undergoing hemodialysis; severe hepatic impairment. Possible hepatotoxicity in combination w/ other anti-epileptics. Consider monitoring of liver function if elevated hepatic enzymes is observed. Women of childbearing potential not using contraception. May decrease effectiveness of progestative-containing hormonal contraceptives; additional non-hormonal form of contraception is recommended. Not recommended during pregnancy. Lactation. Childn <4 yr for POS; <7 yr for PGTC seizures. Elderly ≥65 yr. FC tab: Contains lactose. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Oral susp: Contains sorbitol; benzoic acid & Na benzoate. Not to be taken by patients w/ hereditary fructose intolerance.

Dizziness, somnolence. Decreased/increased 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 mean C_max & AUC values of levonorgestrel. Decreased C_max of ethinylestradiol. Increased total clearance w/ carbamazepine, phenytoin, oxcarbazepine. Decreased conc w/ carbamazepine, oxcarbazepine, phenobarb, phenytoin, topiramate. Decreased conc of carbamazepine, clobazam, lamotrigine & valproic acid. May increase conc of oxcarbazepine. Decreased AUC & exposure of midazolam (or other sensitive CYP3A substrates). Decreased conc w/ strong cytochrome P450 inducers (eg, rifampicin, hypericum); felbamate. Increased AUC & prolonged t_½ by ketoconazole. Additive effect on tasks involving alertness & vigilance (eg, driving) w/ alcohol & other CNS depressants.

Anticonvulsants

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

POM