FYCOMPA FILM-COATED TABLET 8MG [SIN14619P]

Product Info

FYCOMPA FILM-COATED TABLET 8MG

[SIN14619P]

4.1 Therapeutic indications
FYCOMPA is indicated for:

• treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older.

• adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalized epilepsy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Posology
FYCOMPA must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.

Perampanel should be taken orally once daily at bedtime.

The physician should prescribe the most appropriate formulation and strength according to weight and dose. Alternate formulations of perampanel are available, including oral suspension.

Partial Onset Seizures
[Monotherapy]
The following table summarises the recommended posology for adults, adolescents, and children from 4 years of age. More details are provided below the table.

Adults, adolescents age ≥12 years
The starting oral dose is 2 mg once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 2 weeks or longer. The maintenance dose is 4–8 mg once daily.
Dosage may be increased or decreased as necessary by 2 mg or less at intervals of 2 weeks or longer based on individual clinical response and tolerability, but the maximum daily dose should not be over 8 mg.

Children (from 4 to 11 years) weighing ≥30 kg
The starting oral dose is 2 mg once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 2 weeks or longer. The maintenance dose is 4–8 mg once daily.
Dosage may be increased or decreased as necessary by 2 mg or less at intervals of 2 weeks or longer based on individual clinical response and tolerability, but the maximum daily dose should not be over 8 mg.

Children (from 4 to 11 years of age) weighing 20 kg and <30 kg
The starting oral dose is 1 mg once daily as perampanel at bedtime, and the daily dose may then be increased by 1 mg at intervals of 2 weeks or longer. The maintenance dose is 4–6 mg once daily.
Dosage may be increased or decreased as necessary by 1 mg or less at intervals of 2 weeks or longer based on individual clinical response and tolerability, but the maximum daily dose should not be over 6 mg.

Children (from 4 to 11 years of age) weighing <20 kg
The starting oral dose is 1 mg once daily as perampanel at bedtime, and the daily dose may then be increased by 1 mg at intervals of 2 weeks or longer. The maintenance dose is 2–4 mg once daily.
Dosage may be increased or decreased as necessary by 1 mg or less at intervals of 2 weeks or longer based on individual clinical response and tolerability, but the maximum daily dose should not be over 4 mg.

[Adjunctive therapy]
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
The following table summarises the recommended posology for adults, adolescents and children from 4 years of age. More details are provided below the table.

Adults, adolescents age ≥ 12 years
Treatment with FYCOMPA should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2 week intervals. Patients who are taking concomitant medicinal products that shorten the half life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1 week intervals.

Children (from 4 to 11 years) weighing ≥ 30 kg
Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Children (from 4 to 11 years of age) weighing 20 kg and < 30 kg
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 6 mg/day. Depending upon individual clinical response and tolerability at a dose of 6 mg/day, the dose may be increased by increments of 1 mg/day to 8 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Children (from 4 to 11 years of age) weighing < 20 kg
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 2 mg/day to 4 mg/day. Depending upon individual clinical response and tolerability at a dose of 4 mg/day, the dose may be increased by increments of 0.5 mg/day to 6 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Primary Generalised Tonic-Clonic Seizures
Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalized tonic clonic seizures.
The following table summarises the recommended posology for adults, adolescents and children from 7 years of age. More details are provided below the table.

Adults, adolescents age ≥ 12 years
Treatment with FYCOMPA should be initiated at a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased up to 12 mg/day, which may be effective in some patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see Section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Children (from 7 to 11 years) weighing ≥ 30 kg
Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Children (from 7 to 11 years of age) weighing 20 kg and < 30 kg
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 6 mg/day. Depending upon individual clinical response and tolerability at a dose of 6 mg/day, the dose may be increased by increments of 1 mg/day to 8 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Children (from 7 to 11 years of age) weighing < 20 kg
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 2 mg/day to 4 mg/day. Depending upon individual clinical response and tolerability at a dose of 4 mg/day, the dose may be increased by increments of 0.5 mg/day to 6 mg/day. Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be titrated no more frequently than at 1-week intervals.

Paediatrics population
The safety and efficacy of FYCOMPA have not yet been established in children below 4 years of age in the POS indication or in children below 7 years of age in the PGTCS indication.

Elderly Patients (65 years of age and above)
Clinical studies of FYCOMPA in epilepsy did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Analysis of safety information in 905 perampanel-treated elderly patients (in double blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile. In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose adjustment in the elderly is not required. Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
Dose adjustment is not required in patients with mild renal impairment. Use in patients with moderate or severe renal impairment or patients undergoing hemodialysis is not recommended.

Hepatic Impairment
Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability. For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg. Patients should be up-titrated using 2 mg doses no faster than every 2 weeks based on tolerability and effectiveness.
Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg.
Use in patients with severe hepatic impairment is not recommended.

Missed Dose
Single missed dose: As FYCOMPA has a long half-life, the patient should wait and take their next dose as scheduled.
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking FYCOMPA metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking FYCOMPA metabolism-inducing AEDs (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), consideration should be given to re-start treatment from the last dose level.
If a patient has discontinued FYCOMPA for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.

Withdrawal
When withdrawing, the dose should be gradually reduced to minimize the potential for rebound seizures. However, due to its long-half life and subsequent slow decline in plasma concentrations, FYCOMPA can be discontinued abruptly if absolutely needed.

Method of administration
Fycompa should be taken as single oral dose at bedtime. It may be taken with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The tablet should be swallowed whole with a glass of water. It should not be chewed, crushed or split. The tablets cannot be split accurately as there is no break line.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.