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Fycompa is a brand name for Perampanel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fycompa (perampanel) is indicated for the adjunctive treatment of: - partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older. - primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy…
Verbatim from this product's EMA label. Tap a section to expand.
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 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. 5 mg/day (no more frequently than weekly intervals) Recommended maximum dose 12 mg/day 12 mg/day 8 mg/day 6 mg/day 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.
5) should be titrated no more frequently than at 2-week intervals. 5) 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.
5) should be titrated no more frequently than at 2-week intervals. 5) 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.
Summary of the safety profile In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 patients have received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.
In the controlled and uncontrolled study in patients with primary generalised tonic-clonic seizures, 114 patients have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months. 4% (6/442) in patients randomised to receive placebo.
The adverse reactions most commonly (≥ 1% 12 in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence. 2% (1/82) in patients randomised to receive placebo. The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
4). Tabulated list of adverse reactions In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Within each frequency category, adverse reactions are presented in order of decreasing seriousness. 4 Paediatric population Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial-onset seizures and primary generalised tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Based on the clinical trial database of 180 paediatric patients exposed to perampanel from a multicentre, open label study, the overall safety profile in children was similar to that established for adolescents and adults, except for somnolence, irritability, aggression, and agitation which were observed more frequently in the paediatric study compared to studies in adolescents and adults.
Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel. Therefore, patients (children, adolescents, and adults) should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. 8) in association with perampanel treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Symptoms of SJS include typically although not exclusively, skin detachment (epidermal necrosis/blister) < 10%, erythematous skin (confluent), rapid progression, painful atypical target-like lesions and/or purpuric macules in wide dissemination or large erythema (confluent), bullous/erosive involvement of more than 2 mucous membranes.
If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patient has developed a serious reaction such as SJS or DRESS with the use of perampanel, treatment with perampanel must not be restarted in this patient at any time.
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5) should be titrated no more frequently than at 2-week intervals. 5) 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. 5 mg/day to 6 mg/day.
5) should be titrated no more frequently than at 2-week intervals. 5) 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 generalised 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. 5 mg/day (no more frequently than weekly intervals) Recommended maximum dose 12 mg/day 12 mg/day 8 mg/day 6 mg/day Adults, adolescents age ≥ […]
Available data in children did not suggest any clinically significant effects of perampanel on growth and development parameters including body weight, height, thyroid function, insulin-like growth factor-1 (IGF-1) level, cognition (as assessed by Aldenkamp-Baker neuropsychological assessment schedule [ABNAS]), behaviour (as assessed by Child Behavior Checklist [CBCL]), and dexterity (as assessed by Lafayette Grooved Pegboard Test [LGPT]).
However, long term effects [greater than 1 year] on learning, intelligence, growth, endocrine function, and puberty in children remain unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
8 Absence and myoclonic seizures Absence and myoclonic seizures are two common generalised seizure types that frequently occur in IGE patients. Other AEDs are known to induce or aggravate these seizure types. Patients with myoclonic seizures and absence seizures should be monitored while on Fycompa.
7). 6). Falls There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear. Aggression,psychotic disorder Aggressive, hostile, and abnormal behaviours have been reported in patients receiving perampanel therapy.
In perampanel-treated patients in clinical trials, aggression, anger, irritability, and psychotic disorder were reported more frequently at higher doses. Most of the reported events were either mild or moderate, and patients recovered either spontaneously or with dose adjustment.
However, thoughts of harming others, physical assault, or threatening behaviour were observed in some patients (<1% in perampanel clinical trials). Homicidal ideation has been reported in patients. Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted.
2). Abuse potential Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse. Concomitant CYP 3A inducing anti-epileptic medicinal products Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing anti-epileptic medicinal products.
Patients’ response should be monitored when they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme inducing medicinal products and vice versa. 2). Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly.
9 Hepatotoxicity Cases of hepatotoxicity (mainly hepatic enzyme increased) with perampanel in combination with other antiepileptic drugs have been reported. If hepatic enzymes elevation is observed, monitoring of liver function should be considered.
Excipients Lactose intolerance Fycompa tablets contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.