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Fycompa has an antiepileptic effect.
Mechanism of action. Perampanel is the first in its class of selective non-competitive antagonist of ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazol propionate- (AMPA) glutamate receptors on postsynaptic neurons.
Glutamate is the main excitatory neurotransmitter in the CNS, which plays an important role in the pathogenesis of a number of neurological diseases caused by over-stimulation of neurons.
It is assumed that the activation of AMPA receptors by glutamate is responsible for the fastest excitatory synaptic transmission in the brain.
In researchin vitro Perampanel did not compete with AMPA for binding to the AMPA receptor, but it was displaced from binding by noncompetitive AMPA receptor antagonists. This indicates that perampanel is a noncompetitive antagonist of AMPA receptors.
In researchin vitro Perampanel inhibited AMPA-induced (but not N-methyl-D-aspartate (NMDA) -induced) increase in intracellular calcium concentration. Perampanel significantly increased the latent period in the AMPA-induced model of an epileptic seizure.in vivo.
The exact mechanism of development of the anticonvulsant effect of perampanel in humans is for further study.
Pharmacodynamic effects.On the basis of the combined data of the three efficacy studies conducted during partial epileptic seizures, the pharmacokinetics and pharmacodynamics of perampanel were analyzed. The magnitude of the effect of perampanel correlated with the severity of reducing the frequency of attacks.
Influence on psychomotor functions. In doses of 8 and 12 mg of perampanel, with single and multiple doses, dose-dependently worsened psychomotor functions in healthy volunteers. The effect exerted by perampanel on complex psychomotor functions, such as driving, was intensified by alcohol intake. Characteristics of psychomotor functions returned to their original values within 2 weeks after discontinuation of perampanel.
Impact on cognitive function. When evaluated in a series of standard tests, the effect of perampanel on the reaction rate on external stimuli and memory in healthy volunteers did not show any effect, either with a single or multiple dose of the drug in doses up to 12 mg / day.
Influence on mood and speed of reaction to external influence. The rate of reaction to external influence (arousal) in healthy volunteers who received perampanel in doses of 4 to 12 mg / day decreased in a dose-dependent manner. Deterioration of mood in volunteers was noted only while receiving 12 mg / day, mood changes were insignificant and reflected an overall decrease in the rate of reaction to external influences.
Repeated intake of perampanel in a daily dose of 12 mg increased the worsening effect of alcohol on attentiveness and speed of reaction to external influence and increased the intensity of irritation, confusion and depression according to the results of a 5-point scale assessing the mood profile.
The effect on the electrophysiological parameters of the heart. Perampanel in daily doses up to 12 mg did not prolong the QTc interval and did not have any dose-dependent or clinically significant effect on the duration of QRS complexes.
Clinical efficacy and safety. The effectiveness of the drug Faykomp® in partial seizures, it was established during three 19-week randomized, double-blind, placebo-controlled multicenter studies in adults and adolescents with partial seizures with or without secondary generalization that are not adequately controlled by other (one to three) antiepileptic drugs (PEP) . During the 6-week base period, patients should have had more than 5 attacks, the period without attacks should not exceed 25 days. In all three studies, patients had an average disease duration of 21.06 years.From 85.3 to 89.1% of patients took 2 or 3 PEP with or without concomitant stimulation of the vagus nerve.
In the first two studies, Ficomp® at daily doses of 8 and 12 mg, and in the third at daily doses of 2, 4 and 8 mg compared with placebo.
In all three studies, after a 6-week base period, conducted prior to randomization and necessary to establish the base rate of epileptic seizures, patients were randomized and received dose-adjusted values selected to randomized values. During the dose selection period in all three studies, treatment began with a dose of 2 mg / day, which increased weekly by 2 mg / day until the target dose was reached. Patients with intolerable side effects could remain at the same dose or their dose was reduced to a previously well-tolerated dose. In all three studies, a period of selection of the dose was followed by a supporting period that lasted 13 weeks and during which patients should receive a constant dose of Ficomp.
According to the combined results of the three studies, the 50% response rate was respectively 19% for the placebo group, 29% for the 4 mg dose, 35% for the 8 mg and 35% for 12 mg. A statistically significant decrease in the frequency of attacks for 28 days compared with placebo was shown for doses of 4 to 12 mg / day in a single dose.
These results show that taking perampanel in doses of 4 to 12 mg 1 time per day as an additional therapy in this group of patients is much more effective compared to placebo.
A clinically significant improvement in seizure control was observed with a single dose of 4 mg / day of Ficomp, and increased with an increase in the daily dose to 8 mg. With an increase in the daily dose of up to 12 mg, an additional increase in the effectiveness of the drug compared to the dose of 8 mg was not observed for the entire population of patients. An increase in the efficacy of Ficomp at a dose of 12 mg was observed only in patients resistant to a dose of 8 mg.
A clinically significant reduction in the frequency of seizures relative to placebo was achieved already at the 2nd week after reaching a daily dose of 4 mg.
Open extended study
97% (1186) of patients completing randomized trials were recruited to participate in an open, extended study in which they took perampanel for at least 1 year at an average daily dose of 10.05 mg.
In these three baseline double-blind, placebo-controlled studies of phase III, 143 adolescents aged 12 to 18 years participated. The results obtained from adolescents were similar to those of adult patients.
The pharmacokinetics of perampanel were studied in healthy volunteers aged 18 to 79 years, in adults and adolescents with partial epileptic seizures, in adults with Parkinson's disease, diabetic nephropathy and multiple sclerosis, as well as in patients with hepatic insufficiency.
Suction. When taken inside, perampanel is quickly and completely absorbed, the effect of the first passage through the liver is negligible. Eating does not affect the degree of absorption, but slows down its speed. Compared with fasting while taking the drug with food, Cmax Perampanel in plasma is reduced, and the time to reach it is increased by 2 hours.
Distribution. Research datain vitro indicate that perampanel is approximately 95% bound to plasma proteins.In vitro It was shown that perampanel is neither a substrate nor a significant inhibitor of transport peptides of organic anions (OATP) 1B1 and 1B3, carriers of organic anions (OAT) 1, 2, 3 and 4, carriers of organic cations (OCT) 1, 2 and 3, and P-glycoprotein and breast cancer resistance protein (BCRP).
Metabolism. Perampanel is largely metabolized by primary oxidation and subsequent glucuronidation.
According to the researchin vitro with recombinant cytochrome P450 in human liver microsomes, primary oxidative metabolism is mediated by CYP3A4 isoenzymes. However, the metabolism of perampanel is not fully understood; its other paths are not excluded.
After the application of radiolabeled perampanel in plasma, only trace amounts of its metabolites are determined.
Derivation. After taking radioactively labeled perampanel with healthy elderly volunteers, 30% of the radioactive label was detected in the urine and 70% in the feces. The isolated radioactive label was mainly a mixture of oxidized and conjugated metabolites. In a population pharmacokinetic analysis of summary data from 19 clinical studies of phase I, average T1/2 perampanel was 105 hours. When used simultaneously with carbamazepine, which is a powerful inducer of the isoenzyme CYP3A4, T1/2 perampanel was 25 hours.
Linearity / Nonlinearity. In healthy volunteers, the concentration of perampanel in plasma increases in direct proportion to the dose in the range from 2 to 12 mg. In a population pharmacokinetic analysis in patients with partial seizures who received perampanel at doses up to 12 mg / day in a placebo-controlled clinical study, a linear relationship was established between plasma dose and concentration of perampanel in plasma.
Use in special patient groups
Patients with liver failure. The pharmacokinetics of perampanel after administration of a single dose of 1 mg was evaluated in 12 patients with mild to moderate hepatic insufficiency (grades A and B on the Child-Pugh scale) and the 12 healthy volunteers that correspond to them demographically. The average apparent clearance of unbound perampanel in mild hepatic insufficiency was 188 ml / min versus 338 ml / min in healthy volunteers and 120 ml / min (versus 392 ml / min) in moderate degree. T1/2 in patients with hepatic impairment was extended: with a mild degree - up to 306 hours against 125 hours in healthy volunteers, with a moderate degree - up to 295 hours against 139 hours.
Patients with renal failure. The pharmacokinetics of perampanel in patients with renal insufficiency were not studied separately. The elimination of perampanel is carried out almost exclusively by the formation of metabolites with their subsequent rapid excretion. Only trace amounts of perampanel metabolites are detected in plasma. In a population pharmacokinetic analysis in patients with partial seizures and Cl creatinine 39–160 ml / min, who received perampanel in doses up to 12 mg / day during a placebo-controlled study, there was no relationship between perampanel clearance and creatinine clearance.
The effect of sex. In a population-based pharmacokinetic analysis in patients with partial seizures who received perampanel at doses up to 12 mg / day during placebo-controlled studies, the clearance of perampanel in women (0.605 l / h) was 17% lower than in men (0.73 l / h)
Elderly patients (≥65 years). In a population-based pharmacokinetic analysis in patients aged 12 to 74 years with partial seizures who received perampanel at doses up to 12 mg / day during placebo-controlled studies, no significant effect of age was found on clearance of perampanel.
Patients of children's age. In a population pharmacokinetic analysis in adolescent patients who participated in phase III clinical trials, there were no significant differences from the general population.
Drug Interaction Studies
Evaluation of in vitro drug interactions
Inhibition of enzymes involved in drug metabolism. Among the main cytochromes and udp-glucuronyltransferase of the liver, perampanel (30 µmol / l) in experiments on human liver microsomes weakly inhibited CYP2C8 and UGT1A9 isoenzymesin vitro.
Induction of enzymes involved in drug metabolism. Compared to the positive control (including phenobarbital and rifampicin), among the main cytochromes and UDP-glucuronyltransferases in human hepatocyte culture, perampanel weakly induced isoenzymes CYP2B6 (30 µmol / L) and CYP3A4 / 5 (3 µmol / L).
Faykompa drug is shown as an adjunct for the treatment of partial seizures in patients with epilepsy aged 12 years and older in the presence or absence of secondary generalized seizures.
1 tablet, film coated, contains:
active substance: Perampanel (in terms of anhydrous substance) 8 mg.
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Dosage and Administration
Inside beforea dream, regardless of the meal.
Use in adults and adolescents. Perampanel take 1 time per day. The tablet must be swallowed.wholly, drinking 1 glass of water, you can not chew, chop or crush, because the tablet can not be neatly divided, because there are no risks on it.
It was shown that the drug Fycompa® in daily doses of 4 to 12 mg is effective in the treatment of partial epileptic seizures. Acceptance of Fycompa® should be started with a dose of 2 mg / day. The dose can be increased depending on the clinical response and tolerability, in increments of 2 mg no more often than once a week, up to 4-8 mg / day. Depending on the individual clinical response and tolerability of the drug at a dose of 8 mg / day, it is possible to further increase the dose of Faycompe to 12 mg / day, in increments of 2 mg no more than 1 time per week. In patients at the same time receiving AEDs that do not reduce the half-life of perampanel, the dose of perampanel should be adjusted at two-week intervals. In patients who are simultaneously receiving AEDs, reducing the half-life of perampanel, the dose of perampanel should be increased once a week.
The abolition of the drug carried out gradually.
Single skip drug intake: due to the fact that perampanel has a sufficiently long T1/2, the patient must wait and take the next scheduled dose in accordance with the agreed regimen of the drug.
If you miss taking more than 1 dose (total duration without drug less than 5T1/2: 3 weeks - for patients not receiving AEDs, changing the metabolism of perampanel, and 1 week - for patients receiving AEDs, changing the metabolism of perampanel), should consider the issue of resuming the drug in the last dose taken.
If the patient has interrupted the drug for more than 5T1/2, it is necessary to follow the recommendations as in the initiation of treatment.
Use in children under 12 years. The safety and efficacy of perampanel in children under 12 years of age has not been established.
Use in elderly patients (≥65 years). An insufficient number of patients with epilepsy over 65 years of age to assess differences with younger patients participated in the clinical studies of Fycompa®. Analysis of safety information in 905 elderly patients who took perampanel did not reveal differences in safety profile depending on age. These data confirm that dose adjustment of perampanel depending on age is not required. In elderly patients, perampanel should be used with caution.
Use in patients with renal failure. In renal failure, a mild dose of perampanel is not required. The use of Fycompa® in patients with moderate and severe renal insufficiency or patients on hemodialysis is not recommended.
Use in patients with liver failure. Increasing the dose in patients with mild to moderate hepatic insufficiency, as in other patients, is made depending on the clinical response and tolerability. Since when liver failure is mild to moderate T1/2 Perampanel is extended, the minimum time interval before each dose should be 2 weeks, and the maximum dose should not exceed 8 mg / day. Use in severe hepatic impairment is not recommended.
Among 1,639 patients with partial seizures who received perampanel in all clinical trials conducted, 1,174 took the drug for 6 months and 703 for more than 12 months.
Adverse reactions that led to the release of patients from controlled phase III studies were noted in 1.7, 4.2 and 13.7% in patients who received perampanel, respectively, in doses of 4, 8 and 12 mg / day, and 1.4% - in patients receiving placebo.The most common reasons for withdrawal from the studies were dizziness and drowsiness (≥1% in the summary group of those taking the perampanel and more than in the placebo group).
The following are the undesirable phenomena observed when applying perampanel, according to the system-organ classes and their frequency of occurrence. The following classification is used to assess the frequency of occurrence of adverse events: very often (≥1 / 10); often (≥1 / 100,
Disorders from the side of nutrition and metabolism: often - loss of appetite, increased appetite.
Mental Disorders: often - aggression, anger, anxiety, confusion.
Nervous system disorders: very often - dizziness, drowsiness; often - ataxia, dysarthria, imbalance, irritability.
Violations by the organ of vision: often - diplopia, blurred vision.
Disturbances from the ear and labyrinth disorders: often - central dizziness.
Gastrointestinal disorders: often nausea.
Disorders of the musculoskeletal system and connective tissue: often - back pain.
General violations: often - gait disturbance, fatigue.
Laboratory and instrumental data: often - weight gain.
Injuries, intoxications and complications of manipulations: often fall.
Teenagers. Based on data from clinical studies, it can be expected that the frequency, nature and severity of adverse reactions in adolescents are the same as in adults.
- hypersensitivity to perampanel or any of the excipients of the drug;
- galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- severe renal or hepatic impairment;
- hemodialysis patients;
- lactation period;
- children under 12 years old (data on efficacy and safety are not available).
Fycompa®a is not a potent inducer or inhibitor of cytochrome P450 isoenzymes or UGT isoenzyme involved in glucuronidation.
At a dose of 12 mg / day (but not 4 or 8 mg / day), perampanel reduced Cmax and AUC of levonorgestrel by approximately 40%. Perampanel in a daily dose of 12 mg has no effect on ethinyl estradiol AUC, but reduces its Cmax by 18%. Patients taking Fycompa® should consider the probability of reducing the effectiveness of contraceptives containing levonorgestrel and use additional methods of contraception (intrauterine devices or condoms).
Interaction with other antiepileptic drugs (PEP)
The potential interaction of Fycompa®a (with a single daily dose of up to 12 mg) and other AEDs was evaluated based on data from clinical studies and a population pharmacokinetic analysis of summary data from three phase III studies. The effect of this interaction on the equilibrium concentration of the probe is shown in the table:
|Jointly applied probe||The effect of probe on the concentration of the drug Fycompa®||The influence of the drug Faykomp on the concentration of the probe|
|Carbamazepine||Reduced by "70%||Reduction of less than 10%|
|Clobazam||Does not affect||Reduction of less than 10%|
|Clonazepam||Does not affect||Does not affect|
|Lamotrigine||Does not affect||Reduction of less than 10%|
|Levetiracetam||Does not affect||Does not affect|
|Oxcarbazepine||Reduced by "50%||35% increase *|
|Phenobarbital||Does not affect||Does not affect|
|Phenytoin||Reduced by "50%||Does not affect|
|Topiramate||20% reduction||Does not affect|
|Valproic acid||Does not affect||Reduction of less than 10%|
|Zonisamide||Does not affect||Does not affect|
* Excluding the active metabolite of monohydroxycarbazepine.
Some probes that are enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) increase the total clearance of perampanel and, accordingly, reduce its plasma concentrations.
In a study involving healthy volunteers, carbamazepine, a well-known powerful enzyme inducer, reduced the concentration of perampanel by 2/3 (3 times).
A similar result was obtained in a population pharmacokinetic analysis in patients with partial seizures who received Fycompa® in doses up to 12 mg / day during placebo-controlled clinical trials. Acceptance of Phycompe clinically did not significantly affect the clearance of clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, with the highest dose of perampanel (12 mg / day).
At the same time taking the drug perampanel with oxcarbazepine, the clearance of the latter decreased by 26%. Oxcarbazepine is rapidly metabolized with the participation of cytosolic reductase to the active metabolite of monohydroxycarbazepine. The effect of perampanel on monohydroxycarbazepine concentration is unknown.
The dose of perampanel is selected to achieve a clinical effect regardless of the accompanying AEDs.
Effect of perampanel on CYP3A isoenzyme substrates
In healthy volunteers, Fycompa®a (in a daily dose of 6 mg for 20 days) reduced the AUC of midazolam by 13%. A more significant decrease in the exposure of midazolam (and other sensitive substrates of the CYP3A isoenzyme) while taking higher doses of Fycompa® cannot be ruled out.
Effect of cytochrome P450 isoenzyme inducers on perampanel pharmacokinetics
It is expected that powerful inducers of cytochrome P450 isoenzymes, such as rifampicin and St. John's wort, can also reduce the concentration of perampanel in plasma. Felbamate can also reduce the concentration of perampanel in the plasma.
Effect of cytochrome P450 isoenzyme inhibitors on the pharmacokinetics of perampanel
In healthy volunteers, ketoconazole (at a daily dosage of 400 mg for 10 days), an inhibitor of the CYP3A4 isoenzyme, increased the AUC of perampanel by 20% prolonged it T1/2 by 15% (67.8 vs. 58.4 hours). When combining perampanel with another inhibitor of the CYP3A4 isoenzyme with a half-life longer than ketoconazole or with a longer intake of the inhibitor, an enhanced effect cannot be ruled out. Potent inhibitors of other cytochrome P450 isoenzymes also have the potential to increase the concentration of perampanel.
In healthy volunteers, taking Fycompa® (4 mg daily for 19 days) had no effect on AUC or Cmax levodopa.
In a study of pharmacodynamic interactions in healthy volunteers, the effect of a penman on alertness and responsiveness, such as driving, was enhanced by alcohol intake. Repeated intake of perampanel in a daily dose of 12 mg and increased severity of irritation, confusion and depression. This effect is also observed when taking the drug Faykompa in combination with other CNS depressants.
Use in adolescents
Studies of drug interactions were conducted only in adults. In a population pharmacokinetic analysis in adolescents who participated in phase III clinical trials, there were no noticeable differences from the general study population.
Pregnancy and Lactation
Women with preserved childbearing potential who do not use contraceptive methods should take Fycompa® only in case of emergency.
Data on the use of perampanel in pregnant women are significantly limited (
Animal studies have shown that perampanel and / or its metabolites are excreted in breast milk. It is not known whether perampanel is excreted in human breast milk, so the risk to the baby cannot be ruled out.
Considering the advantages of both breastfeeding for the child and therapy for the woman, it is necessary either to stop breastfeeding or to refrain from taking / stop taking Faycompa during the breastfeeding period.
Impact on fertility
In animal studies, it has been shown that in high doses (30 mg / kg), perampanel prolongs and disrupts the regularity of the estrous cycle, but these changes did not affect fertility and early fetal development. No effect on male fertility was found.The effect of perampanel on human fertility has not been studied.
In patients taking AEDs for various indications, there were cases of suicidal thinking and behavior. A meta-analysis of randomized, placebo-controlled probes also showed a slight increase in the risk of suicidal thinking and behavior. The mechanism of increasing the risk is unknown, at present it is not possible to exclude the possibility of increasing this risk when using the drug Fycompa®. As a result, patients should be supervised to identify symptoms of suicidal thinking and behavior; appropriate treatment should be prescribed.
Patients or caregivers should be informed of the need to seek medical attention if they show signs of suicidal thinking or behavior.
Nervous system disorders
Perampanel can cause dizziness and drowsiness and, thereby, affect the ability to drive and use mechanisms.
In the case of taking Fycompa® at a dose of 12 mg / day, the effectiveness of progestogen-containing hormonal contraceptives may be reduced (see the section "Interaction with other drugs"). In these cases, it is necessary to provide for the use of additional non-hormonal methods of contraception.
Completion of therapy
It is recommended to finish therapy with Fycompa® gradually to minimize the chance of an increase in the frequency of attacks. In extreme cases, it is possible to abruptly stop taking the drug, given its long period of excretion and the relatively slow decrease in its plasma concentration after stopping.
There was a tendency to an increase in the number of falls, especially in elderly patients, the cause of which is unknown.
Cases of aggressive and hostile behavior have been reported in patients receiving penile therapy. In clinical studies of perampanel, aggression, anger, and irritability were more common when used in higher doses. Most of these adverse events were mild or moderate and occurred both independently and at lower doses. However, thoughts of harming others, physical aggression or threatening behavior were observed in some patients (
Care must be taken when prescribing Fycompa® to patients with a history of drug dependence. Such patients should be monitored for the timely detection of the development of possible dependence on perampanel.
Concomitant therapy of PEP inducing CYP3A isoenzyme
The effectiveness of perampanel in fixed doses was lower in those patients who received concomitant antiepileptic therapy with inducers of the CYP3A isoenzyme (carbamazepine, phenytoin, oxcarbazepine) than in patients who received no effect on PEP enzymes. 50% of the response to treatment with perampanel at a dose of 4, 8, and 12 mg were achieved, respectively, in 23, 31.5, and 30% of patients with PEP inducing CYP3A isoenzyme, and, respectively, in 33.3, 46, 5 and 50% of patients who took AEDs that do not affect the activity of enzymes. The effect of therapy with perampanel must be carefully monitored when replacing or adding concomitant AEDs. Depending on the individual clinical response to treatment and the tolerability of the drug, the dose may be increased or decreased in steps of 2 mg.
Concomitant therapy with other inducers or inhibitors of cytochrome P450 isoenzymes that are not PEP
Tolerability and the effect of therapy with perampanel must be carefully monitored when adding or canceling inducers or inhibitors of cytochrome P450 isoenzymes, sincethis may alter the concentration of perampanel in the plasma, and a dose adjustment may be necessary.
Within 28 days, convulsions did not occur in 2–6.5% of those who took perampanel in clinical trials (in the placebo group, in 0–1.7%). Information about the effect of the abolition of concomitant anticonvulsant therapy is not available.
Influence on ability to steer vehicles and work with mechanisms. Phycomp has a moderate impact on the ability to drive vehicles and work with mechanisms. Perampanel can cause dizziness and drowsiness and thus affect the ability to manage traffic and use mechanisms. Patients are not advised to drive vehicles, work with complex equipment, or engage in other potentially hazardous activities until it becomes clear whether the pen-panel affects their ability to perform these actions.
Symptoms: The clinical experience of overdose with a human perampanel is limited. In the report of an intentional overdose, which could lead to a dose of up to 264 mg, the patient experienced a change in consciousness, agitation, and aggressive behavior; recovery was without consequences.
Treatment: there is no specific antidote. General supportive therapy is shown, including monitoring of vital signs and the patient’s clinical status. Given the long T1/2 perampanel, its effects may have a longer duration in time. Due to the low renal clearance of perampanel, special procedures, such as forced diuresis, hemodialysis, or hemoperfusion, are ineffective.
- Brand name: Fycompa
- Active ingredient: Perampanel
- Dosage form: Tablets, film coated.
- Manufacturer: Eisai
- Country of Origin: Japan
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