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FYCOMPA is a brand name for Perampanel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FYCOMPA (perampanel) tablets are indicated as: • adjunctive therapy in the management of partial-onset seizures in patients 7 years of age and older FYCOMPA® (Perampanel) Page 4 of 55 who are not satisfactorily controlled with conventional therapy. • adjunctive therapy in the management of primary generalized…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Concomitant CYP3A Enzyme-Inducing AEDs Significantly Reduce Both FYCOMPA Plasma Levels and Efficacy: Carbamazepine, oxcarbazepine and phenytoin all decrease mean FYCOMPA blood levels by approximately 50-70% and substantially decrease FYCOMPA efficacy.
1 Clinical Trials by Indication). • Serious Aggression- and Hostility-Related Adverse Events: Closely monitor patients particularly during the titration period and at higher doses. 2 Clinical Trial Adverse Reactions). 2 Recommended Dose and Dosage Adjustment In order to optimize the balance between efficacy and tolerability, FYCOMPA must always be titrated according to individual patient response.
The maximum recommended daily dose of FYCOMPA is 12 mg/day. Safety of doses higher than 12 mg/day in any age group has not been established. • Adults (≥18 years of age), Adolescents (12 to 17 years of age), and Pediatrics (7 to 11 years of age) Partial-Onset or Primary Generalized Tonic-Clonic Seizures in the Presence of Enzyme- Inducing AEDs (EI-AEDs; including carbamazapine, oxcarbazepine, phenytoin): The recommended starting dose of FYCOMPA in the presence of EI-AEDs, including carbamazepine, oxcarbazepine and phenytoin, is 4 mg/day.
Based on clinical response and tolerability, the dose may be increased by FYCOMPA® (Perampanel) Page 6 of 55 increments of 2 mg to a maximum dose of 12 mg/day. Dose increases should occur no more frequently than at 1-week intervals.
1 Clinical Trials by Indication). This is the result of lower FYCOMPA blood levels (see 7 WARNINGS AND PRECAUTIONS, and 9 DRUG INTERACTIONS), suggesting that relatively higher doses would be needed in this patient population to achieve similar efficacy as those not on EI-AEDs.
However, safety and efficacy of FYCOMPA doses higher than 12 mg/day have not been established in any age group. When these EI-AEDs are introduced or withdrawn from a patient’s treatment regimen, patient should be closely monitored for clinical response and tolerability.
Dose adjustment of FYCOMPA may be necessary. 1 Clinical Trials by Indication). • In the Absence of Enzyme-Inducing AEDs: 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 up to a dose of 8 mg/day.
1 Adverse Reaction Overview In all controlled and uncontrolled studies in adult and adolescent patients with partial-onset seizures, 1639 patients have received perampanel, of whom 1174 have been treated for 6 months and 703 for longer than 12 months.
In the controlled study and open-label extension in patients with primary generalized tonic-clonic seizures (PGTC), 114 patients have received FYCOMPA, of whom 68 have been treated for 6 months and 36 for longer than 12 months. In controlled Phase 3 partial-onset clinical studies, adverse reactions reported in ≥ 5% of patients treated with FYCOMPA (perampanel) were dizziness, somnolence, fatigue, irritability, nausea, ataxia, and fall.
Most events in all treatment groups were considered mild or moderate. The adverse event profile for the PGTC clinical study was similar to that of the partial-onset studies. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Partial-Onset Seizures and Primary Generalized Tonic-Clonic Seizures in Adults:
The partial-onset data are also representative of the PGTC adverse event findings in both adults and adolescents. Table 1 and Table 2 together provide the incidence of treatment-emergent adverse events that occurred in ≥2% of adult patients with partial-onset seizures in three Phase 3 controlled adjunctive studies (n = 780 total randomized to FYCOMPA 4 to 12 mg/day plus other AEDs and for which the frequency was greater than placebo (n=397).
33 9 DRUG INTERACTIONS ................................................................................................ 36 10 CLINICAL PHARMACOLOGY .......................................................................................
37 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 40 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 40 PART II: SCIENTIFIC INFORMATION .......................................................................................
40 13 PHARMACEUTICAL INFORMATION ............................................................................ 40 14 CLINICAL TRIALS ........................................................................................................
44 15 MICROBIOLOGY ........................................................................................................ 45 16 NON-CLINICAL TOXICOLOGY .....................................................................................
45 PATIENT MEDICATION INFORMATION .................................................................................. 48 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS FYCOMPA (perampanel) tablets are indicated as: • adjunctive therapy in the management of partial-onset seizures in patients 7 years of age and older FYCOMPA® (Perampanel) Page 4 of 55 who are not satisfactorily controlled with conventional therapy.
• adjunctive therapy in the management of primary generalized tonic-clonic (PGTC) seizures in patients 12 years of age and older with epilepsy, who are not satisfactorily controlled with conventional therapy. 3 Pharmacokinetics, Special Populations and Conditions).
2 Geriatrics Geriatrics (≥65 years of age): There is limited information on the use of FYCOMPA in patients 65 years of age and older. No dose adjustment based on age is necessary. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics).
FYCOMPA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Perampanel in Canada.
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Dose increases should occur no more frequently than at 2-week intervals. If FYCOMPA is well tolerated at 8 mg/day but clinical response is lacking, the dose may be increased by increments of 2 mg to 12 mg/day, depending upon individual clinical response and tolerability.
The maximum recommended daily dose is 12 mg. 2 Clinical Trial Adverse Reactions). 3 Pharmacokinetics, Special Populations and Conditions, Pediatrics). 1 Clinical trials by Indication). 4 Geriatrics). • Patients with Renal Impairment: Dose adjustment is not required in patients with mild renal impairment.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
FYCOMPA® (Perampanel) Page 7 of 55 • Patients with Hepatic Impairment:
Dosage adjustment is recommended in patients with mild and moderate hepatic impairment, based on higher exposure and the longer half-life of perampanel. The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment.
Starting dose should be 2 mg per day with increments of 2 mg every two weeks until target dose is achieved. Dose increases in patients with mild and moderate hepatic impairment, as with all patients, should be based on clinical response and tolerability.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). • Discontinuing FYCOMPA: When withdrawing FYCOMPA, the dose should be gradually reduced. However, due to its long-half life and subsequent slow decline in plasma concentrations, FYCOMPA can be discontinued abruptly if absolutely needed (see 7 WARNINGS AND PRECAUTIONS, General).
3 Administration FYCOMPA should be taken orally once daily at bedtime. 4 Missed Dose Single missed dose: As perampanel 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 perampanel metabolism-inducing anti-epileptic drugs (AED), 1 […]
, carbamazepine, oxcarbazepine, phenytoin). , Carbamazepine, Oxcarbazepine, Phenytoin), in three Phase 3 Placebo- Controlled Adjunctive Studies in Adult Patients with Partial-Onset Seizures (Events ≥ 2% of patients in the FYCOMPA 12 mg arm and numerically more frequent than placebo) (Patients ≥18 Years) System Organ Class/ Preferred Term Placebo n=227 % FYCOMPA 4 mg n=88 % 8 mg n=230 % 12 mg n=150 % Ear and Labyrinth Disorders Vertigo 1 2 4 5 Eye Disorders Diplopia 1 2 2 5 Vision blurred 2 0 4 5 Gastrointestinal Disorders Abdominal pain 2 1 2 3 FYCOMPA® (Perampanel) Page 22 of 55 System Organ Class/ Preferred Term Placebo n=227 % FYCOMPA 4 mg n=88 % 8 mg n=230 % 12 mg n=150 % Nausea 5 1 4 7 Infections and Infestations Nasopharyngitis 4 1 4 5 Injury, Poisoning and Procedural Complications Falls 3 2 6 7 Head injury 2 1 1 3 Investigations Gamma-Glutamyltransferase increased <1 0 1 2 Weight increased 1 1 5 4 Metabolism and Nutrition Disorders Hyponatraemia <1 0 0 3 Musculoskeletal and Connective Tissue Disorders Back pain 2 2 2 4 Myalgia 2 1 1 3 Nervous System Disorders Asthenia <1 0 2 2 Ataxia 0 0 1 5 Balance disorder <1 0 5 3 Dizziness 8 21 33 42 Dysarthria 0 2 1 2 Fatigue 4 8 7 9 Gait disturbance 1 2 1 4 Headache 10 13 10 15 Hypersomnia 0 1 1 3 Hypoaesthesia <1 0 0 3 Memory impairment 1 0 1 2 Paresthesia 1 0 <1 2 FYCOMPA® (Perampanel) Page 23 of 55 System Organ Class/ Preferred Term Placebo n=227 % FYCOMPA 4 mg n=88 % 8 mg n=230 % 12 mg n=150 % Somnolence 8 11 13 15 Psychiatric Disorders Aggression 0 0 1 2 Anxiety 1 1 4 5 Irritability 1 6 4 11 Mood altered <1 0 <1 2 Respiratory, Thoracic and Mediastinal Disorders Cough 2 0 1 3 Oropharyngeal pain 1 1 1 2 Skin and Subcutaneous Tissue Disorders Rash 2 3 4 3 Central […]
2 CONTRAINDICATIONS FYCOMPA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Serious or life-threatening psychiatric and behavioural adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in both adult and pediatric patients taking FYCOMPA.
• These reactions occurred in patients with and without prior psychiatric history, prior aggressive behaviour, or concomitant use of medications associated with hostility and aggression. • Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behaviour, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA (see 7 WARNINGS AND PRECAUTIONS, Psychiatric and Patient Counselling Information).
FYCOMPA® (Perampanel) Page 5 of 55 • Patients taking FYCOMPA should be advised to avoid the use of alcohol, as it may exacerbate these effects (see 9 DRUG INTERACTIONS). • Closely monitor patients particularly during the titration period and at higher doses.
2 Recommended Dose and Dosage Adjustment, Discontinuing FYCOMPA). 1 Dosing Considerations • Concomitant CYP3A Enzyme-Inducing AEDs Significantly Reduce Both FYCOMPA Plasma Levels and […]