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Important Safety Information
FYCOMPA® (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
In the partial-onset clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm, and/or any unusual changes in mood or behavior. Should suicidal thoughts or behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizures trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizures trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known.
Falls were reported in 5% and 10% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.
A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.
The most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety.
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin, or oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John’s wort or rifampin should be avoided. Multiple dosing of FYCOMPA 12 mg/day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.
FYCOMPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to a nursing woman.
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.
FYCOMPA is a Schedule III controlled drug substance and has the potential to be abused or lead to drug dependence.
For more information about FYCOMPA, see full Prescribing Information.
BEGIN
Today you will have an opportunity to examine a patient with PGTC seizures who may be appropriate for adjunctive treatment with FYCOMPA®. As you select a patient to examine, you will have the opportunity to review the dosing and administration of FYCOMPA® for PGTC seizures.
At the end of this session, you will have the opportunity to visit our resource center where you can request patient samples.*
PGTC=primary generalized tonic-clonic
*Controlled substance samples are not available in Kansas, Kentucky, New York, Ohio, and Rhode Island.
Generalized tonic-clonic seizures are severe events for patients with epilepsy. FYCOMPA can be prescribed as adjunctive treatment for patients who experience these types of seizures.
(Click 
to learn more about each patient; click 
to select.)
AED=antiepileptic drug
EEG=electroencephalogram; MRI=magnetic resonance imaging
ENLARGE
Steven has experienced periodic tonic-clonic seizures while awake, forcing restriction on driving. Serial EEG studies, including a 72-hour ambulatory EEG, have been normal.
FYCOMPA® (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
GTC=generalized tonic-clonic
EEG=electroencephalogram; MRI=magnetic resonance imaging
ENLARGE
At this time, Jessica lives with her boyfriend, is caring for her 2-year-old child, and works evening shifts. She has been reporting more frequent GTC seizures on the 2 AEDs lamotrigine and zonisamide
FYCOMPA® (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
EEG=electroencephalogram; MRI=magnetic resonance imaging
ENLARGE
John is currently on oxcarbazepine monotherapy.
FYCOMPA® (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
median reduction in PGTC seizure frequency1
Phase 3 Study Design Multicenter, randomized, double-blind, placebo-controlled, parallel-group study on effectiveness of FYCOMPA as adjunctive therapy in patients 12 years of age and older. The total treatment period was 17 weeks (4: titration; 13: maintenance). Inclusion criteria included taking 1 to 3 concomitant AEDs at baseline and ≥ 3 PGTC seizures experienced in 8-week baseline period.1
Median percent change in PGTC seizure frequency during the treatment period as compared with the baseline period.
AEDs at baseline: lamotrigine, valproic acid/ergenyl chrono, levetiracetam, topiramate, zonisamide, clonazepam, carbamazepine, phenytoin, phenobarbital, clobazam, ethosuximide, oxcarbazepine, lacosamide, gabapentin, lorazepam, acetazolamide, clorazepic acid, mesuximide, sultiame, tiagabine.
Adverse reactions in PGTC seizure study1
The most common adverse reactions in patients receiving FYCOMPA (≥10% and greater than placebo) were dizziness (32%), fatigue (15%), headache (12%), somnolence (11%), and irritability (11%).
*In PGTC patients not taking enzyme-inducing AEDs, 8 mg is the recommended maintenance dose.
†Closely monitor patients when starting or withdrawing enzyme-inducing AEDs (including carbamazepine, phenytoin, and oxcarbazepine). Dose adjustment may be necessary.
‡For patients taking enzyme-inducing agents, a maintenance dose has not been established. Individual dose should be titrated to clinical effectiveness.
2 mg/day at bedtime
Increase dosage by increments of 2 mg no more frequently than every 2 weeks
The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment
Use in patients with severe hepatic impairment is not recommended
2 mg/day at bedtime
Dose adjustment is not required in patients with mild renal impairment
A slower titration may be considered based on clinical response and tolerability
Use with caution in patients with moderate renal impairment with close monitoring
Use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended
2 mg/day at bedtime
Dosage increases no more frequently than every 2 weeks
Because of increased likelihood for adverse reactions in the elderly, dosing titration should proceed slowly in patients aged 65 years and older
With cytochrome P450 (CYP) inducers
With contraceptives
With alcohol and other CNS depressants
Patients pay no more than 
for their monthly prescription*
Good toward the purchase of 12 FYCOMPA prescriptions for up to 12 months
Direct your patients to FYCOMPA.com
*Restrictions apply. Not available to patients enrolled in federal or state healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE.
UNIQUE MOA
The first and only AMPA receptor antagonist9,10,11
DOSING
Click Prescribing Information to see important dosing instructions.
TITRATION
Terms and Conditions
Please be advised that personal information you provide will be used to satisfy your request to receive product samples. The maker of FYCOMPA, Eisai, Inc., operates this website and our Privacy Policy will govern the collection, use, disclosure and retention of the information you provide here. Please do not submit any personal information unless you have read and agree with the terms of that Privacy Policy. Consistent with the Privacy Policy, we and our service providers may use the personal information you provide to contact you and send you communications, including about products or services that may interest you. By clicking “accept” below, you agree that you have read, understand, and agree to these registration terms.
For more information please contact Eisai’s Compliance Dept. at 201-746-3050.
In the event that I would like to opt out of receiving further communications, I can request that I be removed from the FYCOMPA contact list at any time by clicking on the “Unsubscribe” link found at the bottom of all FYCOMPA email communications.
*Controlled substance samples are not available in Kansas, Kentucky, New York, Ohio, and Rhode Island.
References
