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Expert Commentary on a Broad-Spectrum Treatment Option Which May Offer Convulsive Seizure Freedom for Patients With Partial-Onset Seizures
Presented by Selim Benbadis, MD; and Matthew Holtzman, MD
Experts Dr Eric Piña-Garza and Patricia Dean Offer Commentary on a Patient Case With Primary Generalized Tonic-Clonic Seizures
Presented by Jesus E. Piña-Garza, MD; and Patricia Dean, ARNP, MSN, CNRN
Chapter 1: An Antiseizure Medication by the Numbers
Presented by Imad Najm, MD; Amir Arain, MD, MPH; and Trevor Resnick, MD
Chapter 2: Real Patient Cases
Presented by Imad Najm, MD; Amir Arain, MD, MPH; and Trevor Resnick, MD
Chapter 3: Dosing and Pharmacokinetics of an Antiseizure Medication
Presented by Imad Najm, MD; Amir Arain, MD, MPH; and Trevor Resnick, MD
Partial-Onset Seizures: Open Label Study & Experts’ Real-World Experience with an AED
Presented by Imad Najm, MD; Matthew Holtzman, MD; Lucretia Long, APRN-CNP; and Joanne Rogin, MD
Case Study: 69-Year-Old Woman with Previously Untreated Partial-Onset Seizures with Secondary Generalization
Presented by Julio Cantero, MD
Case Study: 28-Year-Old Woman with Partial-Onset Seizures with Secondary Generalization
Presented by Matthew Holtzman, MD
Case Study: 12-Year-Old Adolescent with Partial-Onset Seizures with Secondary Generalization
Presented by James Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES
Case Study: 17-Year-Old Woman with Inadequately Controlled Primary Generalized Tonic-Clonic Seizures
Presented by James Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES

FACULTY

Amir Arain, MD, MPH
Professor
Vanderbilt University Medical Center
Nashville, TN
Chief of Epilepsy Division
Department of Neurology
University of Utah Medical Center
Salt Lake City, UT
Selim R. Benbadis, MD
Professor and Director
Comprehensive Epilepsy Program
and Clinical Neurophysiology
Laboratory
University of South Florida & Tampa
General Hospital
Tampa, FL
Julio Cantero, MD
Neurology Lecturer and Clinical
Assistant Professor
Florida State University
Neurologist
Intercoastal Medical Group
Sarasota, FL
Patricia Dean, ARNP, MSN, CNRN
Epilepsy Program Specialist
Comprehensive Epilepsy Center
Nicklaus Children’s Hospital
Miami, FL
Matthew Holtzman, MD
Medical Director
Soleo Home Infusion
Detroit, MI
OPTIMDosing
Farmington Hills, MI
Medical Director for Clinical Research
SRI International
Menlo Park, CA
David King-Stephens, MD
Professor of Clinical Neurology
Department of Neurology
Yale University School of Medicine
Co-Director
Center for Neuromodulation in Epilepsy
Yale University
Interim Director
Epilepsy Monitoring Unit
Yale-New Haven Hospital
New Haven, CT
Lucretia Long, APRN-CNP
Clinical Assistant Professor of
Neurology
The Ohio State University
Columbus, OH
Imad Najm, MD
Adjunct Professor
Department of Neurobiology
Kent State University
Kent, OH
Department of Biomedical Engineering
Case Western Reserve University
Vice Chair for Strategy and Development
Cleveland Clinic Neurological Institute
Director
Cleveland Clinic Epilepsy Center
Cleveland, OH
Jesus E. Piña-Garza, MD
Professor
Department of Neurology and Pediatrics
Director of Pediatric Epilepsy
TriStar Centennial Children’s Hospital
Nashville, TN
Trevor Resnick, MD
Associate Professor of Neurology
University of Miami School of Medicine
Chief
Associate Director
Seizure Unit
EEG Laboratories
Department of Neurology
Miami Children’s Hospital
Miami, FL
Joanne Rogin, MD
Clinical Professor of Neurology
University of Minnesota Hospitals
Minneapolis, MN
Neurologist
Minneapolis Clinic of Neurology, Ltd.
Medical Director
Midwest Center for Seizure Disorders
Golden Valley, MN
James Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES
Professor and Chief of Pediatric Neurology
Le Bonheur Chair in Pediatric Neurology
University of Tennessee Health
Science Center
Director
Le Bonheur Comprehensive
Epilepsy Program
Le Bonheur Neuroscience Institute
Le Bonheur Children’s Hospital
Memphis, TN

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
FYCOMPA® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.

WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

  • Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA
  • These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, 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, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA
  • Closely monitor patients particularly during the titration period and at higher doses
  • FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening

SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. 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 (PGTC) seizure clinical trial.

SUICIDAL BEHAVIOR AND IDEATION

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 and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

DIZZINESS AND GAIT DISTURBANCE

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 seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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 seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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 PGTC seizure clinical trial.

SOMNOLENCE AND FATIGUE

FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC 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. Patients should be carefully observed for signs of central nervous system (CNS) depression when FYCOMPA is used with other drugs with sedative properties because of potential additive effects.

FALLS

Falls were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 3% of placebo-treated patients.

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)

DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.

WITHDRAWAL OF AEDs

A gradual withdrawal is generally recommended with AEDs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions in patients aged 12 years and older receiving FYCOMPA (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety. Adverse reactions in patients 4 to <12 years were generally similar to patients aged 12 years and older.

DRUG INTERACTIONS

FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per 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.

PREGNANCY AND LACTATION

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 pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.

HEPATIC AND RENAL IMPAIRMENT

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.

DRUG ABUSE AND DEPENDENCE

FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.

Please see additional Important Safety Information throughout and full US Prescribing Information, including Boxed WARNING.