ability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel (7.1)
Cytochrome P450 Inducers: Carbamazepine, oxcarbazepine, and phenytoin increase clearance of perampanel and decrease perampanel plasma concentrations and decrease FYCOMPA’s effectiveness. When these or related enzyme-inducing AEDs are introduced or withdrawn, patients should be closely monitored. Dose adjustment of FYCOMPA may be necessary (7.2)
Strong CYP3A Inducers Other than AEDs (e.g., rifampin, St. John’s wort): concomitant use is not recommended (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
1 INDICATIONS AND USAGE
1.1 Partial-Onset Seizures 1.2 Primary Generalized Tonic-Clonic Seizures 2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Partial-Onset Seizures 2.2 Dosage for Primary Generalized Tonic-Clonic Seizures 2.3 Dosing in the Presence of Concomitant Enzyme-Inducing Antiepileptic Drugs (AEDs) 2.4 Dosage Adjustment in Patients with Hepatic Impairment 2.5 Dosage Information for Patients with Renal Impairment 2.6 Dosage Information for Elderly Patients 2.7 Administration of Oral Suspension 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Psychiatric and Behavioral Reactions 5.2 Suicidal Behavior and Ideation 5.3 Neurologic Effects 5.4 Falls 5.5 Withdrawal of Antiepileptic Drugs 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Contraceptives 7.2 Cytochrome P450 Inducers 7.3 Alcohol and Other CNS Depressants 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance 9.2 Abuse 9.3 Dependence 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility 14 CLINICAL STUDIES
14.1 Partial-Onset Seizures 14.2 Primary Generalized Tonic-Clonic (PGTC) Seizures 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Partial-Onset Seizures FYCOMPA is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
1.2 Primary Generalized Tonic-Clonic Seizures FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Partial-Onset Seizures In patients not receiving concomitant enzyme- |
