"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within "...
- Clinician Information:
Fycompa Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Fycompa (perampanel) is used to treat partial onset seizures in patients with epilepsy ages 12 years and older. Fycompa is in a new class of drugs to treat drug-resistant partial-onset seizures. Side effects include dizziness, sleepiness, fatigue, irritability, nausea, weight gain, and problems maintaining balance. Serious psychiatric and behavioral reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported. Patients should be monitored for such reactions, as well as changes in mood, behaviors,
Starting dose of Fycompa is 2 mg taken once daily at bedtime. Patients taking anti-eleptic drugs (AEDs) should start on 4 mg of Fycompa. Dosage may be increased based on how well patients tolerate Fycompa. The maximum recommended dose is 12 mg taken once daily. Fycompa is not recommended for patients with decreased liver or kidney function, or patients on dialysis. Fycompa may decrease the effectiveness of hormonal contraceptives. Tegretol (carbamazepine), Carbatrol (carbamazepine), Equetro (carbamazepine), Trileptal (oxcarbazepine), Oxtellar XR (oxcarbazepine), Phenobarbital, and Mysoline (primidone), enzyme-inducing AEDs (phenobarbital and primidone), Rifadin (rifampin), Rifamate (rifampin and isoniazid), Rifater (rifampin, isoniazid and pyrazinamide), and St. John's Wort may interact with Fycompa. Fycompa is not recommended for use during pregnancy. It may cause fetal harm. It is not known if Fycompa passes into breast milk. Nursing mothers and their doctors should decide if the patient will take Fycompa or breastfeed. Patients should not do both. If a patient withdraws from Fycompa, there may be an increase in the frequency of seizures.
Our Fycompa (perampanel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fycompa FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- Serious Psychiatric and Behavioral Reactions[see WARNINGS AND PRECAUTIONS]
- Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
- Dizziness and Gait Disturbance [see WARNINGS AND PRECAUTIONS]
- Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 1,038 patients on perampanel (2, 4, 8, or 12 mg once daily) constituted the safety population in the pooled analysis of Phase 3 placebo controlled studies (Studies 1, 2, and 3) in patients with partial onset seizures. Approximately 51% of patients were female and the mean age was 35 years.
Adverse Reactions Leading to Discontinuation
In controlled Phase 3 clinical trials (Studies 1, 2, and 3), the rate of discontinuation as a result of an adverse reaction was 3%, 8% and 19% in patients randomized to receive FYCOMPA at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 5% in patients randomized to receive placebo [see Clinical Studies]. The adverse events most commonly leading to discontinuation ( ≥ 1% in the 8 mg or 12 mg FYCOMPA group and greater than placebo) were dizziness, somnolence, vertigo, aggression, anger, ataxia, blurred vision, irritability, and dysarthria [see WARNINGS AND PRECAUTIONS].
Most Common Adverse Reactions
Table 2 gives the incidence in the Phase 3 controlled trials (Studies 1, 2, and 3) of the adverse reactions that occurred in ≥ 2% of patients with partial-onset seizures in any FYCOMPA dose group. Overall, the most frequently reported dose-related adverse reactions in patients receiving FYCOMPA at doses of 8 mg or 12 mg ( ≥ 4% and occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability (9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain (4%). For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation.
Table 2: Adverse Reactions in Pooled Double-blind
Trials in Patients with Partial-Onset Seizures (Reactions ≥ 2% of
Patients in Highest FYCOMPA Dose (12 mg) Group and More Frequent than Placebo)
|Ear and Labyrinth Disorders|
|Infections and Infestations|
|Upper respiratory tract infection||3||3||3||4|
|Injury, Poisoning and Procedural Complications|
|Limb injury||< 1||1||1||2|
|Metabolism & Nutrition disorders|
|Musculoskeletal and Connective Tissue disorders|
|Pain in extremity||1||0||2||3|
|Nervous system disorders|
|Coordination abnormal||0||1||< 1||2|
|Confusional state||< 1||1||1||2|
|Euphoric mood||0||0||< 1||2|
|Mood altered||< 1||1||< 1||2|
|Respiratory, Thoracic and Mediastinal Disorders|
Weight gain has been observed with FYCOMPA use in adults.
In the controlled Phase 3 epilepsy clinical trials, FYCOMPA-treated adults gained an average of 1.1 kg (2.5 lbs) compared to an average of 0.3 kg (0.7 lbs) in placebo-treated adults with a median exposure of 19 weeks. The percentages of adults who gained at least 7% and 15% of their baseline body weight in FYCOMPA-treated patients were 9.1% and 0.9%, respectively, as compared to 4.5% and 0.2% of placebo-treated patients, respectively.
Clinical monitoring of weight is recommended.
Comparison of Sex and Race
No significant sex differences were noted in the incidence of adverse reactions.
Although there were few non-Caucasian patients, no differences in the incidences of adverse reactions compared to Caucasian patients were observed.
Read the entire FDA prescribing information for Fycompa (Perampanel Tablets, for Oral Use) »
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