Innovations In Clinical Neuroscience

Current Trends in Epilepsy 2015

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

Issue link: http://innovationscns.epubxp.com/i/618633

Contents of this Issue

Navigation

Page 2 of 15

Indication 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. Important Safety Information Serious Psychiatric and Behavioral Reactions 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 fi rst 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 signifi cantly 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. 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 or 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 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. 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 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 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. Withdrawal of AEDs 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. Most Common Adverse Reactions 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. Drug Interactions FYCOMPA may decrease the effi cacy 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. Pregnancy Category C and Lactation FYCOMPA should be used during pregnancy only if the potential benefi t justifi es 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. 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 drug substance and has the potential to be abused or lead to drug dependence. FYCOMPA ® is a registered trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc. Manufactured and marketed by Eisai Inc., 100 Tice Blvd., Woodcliff Lake, NJ 07677 ©2015 Eisai Inc. All rights reserved. FYCO-US0271 November 2015 WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Ŋ6HULRXVRUOLIHWKUHDWHQLQJSV\FKLDWULFDQGEHKDYLRUDODGYHUVH reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA Ŋ7KHVHUHDFWLRQVRFFXUUHGLQSDWLHQWVZLWKDQGZLWKRXWSULRU psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression Ŋ$GYLVHSDWLHQWVDQGFDUHJLYHUVWRFRQWDFWDKHDOWKFDUHSURYLGHU immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA Ŋ&ORVHO\PRQLWRUSDWLHQWVSDUWLFXODUO\GXULQJWKHWLWUDWLRQSHULRG and at higher doses Ŋ)<&203$VKRXOGEHUHGXFHGLIWKHVHV\PSWRPVRFFXUDQG should be discontinued immediately if symptoms are severe or are worsening

Articles in this issue

Archives of this issue

view archives of Innovations In Clinical Neuroscience - Current Trends in Epilepsy 2015