Dosing and Safety
How many times a day do you dose Fycompa?
QD - in Latin means Quaque die - one a day
What are the most common Adverse reactions (>5% and 1% higher than placebo) ?
Dizziness, Somnolence and fatigue
Is Fycompa a controlled substance?
Yes. Schedule 111 controlled substance
What is POS indication of Fycompa?
Treatment of POS with or without secondarily generalized in patients with epilepsy 4 years of age and older.
What is PGTC indication for Fycompa?
Fycompa is indicated for adjunctive therapy in the treatment of PGTC seizures in patients with epilepsy 12 years of age and older.
How should I store the oral suspension Fycompa?
Use FYCOMPA oral suspension within 90 days after the bottle is first opened.
Does Fycompa need down titration when a patient is going to withdrawal?
No
What are the contraindications with Fycompa?
There are none
What is the highest reported overdose of Fycompa?
300 mg
How many trials did it take to establish Fycompa’s PGTC indication and in How many countries?
One multicentER, randomized double blind placebo controlled study ( Study 4) conducted at 78 sites and in 16 countries.
The highest reported overdose of Fycompa was how many mg?
Section 10
During what timeframe should you closely monitor for serious psychiatric events?
During titration and at higher doses
Can Fycompa be added to any AED?
Yes Gurl!
What are the Hepatic Impairment Recommendations for mild and moderate hepatic impairment?
Mild is 6 mg and Moderate is 4 mg
What is the Median % reduction from Baseline in PGTC Seizure frequency ?
Table 6. Under 14.2
76% at 8 mg
Can Fycompa Tablets be interchangeable with the oral suspension?
Section 12.3
What is To report Suspected Adverse Reactions ?
Contact Eisai at 1- 888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
What is the Half life of Fycompa ?
105 Hours Looooooooong
In the POS trials what was the mean duration of years patients had epilepsy ?
mean duration of years for patients who had epilepsy was 21 years
and a median seizure frequency of 9 to 12 seizures per 28 days…
What was the Primary endpoint in Study 4 for our PGTC?
The PE was the % change from baseline in PGTC seizure frequency per 28 days during the treatment period compared to the baseline period…
What is the Max dosage for fycompa for patients with mild hepatic impairment?
Section 2.4
Patients reported falls at 5% and 10% in what doses of Fycompa?
Section 5.4
Do not increase the dose more than every two weeks ion what population?
The elderly
In controlled partial onset seizure clinical trials, fycompa treated adults gained an average of how many mgs?
Section 6.1
For eligibility in the PGTC trial(s) patients has to be on ____ AED’s and experience at least ____ PGTC seizures during the 8 week baseline period?
Patients had to be on 1 to 3 AED’s and experience at least 3 PGTC seizures during the 8 week baseline period.