Dosing and Safety
Adverse Events
MISC
POS
Clinical Trials
PGTC Clinical trials
100

How many times a day do you dose Fycompa?

QD - in Latin means Quaque die - one a day

100

What are the most common Adverse reactions (>5% and 1% higher than placebo) ?

Dizziness, Somnolence and fatigue

100

Is Fycompa a controlled substance? 

Yes.  Schedule 111 controlled substance 

100

What is POS indication of Fycompa? 

Treatment of POS  with or without secondarily generalized in patients with epilepsy 4 years of age and older.

100

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. 

200

 How should I store the oral suspension Fycompa?

Use FYCOMPA oral suspension within 90 days after the bottle is first opened.

200

Does Fycompa need down titration when a patient is going to withdrawal?

No 

200

What are the contraindications with Fycompa?

There are none

200

What is the highest reported overdose of Fycompa?

300 mg

200

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.

300

The highest reported overdose of Fycompa was how many mg?

Section 10

300

During what timeframe should you closely monitor for serious psychiatric events?

During titration and at higher doses

300

Can Fycompa be added to any AED? 

Yes Gurl!

300

What are the Hepatic Impairment Recommendations for mild and moderate hepatic impairment?

Mild is 6 mg and Moderate is 4 mg

300

What is the Median % reduction from Baseline in PGTC Seizure frequency ?

Table 6. Under 14.2 

76% at 8 mg

400

Can Fycompa Tablets be interchangeable with the oral suspension?

 Section 12.3

400

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

400

What is the Half life of Fycompa ?

105 Hours Looooooooong

400

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…

400

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…

500

What is the Max dosage for fycompa for patients with mild hepatic impairment? 

Section 2.4 

500

Patients reported falls at 5% and 10% in what doses of Fycompa? 

Section 5.4

500

Do not increase the dose more than every two weeks ion what population?

The elderly

500

In controlled partial onset seizure clinical trials, fycompa treated adults gained an average of how many mgs?

Section 6.1

500

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.