oral suspension, 0.5 mg/mL, should be shaken well before every administration. The provided adapter and graduated oral dosing syringe should be used to administer the oral suspension. A household teaspoon or tablespoon is not an adequate measuring device. The adapter, which is supplied in the product carton, should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle. The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle. The cap should be replaced after each use. The cap fits properly when the adapter is in place [see Instructions for Use].
Discard any unused FYCOMPA oral suspension remaining 90 days after first opening the bottle.
3 DOSAGE FORMS AND STRENGTHS
Tablets
2 mg tablets: orange, round, debossed with “2” on one side and “Є 275” on the other.
4 mg tablets: red, round, debossed with “4” on one side and “Є 277” on the other.
6 mg tablets: pink, round, debossed with “6” on one side and “Є 294” on the other.
8 mg tablets: purple, round, debossed with “8” on one side and “Є 295” on the other.
10 mg tablets: green, round, debossed with “10” on one side and “Є 296” on the other.
12 mg tablets: blue, round, debossed with “12” on one side and “Є 297” on the other.
Oral Suspension
0.5 mg/mL white to off-white opaque liquid suspension for oral administration.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Serious Psychiatric and Behavioral Reactions In the controlled partial-onset seizure clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. FYCOMPA-treated patients experienced more hostility- and aggression-related adverse reactions that were serious, severe, and led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients.
In general, in placebo-controlled partial-onset seizure clinical trials, neuropsychiatric events were reported more frequently in patients being treated with FYCOMPA than in patients taking placebo. These events included irritability, aggression, anger, and anxiety, which occurred in 2% or greater of FYCOMPA-treated patients and twice as frequently as in placebo-treated patients. Other symptoms that occurred with FYCOMPA and were more common than with placebo included belligerence, affect lability, agitation, and physical assault. Some of these events were reported as serious and life-threatening. Homicidal ideation and/or threat were exhibited in 0.1% of 4,368 FYCOMPA-treated patients in controlled and open label trials, including non-epilepsy trials. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA.
In the partial-onset seizure clinical trials, these events occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression. Some |
