inducing antiepileptic drugs (AEDs), the recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals.
The recommended maintenance dose range is 8 mg to 12 mg once daily in the absence of enzyme-inducing AEDs, although some patients may respond to a dose of 4 mg daily. A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions. Individual dosing should be adjusted based on clinical response and tolerability [see Clinical Studies (14.1)].
2.2 Dosage for Primary Generalized Tonic-Clonic Seizures In patients not receiving concomitant enzyme-inducing AEDs, the recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals.
In patients not taking enzyme-inducing AEDs, the recommended maintenance dose is 8 mg once daily taken at bedtime. Patients who are tolerating FYCOMPA at 8 mg once daily and require further reduction of seizures may benefit from a dose increase up to 12 mg once daily if tolerated. Individual dosing should be adjusted based on clinical response and tolerability [see Clinical Studies (14.2)].
2.3 Dosing in the Presence of Concomitant Enzyme-Inducing Antiepileptic Drugs (AEDs) Enzyme-inducing AEDs, including phenytoin, carbamazepine, and oxcarbazepine, cause a 50-67% reduction in FYCOMPA plasma levels [see Drug Interactions (7.2), Clinical Pharmacology (12.3)]. In patients receiving concomitant enzyme-inducing AEDs, the recommended starting dosage of FYCOMPA is 4 mg once daily taken orally at bedtime.
Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals. A maintenance dose has not been established in clinical trials. The highest dose studied in patients on concomitant enzyme-inducing AEDs was 12 mg once daily. Individual dosing should be adjusted based on clinical response and tolerability.
When enzyme-inducing AEDs are introduced or withdrawn from a patient’s treatment regimen, the patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.
2.4 Dosage Adjustment in Patients with Hepatic Impairment In patients with mild and moderate hepatic impairment, the starting dose of FYCOMPA is 2 mg once daily. Increase dosage by increments of 2 mg once daily no more frequently than every 2 weeks. The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment. FYCOMPA is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Dosage Information for Patients with Renal Impairment FYCOMPA can be used in patients with moderate renal impairment with close monitoring. A slower titration may be considered, based on clinical response and tolerability. FYCOMPA is not recommended in patients with severe renal impairment or patients undergoing hemodialysis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
2.6 Dosage Information for Elderly Patients In elderly patients, increase dosage no more frequently than every 2 weeks during titration [see Use in Specific Populations (8.5)].
2.7 Administration of Oral Suspension FYCOMPA |
