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Fycompa

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Fycompa

INDICATIONS

FYCOMPA (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.

DOSAGE AND ADMINISTRATION

Dosing Information

In the Absence of Enzyme-Inducing AEDs

The recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by 2 mg per day increments no more frequently than every week to a dose of 4 mg to 8 mg once daily taken at bedtime. In elderly patients, dosage increases during titration are recommended no more frequently than every two weeks.

The recommended dose range is 8 mg to 12 mg once 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].

In the Presence of Enzyme-Inducing AEDs

The recommended starting dosage of FYCOMPA in the presence of enzyme-inducing AEDs, including phenytoin, carbamazepine, and oxcarbazepine, is 4 mg and patients should be monitored closely for response. Clinical trials revealed a substantially reduced effect on seizure rates in these patients. The reduction in seizure frequency was somewhat greater at 12 mg than at 8 mg [see Clinical Studies].

When these enzyme-inducing AEDs are introduced or withdrawn from a patient's treatment regimen, patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.

Dosage Adjustments In Patients With Hepatic Impairment

Based on higher exposure and the longer half-life of perampanel in patients with mild and moderate hepatic impairment, dosage adjustment is recommended. Starting dose should be 2 mg per day with weekly increments of 2 mg per day every two weeks until target dose is achieved. The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment. Dose increases in patients with mild and moderate hepatic impairment, as with all patients, should be based on clinical response and tolerability. Use in patients with severe hepatic impairment is not recommended [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

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. Use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended [see Use in Specific Populations, CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

  • 2 mg Tablets: orange, round, debossed with “2” on one side and “∈ 275” on the other
  • 4 mg Tablets: red, round, debossed with “4” on one side and “∈ 277” on the other.
  • 6 mg Tablets: pink, round, debossed with “6” on one side and “∈ 294” on the other.
  • 8 mg Tablets: purple, round, debossed with “8” on one side and “∈ 295” on the other.
  • 10 mg Tablets: green, round, debossed with “10” on one side and “∈ 296” on the other.
  • 12 mg Tablets: blue, round, debossed with “12” on one side and “∈ 297” on the other.

Storage And Handling

FYCOMPA (perampanel) Tablets 2 mg are orange, round, biconvex, film-coated tablets debossed with “2” on one side and “∈ 275” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-272-30
Bottles of 90 NDC 62856-272-90

FYCOMPA (perampanel) Tablets 4 mg are red, round, biconvex, film-coated tablets debossed with “4” on one side and “∈ 277” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-274-30
Bottles of 90 NDC 62856-274-90

FYCOMPA (perampanel) Tablets 6 mg are pink, round, biconvex, film-coated tablets debossed with “6” on one side and “∈ 294” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-276-30
Bottles of 90 NDC 62856-276-90

FYCOMPA (perampanel) Tablets 8 mg are purple, round, biconvex, film-coated tablets debossed with “8” on one side and “∈ 295” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-278-30
Bottles of 90 NDC 62856-278-90

FYCOMPA (perampanel) Tablets 10 mg are green, round, biconvex, film-coated tablets debossed with “10” on one side and “∈ 296” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-280-30
Bottles of 90 NDC 62856-280-90

FYCOMPA (perampanel) Tablets 12 mg are blue, round, biconvex, film-coated tablets debossed with “12” on one side and “∈ 297” on the other. They are supplied as follows:

Bottles of 30 NDC 62856-282-30
Bottles of 90 NDC 62856-282-90

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]

Manufactured and Marketed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised: February 2014

Last reviewed on RxList: 2/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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