July 31, 2015
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Fycompa

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Fycompa




Indications
Dosage
How Supplied

INDICATIONS

Partial-Onset Seizures

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

Primary Generalized Tonic-Clonic Seizures

FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

DOSAGE AND ADMINISTRATION

Dosage For Partial-Onset Seizures

In patients not receiving concomitant enzyme-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].

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 well at 8 mg once daily and require further control 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].

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, CLINICAL PHARMACOLOGY]. 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.

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, CLINICAL PHARMACOLOGY].

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, CLINICAL PHARMACOLOGY].

Dosage Information For Elderly Patients

In elderly patients, increase dosage no more frequently than every 2 weeks during titration [see Use in Specific Populations].

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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to-86°F). [See USP Controlled Room Temperature]

Manufactured and Marketed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised: June 2015

Last reviewed on RxList: 7/14/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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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