Fycompa

FYCOMPA- perampanel tablet
FYCOMPA- perampanel suspension
Eisai Inc.

WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

  • Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA ( 5.1 ) .

  • These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression ( 5.1 ) .

  • Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA ( 5.1 ) .

  • Closely monitor patients particularly during the titration period and at higher doses ( 5.1 ) .

  • FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1 ) .

1 INDICATIONS AND USAGE

1.1 Partial Onset Seizures

FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

1.2 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Partial-Onset Seizures

Monotherapy or Adjunctive Therapy

The recommended starting dosage of FYCOMPA in adults and pediatric patients 4 years of age and older is 2 mg once daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability.

The recommended maintenance dose range is 8 mg to 12 mg once daily, 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.

Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which include certain antiepileptic drugs (AEDs) [see Dosage and Administration (2.3)].

2.2 Dosage for Primary Generalized Tonic-Clonic Seizures

Adjunctive Therapy

The recommended starting dosage of FYCOMPA in adults and pediatric patients 12 years of age and older is 2 mg once daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability.

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.

Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which include certain AEDs [see Dosage and Administration (2.3)].

2.3 Dosage Modifications with Concomitant Use of Moderate or Strong CYP3A4 Enzyme Inducer s

Moderate and strong CYP3A4 inducers, including enzyme-inducing AEDs such as phenytoin, carbamazepine, and oxcarbazepine, cause a reduction in FYCOMPA plasma levels [ see Drug Interactions (7.2), Clinical Pharmacology (12.3)]. Therefore, in adults and pediatric patients 4 years of age and older receiving these concomitant enzyme-inducing drugs, the recommended starting dosage of FYCOMPA is 4 mg once daily taken orally at bedtime.

Increase dosage by increments of 2 mg once daily based on individual clinical response and tolerability, 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.

When moderate or strong CYP3A4 inducers 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 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 Suspension0.5 mg/mL white to off-white opaque liquid suspension for oral administration.

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