perampanel

(redirected from Fycompa)

perampanel

(per-am-pa-nel) ,

Fycompa

(trade name)

Classification

Therapeutic: anticonvulsants
Pharmacologic: glutamate receptor antagonists
Pregnancy Category: C
Drug schedule to be determined after DEA review.

Indications

Adjunctive treatment (with other anti-epileptic drugs [AEDs])of partial-onset seizures with or without secondarily generalized seizures in epileptic patients ≥12 yr.

Action

Acts as a non-competitive α-amino-3–hydroxy-5–methyl-4–isoxazolepropionic acid (AMPA) antagonist on post-synaptic neuronal glutamate (excitatory) receptors.

Therapeutic effects

Decreased incidence and severity of partial-onset seizures.

Pharmacokinetics

Absorption: Rapidly and completely absorbed following oral administration.
Distribution: Unknown.
Protein Binding: 95–96%.
Metabolism and Excretion: Extensively metabolized by CYP3A4/5 enzyme systems; excreted in urine and feces primarily as metabolites.
Half-life: 105 hr.

Time/action profile

ROUTEONSETPEAKDURATION†
POunknownunknown2 wk
†Duration of effects following cessation.

Contraindications/Precautions

Contraindicated in: Strong P450 inducers (other than AEDs); Severe hepatic impairment.
Use Cautiously in: History of homicidal/suicidal ideation or other psychiatric/behavioral issues; Geriatric: Increased risk of adverse reactions, slower titration recommended; Obstetric: Use in pregnancy only when potential benefits outweighs potential fetal risks.; Lactation: Use cautiously; Pediatric: Safe and effective use in children <12 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)
  • drowsiness (most frequent)
  • headache (most frequent)
  • aggression
  • anger
  • fatigue
  • psychiatric/behavioral problems
  • hostility
  • irritability
  • suicidal ideation
  • vertigo

Metabolic

  • weight gain

Neurologic

  • ataxia
  • balance disorder
  • gait disturbance

Miscellaneous

  • falls

Interactions

Drug-Drug interaction

Doses >12 mg/day may ↓ effectiveness of levonorgestrel-containing hormonal contraceptives. CYPP450 inducers including carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, and topiramate can ↓ levels and effectiveness; careful monitoring is required especially during initiation and withdrawal. Dosage adjustments may be required. ↑ risk of CNS depression with other CNS depressants including alcohol, sedating antihistamines, barbiturates, benzodiazepines, opioids and sedative/hypnotics.Levels and effectiveness may be ↓ by St. John's wort; concurrent use should be avoided.

Route/Dosage

Oral (Adults and Children ≥12 yr) 2 mg once daily at bedtime initially, may be increased by 2 mg weekly up to 4–12 mg daily; Concurrent enzyme-inducers—4 mg once daily at bedtime initially may be increased by 2 mg weekly up to 12 mg daily. Daily dose should not exceed 12 mg.
Oral (Geriatric Patients ) 2 mg once daily at bedtime initially, may be increased by 2 mg every 2 wk up to 4–12 mg daily; Concurrent enzyme-inducers—4 mg once daily at bedtime initially may be increased by 2 mg every 2 wk up to 12 mg daily. Daily dose should not exceed 12 mg.

Hepatic Impairment

Oral (Adults and Children ≥12 yr) Mild hepatic impairment—2 mg once daily at bedtime initially, may be increased by 2 mg every 2 wk up to 6 mg daily; Concurrent enzyme-inducers—4 mg once daily at bedtime initially may be increased by 2 mg every 2 wk up to 6 mg daily. Daily dose should not exceed 6 mg; Moderate hepatic impairment— 2 mg once daily at bedtime initially, may be increased by 2 mg after 2 wk up to 4 mg daily; Concurrent enzyme-inducers—4 mg once daily at bedtime ; daily dose should not exceed 4 mg.

Availability

Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg

Nursing implications

Nursing assessment

  • Assess location, duration, and characteristics of seizure activity. Institute seizure precautions. Assess response to and continued need for perampanel periodically during therapy.
  • Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior, new or worse aggressive behavior, or depression.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Oral: Administer once daily at bedtime.

Patient/Family Teaching

  • Instruct patient to take perampanel as directed. Miss doses should be omitted and dosing resumed the following day. Notify health care professional if more than 1 day of dosing is missed. Medication should be gradually discontinued, do not stop abruptly, to prevent seizures. Advise patient to read the Medication Guide prior to taking ezogabine and with each Rx refill in case of changes.
  • May cause dizziness, sleepiness, fatigue and gait disturbance, increasing risk of falls. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Inform patients and families of risk of suicidal thoughts and behavior (behavioral changes, emergency or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm) and aggressive behavior (hostility, anger, anxiety, irritability, being suspicious or distrustful, believing things that are not true). Advise that these should be reported to health care professional immediately.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John's Wort. Advise patient to avoid taking other CNS depressants or alcohol.
  • Perampanel decreases efficacy of levonorgestrel; advise patients to use a non-hormonal form of birth control during therapy. Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334; information is available at www.aedpregnancyregistry.org.

Evaluation/Desired Outcomes

  • Decreased seizure activity.
References in periodicals archive ?
Eisai Representative Corporate Officer, Japan Business and CIO Hideki Hayashi commented, "Eisai considers neurology a strategic therapeutic area of focus and possesses rich experience and knowledge in neurology products such as Aricept and Fycompa.
Apr 25, 2014: Eisai Presents Research on FYCOMPA (perampanel) CIII at The American Academy of Neurology's 66th Annual Meeting 89
M2 EQUITYBITES-July 27, 2017-Eisai wins US FDA approval for sNDA for FYCOMPA for treating partial-onset seizures in patients with epilepsy
M2 PHARMA-July 27, 2017-Eisai wins US FDA approval for sNDA for FYCOMPA for treating partial-onset seizures in patients with epilepsy
Clinigen Group plc has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven (eribulin), Fycompa (perampanel) and Lenvima (lenvatinib) into 10 African countries.
has submitted a supplemental application for its in-house-discovered antiepileptic drug (AED) Fycompa (perampanel) proposing the inclusion in labelling of a description of use as monotherapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older to the U.
announced that the FDA has approved Fycompa (perampanel) CIII for adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most common and severe forms of generalized seizures with a high incidence of morbidity and mortality.
Eisai's Fycompa (perampanel), the first in a new class of treatment for uncontrolled partial onset seizures (POS), was approved in Israel.
However, the AED dominance landscape will continue to shift towards newer generation drugs particularly following the recent market entry of GlaxoSmithKline's Trobalt/Potiga and Eisai's Fycompa which both offer first-in-class mechanisms of action.
However, the AED dominance landscape will continue to shift towards newer generation drugs particularly following the recent market entry of GlaxoSmithKlines Trobalt/Potiga and Eisais Fycompa which both offer first-in-class mechanisms of action.
Perampanel, which will be marketed by Eisai under the brand name Fycompa, was the first antiepileptic drug to be submitted to the agency on the basis of an excitation mechanism rather than membrane inhibition or stabilization, according to Dr.
Clinigen Group plc (LON:CLIN) and Eisai (TYO:4523), its partner in South Africa, have been granted approval to sell their epilepsy drug Fycompa (perampanel) in South Africa, Clinigen announced on Friday.