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PERAMPANEL .5 mg/mL Suspension — NDC 51672-4256-9 (Billing 51672-4256-09)

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE in 1 CARTON / 340 mL in 1 BOTTLE

This is a package of PERAMPANEL .5 mg/mL Suspension from Sun Pharmaceutical Industries, Inc., marketed since Jun 2026 and currently FDA-listed; retail pharmacies pay about $3.95 per mL (NADAC). It is this product's only package size.

NDC 51672-4256-09
🏷️ FDA NDC (as labeled) 51672-4256-9 billing pads the package segment with a zero
Rx only Generic On market CIII ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Perampanel (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 17, 2026 — Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0628-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51672-4256-9
Product NDC 51672-4256
11-digit billing NDC 51672425609
NCPDP billing unit ML — per mL (volume)
RxCUI 1790122
UNII H821664NPK
Application # ANDA219052
SPL Set ID 3c72a5f7-bb22-4c48-942a-543ca84ed5a9
Established class (EPC) Noncompetitive AMPA Glutamate Receptor Antagonist
Mechanism of action AMPA Receptor Antagonists; UGT2B7 Inhibitors; UGT1A9 Inhibitors; Cytochrome P450 3A4 Inhibitors; Cytochrome P450 2C8 Inhibitors
DEA schedule CIII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-16
Route ORAL
Dosage form SUSPENSION
Substance PERAMPANEL
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 076056
GCN 41309
HICL code 039628
Ingredient (HICL) Perampanel
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.92.00
AHFS class Anticonvulsants, Miscellaneous
FDB label name PERAMPANEL 0.5 MG/ML ORAL SUSP
FDB brand name Perampanel
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 076056
  • GCN: 41309
  • HICL (First Databank): 039628
  • AHFS class code: 28:12.92.00
  • RxCUI (RxNorm): 1790122
Why two NDCs? The FDA registers this code as 51672-4256-9 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51672-4256-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Noncompetitive AMPA Glutamate Receptor Antagonist class.

Pharmacologic class Noncompetitive AMPA Glutamate Receptor Antagonist
Drug family (ATC) Other antiepileptics
How it works AMPA Receptor Antagonists, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 2C8 Inhibitors, UGT2B7 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PERAMPANEL 0.5 MG/ML ORAL SUSP Ingredient Perampanel
📗 Our plain-language guide HelloPharmacist
  • It treats partial-onset seizures in people with epilepsy age 4 and older. It is also used as an add-on medicine for primary generalized tonic-clonic seizures in people 12 and older...
  • Take it by mouth once a day at bedtime, as tablets or liquid suspension. If you use the liquid, measure it with the syringe and adaptor that come with it. Your dose is usually rais...
  • Dizziness, sleepiness, tiredness, irritability, nausea, headache, and weight gain are common. Falls and balance trouble can also happen, especially in older adults. Many of these s...
  • This medicine has a boxed warning for aggression, hostility, anger, irritability, and even threats to harm others. These can happen even if you have never had such problems. Call y...
📖 Read our full Perampanel guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $3.945 $1,341.37 / 340 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.93 $1,335.66 / 340 ml
NADAC price history (per mL) — tap or hover for the price & month
Jul 2026 Aug 2026 Sep 2026 $3.995 $3.945
▼ Down 1% over the last 3 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51672-4256-09 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 340 mL in 1 BOTTLE 2026-06-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Perampanel .5 mg/mLthis 51672-4256-09 Sun 1 bottle $3.945 AB Availability likely —
Perampanel .5 mg/mL 72205-0071-79 Novadoz 340 ml $3.945 AB Availability likely —
Fycompa .5 mg/mL 69616-0290-38 Catalyst 340 ml $4.457 AB Availability likely +13%
Fycompa .5 mg/mL 62856-0290-38 Eisai 340 ml $4.464 AB FDA listed +13%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA219052 (ANDA)
Labeler code51672
First marketedJun 2026
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio890 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

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 perampanel ( 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 perampanel or after discontinuing perampanel ( 5.1 ).

Closely monitor patients particularly during the titration period and at higher doses ( 5.1 ). Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1 ). WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS See full prescribing information for complete boxed warning.

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 perampanel ( 5.1 ) Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses ( 5.1 ) Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1 )

🎯 Indications and Usage 121 words ▾

1 INDICATIONS AND USAGE Perampanel, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 )

1.1Partial-Onset Seizures Perampanel oral suspension 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.

1.2Primary Generalized Tonic-Clonic Seizures Perampanel oral suspension 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 ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosing in the absence of moderate or strong CYP3A4 inducers Starting dose: 2 mg once daily orally at bedtime ( 2.1 , 2.2 ) May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals ( 2.1 , 2.2 ) Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime ( 2.1 ) Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime ( 2.2 ) Measure oral suspension using provided adaptor and dosing syringe ( 2.7 ) Dosing in the presence of concomitant moderate or strong CYP3A4 inducers : see section

2.3Specific Populations Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime ( 2.4 ) Severe Hepatic Impairment: Not recommended ( 2.4 ) Severe Renal Impairment or on Hemodialysis: Not recommended ( 2.5 ) Elderly: Increase dose no more frequently than every 2 weeks ( 2.6 )

2.1Dosage for Partial-Onset Seizures Monotherapy or Adjunctive Therapy The recommended starting dosage of perampanel oral suspension 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) ].

2.2Dosage for Primary Generalized Tonic-Clonic Seizures Adjunctive Therapy The recommended starting dosage of perampanel oral suspension 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 perampanel oral suspension 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) ].

2.3Dosage Modifications with Concomitant Use of Moderate or Strong CYP3A4 Enzyme Inducers Moderate and strong CYP3A4 inducers, including enzyme-inducing AEDs such as phenytoin, carbamazepine, and oxcarbazepine, cause a reduction in perampanel 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 perampanel oral suspension 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 perampanel oral suspension may be necessary.

2.4Dosage Adjustment in Patients with Hepatic Impairment In patients with mild and moderate hepatic impairment,… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 0.5 mg/mL ( 3 ) Oral Suspension 0.5 mg/mL white to off-white, homogenous suspension for oral administration.

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior ( 5.2 ) Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence, and fatigue ( 5.3 ) Patients should use caution when driving or operating machinery ( 5.3 ) Falls: Monitor for falls and injuries ( 5.4 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology ( 5.5 ) Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency ( 5.6 )

5.1Serious Psychiatric and Behavioral Reactions In the controlled partial-onset seizure clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive perampanel at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. perampanel-treated patients experienced more hostility- and aggression-related adverse reactions that were serious, severe, and led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients.

In general, in placebo-controlled partial-onset seizure clinical trials, neuropsychiatric events were reported more frequently in patients being treated with perampanel than in patients taking placebo. These events included irritability, aggression, anger, and anxiety, which occurred in 2% or greater of perampanel-treated patients and twice as frequently as in placebo- treated patients. Other symptoms that occurred with perampanel and were more common than with placebo included belligerence, affect lability, agitation, and physical assault.

Some of these events were reported as serious and life- threatening. Homicidal ideation and/or threat were exhibited in 0.1% of 4,368 perampanel-treated patients in controlled and open label trials, including non-epilepsy trials . Homicidal ideation and/or threat have also been reported postmarketing in patients treated with perampanel.

In the partial-onset seizure clinical trials, these events occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression. Some patients experienced worsening of their pre-existing psychiatric conditions. Patients with active psychotic disorders and unstable recurrent affective disorders were excluded from the clinical trials.

The combination of alcohol and perampanel significantly worsened mood and increased anger. Patients taking perampanel should avoid the use of alcohol [see Drug Interactions (7.3) ] . Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.

In healthy volunteers taking perampanel, observed psychiatric events included paranoia, euphoric mood, agitation, anger, mental status changes, and disorientation/confusional state. In the non-epilepsy trials, psychiatric events that occurred in perampanel-treated patients more often than placebo-treated patients included disorientation, delusion, and paranoia. In the postmarketing setting, there have been reports of psychosis (acute psychosis, hallucinations, delusions, paranoia) and delirium (delirium, confusional state, disorientation, memory impairment) in patients treated with perampanel [see Adverse Reactions (6.2) ].

Patients, their caregivers, and families should be informed that perampanel may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least 1 month after the last dose of perampanel, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Dose of perampanel should be reduced if these symptoms occur.

Perma… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Serious Psychiatric and Behavioral Reactions [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Neurologic Effects [see Warnings and Precautions (5.3) ] Falls [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Partial-Onset Seizures Adult and Adolescent Patients (12 years of age and older) A total of 1,038 patients receiving perampanel (2, 4, 8, or 12 mg once daily) constituted the safety population in the pooled analysis of the placebo-controlled trials (Studies 1, 2, and 3) in patients with partial-onset seizures.

Approximately 51% of patients were female, and the mean age was 35 years. Adverse Reactions Leading to Discontinuation In controlled clinical trials (Studies 1, 2, and 3), the rate of discontinuation as a result of an adverse reaction was 3%, 8%, and 19% in patients randomized to receive perampanel at the recommended doses of 4 mg, 8 mg, and 12 mg per day, respectively, and 5% in patients randomized to receive placebo [see Clinical Studies (14) ]. The adverse reactions most commonly leading to discontinuation (≥1% in the 8 mg or 12 mg perampanel group and greater than placebo) were dizziness, somnolence, vertigo, aggression, anger, ataxia, blurred vision, irritability, and dysarthria [see Warnings and Precautions (5.1 , 5.3) ].

Most Common Adverse Reactions Table 2 gives the incidence in the controlled clinical trials (Studies 1, 2, and 3) of the adverse reactions that occurred in ≥2% of patients with partial-onset seizures in the perampanel 12 mg dose group and more frequent than placebo (in order of decreasing frequency for the 12 mg dose group). The most common dose-related adverse reactions in patients receiving perampanel at doses of 8 mg or 12 mg (≥4% and occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability (9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain (4%).

For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation. Table 2. Adverse Reactions in Pooled Placebo-Controlled Trials in Adult and Adolescent Patients with Partial- Onset Seizures (Studies 1, 2, and 3) (Reactions ≥ 2% of Patients in Highest Perampanel Dose (12 mg) Group and More Frequent than Placebo) Placebo n=442 % Perampanel 4 mg n=172 % 8 mg n=431 % 12 mg n=255 % Dizziness 9 16 32 43 Somnolence 7 9 16 18 Headache 11 11 11 13 Irritability 3 4 7 12 Fatigue 5 8 8 12 Falls 3 2 5 10 Ataxia 0 1 3 8 Nausea 5 3 6 8 Vertigo 1 4 3 5 Back pain 2 2 2 5 Dysarthria 0 1 3 4 Anxiety 1 2 3 4 Blurred vision 1 1 3 4 Gait disturbance 1 1 4 4 Weight gain 1 4 4 4 Cough 3 1 1 4 Upper respiratory tract infection 3 3 3 4 Vomiting 3 2 3 4 Hypersomnia 0 1 2 3 Anger <1 0 1 3 Aggression 1 1 2 3 Balance disorder 1 0 5 3 Diplopia 1 1 1 3 Head injury 1 1 1 3 Hypoaesthesia 1 0 0 3 Pain in extremity 1 0 2 3 Constipation 2 2 2 3 Myalgia 2 1 1 3 Coordination abnormal 0 1 <1 2 Euphoric mood 0 0 <1 2 Confusional state <1 1 1 2 Hyponat… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel ( 7.1 ) Moderate and Strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin): increase clearance of perampanel and decrease perampanel plasma concentrations. When moderate or strong CYP3A4 inducers are introduced or withdrawn, monitor patients closely. Dose adjustment of perampanel may be necessary ( 2.3 , 7.2 )

7.1Contraceptives With concomitant use, perampanel at a dose of 12 mg per day reduced levonorgestrel exposure by approximately 40% [see Clinical Pharmacology (12.3) ] . Use of perampanel with contraceptives containing levonorgestrel may render them less effective. Additional non-hormonal forms of contraception are recommended [see Use in Specific Populations (8.3) ] .

7.2Moderate and Strong CYP3A4 Inducers The concomitant use of known moderate and strong CYP3A4 inducers including carbamazepine, phenytoin, or oxcarbazepine with perampanel decreased the plasma levels of perampanel by approximately 50-67% [see Clinical Pharmacology (12.3) ] . The starting doses for perampanel should be increased in the presence of moderate or strong CYP3A4 inducers [see Dosage and Administration (2.3) ] . When these 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 perampanel may be necessary [see Dosage and Administration (2.3) ] .

7.3Alcohol and Other CNS Depressants The concomitant use of perampanel and CNS depressants including alcohol may increase CNS depression. A pharmacodynamic interaction study in healthy subjects found that the effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol [see Clinical Pharmacology (12.3) ] . Multiple dosing of perampanel 12 mg per day also enhanced the effects of alcohol to interfere with vigilance and alertness, and increased levels of anger, confusion, and depression.

These effects may also be seen when perampanel is used in combination with other CNS depressants. Care should be taken when administering perampanel with these agents. Patients should limit activity until they have experience with concomitant use of CNS depressants (e.g., benzodiazepines, narcotics, barbiturates, sedating antihistamines).

Advise patients not to drive or operate machinery until they have gained sufficient experience on perampanel to gauge whether it adversely affects these activities.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see Data ] . In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses. In a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced fetal body weight were observed at the mid and high doses tested.

The lowest dose tested (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m 2 ). Upon oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rabbits throughout organogenesis, embryo lethality and maternal toxicity were observed at the mid and high doses tested; the no-effect dose for embryo-fetal developmental toxicity in rabbit (1 mg/kg/day) is approximately 2 times a human dose of 8 mg/day based on body surface area (mg/m 2 ). Oral administration of perampanel (1, 3, or 10 mg/kg/day) to rats throughout gestation and lactation resulted in fetal and pup deaths at the mid and high doses (associated with maternal toxicity) and delayed sexual maturation in males and females at the highest dose tested.

No effects were observed on measures of neurobehavioral or reproductive function in the offspring. The no-effect dose for pre- and postnatal developmental toxicity in rat (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m 2 ).

8.2Lactation Risk Summary There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production. Perampanel and/or its metabolites are present in rat milk, and are detected at concentrations higher than that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for perampanel and any potential adverse effects on the breastfed child from perampanel or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Use of perampanel may reduce the efficacy of hormonal contraceptives containing levonorgestrel. Advise women taking perampanel who are using a levonorgestrel-containing contraceptive to use an additional non-hormonal form of contraception while using perampanel and for a month after discontinuation [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ].

8.4Pediatric Use Safety and effectiveness of perampanel for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. The safety and effectiveness of perampanel in patients 12 years of age and older was established by three randomized double-blind, placebo-controlled, multicenter studies, which included 72 pediatric patients between 12 and 16 years of age exposed to perampanel [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ]. Use of perampanel for the treatment of partial-onset seizures in pediatric patients 4 years to less than 12 years of age is supported by evidence from adequate and well-controlled studies of perampanel in patients 12 years of age and older with partial onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 225 pediatric patients 4 years to less than 12 years of age treated with perampanel [see Adverse React… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see Data ] . In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses. In a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced fetal body weight were observed at the mid and high doses tested.

The lowest dose tested (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m 2 ). Upon oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rabbits throughout organogenesis, embryo lethality and maternal toxicity were observed at the mid and high doses tested; the no-effect dose for embryo-fetal developmental toxicity in rabbit (1 mg/kg/day) is approximately 2 times a human dose of 8 mg/day based on body surface area (mg/m 2 ). Oral administration of perampanel (1, 3, or 10 mg/kg/day) to rats throughout gestation and lactation resulted in fetal and pup deaths at the mid and high doses (associated with maternal toxicity) and delayed sexual maturation in males and females at the highest dose tested.

No effects were observed on measures of neurobehavioral or reproductive function in the offspring. The no-effect dose for pre- and postnatal developmental toxicity in rat (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m 2 ).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Safety and effectiveness of perampanel for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. The safety and effectiveness of perampanel in patients 12 years of age and older was established by three randomized double-blind, placebo-controlled, multicenter studies, which included 72 pediatric patients between 12 and 16 years of age exposed to perampanel [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ]. Use of perampanel for the treatment of partial-onset seizures in pediatric patients 4 years to less than 12 years of age is supported by evidence from adequate and well-controlled studies of perampanel in patients 12 years of age and older with partial onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 225 pediatric patients 4 years to less than 12 years of age treated with perampanel [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] .

The safety and efficacy of perampanel for the adjunctive therapy of primary generalized tonic-clonic seizures in pediatric patients 12 years of age and older was established in a single randomized double-blind, placebo-controlled, multicenter trial (n=164), which included 11 pediatric patients 12 to 16 years of age exposed to perampanel; an additional 6 patients were treated with perampanel in the open-label extension of the study [see Clinical Studies (14.2) ] . The safety and effectiveness of perampanel for the treatment of partial-onset seizures in pediatric patients less than 4 years of age or for the treatment of primary generalized tonic-clonic seizures in pediatric patients less than 12 years of age have not been established.

Juvenile Animal Data Oral administration of perampanel (1, 3, 3/10/30 mg/kg/day; high dose increased on postnatal days [PND] 28 and 56) to young rats for 12 weeks starting on PND 7 resulted in reduced body weight, reduced growth, neurobehavioral impairment (water maze performance and auditory startle habituation) at the mid and high doses, and delayed sexual maturation at the high doses. CNS signs (reduced activity, incoordination, excessive grooming/scratching), pup death, decreased hindlimb splay, and decreased hindlimb grip strength were observed at all doses.

Effects on pup body weight, pup growth, hindlimb splay, impairment in the water maze performance, and auditory startle persisted after dosing was stopped. A no-effect dose for postnatal developmental toxicity was not identified in this study. Oral administration of perampanel (1, 5, 5/10 mg/kg/day; high dose increased on PND 56) to juvenile dogs for 33 weeks, starting on PND 42, resulted in CNS signs (incoordination, excessive grooming/licking/scratching, spatial disorientation, and/or ataxic gait) at all doses tested.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Clinical studies of perampanel did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of perampanel in the elderly population. Because of increased likelihood for adverse reactions in the elderly, dosing titration should proceed slowly in patients aged 65 years and older [see Dosage and Administration (2.5) ] .

🆘 Overdosage 111 words ▾

10 OVERDOSAGE The highest reported overdose of perampanel was 300 mg. Events reported after perampanel overdose include somnolence, stupor, coma, psychiatric or behavioral reactions, altered mental status, and dizziness or gait disturbances. There is no available specific antidote to the overdose reactions of perampanel.

In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rhythm and vital sign measurement is recommended. A certified poison control center should be contacted for updated information on the management of overdose with perampanel.

Due to its long half-life, the reactions caused by perampanel could be prolonged.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which perampanel exerts its antiepileptic effects in humans is unknown.

12.2Pharmacodynamics Psychomotor Performance In a healthy volunteer study to assess the effects of perampanel tablets on psychomotor performance using a standard battery of assessments including simulated driving, single and multiple daily doses of perampanel 4 mg did not impair simple psychomotor tasks, driving performance, or sensorimotor coordination. Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in a dose-related manner. Car handling ability was impaired after dosing of perampanel 12 mg, but postural stability was not significantly impaired.

Performance testing returned to baseline within 2 weeks of cessation of perampanel dosing. Interactions with Alcohol In the above study ( see Psychomotor Performance ), when administered to healthy subjects receiving alcohol to achieve a blood concentration of 80 to 100 mg/100 mL, perampanel consistently impaired simple psychomotor performance after single doses of 4 to 12 mg, and after 21 days of multiple 12 mg/day doses. The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.

Perampanel enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. Potential to Prolong QT Interval In a placebo-controlled thorough QT study of perampanel in healthy subjects, there was no evidence that perampanel caused QT interval prolongation of clinical significance at doses of 6 or 12 mg (i.e., the upper bound of the 95% confidence interval for the largest placebo-adjusted baseline-corrected QTc was below 10 msec). The exposures observed with the 12 mg dose in this study will not cover the exposures expected in patients with hepatic impairment taking doses over 6 mg/day.

At the highest recommended dose (12 mg), perampanel did not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Pharmacokinetics of perampanel are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. The half-life of perampanel is about 105 hours, so that steady state is reached in about 2 to 3 weeks. AUC of perampanel increased in a dose-proportional manner after single-dose administration of 0.2 to 12 mg tablets and after multiple-dose administration of 1 to 12 mg tablets once daily.

Perampanel oral suspension has comparable bioavailability to perampanel tablets under steady state. Both formulations may be used interchangeably. The pharmacokinetics of perampanel are similar when used as monotherapy or as adjunctive therapy for the treatment of partial-onset seizures (in the absence of concomitant moderate or strong CYP3A4 inducers).

Absorption Perampanel is rapidly and completely absorbed after oral administration with negligible first-pass metabolism. Median time to reach peak concentration (t max ) ranged from 0.5 to 2.5 hours under fasted condition. Co-administration of perampanel tablet with a high fat meal had no impact on the total exposure (AUC 0 to inf ) of perampanel and reduced the peak plasma concentration (C max ) of perampanel by 11% to 40%.

The t max was delayed by approximately 1 to 3 hours in fed state compared to that under fasted conditions. Distribution Data from in vitro studies indicate that, in the concentration range of 20 to 2000 ng/mL, perampanel is approximately 95 to 96% bound to plasma proteins, mainly bound to albumin and α1-acid glycoprotein. Blood to pla… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 59 words ▾

12.1Mechanism of Action Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which perampanel exerts its antiepileptic effects in humans is unknown.

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Perampanel Oral Suspension 0.5 mg/mL is a white to off-white, homogenous suspension. It is supplied in a round dark amber PET bottle with a child-resistant closure. It is packaged with a dispenser set that provides two 20 mL graduated oral dosing syringes and a push-in bottle adapter. Bottle containing 340 mL NDC 51672-4256-9

16.2Storage Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.

📦 Storage and Handling 22 words ▾

16.2Storage Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.

📋 Description 160 words ▾

11 DESCRIPTION Perampanel oral suspension contains perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C 23 H 15 N 3 O.¾ H 2 O and the molecular weight is 362.90 g/mol (349.40 g/mol for anhydrous perampanel).

It is a white to yellowish white powder. Perampanel is freely soluble in 1-methyl-2-pyrolidinone, soluble in dimethylformamide and dichloromethane, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and in water. Solubility in water shows a slight improvement at acidic pH.

The chemical structure is: Chemical Structure Oral Suspension Perampanel oral suspension is a white to off-white homogenous suspension providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, poloxamer, purified water, simethicone, sodium benzoate and sorbitol.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration of Oral Suspension Advise patients who are prescribed the oral suspension to shake the bottle well before every administration and to use the adaptor and oral dosing syringe provided. Advise patients that a household teaspoon or tablespoon is not an adequate measuring device.

Instruct patients to discard any unused perampanel oral suspension remaining 90 days after first opening the bottle [see Dosage and Administration (2.7) ] . Serious Psychiatric and Behavioral Reactions Counsel patients, families, and caregivers of patients of the need to monitor for the emergence of anger, aggression, hostility, hallucinations, delusions, confusion, unusual changes in mood, personality, or behavior, and other behavioral symptoms. Advise them to report any such symptoms immediately to their healthcare providers [see Warnings and Precautions (5.1) ] .

Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including perampanel oral suspension, may increase the risk of suicidal thinking and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.2) ] Neurologic Effects: Dizziness, Gait Disturbance, Somnolence, and Fatigue Counsel patients that perampanel oral suspension may cause dizziness, gait disturbance, somnolence, and fatigue.

Advise patients taking perampanel oral suspension not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with perampanel oral suspension [see Warnings and Precautions (5.3) ] . Falls Counsel patients that perampanel oral suspension may cause falls and injuries [see Warnings and Precautions (5.4) ] . DRESS/Multi-organ Hypersensitivity Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [see Warnings and Precautions (5.5) ].

Withdrawal of Antiepileptic Drugs Counsel patients that abrupt discontinuation of perampanel oral suspension may increase seizure frequency [see Warnings and Precautions (5.6) ] . Contraceptives Counsel females of reproductive potential that perampanel oral suspension may decrease efficacy of contraceptives containing levonorgestrel, and advise them to use an additional non-hormonal form of contraception while using perampanel oral suspension and for a month after discontinuation [see Drug Interactions (7.1) , Use in Specific Populations (8.3) ] .

Alcohol and Other CNS Depressants Counsel patients that perampanel oral suspension may enhance the impairment effects of alcohol. These effects may also be seen if perampanel oral suspension is taken with other CNS depressants [see Drug Interactions (7.3) ] . Missed Doses Counsel patients that if they miss a dose, they should resume dosing the following day at their prescribed daily dose.

Instruct patients to contact their physician if more than one day of dosing is missed. Controlled Substance Counsel patients that perampanel oral suspension is a controlled substance that can be misused and abused [see Drug Abuse and Dependence (9.1) ] . Pregnancy Registry Advise women who are exposed to perampanel oral suspension during pregnancy that there is a pregnancy exposure registry that monitors pregnancy outcomes.

Encourage these patients to enroll in the NAAED Pregnancy Registry [see Use in Specific Populations (8.1) ] .

💬 Medication Guide 3 words ▾

med-guide med-guide med-guide

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetics of perampanel are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. The half-life of perampanel is about 105 hours, so that steady state is reached in about 2 to 3 weeks. AUC of perampanel increased in a dose-proportional manner after single-dose administration of 0.2 to 12 mg tablets and after multiple-dose administration of 1 to 12 mg tablets once daily.

Perampanel oral suspension has comparable bioavailability to perampanel tablets under steady state. Both formulations may be used interchangeably. The pharmacokinetics of perampanel are similar when used as monotherapy or as adjunctive therapy for the treatment of partial-onset seizures (in the absence of concomitant moderate or strong CYP3A4 inducers).

Absorption Perampanel is rapidly and completely absorbed after oral administration with negligible first-pass metabolism. Median time to reach peak concentration (t max ) ranged from 0.5 to 2.5 hours under fasted condition. Co-administration of perampanel tablet with a high fat meal had no impact on the total exposure (AUC 0 to inf ) of perampanel and reduced the peak plasma concentration (C max ) of perampanel by 11% to 40%.

The t max was delayed by approximately 1 to 3 hours in fed state compared to that under fasted conditions. Distribution Data from in vitro studies indicate that, in the concentration range of 20 to 2000 ng/mL, perampanel is approximately 95 to 96% bound to plasma proteins, mainly bound to albumin and α1-acid glycoprotein. Blood to plasma ratio of perampanel is 0.55 to 0.59.

Metabolism Perampanel is extensively metabolized via primary oxidation and sequential glucuronidation. Oxidative metabolism is primarily mediated by CYP3A4/5 and to a lesser extent by CYP1A2 and CYP2B6, based on results of in vitro studies using recombinant human CYPs and human liver microsomes. Other CYP enzymes may also be involved.

Following administration of radiolabeled perampanel, unchanged perampanel accounted for 74 to 80% of total radioactivity in systemic circulation, whereas only trace amounts of individual perampanel metabolites were detected in plasma. Elimination Following administration of a radiolabeled perampanel tablet dose to 8 healthy elderly subjects, 22% of administered radioactivity was recovered in the urine and 48% in the feces. In urine and feces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.

Population pharmacokinetic analysis of pooled data from 19 Phase 1 studies reported that t 1/2 of perampanel was 105 hours on average. Apparent clearance of perampanel in healthy subjects and patients was approximately 12 mL/min. Specific Populations Hepatic Impairment The pharmacokinetics of perampanel following a single 1 mg tablet dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 demographically matched healthy subjects.

The total (free and protein bound) exposure (AUC 0 to inf ) of perampanel was 50% greater in subjects with mild hepatic impairment and more than doubled (2.55-fold) in subjects with moderate hepatic impairment compared to their healthy controls. The AUC 0 to inf of free perampanel in subjects with mild and moderate hepatic impairment was 1.8-fold and 3.3-fold, respectively, of those in matched healthy controls. The t 1/2 was prolonged in subjects with mild impairment (306 vs.

125 hours) and moderate impairment (295 vs. 139 hours). Perampanel has not been studied in subjects with severe hepatic impairment [see Dosage and Administration (2.4) , Use in Specific Populations (8.6) ] .

Renal Impairment A dedicated study has not been conducted to evaluate the pharmacokinetics of perampanel in patients with renal impairment. Population pharmacokinetic analysis was performed on pooled data from patients with partial-onset seizures and receiving perampanel tablets… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Psychomotor Performance In a healthy volunteer study to assess the effects of perampanel tablets on psychomotor performance using a standard battery of assessments including simulated driving, single and multiple daily doses of perampanel 4 mg did not impair simple psychomotor tasks, driving performance, or sensorimotor coordination. Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in a dose-related manner. Car handling ability was impaired after dosing of perampanel 12 mg, but postural stability was not significantly impaired.

Performance testing returned to baseline within 2 weeks of cessation of perampanel dosing. Interactions with Alcohol In the above study ( see Psychomotor Performance ), when administered to healthy subjects receiving alcohol to achieve a blood concentration of 80 to 100 mg/100 mL, perampanel consistently impaired simple psychomotor performance after single doses of 4 to 12 mg, and after 21 days of multiple 12 mg/day doses. The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.

Perampanel enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. Potential to Prolong QT Interval In a placebo-controlled thorough QT study of perampanel in healthy subjects, there was no evidence that perampanel caused QT interval prolongation of clinical significance at doses of 6 or 12 mg (i.e., the upper bound of the 95% confidence interval for the largest placebo-adjusted baseline-corrected QTc was below 10 msec). The exposures observed with the 12 mg dose in this study will not cover the exposures expected in patients with hepatic impairment taking doses over 6 mg/day.

At the highest recommended dose (12 mg), perampanel did not prolong the QTc interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Partial-Onset Seizures The efficacy of perampanel in partial-onset seizures, with or without secondary generalization, was studied in patients who were not adequately controlled with 1 to 3 concomitant AEDs in 3 randomized, double-blind, placebo-controlled, multicenter trials (Studies 1, 2, and 3) in adult and pediatric patients (12 years of age and older). All trials had an initial 6- week Baseline Period, during which patients were required to have more than five seizures in order to be randomized. The Baseline Period was followed by a 19-week Treatment Period consisting of a 6-week Titration Phase and a 13-week Maintenance Phase.

Patients in these 3 trials had a mean duration of epilepsy of approximately 21 years and a median baseline seizure frequency ranging from 9 to 14 seizures per 28 days. During the trials, more than 85% of patients were taking 2 to 3 concomitant AEDs with or without concurrent vagal nerve stimulation, and approximately 50% were on at least one AED known to induce CYP3A4, an enzyme critical to the metabolism of perampanel (i.e., carbamazepine, oxcarbazepine, or phenytoin), resulting in a significant reduction in perampanel's serum concentration [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] .

Each study evaluated placebo and multiple perampanel dosages (see Figure 1 ). During the Titration period in all 3 trials, patients on perampanel received an initial 2 mg once daily dose, which was subsequently increased in weekly increments of 2 mg per day to the final dose. Patients experiencing intolerable adverse reactions were permitted to have their dose reduced to the previously tolerated dose.

The primary endpoint in Studies 1, 2, and 3 was the percent change in seizure frequency per 28 days during the Treatment Period as compared to the Baseline Period. The criterion for statistical significance was p<0.05. A statistically significant decrease in seizure rate was observed at doses of 4 to 12 mg per day.

Dose response was apparent at 4 to 8 mg with little additional reduction in frequency at 12 mg per day. Figure 1. Median Percent Reduction in Seizure Frequency per 28 Days from Baseline to Treatment Period Tables 4 and 5 present an analysis combining data from all 3 studies, grouping patients based upon whether or not concomitant enzyme-inducing AEDs (carbamazepine, oxcarbazepine, or phenytoin) were used.

The analysis revealed a substantially reduced effect in the presence of inducers. Table 4. Median Percent Reduction for Combined Studies (Study 1, 2 and 3) Based on the Presence or Absence of Concomitant Enzyme-Inducing AEDs (carbamazepine, oxcarbazepine, phenytoin) Patients from Latin American region are excluded because of a significant treatment-by-region interaction due to high placebo response Without Enzyme-Inducing AEDs With Enzyme-Inducing AEDs Placebo % Perampanel % Placebo % Perampanel % 2 mg/day 16 23 14 16 4 mg/day 16 22 14 33 8 mg/day 19 45 12 24 12 mg/day 19 54 9 22 Table 5.

Responder Rate for Combined Studies (Study 1, 2 and 3) Based on the Presence or Absence of Concomitant Enzyme-Inducing AEDs (carbamazepine, oxcarbazepine, phenytoin) Patients from Latin American region are excluded because of a significant treatment-by-region interaction due to high placebo response , The proportion of patients with at least a 50% decrease in seizure frequency Without Enzyme-Inducing AEDs With Enzyme-Inducing AEDs Placebo % Perampanel % Placebo % Perampanel % 2 mg/day 19 26 18 20 4 mg/day 19 35 18 26 8 mg/day 17 45 19 32 12 mg/day 15 54 21 33 Figure 2 shows the proportion of patients with different percent reductions during the maintenance phase over baseline across all three trials.

Patients in whom the seizure frequency increased are shown at left as "worse." Patients in whom the seizure frequency decreased are shown in the remaining four categories. Figure 2. Proportion of Patients Exhibiting Different Percent Reductions During the Maintenance Phase Over Baseli… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~2 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Perampanel oral suspension contains perampanel and is listed as a Schedule III controlled substance.

9.2Abuse Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see Drug Abuse and Dependence (9.3) ] .

Studies of human abuse potential were performed to evaluate the abuse potential of perampanel (8 mg, 24 mg, and 36 mg) as compared to alprazolam C-IV (1.5 mg and 3 mg), and oral ketamine C-III (100 mg) in recreational polydrug users. Supra-therapeutic doses of perampanel 24 and 36 mg produced responses for "Euphoria" that were similar to ketamine 100 mg and alprazolam 3 mg. For "High," perampanel 24 mg and 36 mg produced responses comparable to ketamine 100 mg and significantly higher than both doses of alprazolam on a visual analog scale (VAS). "Drug Liking," "Overall Drug Liking," and "Take Drug Again" for perampanel were each statistically lower than ketamine 100 mg.

In addition, for "Bad Drug Effects," perampanel 24 mg and 36 mg produced responses significantly higher than ketamine 100 mg. For "Sedation," perampanel 24 and 36 mg produced responses similar to alprazolam 3 mg and higher than ketamine 100 mg. Additionally, on VAS measures related to dissociative phenomena such as "Floating," "Spaced Out," and "Detached," perampanel at supratherapeutic doses produced responses similar to ketamine 100 mg and greater than both doses of alprazolam tested.

Of note, due to somnolence a number of subjects had missing data around T max of perampanel. The above described data might represent an underestimate of perampanel's effects. The duration of effects of higher doses of perampanel on the majority of measures was much greater than alprazolam 3 mg and ketamine 100 mg.

In this study, the incidence of euphoria following perampanel administration 8 mg, 24 mg, and 36 mg was 37%, 46%, 46%, respectively, which was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%).

9.3Dependence Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. A nonclinical dependence study in rats demonstrated withdrawal symptoms, including hyperreactivity to handling, muscle rigidity, and decreases in food consumption and body weights. Perampanel may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.

🔒 Controlled Substance 17 words ▾

9.1Controlled Substance Perampanel oral suspension contains perampanel and is listed as a Schedule III controlled substance.

🧪 Nonclinical Toxicology 167 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Perampanel was administered orally to mice (1, 3, 10, or 30 mg/kg/day) and rats (10, 30, or 100 mg/kg/day in males; 3, 10, or 30 mg/kg/day in females) for up to 104 weeks. There was no evidence of drug-related tumors in either species. Plasma perampanel exposures (AUC) at the highest doses tested were less than that in humans dosed at 8 mg/day.

Mutagenesis Perampanel was negative in the in vitro Ames and mouse lymphoma tk assays, and in the in vivo rat micronucleus assay. Impairment of Fertility In male and female rats administered perampanel (oral doses of 1, 10, or 30 mg/kg/day) prior to and throughout mating and continuing in females to gestation day 6, there were no clear effects on fertility. Prolonged and/or irregular estrus cycles were observed at all doses but particularly at the highest dose tested.

Plasma perampanel exposures (AUC) at all doses were lower than that in humans dosed at 8 mg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 164 words ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Perampanel was administered orally to mice (1, 3, 10, or 30 mg/kg/day) and rats (10, 30, or 100 mg/kg/day in males; 3, 10, or 30 mg/kg/day in females) for up to 104 weeks. There was no evidence of drug-related tumors in either species. Plasma perampanel exposures (AUC) at the highest doses tested were less than that in humans dosed at 8 mg/day.

Mutagenesis Perampanel was negative in the in vitro Ames and mouse lymphoma tk assays, and in the in vivo rat micronucleus assay. Impairment of Fertility In male and female rats administered perampanel (oral doses of 1, 10, or 30 mg/kg/day) prior to and throughout mating and continuing in females to gestation day 6, there were no clear effects on fertility. Prolonged and/or irregular estrus cycles were observed at all doses but particularly at the highest dose tested.

Plasma perampanel exposures (AUC) at all doses were lower than that in humans dosed at 8 mg/day.

📖 Instructions for Use ~3 min read ▾

Read this Instructions for Use before you start using perampanel oral suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Prepare the perampanel oral suspension dose You will need the following supplies: See Figure A Perampanel oral suspension bottle Bottle adapter Dosing syringe (2 dosing syringes are included in the perampanel oral suspension box) Figure A Step 1. Remove the perampanel oral suspension bottle, bottle adapter, and 2 syringes from the box. See Figure A Step 2.

Shake the bottle well before each use. See Figure B Figure B Step 3. Uncap the bottle and insert the bottle adapter into the bottle by pressing downward.

See Figure C and Figure D Figure C Figure D After the bottle adapter is in place, it cannot be removed. Step 4. Check the dose in milliliters (mL) as prescribed by your healthcare provider.

Find this number on the syringe. See Figure E Figure E Step 5. Push the plunger of the syringe all the way down then insert the syringe into the upright bottle through the opening in the bottle adapter.

See Figure F Figure F Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of liquid medicine in Step 4).

If you see air bubbles in the oral syringe, fully push in the plunger so that the oral solution flows back into the bottle. Then, withdraw the prescribed dose of oral suspension. See Figure G Figure G Measure the mLs of medicine from the white layer at the end of the plunger, not the black layer.

Step 7. If the dose is more than 20 mL, you can use: 2 syringes or 1 syringe, taking 2 steps to draw up the medicine in that same syringe For example: If the dose is 24 mL, draw up 20 mL in the first syringe and the remaining 4 mL in the second syringe. or If the dose is 24 mL, draw up 20 mL in the single syringe and squirt the medicine into the mouth, then draw up the remaining 4 mL in that same syringe. If the dose is more than 20 mL, repeat Steps 4 through 6 when drawing up the remaining dose of medicine.

Step 8. Turn the bottle right-side up and remove the syringe from the bottle adapter. See Figure H Figure H Step 9.

Slowly squirt the perampanel oral suspension directly into the corner of the mouth until all of the liquid medicine is given. If you need 2 syringes for the dose, slowly squirt the medicine from the first syringe into the mouth, then slowly squirt the medicine from the second syringe into the mouth. See Figure I Figure I Step 10.

Rinse the syringe (or syringes) with tap water after each use. See Figure J Fill a cup with water Pull back on the plunger and draw the water from the cup into the syringe Push down on the plunger to release the water into the sink Figure J Step 11. Cap the bottle tightly.

The cap will fit over the bottle adapter. See Figure K Figure K How should I store perampanel oral suspension? Store perampanel oral suspension below 86°F (30°C).

Do not freeze . Replace the cap tightly after opening. Use perampanel oral suspension within 90 days after the bottle is first opened.

After 90 days safely throw away any perampanel oral suspension that has not been used. Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 02/2026 5258280-0226-00 970 Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I Figure J Figure K

📄 Package Label / Principal Display Panel 40 words ▾

PRINCIPAL DISPLAY PANEL - 340 mL Bottle Carton NDC 51672-4256-9 Perampanel Oral Suspension CIII, 0.5 mg/mL PHARMACIST: DISPENSE THE MEDICATION GUIDE AND INSTRUCTIONS FOR USE PROVIDED SEPARATELY TO EACH PATIENT. Rx only 340 mL SUN PHARMA container label carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Perampanel — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Perampanel. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.83M
Claims incl. refills
8.4K
Beneficiaries
3.4K
Spend / beneficiary
$2,000.38
Spend / claim
$810.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 51672-4255-06 · Sun 51672-4258-01 · Sun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.