NDC 69616-0274-30 — Fycompa perampanel 4 mg Tablet, 30-count

🆔 Identity & classification

FDA NDC (as labeled) 69616-274-30

Product NDC 69616-274

11-digit billing NDC 69616027430

NCPDP billing unit EA — each (per item)

RxCUI 1356557, 1356563, 1356570, 1356572, 1356574, 1356576, 1356578, 1356580,

UNII H821664NPK

UPC 0369616278303, 0369616276309, 0369616274305, 0369616280306 +1 more

Application # NDA202834

SPL Set ID ec812ea3-de3a-4271-957c-db8f692d1ae3

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 NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-01-02

Route ORAL

Dosage form TABLET

Substance PERAMPANEL

GPI-14 72550060000320

GCN Seq No 069989

GCN 33272

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 FYCOMPA 4 MG TABLET

FDB brand name Fycompa

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 69616-274-30 — a 5-3-2 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 product segment → 69616-0274-30. 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.

🏭 Manufacturer & labeler

LabelerCatalyst Pharmaceuticals, Inc.

Application holderCATALYST PHARMACEUTICALS INC

FDA applicationNDA202834 (NDA)

Labeler code69616

First marketedJan 2024

DEA scheduleCIII

Product typeHuman Prescription Drug

Portfolio9 products on file

🔎 All NDCs from Catalyst Pharmaceuticals, Inc.

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.

🩺 Clinical

Label name FYCOMPA 4 MG TABLET Ingredient Perampanel

📖 What it is MedlinePlus · NLM

Perampanel is used to treat certain types of partial onset seizures (seizures that involve only one part of the brain) in adults and children 4 years of age and older. It is also used in combination with other medications to treat certain types of primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 12 years of age or older. Perampanel is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Perampanel is a seizure medicine used to treat two types of epilepsy: partial-onset seizures (seizures that start in one part of the brain) and primary generalized tonic-clonic sei...
What is perampanel actually for — why did my doctor prescribe it?
Taking perampanel at bedtime is intentional — it causes dizziness and drowsiness in many people, and sleeping through the worst of that makes it much easier to tolerate. It also he...
Why do I have to take it at bedtime? Can I take it at a different time?

📖 Read our full Perampanel guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Perampanel — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Perampanel (230 interactions) — ranked by severity →

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.

💊 What it looks like

Color orange / red / pink / purple / green / blue / white

ShapeRound

Imprint12;297

Size8 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII NZ94SDL6WR
Low-substituted hydroxypropyl cellulose is a plant-based thickener and binder made from cellulose. It helps hold the medicine together, controls how quickly it dissolves, and improves texture in tablets and capsules.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$39.092	$1,172.75 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	$39.03	$1,170.82 / 30 tablets
Medicare drug plans payPart D · Q2 2026	$39.22	$1,176.64 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

Flat over the last 10 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Perampanel 4 mg 00480-7063-56	Teva	30 tablets	$15.424	AB	Availability likely	save 61%
Perampanel 4 mg 72205-0222-30	Novadoz	30 tablets	$15.424	AB	Availability likely	save 61%
Fycompa 4 mgthis 69616-0274-30	Catalyst	30 tablets	$39.092	AB	Availability likely	—
Perampanel 4 mg 51672-4205-02	Sun	10 tablets	—	AB	FDA listed	—
Fycompa 4 mg 62856-0274-14	Eisai	14 tablets	—	AB	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

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

🏛️

2012

First FDA approval

Oct 2012

📍

2026

Currently FDA-listed

14 years listed

🔓

·

Listed protection lapsed

listed protections lapsed 2026

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jul 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.

📅 FDA approved Oct 22, 2012 AB TE-rated RLD RS

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 8772497 — drug substance

2012 2014 2016 2018 2020 2022 2024 2026

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)

Patent	Type	Use code	Expires
US 8772497 ↗	Drug substance	—	Jul 1, 2026
US 8772497 ↗	Drug substance	—	Jul 1, 2026
US 8772497 ↗	Drug substance	—	Jul 1, 2026
US 8772497 ↗	Drug substance	—	Jul 1, 2026
US 8772497 ↗	Drug substance	—	Jul 1, 2026
US 8772497 ↗	Drug substance	—	Jul 1, 2026

Common questions

Is there a generic version of FYCOMPA 4 MG TABLET?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for FYCOMPA 4 MG TABLET. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69616-0274-30, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

10.2K

Units reimbursed last 4 qtrs

355.9K

Gross reimbursed last 4 qtrs

$13.89M

Avg / prescription

$1,366.75

Avg / unit

$39.0273

Latest quarter Q4 2025

1.8KRx

Medicaid pays / ea

$39.0273

gross reimbursed

vs

NADAC / ea

$39.0916

acquisition cost

=

Spread

−$0.0643

+0% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

53% FFS 47% MCO

Fee-for-service · 5,380 Rx Managed care · 4,784 Rx

State Medicaid map

Units reimbursed · per 100k residents

7.8245

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Mississippi 245 /100k

2 Ohio 210 /100k

3 Louisiana 207 /100k

4 North Carolina 190 /100k

5 Rhode Island 180 /100k

6 Michigan 160 /100k

7 California 148 /100k

8 Indiana 143 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

30 tablets this page69616-0274-30 10,164 Rx · $13,891,693

14 tablets69616-0274-14 No Medicaid data

90 tablets69616-0274-90 No Medicaid data

Drug total (last 4 qtrs): 10,164 Rx · 355,948 units · $13,891,693 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Fycompa — the program that covers self-administered drugs. 2 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 Fycompa. 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

$8.72M

Claims incl. refills

7.3K

Beneficiaries

2.9K

Spend / beneficiary

$2,993.52

Spend / claim

$1,194.54

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
69616-0274-14	14 TABLET in 1 PACKAGE (69616-274-14)	—	—	2024-01-02	Active
69616-0274-30 You're viewing this	30 TABLET in 1 BOTTLE (69616-274-30)	$39.09 / ea	$1,172.75	2024-01-02	Active
69616-0274-90	90 TABLET in 1 BOTTLE (69616-274-90)	—	—	2024-01-02	Active

You're viewing one of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 69616-0274-30?

NDC 69616-0274-30 is a 30-count package — 30 tablet in 1 bottle.

What is the difference between NDC 69616-0274-30 and NDC 69616-0274-14?

Both are Fycompa perampanel 4 mg Tablet — the drug itself is identical. NDC 69616-0274-30 is the 30-count package, while NDC 69616-0274-14 is the 14 tablets package.

What NDC number is used to bill for this package of Fycompa perampanel 4 mg Tablet?

Bill NDC 69616-0274-30 — the 11-digit billing format is 69616027430. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

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

🎯 Indications and Usage 117 words ▾

1 INDICATIONS AND USAGE FYCOMPA, 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 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.

1.2Primary 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 ~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 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) ].

2.2Dosage 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) ].

2.3Dosage 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 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.

2.4Dosage 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…

💊 Dosage Forms and Strengths 145 words ▾

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 Suspension 0.5 mg/mL white to off-white opaque liquid suspension for oral administration. Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg ( 3 ) Oral Suspension: 0.5 mg/mL ( 3 )

⛔ 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 FYCOMPA 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. FYCOMPA-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 FYCOMPA than in patients taking placebo. These events included irritability, aggression, anger, and anxiety, which occurred in 2% or greater of FYCOMPA-treated patients and twice as frequently as in placebo-treated patients. Other symptoms that occurred with FYCOMPA 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 FYCOMPA-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 FYCOMPA.

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 FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA 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 FYCOMPA, 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 FYCOMPA [see Adverse Reactions (6.2) ].

Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least 1 month after the last dose of FYCOMPA, 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 FYCOMPA should be reduced if these symptoms occur.

Permanently discontinue FYCOMPA for persistent se…

🤒 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 Catalyst Pharmaceuticals at 1-844-347-3277 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 FYCOMPA (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 FYCOMPA 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 FYCOMPA 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 FYCOMPA 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 FYCOMPA 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 FYCOMPA Dose (12 mg) Group and More Frequent than Placebo) Placebo n=442 % FYCOMPA 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 Hyponatremia <1 0 0 2 Limb injury <1 1 1…

🔄 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 FYCOMPA may be necessary ( 2.3 , 7.2 )

7.1Contraceptives With concomitant use, FYCOMPA at a dose of 12 mg per day reduced levonorgestrel exposure by approximately 40% [see Clinical Pharmacology (12.3) ] . Use of FYCOMPA 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 FYCOMPA decreased the plasma levels of perampanel by approximately 50-67% [see Clinical Pharmacology (12.3) ] . The starting doses for FYCOMPA 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 FYCOMPA may be necessary [see Dosage and Administration (2.3) ] .

7.3Alcohol and Other CNS Depressants The concomitant use of FYCOMPA and CNS depressants including alcohol may increase CNS depression. A pharmacodynamic interaction study in healthy subjects found that the effects of FYCOMPA 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 FYCOMPA 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 FYCOMPA is used in combination with other CNS depressants. Care should be taken when administering FYCOMPA 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 FYCOMPA 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 Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as FYCOMPA, during pregnancy. Encourage women who are taking FYCOMPA during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. 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 2-4% and 15-20%, 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 FYCOMPA and any potential adverse effects on the breastfed child from FYCOMPA or from the underlying maternal condition.

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

8.4Pediatric Use Safety and effectiveness of FYCOMPA for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. The safety and effectiveness of FYCOMPA 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 FYCOMPA [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . Use of FYCOMPA for the treatment of partial-onset seizures in pediatric patients 4 y…

🆘 Overdosage 111 words ▾

10 OVERDOSAGE The highest reported overdose of FYCOMPA was 300 mg. Events reported after FYCOMPA 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 FYCOMPA.

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 FYCOMPA.

Due to its long half-life, the reactions caused by FYCOMPA 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 FYCOMPA exerts its antiepileptic effects in humans is unknown.

12.2Pharmacodynamics Psychomotor Performance In a healthy volunteer study to assess the effects of FYCOMPA tablets on psychomotor performance using a standard battery of assessments including simulated driving, single and multiple daily doses of FYCOMPA 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 FYCOMPA 12 mg, but postural stability was not significantly impaired.

Performance testing returned to baseline within 2 weeks of cessation of FYCOMPA dosing. Interactions with Alcohol In the above study ( see Psychomotor Performance ), when administered to healthy subjects receiving alcohol to achieve a blood concentration of 80-100 mg/100 mL, FYCOMPA 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 FYCOMPA on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.

FYCOMPA 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 2-3 weeks. AUC of perampanel increased in a dose-proportional manner after single-dose administration of 0.2-12 mg tablets and after multiple-dose administration of 1-12 mg tablets once daily.

FYCOMPA oral suspension has comparable bioavailability to FYCOMPA 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 FYCOMPA tablet with a high fat meal had no impact on the total exposure (AUC 0-inf ) of perampanel and reduced the peak plasma concentration (C max ) of perampanel by 11%-40%.

The t max was delayed by approximately 1-3 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 95-96% bound to plasma proteins, mainly bound to albumin and α1-acid glycoprotein. Blood to plasma ratio of perampanel is 0.55-0.59.

Metabolism Perampan…

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied FYCOMPA Tablets 2 mg are orange, round, biconvex, film-coated tablets debossed with “2” on one side and “Є 275” on the other. They are supplied as follows: Bottles of 30 NDC 69616-272-30 Bottles of 90 NDC 69616-272-90 4 mg are red, round, biconvex, film-coated tablets debossed with “4” on one side and “Є 277” on the other. They are supplied as follows: Bottles of 30 NDC 69616-274-30 Bottles of 90 NDC 69616-274-90 6 mg are pink, round, biconvex, film-coated tablets debossed with “6” on one side and “Є 294” on the other.

They are supplied as follows: Bottles of 30 NDC 69616-276-30 Bottles of 90 NDC 69616-276-90 8 mg are purple, round, biconvex, film-coated tablets debossed with “8” on one side and “Є 295” on the other. They are supplied as follows: Bottles of 30 NDC 69616-278-30 Bottles of 90 NDC 69616-278-90 10 mg are green, round, biconvex, film-coated tablets debossed with “10” on one side and “Є 296” on the other. They are supplied as follows: Bottles of 30 NDC 69616-280-30 Bottles of 90 NDC 69616-280-90 12 mg are blue, round, biconvex, film-coated tablets debossed with “12” on one side and “Є 297” on the other.

They are supplied as follows: Bottles of 30 NDC 69616-282-30 Bottles of 90 NDC 69616-282-90 FYCOMPA Oral Suspension 0.5 mg/mL is a white to off-white opaque liquid. It is supplied in a round 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 69616-290-38

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

📋 Description ~1 min read ▾

11 DESCRIPTION FYCOMPA tablets and oral suspension contain 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 • ¾H 2 O and the molecular weight is 362.90 (349.39 for anhydrous perampanel).

It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, 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 water. The chemical structure is: Tablets FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel.

Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg).

Oral Suspension FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water. image description

💬 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 FYCOMPA 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 FYCOMPA, 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 FYCOMPA may cause dizziness, gait disturbance, somnolence, and fatigue. Advise patients taking FYCOMPA not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with FYCOMPA [see Warnings and Precautions (5.3) ] . Falls Counsel patients that FYCOMPA 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 FYCOMPA may increase seizure frequency [see Warnings and Precautions (5.6) ] . Contraceptives Counsel females of reproductive potential that FYCOMPA may decrease efficacy of contraceptives containing levonorgestrel, and advise them to use an additional non-hormonal form of contraception while using FYCOMPA 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 FYCOMPA may enhance the impairment effects of alcohol. These effects may also be seen if FYCOMPA 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 FYCOMPA 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 FYCOMPA 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) ] . FYCOMPA ® is a registered trademark owned by Catalyst Pharmaceuticals, Inc. Manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE FYCOMPA ® (fī-COM-puh) FYCOMPA ® (fī-COM-puh) (perampanel) (perampanel) tablets, for oral use, CIII oral suspension, CIII What is the most important information I should know about FYCOMPA? 1. FYCOMPA may cause mental (psychiatric) problems, including: ● new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability ● being suspicious or distrustful (believing things that are not true) ● seeing objects or hearing things that are not there ● confusion ● difficulty with memory ● other unusual or extreme changes in behavior or mood Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: ● thoughts about suicide or dying ● attempt to commit suicide ● new or worse depression ● new or worse anxiety ● feeling agitated or restless ● panic attacks ● trouble sleeping (insomnia) ● new or worse irritability ● acting aggressive, being angry, or violent ● acting on dangerous impulses ● an extreme increase in activity and talking (mania) ● other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? ● Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. ● Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with a healthcare provider. Stopping FYCOMPA suddenly can cause serious problems. Stopping FYCOMPA suddenly can cause you to have seizures more often.

What is FYCOMPA? FYCOMPA is a prescription medicine used: ● to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 4 years of age and older ● with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep your FYCOMPA in a safe place to protect it from theft.

Never give your FYCOMPA to anyone else because it may harm them. Selling or giving away this medicine is against the law. It is not known if FYCOMPA is safe and effective for partial onset seizures in children under 4 years of age or for primary generalized tonic clonic seizures in patients under 12 years of age.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you: ● have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems. ● have liver or kidney problems ● drink alcohol ● have abused prescription medicines, street drugs, or alcohol in the past ● are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. ○ If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.

You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of FYCOMPA and other antiepileptic medicine during pregnancy. ● are breastfeeding or plan to breastfeed. It is not known if FYCOMPA passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA. You and your healthcare provider should decide…

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

competitive antagonist: A blocker that competes with another substance for the same docking spot; adding more of the other substance can overcome the block.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

controlled substance: A medicine regulated by law because it can be misused or lead to dependence, with special rules for prescribing and storage.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

delusion: A false belief that a person holds strongly even when there is clear evidence that it is not true.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysarthria: Slurred or slow speech caused by weakness or poor control of the muscles used for speaking.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

first-pass metabolism: The breakdown of a swallowed medicine by the liver before it reaches the rest of the body.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

pharmacodynamic interaction: When two medicines affect the body in the same or opposite ways, changing the overall effect without changing each other's blood levels.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

🔗 Related NDC lookups

🧪 All Perampanel NDCsSame ingredient 🏭 All Catalyst labeler NDCsLabeler code 69616 📚 All Noncompetitive AMPA Glutamate Receptor Antagonist NDCsDrug class 📖 Read the Perampanel drug informationUses, warnings & side effects

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Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.