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Wakix PITOLISANT HYDROCHLORIDE 4.45 mg Tablet, Film Coated, 30-count — NDC 72028-0045-03 package photo

Wakix PITOLISANT HYDROCHLORIDE 4.45 mg Tablet, Film Coated, 30-count

by Harmony Biosciences, LLC · 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC 72028-0045-03
🏷️ FDA NDC (as labeled) 72028-045-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 72028-045-03
Product NDC 72028-045
11-digit billing NDC 72028004503
NCPDP billing unit EA — each (per item)
RxCUI 2197884, 2197890, 2197892, 2197894
UNII YV33CH63HI
Application # NDA211150
SPL Set ID 8daa5562-824e-476c-9652-26ceef3d4b0e
Established class (EPC) Histamine-3 Receptor Antagonist/Inverse Agonist
Mechanism of action Cytochrome P450 3A4 Inducers; Histamine H3 Receptor Antagonists; Histamine H3 Receptor Inverse Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance PITOLISANT HYDROCHLORIDE
GPI-14 61450070100318
GPI class Wakix
GCN Seq No 079457
GCN 45948
HICL code 045575
Ingredient (HICL) Pitolisant Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H1
Therapeutic class — intermediate (HIC2) Drugs Affecting Principally The Brain
HIC3 code H1G
Therapeutic class — specific (HIC3) Narcolepsy Tx-H3-Recept.antagonist/Inverse Agonist
AHFS code 28:20.80.00
AHFS class Wakefulness-Promoting Agents
FDB label name WAKIX 4.45 MG TABLET
FDB brand name Wakix
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 72028-045-03 — 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 → 72028-0045-03. 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 Histamine-3 Receptor Antagonist/Inverse Agonist class.

Pharmacologic class Histamine-3 Receptor Antagonist/Inverse Agonist
Drug family (ATC) Other nervous system drugs
How it works Histamine H3 Receptor Antagonists, Cytochrome P450 3A4 Inducers, Histamine H3 Receptor Inverse Agonists
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

LabelerHarmony Biosciences, LLC
Application holderHARMONY BIOSCIENCES MANAGEMENT INC
FDA applicationNDA211150 (NDA)
Labeler code72028
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio2 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.

🩺 Clinical

Label name WAKIX 4.45 MG TABLET Ingredient Pitolisant Hcl
📖 What it is MedlinePlus · NLM

Pitolisant is used to treat excessive daytime sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) in adults and children 6 years of age and older and to treat cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) in adults with narcolepsy. Pitolisant is in a class of medications called H3 blockers. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Wakix is designed to help with two of the most disruptive symptoms of narcolepsy. First, it reduces excessive daytime sleepiness — that irresistible urge to fall asleep during the...
  • What exactly is Wakix supposed to do for me?
  • Take Wakix once in the morning, right when you wake up. The good news is that food doesn't significantly affect how it works, so you can take it with or without breakfast — whateve...
  • When should I take it, and does it matter if I eat first?
📖 Read our full Pitolisant 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.

💊 What it looks like

Color White
ShapeRound
ImprintH
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

8 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $140.13 $4,203.99 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $149.13 $4,473.85 / 30 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Wakix 4.45 mgthis 72028-0045-03 Harmony 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2019
First FDA approval
Aug 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 14, 2019 RLD RS ⏳ ~6.5 yr to latest listed protection

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 8354430 — method of use (U-1101)
US 8486947 — method of use (U-1101)
US 8486947 — method of use (U-1101)
US 8354430 — method of use (U-1101)
US 8486947 — method of use (U-1102)
US 8354430 — method of use (U-1102)
US 8354430 — method of use (U-1102)
US 8486947 — method of use (U-1102)
US 8207197 — drug substance
US 8207197 — drug substance
Exclusivity NPP
Exclusivity ODE-255
Exclusivity ODE-331
Exclusivity ODE-489
Exclusivity ODE-519
Exclusivity NPP
Exclusivity ODE-255
Exclusivity ODE-331
Exclusivity ODE-489
Exclusivity ODE-519
2019 2021 2023 2025 2027 2029 2031 2033
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 (10)
PatentTypeUse codeExpires
US 8354430 ↗ Method of use U-1101 Feb 6, 2026
US 8486947 ↗ Method of use U-1101 Sep 26, 2029
US 8486947 ↗ Method of use U-1101 Sep 26, 2029
US 8354430 ↗ Method of use U-1101 Feb 6, 2026
US 8486947 ↗ Method of use U-1102 Sep 26, 2029
US 8354430 ↗ Method of use U-1102 Feb 6, 2026
US 8354430 ↗ Method of use U-1102 Feb 6, 2026
US 8486947 ↗ Method of use U-1102 Sep 26, 2029
US 8207197 ↗ Drug substance — Mar 7, 2030
US 8207197 ↗ Drug substance — Mar 7, 2030
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationJun 21, 2027
ODE-255Orphan Drug Exclusivity (7-year)Aug 14, 2026
ODE-331Orphan Drug Exclusivity (7-year)Oct 13, 2027
ODE-489Orphan Drug Exclusivity (7-year)Jun 21, 2031
ODE-519Orphan Drug Exclusivity (7-year)Feb 13, 2033
NPPNew Patient PopulationJun 21, 2027
ODE-255Orphan Drug Exclusivity (7-year)Aug 14, 2026
ODE-331Orphan Drug Exclusivity (7-year)Oct 13, 2027
ODE-489Orphan Drug Exclusivity (7-year)Jun 21, 2031
ODE-519Orphan Drug Exclusivity (7-year)Feb 13, 2033
Common questions
Is there a generic version of WAKIX 4.45 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for WAKIX 4.45 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2033 — an estimate, not a guaranteed launch date.
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 72028-0045-03, 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 – Q1 2026 · 5 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
909
Units reimbursed last 4 qtrs
28.5K
Gross reimbursed last 4 qtrs
$4M
Avg / prescription
$4,398.55
Avg / unit
$140.13
Latest quarter Q1 2026
232Rx
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 303 Rx Managed care · 606 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 863 units · 11.0 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 3,187 units · 31.8 per 100k residents MI New York: 1,933 units · 9.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,572 units · 12.5 per 100k residents IL Indiana: 2,004 units · 29.2 per 100k residents IN Ohio: 4,339 units · 36.8 per 100k residents OH Pennsylvania: 5,428 units · 41.9 per 100k residents PA New Jersey: 669 units · 7.2 per 100k residents NJ Massachusetts: no data reported MA California: 529 units · 1.4 per 100k residents CA Utah: no data reported UT Colorado: 3,212 units · 54.6 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 338 units · 7.5 per 100k residents KY West Virginia: no data reported WV Virginia: 1,939 units · 22.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 161 units · 2.3 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,425 units · 4.7 per 100k residents TX Florida: 933 units · 4.1 per 100k residents FL
Units reimbursed · per 100k residents
1.454.6
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 Colorado 54.6 /100k
2 Pennsylvania 41.9 /100k
3 Ohio 36.8 /100k
4 Michigan 31.8 /100k
5 Indiana 29.2 /100k
6 Virginia 22.2 /100k
7 Illinois 12.5 /100k
8 Washington 11.0 /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.

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

Medicare Part D (outpatient prescription) spending for Wakix — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Wakix. 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
$44.1M
Claims incl. refills
2.9K
Beneficiaries
1.2K
Spend / beneficiary
$37,948.03
Spend / claim
$15,268.56
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Wakix (this brand).

Top reported reactions

Nausea235
Anxiety229
Headache218
Insomnia217
Product Administration Interrupted203
Somnolence185
Fatigue180

Age at onset

Neonate1
Adolescent1
Adult148
Elderly8

Reporter sex

2,067 reports
Male · 30%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization234
Life-threatening17
Disabling16
Death9
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 444 76
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72028-0045-03 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2019-08-14 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72028-045-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72028-0045-03, written without dashes as 72028004503. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72028-0045-03, the first segment (72028) is the labeler code FDA assigned to Harmony Biosciences, LLC; the middle segment (0045) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Harmony Biosciences, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Harmony Biosciences, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🎯 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 58 words ▾

1 INDICATIONS AND USAGE WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy patients 6 years of age and older with narcolepsy ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for complete dosage instructions ( 2.2 , 2.3 ) Administer orally once daily in the morning upon wakening ( 2.2 , 2.3 ) Dosage Recommendations: Adults ( 2.2 ) Week 1 Initiate with a dosage of 8.9 mg once daily Week 2 Increase dosage to 17.8 mg once daily Week 3 May increase to the maximum recommended dosage of 35.6 mg once daily Pediatric Patients (6 years and older) ( 2.3 ) Week 1 Initiate with a dosage of 4.45 mg once daily Week 2 Increase dosage to 8.9 mg once daily Week 3 Increase dosage to 17.8 mg once daily, the maximum recommended dosage for patients weighing <40 kg Week 4 For patients weighing ≥40 kg, may increase to the maximum recommended dosage of 35.6 mg once daily Hepatic impairment ( 2.4 , 8.6 , 12.3 ): Moderate hepatic impairment (Child-Pugh Class B): Adults: Initial dosage is 8.9 mg once daily.

Increase to a maximum dosage of 17.8 mg once daily after 14 days Pediatric Patients: Initial dosage is 4.45 mg once daily. Increase to 8.9 mg once daily after 14 days; for patients weighing ≥40 kg, may increase to 17.8 mg once daily after another 14 days Renal impairment (eGFR less than 60 mL/minute/1.73 m 2 ) ( 2.5 , 8.7 , 12.3 ): Adults: Initial dosage is 8.9 mg once daily. Increase to a maximum dosage of 17.8 mg once daily after 7 days Pediatric Patients: Initial dosage is 4.45 mg once daily.Increase to 8.9 mg once daily after 7 days; for patients weighing ≥40 kg, may increase to 17.8 mg once daily after another 7 days End-stage renal disease (ESRD): Not recommended Poor Metabolizers of CYP2D6 ( 2.7 ): Adults: Maximum recommended dosage is 17.8 mg once daily Pediatric Patients: Maximum recommended dosage is 8.9 mg once daily for patients weighing <40 kg and 17.8 mg for patients weighing ≥40 kg

2.1Recommendations Prior to WAKIX Initiation Consider genotyping patients for CYP2D6 metabolizer status to determine the maximum recommended dosage [see Dosage and Administration ( 2.7 )].

2.2Recommended Dosage in Adult Patients The recommended dosage range for WAKIX for the treatment of EDS or cataplexy in adult patients is 17.8 mg to 35.6 mg administered orally once daily in the morning upon wakening. Titrate dosage as follows: Week 1: Initiate with a dosage of 8.9 mg (two 4.45 mg tablets) once daily Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily Week 3: May increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily Dose may be adjusted based on tolerability.If a dose is missed, patients should take the next dose the following day in the morning upon wakening.It may take up to 8 weeks for some patients to achieve a clinical response.

2.3Recommended Dosage in Pediatric Patients 6 Years and Older The recommended starting dosage of WAKIX for the treatment of EDS or cataplexy in pediatric patients 6 years and older is 4.45 mg administered orally once daily in the morning upon wakening. Titrate dosage as follows: Week 1: Initiate with a dosage of 4.45 mg (one 4.45 mg tablet) once daily Week 2: Increase dosage to 8.9 mg (two 4.45 mg tablets) once daily Week 3: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily, which is the maximum recommended dosage for patients weighing <40 kg Week 4: For patients weighing ≥40 kg, may increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily Dose may be adjusted based on tolerability.

If a dose is missed, patients should take the next dose the following day in the morning upon wakening. It may take up to 8 weeks for some patients to achieve a clinical response.

2.4Dosage Recommendations in Patients with Hepatic Impairment Adult Patients with Moderate (Child-Pugh Class B) Hepatic Impairment Initiate WAKIX at 8.9 mg once daily and increase after 14 days to a maximum recommended dosage of 17.8 mg once daily [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Pediatric Patients (6 years and older)…

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS WAKIX 4.45 mg tablets: white, round, biconvex film-coated tablet, marked with “S” on one side and plain on the other side. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant. WAKIX 17.8 mg tablets: white, round, biconvex film-coated tablet, marked with “H” on one side and plain on the other side.

Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant. Tablets: 4.45 mg and 17.8 mg ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS WAKIX is contraindicated in patients with: known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with WAKIX [see Adverse Reactions ( 6.2 )] . severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate hepatic impairment [see Use in Specific Populations ( 8.6 )] .

Known hypersensitivity to pitolisant or any component of the formulation ( 4 ) Severe hepatic impairment ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS QT Interval Prolongation : Increases in QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. Monitor patients with hepatic or renal impairment for increased QTc ( 5.1 )

5.1QT Interval Prolongation WAKIX prolongs the QT interval. The use of WAKIX should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval [see Drug Interactions ( 7.1 )]. WAKIX should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval [see Clinical Pharmacology ( 12.2 )].

The risk of QT prolongation may be greater in patients with higher concentrations of pitolisant (e.g., patients with hepatic or renal impairment). Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment [see Dosage and Administration ( 2.4 , 2.5 )] .

WAKIX is contraindicated in patients with severe hepatic impairment [see Contraindications ( 4 )] . WAKIX is not recommended in patients with end-stage renal disease (ESRD) [see Dosage and Administration ( 2.5 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: QT Interval Prolongation [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥5% and at least twice placebo) in adults: insomnia, nausea, and anxiety ( 6.1 ). Most common adverse reactions (≥5% and greater than placebo) in pediatric patients 6 years and older: headache and insomnia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Harmony Biosciences at 1-800-833-7460 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 practice. Adult Patients with Narcolepsy In clinical trials for narcolepsy, 172 adult patients were treated with WAKIX in placebo-controlled trials for up to 8 weeks and in open-label extension trials for up to 5 years. In trials in which WAKIX was directly compared to placebo, 6 of the 152 patients (3.9%) who received WAKIX and 4 of the 114 patients (3.5%) who received placebo discontinued because of an adverse reaction.

Most Common Adverse Reactions In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at least twice the rate of placebo) with the use of WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Table 1 presents the adverse reactions that occurred at a rate of ≥2% in patients treated with WAKIX and more frequently than in patients treated with placebo in the placebo-controlled clinical trials in narcolepsy.

Table 1: Adverse Reactions that Occurred in ≥2% of WAKIX-Treated Patients and More Frequently than in Placebo-Treated Patients in Three Placebo-Controlled Narcolepsy Studies * The following terms were combined: Abdominal pain includes: abdominal discomfort; abdominal pain; abdominal pain upper Anxiety includes: anxiety; nervousness; stress; stress at work Hallucinations includes: hallucination; hallucination visual; hypnagogic hallucination Headache includes: cluster headache; headache; migraine; premenstrual headache; tension headache Heart rate increased includes: heart rate increased; sinus tachycardia; tachycardia Insomnia includes: initial insomnia; insomnia; middle insomnia; poor quality sleep Musculoskeletal pain includes: arthralgia; back pain; carpal tunnel syndrome; limb discomfort; musculoskeletal pain; myalgia; neck pain; osteoarthritis; pain in extremity; sciatica Rash includes: eczema; erythema migrans; rash; urticaria Sleep disturbance includes: dyssomnia; sleep disorder; sleep paralysis; sleep talking Upper respiratory tract infection includes: pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; upper respiratory tract inflammation; viral upper respiratory tract infection Adverse Reaction WAKIX (n=152) % Placebo (n=114) % Headache * 18 15 Insomnia * 6 2 Nausea 6 3 Upper respiratory tract infection * 5 3 Musculoskeletal pain * 5 3 Anxiety * 5 1 Heart rate increased * 3 0 Hallucinations * 3 0 Irritability 3 2 Abdominal pain * 3 1 Sleep disturbance * 3 2 Decreased appetite 3 0 Cataplexy 2 1 Dry mouth 2 1 Rash * 2 1 Pediatric Patients (6 years and older) with Narcolepsy In a clinical trial for narcolepsy, 73 pediatric patients 6 years and older were treated with WAKIX in the placebo-controlled phase for up to 8 weeks and 105 patients in the open-label extension phase for up to 8 years.

Most Common Adverse Reactions In the placebo-controlled phase of the study, the most common adverse reactions (occurring in ≥5% of patients and greater than the rate of placebo) with the use of WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the ad…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP2D6 Inhibitors: Increased exposure of WAKIX; reduce the maximum recommended dose of WAKIX by half ( 2.6 , 7.1 ) Strong CYP3A4 Inducers: Decreased exposure of WAKIX; consider dosage adjustment of WAKIX ( 2.6 , 7.1 ) Sensitive CYP3A4 Substrates (including hormonal contraceptives): WAKIX may reduce effectiveness of sensitive CYP3A4 substrates. Use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment ( 7.1 , 8.3 )

7.1Drugs Having Clinically Important Interactions with WAKIX Table 2: Clinically Significant Drug Interactions with WAKIX Effect of Other Drugs on WAKIX Strong CYP2D6 Inhibitors Clinical Implication: Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Prevention or Management: Reduce the dose of WAKIX by half [see see Dosage and Administration ( 2.6 ), Clinical Pharmacology ( 12.3 )] . Strong CYP3A4 Inducers Clinical Implication: Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%.

Prevention or Management: Assess for loss of efficacy after initiation of a strong CYP3A4 inducer. For patients stable on WAKIX 8.9 mg or 17.8 mg once daily, increase the dose of WAKIX to reach double the original daily dose (i.e., 17.8 mg or 35.6 mg, respectively) over 7 days. If concomitant dosing of a strong CYP3A4 inducer is discontinued, decrease WAKIX dosage by half [see see Dosage and Administration ( 2.6 ), Clinical Pharmacology ( 12.3 )] .

Histamine-1 (H1) Receptor Antagonists Clinical Implication: WAKIX increases the levels of histamine in the brain; therefore, H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Prevention or Management: Avoid centrally acting H1 receptor antagonists. QT Interval Prolongation Clinical Implication: Concomitant use of drugs that prolong the QT interval may add to the QT effects of WAKIX and increase the risk of cardiac arrhythmia.

Prevention or Management: Avoid the use of WAKIX in combination with other drugs known to prolong the QT interval [see Warnings and Precautions ( 5.1 )] . Effect of WAKIX on Other Drugs Sensitive CYP3A4 Substrates Clinical Implication: WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX [see Clinical Pharmacology ( 12.3 )] .

The effectiveness of hormonal contraceptives (e.g., ethinyl estradiol) may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy. Prevention or Management: Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment [see Use in Specific Populations ( 8.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.

Risk Summary Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproductive studies, administration of pitolisant during organogenesis caused maternal and embryofetal toxicity in rats and rabbits at doses ≥13 and >4 times the maximum recommended human dose (MRHD) of 35.6 mg based on mg/m 2 body surface area, respectively. Oral administration of pitolisant to female rats during pregnancy and lactation adversely affected maternal and fetal health and produced developmental delay at doses ≥13 times the MRHD, based on mg/m 2 body surface area and increased the incidence of major malformations at 22 times the MRHD (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Data Animal Data Pitolisant was administered orally to pregnant rats during the period of organogenesis at doses of 30, 52, 90 and 110 mg/kg/day, which are approximately 7, 13, 22 and 27 times the MRHD, based on mg/m2 body surface area, respectively. Maternal toxicity occurred at >22 times the MRHD and included convulsions and decreases in body weight and food consumption. At these maternally toxic doses, no adverse effects on embryofetal development were noted and the no observed-adverse-effect-level for embryofetal toxicity is 27 times the MRHD based on mg/m 2 body surface area.

Pitolisant was administered intramuscularly to pregnant rabbits during the period of organogenesis at doses of 4, 8, and 16 mg/kg/day, which are approximately 2, 4 and 8 times the MRHD, based on mg/m 2 body surface area, respectively. Maternal toxicity occurred at ≥4 times the MRHD and included significant body weight loss and decreased food consumption. Mortality (1 animal) and convulsions (2 animals) occurred at 8 times the MRHD.

At the maternally toxic dose (8 times the MRHD), the incidence of pre-implantation loss and abortions increased with a consequent decrease in both the number of implantations and live fetuses. Pitolisant was not teratogenic at doses up to 8 times the MRHD; however, delayed skeletal development (incomplete ossification and supernumerary ribs) was observed. The no-observed-adverse-effect-level for maternal toxicity and embryofetal development is 2 and 4 times the MRHD based on mg/m 2 body surface area, respectively.

Pitolisant was administered orally to pregnant rats from gestation day 7 through lactation day 20 post-partum at doses of 30, 52, and 90 mg/kg/day, which are 7, 13 and 22 times the MRHD, based on mg/m 2 body surface area, respectively. Maternal toxicity included death, CNS signs including convulsions, and significant decrease in body weight and food consumption at 22 times the MRHD based on mg/m 2 body surface area. At the maternally toxic dose (22 times the MRHD), fetal toxicity included stillbirths, postnatal pup mortality (due to lack of milk and/or failure to nurse), and decreased pup length and weight.

A single female at the mid dose (13 times the MRHD) also failed to produce milk resulting in pup mortality. At the maternally toxic dose (22 times the MRHD), pitolisant was teratogenic causing major malformations (cleft palate, abnormal limb flexure). F 1 toxicity include…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.

Risk Summary Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproductive studies, administration of pitolisant during organogenesis caused maternal and embryofetal toxicity in rats and rabbits at doses ≥13 and >4 times the maximum recommended human dose (MRHD) of 35.6 mg based on mg/m 2 body surface area, respectively. Oral administration of pitolisant to female rats during pregnancy and lactation adversely affected maternal and fetal health and produced developmental delay at doses ≥13 times the MRHD, based on mg/m 2 body surface area and increased the incidence of major malformations at 22 times the MRHD (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Data Animal Data Pitolisant was administered orally to pregnant rats during the period of organogenesis at doses of 30, 52, 90 and 110 mg/kg/day, which are approximately 7, 13, 22 and 27 times the MRHD, based on mg/m2 body surface area, respectively. Maternal toxicity occurred at >22 times the MRHD and included convulsions and decreases in body weight and food consumption. At these maternally toxic doses, no adverse effects on embryofetal development were noted and the no observed-adverse-effect-level for embryofetal toxicity is 27 times the MRHD based on mg/m 2 body surface area.

Pitolisant was administered intramuscularly to pregnant rabbits during the period of organogenesis at doses of 4, 8, and 16 mg/kg/day, which are approximately 2, 4 and 8 times the MRHD, based on mg/m 2 body surface area, respectively. Maternal toxicity occurred at ≥4 times the MRHD and included significant body weight loss and decreased food consumption. Mortality (1 animal) and convulsions (2 animals) occurred at 8 times the MRHD.

At the maternally toxic dose (8 times the MRHD), the incidence of pre-implantation loss and abortions increased with a consequent decrease in both the number of implantations and live fetuses. Pitolisant was not teratogenic at doses up to 8 times the MRHD; however, delayed skeletal development (incomplete ossification and supernumerary ribs) was observed. The no-observed-adverse-effect-level for maternal toxicity and embryofetal development is 2 and 4 times the MRHD based on mg/m 2 body surface area, respectively.

Pitolisant was administered orally to pregnant rats from gestation day 7 through lactation day 20 post-partum at doses of 30, 52, and 90 mg/kg/day, which are 7, 13 and 22 times the MRHD, based on mg/m 2 body surface area, respectively. Maternal toxicity included death, CNS signs including convulsions, and significant decrease in body weight and food consumption at 22 times the MRHD based on mg/m 2 body surface area. At the maternally toxic dose (22 times the MRHD), fetal toxicity included stillbirths, postnatal pup mortality (due to lack of milk and/or failure to nurse), and decreased pup length and weight.

A single female at the mid dose (13 times the MRHD) also failed to produce milk resulting in pup mortality. At the maternally toxic dose (22 times the MRHD), pitolisant was teratogenic causing major malformations (cleft palate, abnormal limb flexure). F 1 toxicity included delay in postnatal developme…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of WAKIX have been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients 6 years of age and older with narcolepsy. Use of WAKIX in this age group is supported by one adequate and well-controlled study in 110 pediatric patients with narcolepsy ages 6 to less than 18 years of age [see Clinical Studies ( 14.1 )] . The safety and effectiveness of WAKIX have not been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients less than 6 years of age with narcolepsy.

Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were administered pitolisant at 9, 21, or 48 mg/kg/day by oral gavage from postnatal day (PND) 7 to PND 70. Mortality occurred at the highest dose of 48 mg/kg/day; however, death was primarily related to aspiration/inhalation of food material. No adverse effects on growth and development up to the high dose were observed; however, plasma exposures at this dose were lower than those predicted to occur in pediatric patients at the maximum recommended human dose (MRHD) of 35.6 mg due to low oral bioavailability in juvenile rats.

In a second juvenile animal study, male and female rats were administered pitolisant at 15 or 30 mg/kg/day or 30 mg/kg/twice daily (60 mg/kg/day) by intraperitoneal injection from PND 7 to PND 70. Mortality and convulsions were observed at the top two doses of 30 and 60 mg/kg/day. Similar findings of convulsions and mortality were also observed in studies in adult rats at comparable doses.

The no-observed-adverse-effect-level (NOAEL) is 15 mg/kg/day in juvenile animals administered pitolisant by intraperitoneal injection, which corresponds to plasma exposures that are approximately 4 times and 1 times the predicted pediatric exposures at the MRHD of 35.6 mg, based on C max and AUC, respectively.

🧓 Geriatric Use 139 words ▾

8.5Geriatric Use Limited pharmacokinetic data are available in healthy elderly subjects. A pharmacokinetic study that compared 12 elderly subjects (age 68 to 82 years) to 12 healthy adults (age 18 to 45 years) did not reveal any significant differences in drug exposure [see Clinical Pharmacology ( 12.3 )] . Of the total number of adult patients with narcolepsy in clinical studies of WAKIX, 14 patients (5%) were ≥65 years old.

No overall differences in safety or effectiveness were observed between these patients and younger patients in these clinical trials, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of pitolisant in excessive daytime sleepiness (EDS) or cataplexy in patients 6 years and older with narcolepsy is unclear. However, its efficacy could be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors.

12.2Pharmacodynamics Pitolisant binds to H3 receptors with a high affinity (K i = 1 nM) and has no appreciable binding to other histamine receptors (H1, H2, or H4 receptors; K i ≥10 µM). Cardiac Electrophysiology WAKIX at the highest recommended dosage (i.e., 35.6 mg daily) led to a QTc increase of 4.2 msec. Exposures 3.8-fold higher than achieved at the highest recommended dose increased QTc 16 msec (mean) [see Warnings and Precautions ( 5.1 )] .

12.3Pharmacokinetics Following oral administration of pitolisant 35.6 mg once daily, the steady state C max and AUC are 73 ng/mL (range: 49.2 to 126 ng/mL) and 812 ng*hr/mL (range: 518 to 1468 ng*hr/mL), respectively. Pitolisant exposure (C max and AUC) increases proportionally with dose and steady state is reached by day 7. Absorption The median time to maximum plasma concentration (T max ) of pitolisant is 3.5 hours (2 to 5 hours).

The oral absorption of WAKIX is around 90%. Food Effect No clinically significant differences in the pharmacokinetics of pitolisant were observed following administration with a high-fat meal (approximately 950 calories, 62% fat). Distribution The apparent volume of distribution of pitolisant is approximately 700 L (5 to 10 L/kg).

Serum protein binding is approximately 91% to 96%. The blood to plasma ratio of pitolisant is 0.55 to 0.89. Elimination After a single dose of 35.6 mg, the median half-life of pitolisant is approximately 20 hours (7.5 to 24.2 hours).

The apparent oral clearance (CL/F) of pitolisant is

43.9L/hr and renal clearance accounts for <2% of the total clearance of pitolisant. Metabolism Pitolisant is primarily metabolized by CYP2D6 and to a lesser extent by CYP3A4; these metabolites are further metabolized or conjugated with glycine or glucuronic acid. None of these metabolites are pharmacologically active.

Excretion After a single oral radiolabeled pitolisant 17.8 mg dose, approximately 90% of the dose was excreted in urine (<2% unchanged) and 2.3% in feces. Specific Populations No clinically significant differences in the pharmacokinetics of pitolisant were observed based on age (18 to 82 years old), sex, race/ethnicity (Caucasians or Blacks), or body weight (48 to 103 kg). The effects of end-stage renal disease and severe hepatic impairment on the pharmacokinetics of pitolisant are unknown.

Pediatric Patients Pharmacokinetic data from 24 pediatric patients with narcolepsy (ages 7 to 17 years) receiving a single dose of WAKIX suggest that pediatric patients have higher exposure to pitolisant than adults. The geometric mean C max and AUC 0-10h of pitolisant were 2.2 and 2.0-fold higher, respectively, in pediatric patients 12 to 17 years and 3.4 and 3.6-fold higher, respectively, in pediatric patients 7 to 11 years compared to adults. Patients with Hepatic Impairment Six subjects with mild hepatic impairment (Child-Pugh Class A), 6 subjects with moderate hepatic impairment (Child-Pugh Class B), and 12 healthy subjects matched for age, sex, body mass index and ethnicity received a single dose of WAKIX 17.8 mg to assess the pharmacokinetics of WAKIX in patients with hepatic impairment.

Exposure of pitolisant in patients with mild or moderate hepatic impairment is summarized in Figure 1 . No studies have been conducted in patients with severe hepatic impairment. Figure 1: Effect of Hepatic Impairment on Pitolisant Pharmacokinetics Dots = Geometric least squares mean ratios, Error bars = 90% CI; reference dashed lines are 0.8 and 1.25.

AUC inf = area under the curve from time 0 to time infinity; C max = maximum plasma concentration. Patients with Renal Impairment A single dose of WAKIX 17.8 mg was administered to 4 subjec…

🧬 Mechanism of Action 44 words ▾

12.1Mechanism of Action The mechanism of action of pitolisant in excessive daytime sleepiness (EDS) or cataplexy in patients 6 years and older with narcolepsy is unclear. However, its efficacy could be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors.

📦 How Supplied / Storage and Handling 169 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied WAKIX (pitolisant) tablets are available as: 4.45 mg: white, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “S” on one side and plain on the other side. NDC 72028-045-03 – Bottles of 30 17.8 mg: white, round, biconvex film-coated tablet, 7.5 mm diameter, marked with “H” on one side and plain on the other side. NDC 72028-178-03 – Bottles of 30

16.2Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

16.1How Supplied WAKIX (pitolisant) tablets are available as: 4.45 mg: white, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “S” on one side and plain on the other side. NDC 72028-045-03 – Bottles of 30 17.8 mg: white, round, biconvex film-coated tablet, 7.5 mm diameter, marked with “H” on one side and plain on the other side. NDC 72028-178-03 – Bottles of 30

📦 Storage and Handling 34 words ▾

16.2Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

📋 Description 146 words ▾

11 DESCRIPTION WAKIX tablets contain pitolisant hydrochloride. Pitolisant is an antagonist/inverse agonist of the histamine-3 (H3) receptor. Pitolisant hydrochloride is a white or almost white crystalline powder with a molecular formula of C 17 H 26 ClNO·HCl and a molecular weight of 332.31.

Pitolisant hydrochloride is soluble in water, ethanol, and methylene chloride and practically insoluble in cyclohexane. The chemical name of pitolisant hydrochloride is 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride and its structural formula is: The molecular formula of the pitolisant free base is C 17 H 26 ClNO and its molecular weight is 295.85. WAKIX tablets are for oral administration and each film-coated tablet contains 5 mg or 20 mg of pitolisant hydrochloride (equivalent to 4.45 mg or 17.8 mg of pitolisant free base, respectively) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. chemical structure

💬 Information for Patients 220 words ▾

17 PATIENT COUNSELING INFORMATION Prolongation of the QT Interval Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions ( 5.1 )] . Advise patients to inform their healthcare provider that they are taking WAKIX before any new drug is taken. Contraception Advise patients that use of WAKIX may reduce the efficacy of hormonal contraceptives.

Advise patients using a hormonal contraceptive to use an alternative non-hormonal contraceptive method of contraception during treatment and for at least 21 days after discontinuing treatment [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.3 )]. Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to WAKIX during pregnancy [see Use in Specific Populations ( 8.1 )]. Concomitant Medication Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between WAKIX and other drugs [see Drug Interactions ( 7 )].

Distributed by: Harmony Biosciences, LLC, Plymouth Meeting, PA 19462 USA WAKIX is a registered trademark of Bioprojet Europe, Ltd. Protected by US Patent Numbers 8,207,197 and 8,486,947 Harmony Biosciences name and logo are trademarks of Harmony Biosciences Management, Inc. and are used herein by permission. Label #100.10

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