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APONVIE APREPITANT 32 mg/4.4mL Emulsion, 10 vials — NDC 47426-0401-10 package photo

APONVIE APREPITANT 32 mg/4.4mL Emulsion, 10 vials

by Heron Therapeutics, Inc. · 10 VIAL, GLASS in 1 CARTON (47426-401-10) / 4.4 mL in 1 VIAL, GLASS (47426-401-01)
NDC 47426-0401-10
🏷️ FDA NDC (as labeled) 47426-401-10 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

⚠️
Other active recalls for Aprepitant (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 12, 2025 — Presence of particulate matter: potential presence of metal particulates in the product. (Merck Sharp & Dohme LLC) · FDA recall D-0241-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 47426-401-10
Product NDC 47426-401
11-digit billing NDC 47426040110
NCPDP billing unit ML — per mL (volume)
RxCUI 2631783, 2631788
UNII 1NF15YR6UY
Application # NDA216457
SPL Set ID d1b111eb-659a-496b-a86a-8f0fa370f147
Established class (EPC) Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of action Neurokinin 1 Antagonists; Cytochrome P450 3A4 Inhibitors; Cytochrome P450 2C9 Inducers; Cytochrome P450 3A4 Inducers
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-06
Route INTRAVENOUS
Dosage form EMULSION
Substance APREPITANT
GPI-14 50280020001605
GCN Seq No 083852
GCN 52923
HICL code 025058
Ingredient (HICL) Aprepitant
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.32.00
AHFS class Neurokinin-1 Receptor Antagonists
FDB label name APONVIE 32 MG/4.4 ML VIAL
FDB brand name Aponvie
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 47426-401-10 — 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 → 47426-0401-10. 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 Substance P/Neurokinin-1 Receptor Antagonist class.

Pharmacologic class Substance P/Neurokinin-1 Receptor Antagonist
Drug family (ATC) Other antiemetics
How it works Neurokinin 1 Antagonists, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 3A4 Inducers, Cytochrome P450 2C9 Inducers
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

LabelerHeron Therapeutics, Inc.
Application holderHERON THERAPEUTICS INC
FDA applicationNDA216457 (NDA)
Labeler code47426
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio5 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 APONVIE 32 MG/4.4 ML VIAL Ingredient Aprepitant
📗 Our plain-language guide HelloPharmacist
  • Aprepitant is designed to prevent nausea and vomiting before they start — not to treat them once they've kicked in. It's given as part of a combination of anti-nausea medicines, us...
  • What exactly is this medicine supposed to do for me?
  • Not without a backup plan. Aprepitant can reduce how well hormonal birth control works — that includes the pill, the patch, implants, and some IUDs. This effect can last for a full...
  • Can I take my birth control as usual while I'm on this?
📖 Read our full Aprepitant 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.

🧪 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.

  • 125 mg / 4.4 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 636 mg / 4.4 mL UNII 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • 21 mg / 4.4 mL UNII 399SL044HN
    Sodium oleate is a salt derived from oleic acid, a natural fatty acid. In medicines, it acts as an emulsifier and surfactant, helping mix oil and water ingredients together and improving how the drug dissolves and spreads in the body.
  • 424 mg / 4.4 mL UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • 238 mg / 4.4 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 2968 mg / 4.4 mL UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $20.57 $905.08 / 44 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J8502 $1.998 / J8502 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)47426-401-10
11-digit billing NDC47426-0401-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ8502
Descriptor1 MG
Billing units / pkg320 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aponvie 32 mg/4.4mLthis 47426-0401-10 Heron 10 vials — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2022
First FDA approval
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 16, 2022 RLD RS ⏳ ~9 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 10953018 — method of use (U-3440)
US 10624850 — method of use (U-3440)
US 9974794 — method of use (U-3440)
US 9808465 — method of use (U-3440)
US 9561229 — method of use (U-3440)
US 11744800 — method of use (U-3690)
US 11878074 — method of use (U-3787)
US 10500208 — drug product
US 9974793 — drug product
US 12290520 — drug product
US 12115254 — drug product
US 9974742 — drug product
US 11173118 — drug product
US 12115255 — drug product
2022 2024 2026 2028 2030 2032 2034
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 (14)
PatentTypeUse codeExpires
US 10953018 ↗ Method of use U-3440 Sep 18, 2035
US 10624850 ↗ Method of use U-3440 Sep 18, 2035
US 9974794 ↗ Method of use U-3440 Sep 18, 2035
US 9808465 ↗ Method of use U-3440 Sep 18, 2035
US 9561229 ↗ Method of use U-3440 Sep 18, 2035
US 11744800 ↗ Method of use U-3690 Sep 18, 2035
US 11878074 ↗ Method of use U-3787 Sep 18, 2035
US 10500208 ↗ Drug product — Sep 18, 2035
US 9974793 ↗ Drug product — Sep 18, 2035
US 12290520 ↗ Drug product — Sep 18, 2035
US 12115254 ↗ Drug product — Sep 18, 2035
US 9974742 ↗ Drug product — Sep 18, 2035
US 11173118 ↗ Drug product — Sep 18, 2035
US 12115255 ↗ Drug product — Sep 18, 2035
Common questions
Is there a generic version of APONVIE 32 MG/4.4 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for APONVIE 32 MG/4.4 ML VIAL. 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 47426-0401-10, 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
1.2K
Units reimbursed last 4 qtrs
5.1K
Gross reimbursed last 4 qtrs
$105.2K
Avg / prescription
$90.31
Avg / unit
$20.5705
Latest quarter Q4 2025
227Rx
Fee-for-service vs managed care ⓘ
12% FFS 88% MCO
Fee-for-service · 134 Rx Managed care · 1,031 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 57 units · 1.0 per 100k residents MN Wisconsin: no data reported WI Michigan: 263 units · 2.6 per 100k residents MI New York: 53 units · 0.3 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: 126 units · 3.9 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,015 units · 17.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,052 units · 2.7 per 100k residents CA Utah: no data reported UT Colorado: 48 units · 0.8 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 387 units · 8.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported 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: no data reported 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: 1,113 units · 10.1 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.317.1
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 Ohio 17.1 /100k
2 Georgia 10.1 /100k
3 Kentucky 8.6 /100k
4 Iowa 3.9 /100k
5 California 2.7 /100k
6 Michigan 2.6 /100k
7 Minnesota 1.0 /100k
8 Colorado 0.8 /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 Aprepitant (matched by generic name) — the program that covers self-administered drugs. 4 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 Aprepitant. CMS lists 3 products for this generic; we show the highest-spend one. 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
$2.62M
Claims incl. refills
3K
Beneficiaries
1.8K
Spend / beneficiary
$1,460.29
Spend / claim
$873.74
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 APREPITANT — the ingredient across all brands.

Top reported reactions

Nausea2,245
Fatigue1,943
Pyrexia1,653
Diarrhoea1,604
Dyspnoea1,583
Vomiting1,542
Alopecia1,327

Age at onset

Neonate17
Infant13
Child65
Adolescent58
Adult1,952
Elderly1,019

Reporter sex

18,355 reports
Male · 37%
Female · 62%
Unknown · 1%

Serious outcomes

Hospitalization10,066
Death3,080
Life-threatening2,783
Disabling1,810
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,386 0
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
47426-0401-10 You're viewing this 10 VIAL, GLASS in 1 CARTON (47426-401-10) / 4.4 mL in 1 VIAL, GLASS (47426-401-01) 2023-03-06 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 ✓ Available
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 47426-401-10, 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: 47426-0401-10, written without dashes as 47426040110. 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 47426-0401-10, the first segment (47426) is the labeler code FDA assigned to Heron Therapeutics, Inc.; the middle segment (0401) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Heron Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Heron Therapeutics, Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J8502 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE APONVIE is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. APONVIE is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Limitations of Use : APONVIE has not been studied for treatment of established nausea and vomiting.

( 1 ) Limitations of Use APONVIE has not been studied for the treatment of established nausea and vomiting.

⏱️ Dosage and Administration 125 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is 32 mg administered as a 30 second intravenous injection prior to induction of anesthesia. ( 2.1 )

2.1Recommended Dosage The recommended dose in adults of APONVIE is 32 mg administered as a 30 second intravenous injection prior to induction of anesthesia.

2.2Preparation and Administration Inspect the vial for particulate matter and discoloration prior to administration; discard if present. APONVIE is opaque and off-white to amber in color. Aseptically withdraw 4.4 mL from the vial. Flush the infusion line with normal saline before and after administration of APONVIE.

2.3Compatibilities APONVIE is compatible with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, and solutions containing divalent cations (e.g., calcium, magnesium), including Lactated Ringer's Solution.

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Injectable emulsion: 32 mg/4.4 mL (7.2 mg/mL) aprepitant as an opaque, off-white to amber emulsion, in a single-dose vial. Injectable emulsion: 32 mg/4.4 mL (7.2 mg/mL) in single-dose vial. ( 3 )

⛔ Contraindications 99 words ▾

4 CONTRAINDICATIONS APONVIE is contraindicated in patients: with a history of hypersensitivity to aprepitant or any component of the product [see Description (11) ] . Hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . taking pimozide. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of pimozide, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Drug Interactions (7.1) ] .

Known hypersensitivity to any component of this product. ( 4 , 5.1 ) Concurrent use with pimozide. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions (including anaphylaxis) : May occur during or soon after administration. If symptoms occur, administer appropriate medical therapy. ( 4 , 5.1 ) CYP3A4 Interactions : Aprepitant is a substrate, weak-to-moderate inhibitor, and inducer of CYP3A4; see full prescribing information.

( 5.2 , 7.2 ) Warfarin (a CYP2C9 substrate) : Risk of decreased INR of prothrombin time; monitor INR in 2-week period, particularly at 7 to 10 days, following administration of APONVIE. ( 5.3 , 7.1 ) Hormonal Contraceptives : Efficacy of contraceptives may be reduced for 28 days following administration of aprepitant. Use effective alternative or back-up methods of non-hormonal contraception.

( 5.4 , 7.1 , 8.3 )

5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of aprepitant have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported [see Adverse Reactions (6.2) ] . Monitor patients during and after administration.

If hypersensitivity reactions occur, administer appropriate medical therapy. Do not administer APONVIE in patients who experience these symptoms with previous use of aprepitant.

5.2Clinically Significant CYP3A4 Drug Interactions Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Use of pimozide, a CYP3A4 substrate, with APONVIE is contraindicated [see Contraindications (4) ] . Use of APONVIE with strong CYP3A4 inhibitors (e.g., ketoconazole) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to APONVIE [see Drug Interactions (7.2) ] .

Use of APONVIE with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of APONVIE [see Drug Interactions (7.2) ].

5.3Decrease in INR with Concomitant Warfarin Use of aprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time [see Clinical Pharmacology (12.3) ] . Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following administration of APONVIE [see Drug Interactions (7.1) ] .

5.4Risk of Reduced Efficacy of Hormonal Contraceptives The efficacy of hormonal contraceptives may be reduced for 28 days following administration of APONVIE [see Clinical Pharmacology (12.3) ] . Advise patients to use effective alternative or back-up methods of non-hormonal contraception for 1 month following administration of APONVIE [see Drug Interactions (7.1) and Use in Specific Populations (8.3) ] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥3%) are ( 6.1 ): Single-dose APONVIE: constipation, fatigue, and headache. Single-dose oral aprepitant: constipation and hypotension. To report SUSPECTED ADVERSE REACTIONS, contact Heron Therapeutics, Inc. at 1-844-437-6611 and www.APONVIE.com 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. The safety of APONVIE for prevention of PONV was evaluated as a single dose in healthy subjects and established from adequate and well-controlled studies of oral aprepitant [see Clinical Studies (14) ] . Adverse reactions observed in these studies are described below.

Safety of APONVIE A total of 51 healthy subjects received a single 32 mg dose of APONVIE as a 30 second intravenous injection. Adverse reactions reported in at least 3% of subjects were constipation (8%), fatigue (6%), and headache (4%). Safety of Oral Aprepitant In 2 active-controlled, double-blind clinical studies in patients receiving general anesthesia (Studies 1 and 2), 40 mg oral aprepitant was compared to 4 mg intravenous ondansetron [see Clinical Studies (14) ] .

There were 564 patients treated with oral aprepitant and 538 patients treated with ondansetron. The most common adverse reactions reported in patients treated with oral aprepitant for PONV in pooled Studies 1 and 2 are listed in Table 1. Table 1: Most Common Adverse Reactions in Oral Aprepitant-Treated Patients in a Pooled Analysis of PONV Studies Reported in ≥3% of patients treated with oral aprepitant 40 mg and at a greater incidence than with ondansetron.

Oral Aprepitant 40 mg (N = 564) Ondansetron (N = 538) Constipation 9% 8% hypotension 6% 5% In a pooled analysis of PONV studies, less common adverse reactions reported in more than 0.5% of patients treated with oral aprepitant and at a greater incidence than ondansetron were dizziness and urticaria. In addition, two serious adverse reactions were reported in PONV clinical studies of oral aprepitant in patients taking a higher than recommended dose: one case of constipation, and one case of sub-ileus. Other Studies Angioedema, urticaria, and Stevens-Johnson syndrome were reported as serious adverse reactions in patients receiving oral aprepitant in non-PONV studies.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders : pruritus, rash, urticaria, Stevens-Johnson syndrome/toxic epidermal necrolysis [see Warnings and Precautions (5.1) ] .

Immune system disorders : hypersensitivity reactions including anaphylaxis and anaphylactic shock [see Contraindications (4) and Warnings and Precautions (5.1) ] . Nervous system disorders : ifosfamide-induced neurotoxicity reported after aprepitant and ifosfamide coadministration.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See full prescribing information for a list of clinically significant drug interactions. ( 4 , 5.2 , 5.3 , 5.4 , 7.1 , 7.2 )

7.1Effect of Aprepitant on the Pharmacokinetics of Other Drugs Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see Clinical Pharmacology (12.3) ] . Table 2 includes drug interactions affecting drugs co-administered with APONVIE and instructions for preventing or managing them.

Table 2: Drug Interactions Affecting Drugs When Co-Administered with APONVIE Pimozide Clinical Impact Increased pimozide exposure. Intervention APONVIE is contraindicated [see Contraindications (4) ] . Hormonal Contraceptives Clinical Impact Decreased hormonal exposure for 28 days after administration of APONVIE [see Warnings and Precautions (5.3) , Use in Specific Populations (8.3) , and Clinical Pharmacology (12.3) ] .

Intervention Effective alternative or back-up methods of contraception (such as condoms and spermicides) should be used for 1 month following administration of APONVIE. Examples birth control pills, transdermal systems, implants, and certain intrauterine systems CYP2C9 Substrates Warfarin Clinical Impact Decreased warfarin exposure and decreased prothrombin time (INR) [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ] . Intervention In patients on chronic warfarin therapy, monitor prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following administration of APONVIE.

Other Antiemetic Agents 5-HT 3 Antagonists Clinical Impact No change in the exposure of the 5-HT 3 antagonist [see Clinical Pharmacology (12.3) ]. Intervention No dosage adjustment needed. Examples ondansetron, granisetron, dolasetron Corticosteroids Clinical Impact No clinically significant change in the exposure of dexamethasone or methylprednisolone [see Clinical Pharmacology (12.3) ].

Intervention No dosage adjustment needed.

7.2Effect of Other Drugs on the Pharmacokinetics of Aprepitant Aprepitant is a CYP3A4 substrate [see Clinical Pharmacology (12.3) ] . Table 3 includes drug interactions affecting APONVIE when co-administered with other drugs and instructions for preventing them. Table 3: Drug Interactions Affecting APONVIE When Co-Administered with Other Drugs Strong CYP3A4 Inhibitors Clinical Impact Significantly increased exposure of aprepitant may increase the risk of adverse reactions associated with APONVIE [see Clinical Pharmacology (12.3) ].

Intervention Avoid concomitant use of APONVIE. Examples ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir Strong CYP3A4 Inducers Clinical Impact Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of APONVIE [see Clinical Pharmacology (12.3) ]. Intervention Avoid concomitant use of APONVIE.

Examples rifampin, carbamazepine, phenytoin

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary There are insufficient data on aprepitant use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Avoid use of APONVIE in pregnant women due to the alcohol content (see Clinical Considerations ) . In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug concentrations (area under the plasma-concentration time curve [AUC]) of oral aprepitant approximately 4.8 times the exposure at the recommended human dose of APONVIE (see Data ) .

The background risk of major birth defects and miscarriage for the indicated populations 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.

Clinical Considerations Fetal/Neonatal Adverse Reactions APONVIE contains alcohol. Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. There is no safe level of alcohol exposure in pregnancy; therefore, avoid use of APONVIE in pregnant women.

Data Animal Data In embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 125 mg/kg/day (rabbits). No embryofetal lethality or malformations were observed at any dose level in either species. The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 125 mg/kg/day were approximately 4.8 times the exposure at the recommended human dose of APONVIE.

Aprepitant crosses the placenta in rats and rabbits.

8.2Lactation Risk Summary There are no data on the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. Aprepitant is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for APONVIE and any potential adverse effects on the breastfed infant from APONVIE or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Upon administration of APONVIE, the efficacy of hormonal contraceptives may be reduced. Advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms or spermicides) for 1 month following administration of APONVIE [see Warnings and Precautions (5.4) , Drug Interactions (7.1) , and Clinical Pharmacology (12.3) ] .

8.4Pediatric Use The safety and effectiveness of APONVIE have not been established in pediatric patients. Juvenile Animal Study A study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily from the early postnatal period (Postnatal Day 10) through Postnatal Day 58.

Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

8.5Geriatric Use Of the 1120 adult patients treated with oral aprepitant in PONV clinical studies, 7% were aged 65 and over, while 2% were aged 75 and over. Clinical studies of aprepitant did…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are insufficient data on aprepitant use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Avoid use of APONVIE in pregnant women due to the alcohol content (see Clinical Considerations ) . In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug concentrations (area under the plasma-concentration time curve [AUC]) of oral aprepitant approximately 4.8 times the exposure at the recommended human dose of APONVIE (see Data ) .

The background risk of major birth defects and miscarriage for the indicated populations 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.

Clinical Considerations Fetal/Neonatal Adverse Reactions APONVIE contains alcohol. Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. There is no safe level of alcohol exposure in pregnancy; therefore, avoid use of APONVIE in pregnant women.

Data Animal Data In embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 125 mg/kg/day (rabbits). No embryofetal lethality or malformations were observed at any dose level in either species. The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 125 mg/kg/day were approximately 4.8 times the exposure at the recommended human dose of APONVIE.

Aprepitant crosses the placenta in rats and rabbits.

🧒 Pediatric Use 116 words ▾

8.4Pediatric Use The safety and effectiveness of APONVIE have not been established in pediatric patients. Juvenile Animal Study A study was conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily from the early postnatal period (Postnatal Day 10) through Postnatal Day 58.

Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs. There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Of the 1120 adult patients treated with oral aprepitant in PONV clinical studies, 7% were aged 65 and over, while 2% were aged 75 and over. Clinical studies of aprepitant did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

No clinically meaningful differences in the pharmacokinetics of oral aprepitant were observed in healthy geriatric subjects compared to younger adult subjects [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 64 words ▾

10 OVERDOSAGE Headache, fatigue, and dizziness were reported in healthy subjects receiving a single dose of 100 or 130 mg aprepitant injectable emulsion (3.1 to 4 times the recommended dose). Drowsiness and headache were reported in one patient who ingested 1440 mg of oral aprepitant. In the event of overdose, general supportive treatment and monitoring should be provided. Aprepitant is not removed by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK 1 ) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for postoperative nausea and vomiting (PONV). Aprepitant has been shown in animal models to inhibit emesis via central actions.

Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors.

12.2Pharmacodynamics NK 1 Receptor Occupancy In two single-blind, multiple-dose, randomized, and placebo-controlled studies, healthy young men received oral aprepitant doses of 10 mg (N=2), 30 mg (N=3), 100 mg (N=3), or 300 mg (N=5) once daily (0.08, 0.24, 0.8, and 2.4 times a single 125 mg dose of oral aprepitant, respectively) for 14 days with 2 or 3 subjects on placebo. Both plasma aprepitant concentration and NK 1 receptor occupancy in the corpus striatum by PET were evaluated, at predose and 24 hours after the last dose.

At aprepitant plasma concentrations of approximately 10 ng/mL and 100 ng/mL, the NK 1 receptor occupancies were approximately 50% and 90%, respectively. The oral aprepitant regimen produced mean trough plasma aprepitant concentrations greater than 500 ng/mL in adults, which would be expected to, based on the fitted curve with the Hill equation, result in greater than 95% brain NK 1 receptor occupancy. However, the receptor occupancy for the PONV dosing regimen has not been determined.

In addition, the relationship between NK 1 receptor occupancy and the clinical efficacy of aprepitant has not been established. Cardiac Electrophysiology In a randomized, double-blind, positive-controlled, thorough QTc study, a single 200 mg intravenous dose of fosaprepitant, a prodrug of aprepitant, had no effect on the QTc interval. QT prolongation with the recommended APONVIE dosing regimen is not expected.

12.3Pharmacokinetics Absorption Following administration of a single intravenous 32 mg dose of APONVIE administered as a 30 second injection to healthy subjects, mean (CV%) area under the plasma concentration-time curve (AUC 0-∞ ) was 7.8 (27.4%) mcg∙hr/mL and mean plasma concentration at 5 minutes post-dose was 2.1 (19%) mcg/mL. In healthy subjects, a single dose of 32 mg of APONVIE administered as a 30 second intravenous injection resulted in a 13% higher AUC 0-∞ of aprepitant compared to a single oral dose of 40 mg aprepitant, which was not considered clinically meaningful.

Distribution Aprepitant was greater than 99% bound to plasma proteins. The mean volume of distribution following APONVIE administration was approximately 72 L in healthy subjects. Aprepitant crossed the blood-brain barrier in humans [see Clinical Pharmacology (12.1) ] .

Elimination Metabolism Aprepitant underwent extensive metabolism. In vitro studies using human liver microsomes indicated that aprepitant was metabolized primarily by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19. Metabolism was largely via oxidation at the morpholine ring and its side chains.

No metabolism by CYP2D6, CYP2C9, or CYP2E1 was detected. In healthy young adults, aprepitant accounted for approximately 24% of the radioactivity in plasma over 72 hours following a single oral 300 mg dose of [ 14 C]-aprepitant, indicating a substantial presence of metabolites in the plasma. Seven metabolites of aprepitant, which were only weakly active, had been identified in human plasma.

Excretion Aprepitant was eliminated primarily by metabolism; aprepitant was not renally excreted. The mean terminal half-life of aprepitant following administration of APONIVE was 12 hours. The mean plasma clearance of aprepitant was

4.4L/h. Specific Populations Geriatric Patients Following oral administration of a single 125 mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC 0-24hr of aprepitant wa…

🧬 Mechanism of Action 83 words ▾

12.1Mechanism of Action Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK 1 ) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for postoperative nausea and vomiting (PONV). Aprepitant has been shown in animal models to inhibit emesis via central actions.

Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING APONVIE injectable emulsion is supplied as an opaque, off-white to amber emulsion in a single-dose glass vial containing 32 mg/4.4 mL (7.2 mg/mL) aprepitant: NDC 47426-401-10 10 single-dose vials (NDC 47426-401-01) per carton Storage Refrigerate APONVIE at 2°C to 8°C (36°F to 46°F). APONVIE can remain at room temperature 20°C to 25°C (68°F to 77°F) up to 60 days. Do not freeze.

📦 Storage and Handling 29 words ▾

Storage Refrigerate APONVIE at 2°C to 8°C (36°F to 46°F). APONVIE can remain at room temperature 20°C to 25°C (68°F to 77°F) up to 60 days. Do not freeze.

📋 Description 156 words ▾

11 DESCRIPTION APONVIE injectable emulsion contains the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, and chemically described as 5-[[(2 R ,3 S )-2-[(1 R )-1-[3,5­-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H -1,2,4-triazol-3-one. Its empirical formula is C 23 H 21 F 7 N 4 O 3 , and its structural formula is: Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43.

It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile. APONVIE (aprepitant) injectable emulsion is a sterile, opaque, off-white to amber liquid in a single-dose vial for intravenous use.

Each vial contains 32 mg aprepitant in 4.4 mL of emulsion. The emulsion also contains the following inactive ingredients: dehydrated alcohol (125 mg), egg lecithin (636 mg), sodium oleate (21 mg), soybean oil (424 mg), sucrose (238 mg), and water for injection (2968 mg). Chemical Structure

💬 Information for Patients 219 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported with aprepitant [see Warnings and Precautions (5.1) ] . Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint. Drug Interactions Advise patients to discuss all medications they are taking, including other prescription, non- prescription medication or herbal products [see Contraindications (4) and Warnings and Precautions (5.2) ] .

Warfarin : Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following administration of APONVIE [see Warnings and Precautions (5.3) ] . Hormonal Contraceptives : Advise patients that administration of APONVIE may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of non-hormonal contraception (such as condoms or spermicides) for 1 month following administration of APONVIE [see Warnings and Precautions (5.4) and Use in Specific Populations (8.3) ] .

Pregnancy Advise pregnant women of the potential risk to a fetus and to avoid use of APONVIE during pregnancy [see Use in Specific Populations (8.1) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 47426-0201-01 · Heron 47426-0501-02 · Heron →
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.