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XENOVIEW xenon Xe 129 hyperpolarized 75 mL/300mL Gas — NDC 80534-0300-01 package photo

XENOVIEW xenon Xe 129 hyperpolarized 75 mL/300mL Gas

by Polarean, Inc. · 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG
NDC 80534-0300-01
🏷️ FDA NDC (as labeled) 80534-0300-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 80534-0300-1
Product NDC 80534-0300
11-digit billing NDC 80534030001
UNII N762921K75, 726Q6M95ZA, 9C7571UDT5, 206GF3GB41
Application # NDA214375
SPL Set ID 70e33fe3-c722-439b-b3db-c2a22f229c8a
Established class (EPC) Hyperpolarized Contrast Agent
Mechanism of action Magnetic Resonance Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-23
Route RESPIRATORY (INHALATION)
Dosage form GAS
Substance XENON XE-129, HYPERPOLARIZED
Why two NDCs? The FDA registers this code as 80534-0300-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80534-0300-01. 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.

🏭 Manufacturer & labeler

LabelerPolarean, Inc.
Application holderPOLAREAN INC
FDA applicationNDA214375 (NDA)
Labeler code80534
First marketedDec 2022
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

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Xenoview 75 mL/300mLthis 80534-0300-01 Polarean, 300 ml — — 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

🏛️
2022
First FDA approval
Dec 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2035
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 Dec 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 23, 2022 RLD RS ⏳ ~9.3 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 10583205 — drug product
US 11052161 — drug product
Exclusivity NCE
2022 2024 2026 2028 2030 2032 2034 2036
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 (2)
PatentTypeUse codeExpires
US 10583205 ↗ Drug product — Feb 20, 2035
US 11052161 ↗ Drug product — Dec 29, 2035
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Dec 23, 2027
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2035 — 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80534-0300-01 You're viewing this 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG 2025-05-30 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 80534-0300-1, 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: 80534-0300-01, written without dashes as 80534030001. 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 80534-0300-01, the first segment (80534) is the labeler code FDA assigned to Polarean, Inc.; the middle segment (0300) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Polarean, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Polarean, 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.
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 107 words ▾

1 INDICATIONS AND USAGE XENOVIEW ® , prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older.

Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended target dose of XENOVIEW for adult and pediatric patients aged 6 years and older is 75 mL to 100 mL Dose Equivalent (DE) volume of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one XENOVIEW Dose Delivery Bag. ( 2.1 ) Choose an appropriate size of the Dose Delivery Bag based on patient’s Total Lung Capacity (TLC) or Forced Vital Capacity (FVC). ( 2.1 ) Administer dose within 5 minutes of DE measurement.

( 2.2 ) Initiate imaging immediately after inhalation. ( 2.2 ) See Full Prescribing Information for detailed information regarding preparation, administration, image acquisition, and image interpretation. ( 2.2 , 2.3 )

2.1Recommended Dosage The recommended target dose of XENOVIEW for adults and pediatric patients aged 6 years and older is 75 mL to 100 mL Dose Equivalent (DE) volume of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one XENOVIEW Dose Delivery Bag. Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added to reach a total volume of the Dose Delivery Bag.

Select the Dose Delivery Bag based on the patient’s Total Lung Capacity (TLC) according to Table 1. If TLC is not available at the time of the procedure, select the Dose Delivery Bag based on patient’s Forced Vital Capacity (FVC). If neither TLC nor FVC values are available in the patient’s medical records, select the Dose Delivery Bag based on estimates of the patient’s TLC using American Thoracic Society (ATS)-endorsed plethysmography-based predictive equations based on sex and height.

Table 1. Recommended Dose Delivery Bag Volume Based on TLC TLC (L) FVC † (L) Dose Delivery Bag (mL) <2.0 <1.5 300 2.0 to <3.3 1.5 to <2.5 500 3.3 to <5.0 2.5 to <3.8 750 ≥5.0 ≥3.8 1,000 † FVC is used when TLC is not available. The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 mL to 100 mL.

DE of greater than 100 mL is acceptable. DE is the volume (mL) of 100% isotopically enriched, 100% hyperpolarized, xenon Xe 129 that would produce the equivalent net magnetization as the Xe 129 dose. The HPX Polarization Measurement Station measures DE.

DE is defined by the following formula: DE = (total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization) where the total volume of xenon gas is 250 mL to 750 mL, the fraction of xenon Xe 129 isotopic enrichment is > 80% and the mean fraction of hyperpolarization is no less than 38% to 54% at the completion of polarization of 250 mL of xenon gas. For example, if 300 mL of total xenon gas with 83% enrichment of xenon Xe 129 is dispensed from the HPX Hyperpolarizer at 40% hyperpolarization: DE = 300 mL × 0.83 × 0.40 = 99.6 mL

2.2Preparation, Administration, and Image Acquisition Preparation Choose an appropriate Dose Delivery Bag according to Table 1 [see Dosage and Administration ( 2.1 )] . Prepare hyperpolarized xenon Xe 129 in the HPX Hyperpolarizer from the Xenon Xe 129 Gas Blend and add Nitrogen, NF (99.999% purity) as necessary to fill the remaining volume in the XENOVIEW Dose Delivery Bag, according to the HPX Hyperpolarization System Operator’s Manual. Measure the volume and DE in the XENOVIEW Dose Delivery Bag using the HPX Polarization Measurement Station no more than 5 minutes prior to administration.

The DE measurement should be at least 75 mL. Do not use and discard the dose of XENOVIEW ® if the volume is determined to be outside of the acceptable range or the DE is less than 75 mL. Administer dose within 5 minutes of DE measurement.

Do not use and discard the dose of XENOVIEW 60 minutes after filling of Dose Delivery Bag. Administration Administer XENOVIEW according to the directions provided in the HPX Hyperpolarization System Operator’s Manual, Administering XENOVIEW. Fit the patient with a…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS XENOVIEW, prepared from the Xenon Xe 129 Gas Blend by the HPX Hyperpolarizer, is a clear, colorless, odorless gas contained in a 300 mL, 500 mL, 750 mL or 1,000 mL XENOVIEW Dose Delivery Bag. Each bag contains at least 75 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon and a total volume administered of 300 mL, 500 mL, 750 mL, or 1,000 mL. The strength is DE per volume administered (see Table 2).

The minimum DE for a dose of XENOVIEW ® is 75 mL with a recommended DE target range of 75 mL to 100 mL. DE of greater than 100 mL is acceptable. Table 2.

Minimum Dosage Strength for Each Dose Delivery Bag Dose Delivery Bag (mL) Minimum Dose Equivalent (mL) Total Volume Administered (mL) Minimum Dosage Strength * 300 75 300 75 mL DE per 300 mL total volume 500 75 500 75 mL DE per 500 mL total volume 750 75 750 75 mL DE per 750 mL total volume 1,000 75 1,000 75 mL DE per 1,000 mL total volume * Minimum Dosage Strength = mL Minimum Dose Equivalent per mL Total Volume Administered XENOVIEW is a clear, colorless, odorless gas contained in a XENOVIEW Dose Delivery Bag. The bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon.

The bag total volume administered is 300 mL, 500 mL, 750 mL, or 1,000 mL. The dosage strength is DE per volume administered. The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 mL to 100 mL.

DE of greater than 100 mL is acceptable. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 194 words ▾

5 WARNINGS AND PRECAUTIONS Risk of Decreased Image Quality from Supplemental Oxygen : Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. ( 5.1 ) Risk of Transient Hypoxia : Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients.

Monitor all patients for oxygen saturation and symptoms of hypoxemia, and treat as clinically indicated. ( 5.2 )

5.1Risk of Decreased Image Quality from Supplemental Oxygen Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality due to depolarization of XENOVIEW. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold [see Dosage and Administration ( 2.2 )] .

5.2Risk of Transient Hypoxia Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients [see Adverse Reactions ( 6.1 )] . Monitor all patients for oxygen desaturation and symptoms of hypoxemia, and treat as clinically indicated.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The adverse reactions (> one patient) in efficacy trials in adults were oropharyngeal pain, headache, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Polarean, Inc. at 1‑844-936-6843 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. Adverse Reactions in Adult Patients The safety of XENOVIEW was evaluated in two prospective efficacy trials that enrolled a total of 83 adult patients with various lung disorders who were being evaluated for possible lung surgery [see Clinical Studies ( 14 ) ] .

Mean age of these patients was 62 years, 88% were White and 69% were male. In these two trials, mean xenon gas volume per XENOVIEW dose was 330.2 mL and 81 of 83 patients (98%) received a single administration of XENOVIEW. For safety assessment, the volume of administered xenon gas in the XENOVIEW dose is noted rather than the DE, because isotopic enrichment and hyperpolarization are not known to affect the safety profile of xenon gas.

Adverse reactions were reported in 12 (14%) of the 83 patients. Adverse reactions reported by more than one patient were oropharyngeal pain (n = 4 patients), headache (n = 2 patients), and dizziness (n = 2 patients). A hypersensitivity reaction that included transient pruritus and erythema occurred in one patient with a history of allergic reactions to several drugs, foods, and other substances.

In pooled data of 123 adult patients from published studies, most of whom had lung disorders such as COPD, idiopathic pulmonary fibrosis, and asthma, who received 1 dose to 2 doses of hyperpolarized xenon Xe 129 with xenon volumes of approximately 500 mL to 1,000 mL of xenon gas per dose, the following transient adverse reactions were reported: numbness, tingling, euphoria, and dizziness. Overall frequency of these adverse reactions could not be determined from the published information. Adverse Reactions in Pediatric Patients In pooled data of 120 pediatric patients aged 6 to 18 years from published studies, most of whom had either asthma or cystic fibrosis, who received 1 dose to 2 doses of hyperpolarized xenon Xe 129 with xenon volumes based on predicted TLC, the following transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria.

Overall frequency of these adverse reactions could not be determined from the published information. In one of the published studies of 23 pediatric patients aged 6 to 18 years, 11 of whom had cystic fibrosis and 12 of whom were healthy, the mean difference of SpO 2 % from baseline was -6% following hyperpolarized xenon Xe 129 administration with xenon volumes based on predicted total lung capacity. In the same study, the mean change in heart rate from baseline was +6.6 beats per minute following hyperpolarized xenon Xe 129 administration.

Both reported oxygen desaturation and heart rate elevation resolved by 2 minutes post-dose without intervention.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature.

Animal reproduction studies were conducted in rats by administering an 80% Xe/20% O 2 gas mixture for 2 hours twice a week for 2 and 10 weeks, with no observed effects on fertility or pregnancy. Gas mixtures containing 70% to 75% Xe gas and 25% to 30% O 2 gas were found to be non-teratogenic in rats when administered for 24 hours. In a separate study, rats were administered an 80%/20% Xe/O 2 gas mixture for 2 hours twice a week from the first to nineteenth day of pregnancy with no observed effects on embryo-fetal development or signs of teratogenicity.

The 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 risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary XENOVIEW ® is minimally absorbed systemically following the inhalation route of administration, and breastfeeding is not expected to result in exposure of the infant to the drug [see Clinical Pharmacology ( 12.3 )]. There is no information on the presence of hyperpolarized xenon Xe 129 in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XENOVIEW ® and any potential adverse effects on the breastfed child from XENOVIEW or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of XENOVIEW have been established in pediatric patients aged 6 years and older for use with MRI to evaluate lung ventilation. Use of XENOVIEW in this age group is supported by evidence from adequate and well-controlled studies in adults with additional safety data from published studies [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . Safety and effectiveness of XENOVIEW have not been established in pediatric patients less than 6 years of age.

8.5Geriatric Use Of the total number of patients in clinical studies of XENOVIEW, 36 (43%) were 65 years of age and older, while 6 (7%) were 75 years of age and older. No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients although the number of patients in the trials was not large enough to allow definitive comparison.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature.

Animal reproduction studies were conducted in rats by administering an 80% Xe/20% O 2 gas mixture for 2 hours twice a week for 2 and 10 weeks, with no observed effects on fertility or pregnancy. Gas mixtures containing 70% to 75% Xe gas and 25% to 30% O 2 gas were found to be non-teratogenic in rats when administered for 24 hours. In a separate study, rats were administered an 80%/20% Xe/O 2 gas mixture for 2 hours twice a week from the first to nineteenth day of pregnancy with no observed effects on embryo-fetal development or signs of teratogenicity.

The 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 risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 84 words ▾

8.4Pediatric Use The safety and effectiveness of XENOVIEW have been established in pediatric patients aged 6 years and older for use with MRI to evaluate lung ventilation. Use of XENOVIEW in this age group is supported by evidence from adequate and well-controlled studies in adults with additional safety data from published studies [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . Safety and effectiveness of XENOVIEW have not been established in pediatric patients less than 6 years of age.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Of the total number of patients in clinical studies of XENOVIEW, 36 (43%) were 65 years of age and older, while 6 (7%) were 75 years of age and older. No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients although the number of patients in the trials was not large enough to allow definitive comparison.

🧬 Clinical Pharmacology 199 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action When hyperpolarized xenon Xe 129 gas is inhaled, a multi-nuclear capable MRI scanner can be used to image the hyperpolarized xenon Xe 129 distribution throughout the ventilated lung. Hyperpolarized xenon Xe 129 nuclei are directly detected by a Xe 129 MRI coil.

12.2Pharmacodynamics The MRI signal of hyperpolarized xenon Xe 129 is dependent on the volume of the xenon gas inhaled, degree of xenon Xe 129 isotopic enrichment, and degree of hyperpolarization [see Dosage and Administration ( 2.1 )] .

12.3Pharmacokinetics The pharmacokinetics of hyperpolarized xenon Xe 129 are similar to those of non-polarized xenon. Distribution Xenon is a readily diffusible gas. Inhalation of xenon results in dispersion in the ventilated areas of the lung with uptake of a small amount of xenon into the pulmonary vessels followed by distribution to more distal organs.

The solubility of xenon is higher in fatty tissues than in aqueous tissues and body compartments such as plasma. Elimination Following a single breath hold, xenon is eliminated through exhalation with an elimination half-life of 14.5 seconds for a 75% Xe/25% N 2 gas mixture and 14.3 seconds for a 25% Xe/75% N 2 gas mixture.

🧬 Mechanism of Action 46 words ▾

12.1Mechanism of Action When hyperpolarized xenon Xe 129 gas is inhaled, a multi-nuclear capable MRI scanner can be used to image the hyperpolarized xenon Xe 129 distribution throughout the ventilated lung. Hyperpolarized xenon Xe 129 nuclei are directly detected by a Xe 129 MRI coil.

📦 How Supplied / Storage and Handling 217 words ▾

16 HOW SUPPLIED How Supplied XENOVIEW (xenon Xe 129 hyperpolarized) is prepared from the Xenon Xe 129 Gas Blend by the HPX Hyperpolarizer and is contained in a XENOVIEW Dose Delivery Bag as a clear, colorless, odorless gas. XENOVIEW Dose Delivery Bags are available in four different sizes co-packaged with attachable mouthpieces and affixable dose labels: 300 mL bags in a box of 50 (NDC 80534-0300-1) 500 mL bags in a box of 50 (NDC 80534-0500-1) 750 mL bags in a box of 50 (NDC 80534-0750-1) 1,000 mL bags in a box of 50 (NDC 80534-1000-2) Xenon Xe 129 Gas Blend for preparation of XENOVIEW is supplied as a compressed gas under high pressure (2,105 pounds per square inch gauge [psig]) in size 302 aluminum cylinders with a volume of 6,350 liters (NDC 80534-6350-1).

Storage and Handling Store XENOVIEW at 20° to 25°C (68° to 77°F) for no more than 5 minutes after final DE measurement. Do not use and discard XENOVIEW 60 minutes after filling of Dose Delivery Bag. Store Xenon Xe 129 Gas Blend at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F).

Manufactured for: Polarean, Inc. 2500 Meridian Parkway, #175 Durham, NC 27713 Tel: +1-844-936-6843 XENOVIEW ® is a trademark of Polarean, Inc. Doc #: 34660D

📋 Description ~1 min read ▾

11 DESCRIPTION XENOVIEW (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent produced on site by the HPX Hyperpolarization System from the isotopically enriched Xenon Xe 129 Gas Blend. The Gas Blend cylinder distributed by Polarean contains xenon (1% total; > 80% isotopic purity Xe 129), nitrogen, NF (10%), and helium, NF (89%). The active pharmaceutical ingredient in XENOVIEW is hyperpolarized xenon Xe 129.

Hyperpolarized xenon Xe 129 is chemically identical to non-polarized xenon Xe 129. Xenon is a clear, colorless, monoatomic, inert, stable, noble gas. It is naturally abundant in air at a level of 0.087 ppm.

Atmospheric xenon is composed of nine non-radioactive isotopes, of which xenon Xe 129 comprises 26.4%. The atomic weight of xenon Xe 129 is 128.9. XENOVIEW is a clear, colorless, odorless gas for oral inhalation use.

Each XENOVIEW Dose Delivery Bag contains a Dose Equivalent (DE) volume of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added as an inert buffer to ensure the total volume of gas reaches the dose delivery bag volume (300 mL, 500 mL, 750 mL, or 1,000 mL). The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 to 100 mL. DE of greater than 100 mL is acceptable.

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