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Tyvaso DPI treprostinil 80 ug Inhalant — NDC 66302-0780-04 package photo

Tyvaso DPI treprostinil 80 ug Inhalant

by United Therapeutics Corporation · 1 BLISTER PACK in 1 KIT (66302-780-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK
NDC 66302-0780-04
🏷️ FDA NDC (as labeled) 66302-780-04 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 66302-780-04
Product NDC 66302-780
11-digit billing NDC 66302078004
NCPDP billing unit EA — each (per item)
RxCUI 2602751, 2602754, 2602756, 2602758, 2602760, 2602762, 2602764, 2602766,
UNII RUM6K67ESG
Application # NDA214324
SPL Set ID ddc3d400-bcb3-4b09-aae2-0768b10a5b0f
Established class (EPC) Prostacycline Vasodilator
Physiologic effect Vasodilation
Chemical class Prostaglandins I
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-24
Route ORAL
Dosage form INHALANT
Substance TREPROSTINIL
GPI-14 40170080002955
GCN Seq No 088396
GCN 58525
HICL code 036541
Ingredient (HICL) Treprostinil
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B1
Therapeutic class — intermediate (HIC2) Affect Primarily Lungs
HIC3 code B1C
Therapeutic class — specific (HIC3) Pulmonary Antihypertensives, Prostacyclin-Type
AHFS code 24:12.92.00
AHFS class Vasodilating Agents, Miscellaneous
FDB label name TYVASO DPI 80 MCG CARTRIDGE
FDB brand name Tyvaso Dpi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 66302-780-04 — 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 → 66302-0780-04. 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 Prostacycline Vasodilator class.

Pharmacologic class Prostacycline Vasodilator
Drug family (ATC) Platelet aggregation inhibitors excl. heparin
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

LabelerUnited Therapeutics Corporation
Application holderUNITED THERAPEUTICS CORP
FDA applicationNDA214324 (NDA)
Labeler code66302
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio35 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 TYVASO DPI 80 MCG CARTRIDGE Ingredient Treprostinil
📖 What it is MedlinePlus · NLM

Treprostinil oral inhalation is used to treat certain kinds of pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Treprostinil oral inhalation is also used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; high blood pressure in the lungs resulting from a lung disease that involves inflammation and scarring of the lungs). Treprostinil may improve the ability to exercise and slow the worsening of symptoms in patients with PAH and PH-ILD. Treprostinil is in...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Treprostinil mimics a natural substance your body makes to keep blood vessel walls relaxed. In pulmonary arterial hypertension (PAH) — and in some lung-disease-related forms of hig...
  • What exactly is treprostinil and why did my doctor prescribe it?
  • The inhaled products are all used multiple times per day, spaced out across your waking hours. Tyvaso and Tyvaso DPI are typically used 4 times a day, roughly 4 hours apart. Yutrep...
  • I'm on the inhaled version — how often do I need to use it each day?
📖 Read our full Treprostinil guide →
1
Nutrient depletion considerations

Treprostinil (Inh) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Treprostinil (Inh) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

  • UNII XB09609XSL
    A synthetic compound used as a glidant and anti-caking agent. It reduces friction between particles and prevents clumping in powdered formulations, helping the medicine flow smoothly during manufacturing and packaging.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $100.95 $1,615.24 / 16 inhalants
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
Tyvaso DPI 80 ug 66302-0680-03 United 1 kit — — FDA listed —
Tyvaso DPI 80 ugthis 66302-0780-04 United 1 kit — — 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
May 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 23, 2022 RLD RS ⏳ ~15.4 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 11357782 — method of use (U-1849)
US 11357782 — method of use (U-1849)
US 11357782 — method of use (U-1849)
US 11357782 — method of use (U-1849)
US 11357782 — method of use (U-1849)
US 11826327 — method of use (U-3749)
US 11826327 — method of use (U-3749)
US 11826327 — method of use (U-3749)
US 11826327 — method of use (U-3749)
US 11826327 — method of use (U-3749)
US 9593066 — drug substance
US 10421729 — drug product
US 10421729 — drug product
US 11723887 — drug substance
US 10421729 — drug product
US 9593066 — drug substance
US 9593066 — drug substance
US 11723887 — drug substance
US 11723887 — drug substance
US 11723887 — drug substance
US 10772883 — drug product
US 10772883 — drug product
US 10772883 — drug product
US 9593066 — drug substance
US 10772883 — drug product
US 10421729 — drug product
US 10421729 — drug product
US 10772883 — drug product
US 9593066 — drug substance
US 11723887 — drug substance
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042
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 (30)
PatentTypeUse codeExpires
US 11357782 ↗ Method of use U-1849 May 14, 2027
US 11357782 ↗ Method of use U-1849 May 14, 2027
US 11357782 ↗ Method of use U-1849 May 14, 2027
US 11357782 ↗ Method of use U-1849 May 14, 2027
US 11357782 ↗ Method of use U-1849 May 14, 2027
US 11826327 ↗ Method of use U-3749 Feb 3, 2042
US 11826327 ↗ Method of use U-3749 Feb 3, 2042
US 11826327 ↗ Method of use U-3749 Feb 3, 2042
US 11826327 ↗ Method of use U-3749 Feb 3, 2042
US 11826327 ↗ Method of use U-3749 Feb 3, 2042
US 9593066 ↗ Drug substance — Dec 15, 2028
US 10421729 ↗ Drug product — Apr 1, 2035
US 10421729 ↗ Drug product — Apr 1, 2035
US 11723887 ↗ Drug substance — Dec 15, 2028
US 10421729 ↗ Drug product — Apr 1, 2035
US 9593066 ↗ Drug substance — Dec 15, 2028
US 9593066 ↗ Drug substance — Dec 15, 2028
US 11723887 ↗ Drug substance — Dec 15, 2028
US 11723887 ↗ Drug substance — Dec 15, 2028
US 11723887 ↗ Drug substance — Dec 15, 2028
US 10772883 ↗ Drug product — Jun 11, 2030
US 10772883 ↗ Drug product — Jun 11, 2030
US 10772883 ↗ Drug product — Jun 11, 2030
US 9593066 ↗ Drug substance — Dec 15, 2028
US 10772883 ↗ Drug product — Jun 11, 2030
US 10421729 ↗ Drug product — Apr 1, 2035
US 10421729 ↗ Drug product — Apr 1, 2035
US 10772883 ↗ Drug product — Jun 11, 2030
US 9593066 ↗ Drug substance — Dec 15, 2028
US 11723887 ↗ Drug substance — Dec 15, 2028
Common questions
Is there a generic version of TYVASO DPI 80 MCG CARTRIDGE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TYVASO DPI 80 MCG CARTRIDGE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2042 — 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.

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

Medicare Part D (outpatient prescription) spending for Tyvaso Dpi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tyvaso Dpi. 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
$261.84M
Claims incl. refills
9.6K
Beneficiaries
3.5K
Spend / beneficiary
$75,457.66
Spend / claim
$27,161.63
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 Tyvaso DPI (this brand).

Top reported reactions

Cough3,559
Dyspnoea3,350
Headache2,887
Diarrhoea2,275
Nausea1,779
Dizziness1,776
Fatigue1,770

Reporter sex

16,110 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,081 456
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
66302-0780-04 You're viewing this 1 BLISTER PACK in 1 KIT (66302-780-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK 2024-10-24 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — 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 66302-780-04, 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: 66302-0780-04, written without dashes as 66302078004. 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 66302-0780-04, the first segment (66302) is the labeler code FDA assigned to United Therapeutics Corporation; the middle segment (0780) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 United Therapeutics Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
United Therapeutics Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Tyvaso DPI is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). ( 1.1 ) Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). ( 1.2 )

1.1Pulmonary Arterial Hypertension Tyvaso DPI is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with Tyvaso was limited to 12 weeks in duration [see Clinical Studies (14) ] .

1.2Pulmonary Hypertension Associated with ILD Tyvaso DPI is indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%) [see Clinical Studies (14.3) ] .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Use only with the Tyvaso DPI Inhaler. ( 2.1 ) Administer using a single inhalation per cartridge. ( 2.1 ) Administer in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours.

( 2.1 ) Initial dosage: one 16 mcg cartridge per treatment session. ( 2.2 ) Dosage should be increased by an additional 16 mcg per treatment session at approximately 1- to 2-week intervals, if tolerated. ( 2.2 ) Titrate to target maintenance doses of 48 mcg to 64 mcg per treatment session, 4 times daily.

( 2.2 )

2.1Administration Use Tyvaso DPI only with the Tyvaso DPI Inhaler. Tyvaso DPI is administered using a single inhalation per cartridge. Administer Tyvaso DPI in 4 separate, equally spaced treatment sessions per day, during waking hours.

The treatment sessions should be approximately 4 hours apart. If the prescribed dose is higher than 80 mcg per treatment session, more than 1 cartridge will be needed per session. Patients should follow the instructions for use for operation and care of the Tyvaso DPI Inhaler.

Do not use the Tyvaso DPI Inhaler with other medications. Between each of the 4 daily treatment sessions, store the Tyvaso DPI Inhaler with the mouthpiece attached and empty. Wipe the outside of the inhaler with a clean, dry cloth only, if needed.

Do not rinse or wash the Tyvaso DPI Inhaler; always keep the inhaler dry. After 7 days of use, throw away the used Tyvaso DPI Inhaler into regular household trash.

2.2Usual Dosage in Adults Initial Dosage: Tyvaso DPI therapy should begin with one 16 mcg cartridge per treatment session, 4 times daily. Maintenance Dosage: Increase dosage by an additional 16 mcg per treatment session at approximately 1- to 2-week intervals. The target maintenance dosage is usually 48 mcg to 64 mcg per session.

If adverse effects preclude titration, continue Tyvaso DPI at the highest tolerated dose. If a scheduled treatment session is missed, resume therapy as soon as possible at the usual dose. Dosage for Transition from Tyvaso ® (treprostinil) Inhalation Solution: The following regimens of Tyvaso DPI and Tyvaso give similar exposure: Tyvaso DPI Cartridge Strength Tyvaso Number of Breaths 16 mcg ≤5 (≤30 mcg) 32 mcg 6 to 7 (36 to 42 mcg) 48 mcg 8 to 10 (48 to 60 mcg) 64 mcg 11 to 13 (66 to 78 mcg) 80 mcg 14 to 15 (84 to 90 mcg)

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation powder: Single-dose plastic cartridges containing 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil as a dry powder formulation. Inhalation powder: Single-dose plastic cartridges containing 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil as a dry powder formulation. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Tyvaso DPI may cause symptomatic hypotension. ( 5.1 ) Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) Tyvaso DPI dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.3 ) May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 )

5.1Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Tyvaso DPI may produce symptomatic hypotension.

5.2Risk of Bleeding Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding.

5.3Effect of Other Drugs on Treprostinil Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] .

5.4Bronchospasm Like other inhaled prostaglandins, Tyvaso DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with Tyvaso DPI.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions (5): - Decrease in systemic blood pressure [see Warnings and Precautions (5.1) ] . - Bleeding [see Warnings and Precautions (5.2) ] . Most common adverse reactions (≥4%) are cough, headache, throat irritation/pharyngolaryngeal pain, nausea, flushing, dyspnea, and syncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 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. Pulmonary Arterial Hypertension Tyvaso DPI In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of Tyvaso Inhalation Solution who switched to a corresponding dose of Tyvaso DPI, the most commonly reported adverse events on Tyvaso DPI during the 3-week treatment phase included cough, headache, dyspnea, and nausea.

Patient tolerability, as assessed by incidence of new adverse events following transition to Tyvaso DPI, was consistent with the expected known safety profile of Tyvaso Inhalation Solution. Table 1 lists the adverse events that occurred at a rate of at least 4%. Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso DPI in BREEZE (Treatment Phase) Adverse Event Tyvaso DPI (n=51) n (%) Cough 18 (35.3) Headache 8 (15.7) Dyspnea 4 (7.8) Nausea 3 (5.9) The safety of Tyvaso DPI was also studied in an extension phase of the study in which 49 patients were dosed for a duration of 43 patient-years.

Fifty-nine percent (59%) of patients achieved a dose of 64 mcg, 4 times daily or higher. The adverse events during this long-term, extension phase were similar to those observed in the 3-week treatment phase. Tyvaso Inhalation Solution In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most commonly reported adverse reactions on Tyvaso Inhalation Solution included cough and throat irritation, headache, gastrointestinal effects, muscle, jaw or bone pain, dizziness, flushing, and syncope.

Table 2 lists the adverse reactions that occurred at a rate of at least 4% and were more frequent in patients treated with Tyvaso Inhalation Solution than with placebo. Table 2: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso Inhalation Solution and More Frequent More than 3% greater than placebo than Placebo in TRIUMPH I Adverse Event Treatment n (%) Tyvaso Inhalation Solution n=115 Placebo n=120 Cough 62 (54) 35 (29) Headache 47 (41) 27 (23) Throat Irritation / Pharyngolaryngeal Pain 29 (25) 17 (14) Nausea 22 (19) 13 (11) Flushing 17 (15) 1 (<1) Syncope 7 (6) 1 (<1) Pulmonary Hypertension Associated with ILD In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions on Tyvaso Inhalation Solution were similar to the experience in studies of PAH.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Bosentan In a human pharmacokinetic study conducted with bosentan (250 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and bosentan were observed.

7.2Sildenafil In a human pharmacokinetic study conducted with sildenafil (60 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and sildenafil were observed.

7.3Effect of Cytochrome P450 Inhibitors and Inducers In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A. Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both C max and AUC) to treprostinil.

Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see Warnings and Precautions (5.3) ] .

7.4Effect of Other Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. These studies did not show a clinically significant effect on the pharmacokinetics of treprostinil. Treprostinil does not affect the pharmacokinetics or pharmacodynamics of warfarin.

The pharmacokinetics of R- and S- warfarin and the international normalized ratio (INR) in healthy subjects given a single 25 mg dose of warfarin were unaffected by continuous subcutaneous infusion of treprostinil at an infusion rate of 10 ng/kg/min.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations ) . In animal studies, no adverse reproductive and developmental effects were seen for treprostinil at ≥8 and ≥134 times the human exposure when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder.

The estimated 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 Disease-associated maternal and embryo-fetal risk Pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. Data Animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. In studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats.

In pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 129 and 1366 times the human exposure, when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder. In pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. The dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 8 and 134 times the human exposure, when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder.

No treprostinil treatment-related effects on labor and delivery were seen in animal studies. Animal reproduction studies are not always predictive of human response.

8.2Lactation Risk Summary There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Clinical studies of inhaled treprostinil did not include patients younger than 18 years to determine whether they respond differently from older patients.

8.5Geriatric Use Across clinical studies used to establish the effectiveness of Tyvaso Inhalation Solution in patients with PAH and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

8.6Patients with Hepatic Insufficiency Plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects with mild-to-moderate hepatic insufficiency. Uptitrate slowly when treating patients with hepatic insufficiency because of the risk of an increase in systemic exposure which may lead to an increase in dose-dependent adverse effects. Treprostinil has not been studied in patients with severe hepatic insufficiency [see Clinical Pharmacology (12.3) ] .

8.7Patients with Renal Impairment No dose adjustments are required in patients with renal impairment. Treprostinil is not cleared by dialysis [see Clinical Pharmacology (12.3) ] .

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations ) . In animal studies, no adverse reproductive and developmental effects were seen for treprostinil at ≥8 and ≥134 times the human exposure when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder.

The estimated 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 Disease-associated maternal and embryo-fetal risk Pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. Data Animal reproduction studies have been conducted with treprostinil via continuous subcutaneous administration and with treprostinil diolamine administered orally. In studies with orally administered treprostinil diolamine, no adverse effect doses for fetal viability/growth, fetal development (teratogenicity), and postnatal development were determined in rats.

In pregnant rats, no evidence of harm to the fetus was observed following oral administration of treprostinil diolamine at the highest dose tested (20 mg/kg/day), which represents about 129 and 1366 times the human exposure, when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder. In pregnant rabbits, external fetal and soft tissue malformations and fetal skeletal malformation occurred. The dose at which no adverse effects were seen (0.5 mg/kg/day) represents about 8 and 134 times the human exposure, when based on C max and AUC, respectively, following a single, inhaled 64 mcg dose of treprostinil inhalation powder.

No treprostinil treatment-related effects on labor and delivery were seen in animal studies. Animal reproduction studies are not always predictive of human response.

🧒 Pediatric Use 35 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Clinical studies of inhaled treprostinil did not include patients younger than 18 years to determine whether they respond differently from older patients.

🧓 Geriatric Use 75 words ▾

8.5Geriatric Use Across clinical studies used to establish the effectiveness of Tyvaso Inhalation Solution in patients with PAH and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

🆘 Overdosage 29 words ▾

10 OVERDOSAGE In general, symptoms of overdose with inhaled treprostinil include flushing, headache, hypotension, nausea, vomiting, and diarrhea. Provide general supportive care until the symptoms of overdose have resolved.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.

12.2Pharmacodynamics In a clinical trial of 240 healthy volunteers, single doses of Tyvaso Inhalation Solution 54 mcg (the target maintenance dose per session) and 84 mcg (supratherapeutic inhalation dose) prolonged the corrected QTc interval by approximately 10 ms. The QTc effect dissipated as the concentration of treprostinil decreased.

12.3Pharmacokinetics Absorption Treprostinil plasma exposure data were obtained from a 6-treatment, 6-period, 6-sequence, crossover study of Tyvaso DPI and Tyvaso Inhalation Solution in healthy volunteers. The mean C max for the 16, 48, and 64 mcg doses of Tyvaso DPI were 0.39, 1.11, and 1.33 ng/mL, respectively, with corresponding median T max of 0.17 hr. The mean AUC 0-5hr for the 16, 48, and 64 mcg doses of Tyvaso DPI were 0.275, 0.774, and 0.964 hr∙ng/mL, respectively.

Treprostinil systemic exposure (AUC 0-5hr and C max ) of Tyvaso DPI post-inhalation was approximately proportional to the doses administered (16 to 64 mcg). Distribution Following parenteral infusion, the steady state volume of distribution (V ss ) of treprostinil is approximately 14 L/70 kg ideal body weight. In vitro treprostinil is 91% bound to human plasma proteins over the 330 to 10,000 mcg/L concentration range.

Elimination With a single dose of Tyvaso DPI, the mean terminal half-life of treprostinil ranged from 27 to 50 minutes. Metabolism : Treprostinil is substantially metabolized by the liver, primarily by CYP2C8. Metabolites are excreted in urine (79%) and feces (13%) over 10 days.

Five apparently inactive metabolites were detected in the urine, each accounting for 10 to 15% of the dose administered. Four of the metabolites are products of oxidation of the 3-hydroxyloctyl side chain and one is a glucuroconjugated derivative (treprostinil glucuronide). Excretion : Of subcutaneously administered treprostinil, only 4% is excreted unchanged in urine.

Specific Populations Hepatic Insufficiency Plasma clearance of treprostinil, delivered subcutaneously, was reduced up to 80% in subjects presenting with mild-to-moderate hepatic insufficiency. Treprostinil has not been studied in patients with severe hepatic insufficiency [see Use in Specific Populations (8.6) ] . Renal Impairment In patients with severe renal impairment requiring dialysis (n=8), administration of a single 1 mg dose of orally administered treprostinil pre- and post-dialysis resulted in AUC 0-inf that was not significantly altered compared to healthy subjects [see Use in Specific Populations (8.7) ] .

🧬 Mechanism of Action 30 words ▾

12.1Mechanism of Action Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tyvaso DPI (treprostinil) inhalation powder is available as 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil in single-dose plastic cartridges with approximate fill weights of 1.6 mg, 3.2 mg, 4.8 mg, 6.4 mg, or 8.0 mg of Tyvaso DPI, respectively. Four cartridges are contained in a single cavity of a blister strip. A card contains 7 blister strips separated by perforations for a total of 28 cartridges of each labeled strength in Titration and Maintenance Kits.

For convenience, the perforation allows users to remove a single blister strip containing 4 cartridges. The Institutional Kits contain 4 blister strips for a total of 16 cartridges of each labeled strength. The cartridges are color-coded, purple for 16 mcg, dark blue for 32 mcg, light blue for 48 mcg, light green for 64 mcg, and orange for 80 mcg.

Each cartridge is marked with "Tyvaso DPI" and the corresponding dosage strength of "16 mcg", "32 mcg", "48 mcg", "64 mcg", or "80 mcg". The Tyvaso DPI Inhaler is individually packaged in a clear overwrap. The inhaler is fully assembled with a removable mouthpiece cover.

The Tyvaso DPI Inhaler can be used for up to 7 days from the date of first use. After 7 days of use, the inhaler must be discarded and replaced with a new inhaler. Tyvaso DPI is available in the following configurations: Kit Contents Description NDC Number of Cartridges and Strength Number of Inhalers Tyvaso DPI (treprostinil) Inhalation Powder Titration Kit 66302-600-02 112 cartridges, each containing 16 mcg per cartridge 5 84 cartridges, each containing 32 mcg per cartridge 66302-610-02 112 cartridges, each containing 16 mcg per cartridge 5 112 cartridges, each containing 32 mcg per cartridge 28 cartridges, each containing 48 mcg per cartridge Tyvaso DPI (treprostinil) Inhalation Powder Maintenance Kit 66302-616-03 112 cartridges, each containing 16 mcg per cartridge 5 66302-632-03 112 cartridges, each containing 32 mcg per cartridge 5 66302-648-03 112 cartridges, each containing 48 mcg per cartridge 5 66302-664-03 112 cartridges, each containing 64 mcg per cartridge 5 66302-680-03 112 cartridges, each containing 80 mcg per cartridge 5 66302-620-03 112 cartridges, each containing 32 mcg per cartridge 5 112 cartridges, each containing 48 mcg per cartridge 66302-630-03 112 cartridges, each containing 32 mcg per cartridge 5 112 cartridges, each containing 64 mcg per cartridge 66302-640-03 112 cartridges, each containing 48 mcg per cartridge 5 112 cartridges, each containing 64 mcg per cartridge 66302-650-03 112 cartridges, each containing 16 mcg per cartridge 5 112 cartridges, each containing 48 mcg per cartridge 112 cartridges, each containing 64 mcg per cartridge 66302-660-03 112 cartridges, each containing 48 mcg per cartridge 5 112 cartridges, each containing 80 mcg per cartridge 66302-670-03 112 cartridges, each containing 64 mcg per cartridge 5 112 cartridges, each containing 80 mcg per cartridge Tyvaso DPI (treprostinil) Inhalation Powder Institutional Kit 66302-716-04 16 cartridges, each containing 16 mcg per cartridge 2 66302-732-04 16 cartridges, each containing 32 mcg per cartridge 2 66302-748-04 16 cartridges, each containing 48 mcg per cartridge 2 66302-764-04 16 cartridges, each containing 64 mcg per cartridge 2 66302-780-04 16 cartridges, each containing 80 mcg per cartridge 2 66302-720-04 16 cartridges, each containing 32 mcg per cartridge 2 16 cartridges, each containing 48 mcg per cartridge Blister Storage: Storage Tyvaso DPI Presentation Refrigerated storage 2°C to 8°C (36°F to 46°F) Room temperature storage 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) Sealed (Unopened) Blister Cards or Strips May be stored until the expiration date printed on the blisters.

Must be used within 8 weeks. Opened Blister Strips Do not put a blister card or strip back into the refrigerator after being opened or stored at room temperature. Must be used within 3 days.

Inhaler Storage: Store…

📦 Storage and Handling 162 words ▾

Blister Storage: Storage Tyvaso DPI Presentation Refrigerated storage 2°C to 8°C (36°F to 46°F) Room temperature storage 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) Sealed (Unopened) Blister Cards or Strips May be stored until the expiration date printed on the blisters. Must be used within 8 weeks. Opened Blister Strips Do not put a blister card or strip back into the refrigerator after being opened or stored at room temperature.

Must be used within 3 days.

Inhaler Storage: Store at 2°C to 25°C (36°F to 77°F); excursions permitted. The Tyvaso DPI Inhaler may be stored refrigerated but should be at room temperature for 10 minutes before use. The inhaler can be used for up to 7 days from the date of first use. After 7 days of use, the inhaler must be discarded and replaced with a new inhaler.

Handling: If refrigerated, cartridges and inhaler should be at room temperature for 10 minutes before use.

📋 Description 131 words ▾

11 DESCRIPTION

11.1Tyvaso DPI Cartridges Tyvaso DPI consists of single-dose plastic cartridges filled with a white powder containing 1% of treprostinil, a prostacyclin mimetic, which is intended for administration by oral inhalation using the Tyvaso DPI Inhaler only. Treprostinil is adsorbed onto carrier particles consisting of fumaryl diketopiperazine (FDKP). Each cartridge contains 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil with approximate fill weights of 1.6 mg, 3.2 mg, 4.8 mg, 6.4 mg, or 8.0 mg of Tyvaso DPI, respectively.

Treprostinil is (1 R ,2 R ,3a S ,9a S )-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3 S )-3-hydroxyoctyl]-1 H -benz[ f ]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C 23 H 34 O 5 . The structural formula of treprostinil is: Chemical Structure

💬 Information for Patients 115 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Train patients in the administration process for Tyvaso DPI, including dosing, Tyvaso DPI Inhaler setup, operation, cleaning, and maintenance, according to the instructions for use [see Dosage and Administration (2.1 , 2.2) ] . Advise patients that after 7 days of use, the inhaler must be discarded and replaced with a new inhaler [see Dosage and Administration (2.1) ] .

Instruct patients to use Tyvaso DPI only with the Tyvaso DPI Inhaler [see Dosage and Administration (2.1) ] . If a scheduled treatment session is missed, resume therapy as soon as possible [see Dosage and Administration (2.2) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.