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LASIX ONYU furosemide 30 mg/mL Injection, 1 kit — NDC 81137-0001-15 package photo

LASIX ONYU furosemide 30 mg/mL Injection, 1 kit

by SQ Innovation, Inc. · 1 CARTON in 1 KIT (81137-001-15) / 1 CARTRIDGE in 1 CARTON / 2.67 mL in 1 CARTRIDGE
NDC 81137-0001-15
🏷️ FDA NDC (as labeled) 81137-001-15 billing pads the product segment with a zero
This package
Contains1 kit Pack sizes2 compare ↓
Also comes in: 2.67 mL 81137-0001-35
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Furosemide (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. (Leading Pharma, LLC) · FDA recall D-0486-2026
Class II · Jan 10, 2026 — Presence of Foreign Substance (Graviti Pharmaceuticals Private Limited) · FDA recall D-0293-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81137-001-15
Product NDC 81137-001
11-digit billing NDC 81137000115
NCPDP billing unit EA — each (per item)
RxCUI 2725542, 2725546
UNII 7LXU5N7ZO5
Application # NDA217294
SPL Set ID cb27654f-c7a1-4796-ab08-60a5fa16f5c0
Established class (EPC) Loop Diuretic
Physiologic effect Increased Diuresis at Loop of Henle
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-01
Route SUBCUTANEOUS
Dosage form INJECTION
Substance FUROSEMIDE
GPI-14 3720003000F715
GCN Seq No 088337
GCN 58457
HICL code 003660
Ingredient (HICL) Furosemide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1M
Therapeutic class — specific (HIC3) Loop Diuretics
AHFS code 24:36.08.00
AHFS class Loop Diuretics (24:36)
FDB label name LASIX ONYU 80 MG/2.67 ML KIT
FDB brand name Lasix Onyu
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 81137-001-15 — 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 → 81137-0001-15. 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 Loop Diuretic class.

Pharmacologic class Loop Diuretic
Drug family (ATC) Sulfonamides, plain
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

LabelerSQ Innovation, Inc.
Application holderSQ INNOVATION INC
FDA applicationNDA217294 (NDA)
Labeler code81137
First marketedDec 2025
Product typeHuman Prescription Drug
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 LASIX ONYU 80 MG/2.67 ML KIT Ingredient Furosemide
📖 What it is MedlinePlus · NLM

Furosemide is used alone or with other medications to treat high blood pressure. Furosemide is used to treat edema excess fluid held in body tissues caused by various medical problems. Furosemide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body. High blood pressure is a common condition. When not treated, it can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. This damage may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vi...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Injectable furosemide is used when you need faster action than a pill can provide, or when you can't take oral medication — for example, in an emergency like acute pulmonary edema...
  • Why am I getting this as an injection instead of a pill?
  • The biggest things to watch for are signs of dehydration — feeling very dizzy, lightheaded, or faint, especially when you stand up — and muscle cramps or weakness, which can signal...
  • What should I watch out for while using furosemide injection?
📖 Read our full Furosemide Injection guide →
9
Nutrient depletion considerations

Furosemide may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Furosemide 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.

  • 300 mg / 1 mL UNII 2PP9364507
    A modified form of beta-cyclodextrin, a natural sugar-like molecule. It helps dissolve and stabilize drugs in liquid medicines and improves how well the body absorbs certain medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 3 mg / 1 mL UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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.
Try another pack size: 2.67 mL
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
Lasix Onyu 30 mg/mLthis 81137-0001-15 SQ 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

🏛️
2025
First FDA approval
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 Jan 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 7, 2025 RLD RS ⏳ ~15.3 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 12403120 — method of use (U-4576)
US 11246851 — method of use (U-4576)
US 12318363 — drug product
2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (3)
PatentTypeUse codeExpires
US 12403120 ↗ Method of use U-4576 Jan 10, 2042
US 11246851 ↗ Method of use U-4576 Jan 3, 2040
US 12318363 ↗ Drug product — Jan 3, 2040
Common questions
Is there a generic version of LASIX ONYU 80 MG/2.67 ML KIT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LASIX ONYU 80 MG/2.67 ML KIT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 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 Furosemide (matched by generic name) — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Furosemide. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$31.03M
Claims incl. refills
5.6M
Beneficiaries
3.6M
Spend / beneficiary
$8.60
Spend / claim
$5.52
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 LASIX ONYU (this brand).

Top reported reactions

Dyspnoea18,116
Acute Kidney Injury16,205
Fatigue13,009
Diarrhoea12,937
Death12,181
Nausea11,332
Fall10,821

Age at onset

Neonate440
Infant337
Child410
Adolescent290
Adult14,387
Elderly28,826

Reporter sex

0 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization127,975
Death40,335
Life-threatening18,483
Disabling6,880
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 23,004 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81137-0001-15 You're viewing this 1 CARTON in 1 KIT (81137-001-15) / 1 CARTRIDGE in 1 CARTON / 2.67 mL in 1 CARTRIDGE 2025-12-01 Active
81137-0001-35 3 CARTON in 1 KIT (81137-001-35) / 1 CARTRIDGE in 1 CARTON / 2.67 mL in 1 CARTRIDGE 2026-06-15 Active

Pack size FAQ

What quantity is in NDC 81137-0001-15?
NDC 81137-0001-15 contains 1 kit — 1 carton in 1 kit / 1 cartridge in 1 carton / 2.67 ml in 1 cartridge.
What NDC number is used to bill for this package of LASIX ONYU furosemide 30 mg/mL Injection?
Bill NDC 81137-0001-15 — the 11-digit billing format is 81137000115. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 81137-001-15, 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: 81137-0001-15, written without dashes as 81137000115. 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 81137-0001-15, the first segment (81137) is the labeler code FDA assigned to SQ Innovation, Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 SQ Innovation, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (81137-0001-35). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
SQ Innovation, 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 ⏱️ 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 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 62 words ▾

1 INDICATIONS AND USAGE Lasix ONYU is a loop diuretic indicated for the treatment of edema in adult patients with chronic heart failure. ( 1.1 )

1.1Congestion Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure.

1.1Congestion Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The Infusor is pre-programmed to deliver 30 mg of Lasix ONYU over the first hour then 12.5 mg per hour for the subsequent 4 hours. ( 2.1 ) Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical. ( 2.1 ) See Full Prescribing Information for important administration instructions. ( 2.2 )

2.1Dosage The Infusor with single-dose prefilled cartridge delivers 30 mg of Lasix ONYU over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Clinical Pharmacology ( 12 )]. Administer Lasix ONYU once or twice daily as needed for edema. Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical.

2.2Important Administration Instructions Lasix ONYU is intended for use in a setting where the patient can limit their activity for the duration of administration [see Warnings and Precautions ( 5.5 )] . The Infusor for Lasix ONYU is not compatible with use in an MRI setting. Inspect Lasix ONYU prefilled cartridge prior to administration.

Lasix ONYU is a clear to slightly yellow solution. Do not use Lasix ONYU if solution is discolored or cloudy [see Description ( 11 )] . Refer to the Instructions for Use for additional information.

Push the Lasix ONYU prefilled cartridge into Disposable Unit. Slide the Reusable Unit and Disposable Unit together until the Status Light on the Reusable Unit turns on. The Infusor will remain ready to start infusion for 7 hours.

Peel away the paper liner on the Infusor and apply onto a clean, dry area of the abdomen between the top of the beltline and the bottom of the ribcage that is not tender, bruised, red, or indurated. Make sure the Status Lights and the Start/Stop Button are facing up in a horizontal position. Start the injection by firmly pressing and holding the Start/Stop Button until you hear the motor and see the blue Status Light change to flashing slowly.

Do not remove until the injection is complete which is signaled by the solid blue Status Light and the OK tone (one long beep). Rotate the site of each subcutaneous administration.

2.1Dosage The Infusor with single-dose prefilled cartridge delivers 30 mg of Lasix ONYU over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Clinical Pharmacology ( 12 )]. Administer Lasix ONYU once or twice daily as needed for edema. Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical.

2.2Important Administration Instructions Lasix ONYU is intended for use in a setting where the patient can limit their activity for the duration of administration [see Warnings and Precautions ( 5.5 )] . The Infusor for Lasix ONYU is not compatible with use in an MRI setting. Inspect Lasix ONYU prefilled cartridge prior to administration.

Lasix ONYU is a clear to slightly yellow solution. Do not use Lasix ONYU if solution is discolored or cloudy [see Description ( 11 )] . Refer to the Instructions for Use for additional information.

Push the Lasix ONYU prefilled cartridge into Disposable Unit. Slide the Reusable Unit and Disposable Unit together until the Status Light on the Reusable Unit turns on. The Infusor will remain ready to start infusion for 7 hours.

Peel away the paper liner on the Infusor and apply onto a clean, dry area of the abdomen between the top of the beltline and the bottom of the ribcage that is not tender, bruised, red, or indurated. Make sure the Status Lights and the Start/Stop Button are facing up in a horizontal position. Start the injection by firmly pressing and holding the Start/Stop Button until you hear the motor and see the blue Status Light change to flashing slowly.

Do not remove until the injection is complete which is signaled by the solid blue Status Light and the OK tone (one long beep). Rotate the site of each subcutaneous administration.

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 80 mg per 2.67 mL as a clear to slightly yellow solution in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor. Injection: 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor. ( 3 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS Lasix ONYU is contraindicated in patients with anuria. Lasix ONYU is contraindicated in patients with a history of hypersensitivity to furosemide, any component of the Lasix ONYU formulation, or medical adhesives. Anuria. ( 4 ) Hypersensitivity to furosemide or medical adhesives. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Fluid, Electrolyte, and Metabolic Abnormalities : Monitor serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid. ( 5.1 ) Worsening Renal Function : Monitor for dehydration and azotemia. ( 5.2 ) Ototoxicity : Avoid higher than recommended doses.

( 5.3 , 7.1 ) Acute Urinary Retention : Monitor patients with symptoms of urinary retention. ( 5.4 ) Incomplete Dosing : Fluid contact and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

( 5.5 )

5.1Fluid, Electrolyte, and Metabolic Abnormalities Furosemide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possible vascular thrombosis and embolism, particularly in elderly patients.

Serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

5.2Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide [see Clinical Pharmacology ( 12.3 )].

5.3Ototoxicity Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high-dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) [see Drug Interactions ( 7 )].

5.4Acute Urinary Retention In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

5.5Incomplete Dosing The Lasix ONYU Infusor should not come in contact with water or any other fluids (blood or drug product). Fluid contact with the Infusor circuit board can lead to device errors and premature termination of infusion. The Lasix ONYU is intended for use in a setting where the patient can limit their activity for the duration of administration.

Certain patient movements may cause interruption of device adherence to skin and premature termination of infusion. Lasix ONYU should only be used in patients who can detect and respond to alarms to ensure a complete dose is administered.

5.1Fluid, Electrolyte, and Metabolic Abnormalities Furosemide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possible vascular thrombosis and embolism, particularly in elderly patients.

Serum electrolytes, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

5.2Worsening Renal Function Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, disconti…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are discussed elsewhere in the labeling: Fluid, Electrolyte, and Metabolic Abnormalities [see Warnings and Precautions ( 5.1 )]. Ototoxicity [see Warnings and Precautions ( 5.3 )] The following adverse reactions associated with the use of furosemide were identified in clinical trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably, or to establish a causal relationship to drug exposure.

Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions: pancreatitis, jaundice (intrahepatic cholestatic jaundice), increased liver enzymes, anorexia, oral and gastric irritation, cramping, diarrhea, constipation, nausea, vomiting. Systemic Hypersensitivity Reactions: severe anaphylactic or anaphylactoid reactions (e.g., with shock), systemic vasculitis, interstitial nephritis, necrotizing angiitis.

Central Nervous System Reactions: tinnitus and hearing loss, paresthesias, vertigo, dizziness, headache, blurred vision, xanthopsia. Hematologic Reactions: aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia, anemia, eosinophilia. Dermatologic Hypersensitivity Reactions: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid, purpura, photosensitivity, rash.

Cardiovascular Reactions: orthostatic hypotension, increase in cholesterol and triglyceride serum levels. Administration Site and Skin Reactions: erythema, bruising, edema, infusion site pain. Other Reactions: glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever.

The most common adverse reactions during treatment with the Lasix ONYU Infusor were administration site and skin reactions: erythema, bruising, edema, and infusion site pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact SQ Innovation, at 1-855-452-7496 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Aminoglycoside antibiotics : Increased potential ototoxicity of the antibiotics. Avoid combination. ( 7.1 ) Ethacrynic acid : Risk of ototoxicity.

Avoid combination. ( 7.1 ) Salicylates : Risk of salicylate toxicity. ( 7.1 ) Cisplatin and nephrotoxic drugs : Risk of ototoxicity and nephrotoxicity.

( 7.1 ) Lithium : Risk of lithium toxicity. ( 7.1 ) Renin-angiotensin inhibitors : Increased risk of hypotension and renal failure. ( 7.1 ) Adrenergic blocking drugs : Risk of potentiation.

( 7.1 ) Drugs undergoing renal tubular secretion : Risk of toxicity potentiation. ( 7.1 )

7.1Effects of Furosemide on Other Drugs Table 1: Effects of Furosemide on Other Drugs Drug/Substance Class or Name Drug Interaction Effect Recommendations Aminoglycoside antibiotics Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function [see Warnings and Precautions ( 5.3 )]. Avoid combination except in life-threatening situations. Ethacrynic acid Possibility of ototoxicity [see Warnings and Precautions ( 5.3 )].

Avoid concomitant use with ethacrynic acid. Salicylates May experience salicylate toxicity at lower doses because of competitive renal excretory sites. Monitor for symptoms of salicylate toxicity.

Cisplatin Cisplatin and nephrotoxic drugs There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions ( 5.3 )]. Nephrotoxicity Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function.

Paralytic agents Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Monitor for skeletal muscle effect. Lithium Furosemide reduces lithium’s renal clearance and adds a high-risk of lithium toxicity.

Avoid concomitant use with lithium. Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers May lead to severe hypotension and deterioration in renal function, including renal failure. Monitor for changes in blood pressure and renal function and interrupt or reduce the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers if needed.

Antihypertensive drugs Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Monitor for changes in blood pressure and adjust the dose of other antihypertensive drugs if needed. Adrenergic blocking drugs or peripheral adrenergic blocking drugs Potentiation occurs.

Monitor for changes in blood pressure and adjust the dose of adrenergic blocking drugs if needed. Norepinephrine Furosemide may decrease arterial responsiveness (vasoconstricting effect) to norepinephrine. Monitor blood pressure (or mean arterial pressure).

Chloral hydrate In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Concomitant use with chloral hydrate is not recommended. Methotrexate and other drugs undergoing renal tubular secretion Furosemide may decrease renal elimination of other drugs that undergo tubular secretion.

High-dose treatment of furosemide may result in elevated serum levels of these drugs and may potentiate their toxicity. Monitor serum levels of drugs undergoing renal tubular secretion and adjust the dose if needed. Cephalosporin Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.

Monitor for changes in renal function. Cyclosporine Increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. Monitor serum urate levels.

Thyroid hormones High doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carri…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published observational studies, case reports, and post marketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. Untreated congestive heart failure can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (BSA) and oral bioavailability corrections, presumably secondary to volume depletion (see Data).

The background risk for 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 the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth.

Closely monitor pregnant patients for destabilization of their heart failure. Data Animal Data The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats, and rabbits. Furosemide caused unexplained maternal deaths and abortions in rabbits at the lowest dose of 25 mg/kg (approximately 4 times the human i.v. dose of 80 mg based on BSA and oral bioavailability corrections).

In another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.

The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group.

8.2Lactation Risk Summary The presence of furosemide has been reported in human breast milk. There are no data on the effects on the breastfed infant or the effects on milk production. Doses of furosemide associated with clinically significant diuresis may impair milk production.

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

8.4Pediatric Use Safety and efficacy for pediatric use have not been established [see Indications and Usage ( 1 )].

8.5Geriatric Use Controlled clinical studies did not include sufficient numbers of subjects to determine whether subjects aged 65 and over respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Lasix ONYU is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published observational studies, case reports, and post marketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. Untreated congestive heart failure can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (BSA) and oral bioavailability corrections, presumably secondary to volume depletion (see Data).

The background risk for 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 the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/fetal Risk Pregnant women with congestive heart failure are at increased risk for pre-term birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth.

Closely monitor pregnant patients for destabilization of their heart failure. Data Animal Data The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats, and rabbits. Furosemide caused unexplained maternal deaths and abortions in rabbits at the lowest dose of 25 mg/kg (approximately 4 times the human i.v. dose of 80 mg based on BSA and oral bioavailability corrections).

In another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on BSA and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.

The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group.

🧒 Pediatric Use 20 words ▾

8.4Pediatric Use Safety and efficacy for pediatric use have not been established [see Indications and Usage ( 1 )].

🧓 Geriatric Use 134 words ▾

8.5Geriatric Use Controlled clinical studies did not include sufficient numbers of subjects to determine whether subjects aged 65 and over respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Lasix ONYU is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 95 words ▾

10 OVERDOSAGE The principal signs and symptoms of overdose with Lasix ONYU are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia, and hypochloremic alkalosis, and are extensions of its diuretic action. The concentration of furosemide in biological fluids associated with toxicity or death is not known. Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses.

Serum electrolytes, carbon dioxide level, and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Furosemide primarily inhibits the reabsorption of sodium and chloride in the proximal and distal tubules and in the loop of Henle. The high degree of diuresis is largely due to the unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.

12.2Pharmacodynamics In patients with NYHA Class II and Class III heart failure, subcutaneous administration of Lasix ONYU (30 mg furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours, total 80 mg furosemide within 5 hours) produced similar diuresis and natriuresis to intravenous administration (single 80 mg bolus) at 8- and 24-hour post-dose. The duration of diuretic effect with Lasix ONYU is at least 8 hours after initiation of dosing.

12.3Pharmacokinetics Absorption In patients with NYHA Class II and Class III heart failure, subcutaneous infusion of Lasix ONYU (30 mg furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours, 80 mg furosemide total), the bioavailability was 112% (90% CI: 104, 120%), with a median Tmax of 5 hours relative to 80 mg intravenous furosemide (single 80 mg bolus). The pharmacokinetic parameters of Lasix ONYU are presented in Table 3 below: Table 3: Pharmacokinetic Data of Lasix ONYU Following Subcutaneous Infusion (n = 18) Dose C max (ng/mL) Mean ± SD AUC t (ng×hr/mL) T 1/2 (hr) AUC ∞ (ng×hr/mL) Lasix ONYU: 30 mg subcutaneously infused over the first hour followed by 12.5 mg per hour for the subsequent 4 hours (total dose: 80 mg furosemide) 2010 ± 391 13000 ± 2510 3.7 ± 0.7 13100 ± 2550 Furosemide administered as single 80 mg bolus dose intravenously 13800 ± 4100 11900 ± 3380 3.7 ± 1.3 12000 ± 3400 The terminal half-life of furosemide is approximately 2 hours.

The impact of subcutaneous edema at the administration site of Lasix ONYU on drug absorption is unknown. Distribution Furosemide is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 mcg per mL to 400 mcg per mL are 91% to 99% bound in healthy individuals.

The unbound fraction averages 2.3% to 4.1% at therapeutic concentrations. Furosemide binding to albumin may be reduced in elderly patients. Elimination Significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution.

Furosemide is predominantly excreted unchanged in the urine. The renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is significantly less than in younger healthy male subjects (20 to 35 years of age). Metabolism Furosemide glucuronide is the only or at least the major biotransformation product of furosemide in humans.

12.1Mechanism of Action Furosemide primarily inhibits the reabsorption of sodium and chloride in the proximal and distal tubules and in the loop of Henle. The high degree of diuresis is largely due to the unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.

12.2Pharmacodynamics In patients with NYHA Class II and Class III heart failure, subcutaneous administration of Lasix ONYU (30 mg furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours, total 80 mg furosemide within 5 hours) produced similar diuresis and natriuresis to intravenous administration (single 80 mg bolus) at 8- and 24-hour post-dose. The duration of diuretic effect with Lasix ONYU is at least 8 hours after initiation of dosing.

12.3Pharmacokinetics Absorption In patients with NYHA Class II and Class III heart failure, subcutaneous infusion of Lasix ONYU (30 mg furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours, 80 mg furosemide total), the bioavailability was 112% (90% CI: 104, 120%), with a median Tmax of 5 hours relative to 80 mg intravenous furosemide (sin…

📦 How Supplied / Storage and Handling 156 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lasix ONYU injection is a sterile, clear to slightly yellow, non-pyrogenic liquid supplied in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with a Disposable Unit. The Infusor with single-dose prefilled cartridge is designed to deliver 80 mg of Lasix ONYU in 2.67 mL solution over 5 hours. Lasix ONYU Kit: Carton containing one 80 mg/2.67 mL single-dose prefilled cartridge co-packaged with a Disposable Unit and two alcohol pads.

NDC 81137‐001‐15 Starter Kit: Carton containing three Lasix ONYU Kits co-packaged with one Reusable Unit and one wall charger. NDC 81137‐001‐35 Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze.

Protect Lasix ONYU from light. Do not remove the prefilled cartridge from carton until it is ready for use. Do not use if the solution is discolored or cloudy.

Protect the Infusor from water.

📋 Description ~1 min read ▾

11 DESCRIPTION Lasix ONYU (furosemide injection) for subcutaneous use is a loop diuretic. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow crystalline powder.

It is sparingly soluble in alcohol, freely soluble in dilute alkali solutions, and insoluble in dilute acids. The structural formula is as follows: Molecular Formula: C 12 H 11 ClN 2 O 5 S Molecular Weight: 330.75 g/mol Lasix ONYU is a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor. The single-dose prefilled cartridge contains 80 mg furosemide in a 2.67 mL sterile, clear to slightly yellow, and nonpyrogenic aqueous solution.

The pH of Lasix ONYU, 7.5, differs from that of Furosemide Injection, USP. Each 1 mL dose of Lasix ONYU contains 30 mg of furosemide and the following inactive ingredients: betadex sulfobutyl ether sodium (300 mg), hydrochloric acid for pH adjustment if needed, sodium hydroxide for pH adjustment if needed, tromethamine (3 mg), and water for injection (q.s.). Each single-dose of Lasix ONYU is administered via an electromechanical (battery powered, microprocessor controlled) Infusor, pre-programmed to deliver 80 mg of Lasix ONYU over 5-hours using a bi-phasic delivery profile.

The Infusor consists of a custom Reusable Unit which can be used for close to 50 treatments. The Reusable Unit is used with a Disposable Unit and single-dose prefilled cartridge which are provided together for the user as a Lasix ONYU Kit. The Disposable Unit must be discarded after use. image-Structure

💬 Information for Patients 198 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling [Instructions for Use] . Advise the patient that Lasix ONYU should not come into contact with water or other fluids. Patients should check the device for alarms to ensure a complete dose is administered [see Warnings and Precautions ( 5.5 )] .

Fluid, Electrolyte, and Metabolic Abnormalities Advise patients that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia [see Warnings and Precautions ( 5.1 )].

Advise patients that furosemide may increase blood glucose levels and thereby affect urine glucose tests [see Warnings and Precautions ( 5.1 )]. Photosensitivity The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide [see Adverse Reactions ( 6 )]. For more information about Lasix® ONYU, go to www.Lasix-ONYU.com or call 1-855-452-7496 (1-855-4LASIX6).

Lasix ® ONYU (furosemide injection 80 mg/2.67 mL) for subcutaneous use Manufactured for: SQ Innovation, Inc. 20 Burlington Mall Road, Suite 220 Burlington, MA 01803 USA Patent Protected ©2023 image-logo

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