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FUROSCIX furosemide 80 mg/mL Injection, 1 syringe — NDC 71767-0111-01 package photo

FUROSCIX furosemide 80 mg/mL Injection, 1 syringe

by scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation · 1 SYRINGE, GLASS in 1 CARTON (71767-111-01) / 1 mL in 1 SYRINGE, GLASS
NDC 71767-0111-01
🏷️ FDA NDC (as labeled) 71767-111-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 13, 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) 71767-111-01
Product NDC 71767-111
11-digit billing NDC 71767011101
RxCUI 2621022, 2621028, 2747765, 2747769
UNII 7LXU5N7ZO5
UPC 0371767100013
Application # NDA209988
SPL Set ID eac958dd-8d43-e44e-e053-2995a90a4d5e
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 2026-07-27
Route SUBCUTANEOUS
Dosage form INJECTION
Substance FUROSEMIDE
Why two NDCs? The FDA registers this code as 71767-111-01 — 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 → 71767-0111-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ 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

LabelerscPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation
Application holderSCPHARMACEUTICALS INC A WHOLLY OWNED SUB OF MANNKIND CORP
FDA applicationNDA209988 (NDA)
Labeler code71767
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Furosemide is a strong 'water pill' that tells your kidneys to flush out excess sodium and water through your urine. If your legs are swollen or you're short of breath from fluid b...
  • Why did my doctor prescribe furosemide — what is it actually doing for me?
  • Yes, that's exactly what furosemide is supposed to do. The whole point is to increase urine output so your body can shed excess fluid. Many people notice it kicks in within an hour...
  • I'm going to the bathroom a lot more — is that normal?
📖 Read our full Furosemide 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.

💊 What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 35 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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.
  • 9.7 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.
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
Furoscix 80 mg/mLthis 71767-0111-01 scPharmaceuticals 1 syringe — — 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
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2034
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 Apr 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 7, 2022 RLD RS ⏳ ~7.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11433044 — method of use (U-3462)
US 9884039 — method of use (U-3462)
US 12370168 — method of use (U-3462)
US 10272064 — drug product
2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 11433044 ↗ Method of use U-3462 Apr 3, 2034
US 9884039 ↗ Method of use U-3462 Apr 3, 2034
US 12370168 ↗ Method of use U-3462 Apr 3, 2034
US 10272064 ↗ Drug product — Apr 3, 2034
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2034 — 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 Furoscix — 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 Furoscix. 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
$15.94M
Claims incl. refills
1.9K
Beneficiaries
1.5K
Spend / beneficiary
$10,784.27
Spend / claim
$8,250.08
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 FUROSCIX (this brand).

Top reported reactions

Dyspnoea18,125
Acute Kidney Injury16,207
Fatigue13,015
Diarrhoea12,939
Death12,187
Nausea11,335
Fall10,822

Age at onset

Neonate440
Infant337
Child410
Adolescent290
Adult14,388
Elderly28,827

Reporter sex

261,674 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization128,016
Death40,346
Life-threatening18,485
Disabling6,881
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
71767-0111-01 You're viewing this 1 SYRINGE, GLASS in 1 CARTON (71767-111-01) / 1 mL in 1 SYRINGE, GLASS 2026-07-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — 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 71767-111-01, 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: 71767-0111-01, written without dashes as 71767011101. 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 71767-0111-01, the first segment (71767) is the labeler code FDA assigned to scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation; the middle segment (0111) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
scPharmaceuticals Inc., a wholly owned subsidiary of MannKind 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE FUROSCIX is indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. FUROSCIX is a loop diuretic indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. ( 2.1 ) The FUROSCIX ReadyFlow™ is pre-filled to deliver 80 mg of furosemide subcutaneously in about 10 seconds. The single-use, On-body Infusor is pre-programmed to deliver 30 mg of furosemide subcutaneously over the first hour then 12.5 mg per hour for the subsequent 4 hours.

( 2.1 ) See Full Prescribing Information for important administration instructions. ( 2.2 )

2.1Recommended Dosage FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. Adult Patients: FUROSCIX ReadyFlow: The FUROSCIX ReadyFlow is an autoinjector that delivers 80 mg of furosemide subcutaneously in about 10 seconds [see Clinical Pharmacology ( 12 )] . Adult and Pediatric Patients 43 kg and Above: On-body Infusor for FUROSCIX: The single-use, On-body Infusor with prefilled cartridge is pre-programmed to deliver 30 mg of furosemide subcutaneously over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12 )].

2.2Important Administration Instructions Inspect the parenteral drug product through the autoinjector viewing window or the prefilled cartridge for the On-body Infusor prior to administration. FUROSCIX is a clear, colorless to slightly yellow solution. Do not use FUROSCIX if you see particles or the solution is discolored or cloudy [see Description ( 11 )] .

FUROSCIX is intended for administration to the abdomen only. For each subcutaneous administration, rotate the site on the abdomen. Refer to the Instructions for Use for additional information.

FUROSCIX ReadyFlow (Adult Patients) : ​Instruct patients to select and clean an injection site on the abdomen at least two inches away from the belly button (navel) and avoid skin that is irritated or broken and areas with scars or stretch marks. Pull the blue cap straight off the FUROSCIX ReadyFlow and then firmly push and hold against the skin until the yellow plunger rod stops moving and fills the viewing window, about 10 seconds. On-body Infusor for FUROSCIX (Adult and Pediatric Patients 43 kg and above) : The On-body Infusor for FUROSCIX is not compatible with use in an MRI setting.

The On-body Infusor for FUROSCIX 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 )] . Load the prefilled cartridge of furosemide into the On-body Infusor and close the cartridge holder. Peel away the adhesive liner on the On-body 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.

The distance from the top of the beltline to the bottom of the ribcage should be at least 2 ½ inches. Start the injection by firmly pressing and releasing the blue start button. Do not remove until the injection is complete (signaled by the solid green status light, beeping sound, and the white plunger rod filling the cartridge window).

In pediatric patients weighing at least 43 kg, FUROSCIX On-body Infusor must be administered by a healthcare provider or adult caregiver. Adult patients or caregivers should receive proper instruction in preparing and administering FUROSCIX before using the FUROSCIX On-body Infusor.

2.1Recommended Dosage FUROSCIX is not for chronic use and should be replaced with oral diuretics as soon as practical. Adult Patients: FUROSCIX ReadyFlow: The FUROSCIX ReadyFlow is an autoinjector that delivers 80 mg of furosemide subcutaneously in about 10 seconds [see Clinical Pharmacology ( 12 )] . Adult and Pediatric Patients 43 kg and Above: On-body Infusor for FUROSCIX: The single-use, On-body Infusor with prefilled cartridge is pre-programmed to deliver 30 mg of furosemide subcutaneously over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see U…

💊 Dosage Forms and Strengths 77 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection : 80 mg/mL as a clear, colorless to slightly yellow solution in a single-dose prefilled autoinjector. 80 mg/10 mL (8 mg/mL) as a clear to slightly yellow solution in a single-dose prefilled cartridge for use only with co-packaged single-use, On-body Infusor. Injection: 80 mg/mL in a single-dose prefilled autoinjector ( 3 ) 80 mg/10 mL (8 mg/mL) in a single-dose prefilled cartridge co-packaged with a single-use On-body Infusor.

( 3 )

⛔ Contraindications 66 words ▾

4 CONTRAINDICATIONS FUROSCIX is contraindicated in: Patients with anuria. Patients with a history of hypersensitivity to furosemide, or any component of the FUROSCIX formulation. The On-body Infusor for FUROSCIX is contraindicated in patients with a history of hypersensitivity to medical adhesives Anuria ( 4 ) Hypersensitivity to furosemide, or components of FUROSCIX formulation ( 4 ) FUROSCIX On-body Infusor: Hypersensitivity to 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 the patient or caregiver 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 possibly 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 [see Use in Specific Populations ( 8.6 )] .

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 ( 7.1 )].

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 FUROSCIX ReadyFlow should be held against the abdomen until the yellow plunger rod stops moving and fills the viewing window. This may take about 10 seconds. The On-body Infusor for FUROSCIX should not be allowed to get wet from water or any other fluids (blood or drug product).

Fluid contact with the circuit board can lead to device errors and premature termination of infusion. The On-body Infusor for FUROSCIX 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.

The On-body Infusor for FUROSCIX should only be administered in settings where alarms can be detected and responded to in order to ensure a complete dose is administered [see Dosage and Administration ( 2.2 )] .

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 possibly vascular thrombosis and embolism, pa…

🤒 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 : administration site erythema, bruising, edema, mass, pruritus, and 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 FUROSCIX were administration site and skin reactions: erythema, bruising, edema and pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact MannKind Corporation at 1-877-323-8505 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 ) See 17 for PATIENT COUNSELING INFORMATION .

7.1Effects 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 There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions ( 5.3 )]. Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function.

Cisplatin and nephrotoxic drugs Nephrotoxicity 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 add 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 carrier p…

👥 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 and cirrhosis of the liver 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).

FUROSCIX ReadyFlow contains benzyl alcohol (BA) as a preservative. Because BA is rapidly metabolized by a pregnant female, BA exposure in the fetus is unlikely. The estimated 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.

Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Carefully monitor pregnant women with cirrhosis of the liver.

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 the rabbit 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.

FUROSCIX ReadyFlow contains benzyl alcohol (BA) as a preservative. Because BA is rapidly metabolized by a pregnant female, BA exposure in the breastfed neonate is unlikely. 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 of the FUROSCIX ReadyFlow for pediatric use have not been establi…

🆘 Overdosage 94 words ▾

10 OVERDOSAGE The principal signs and symptoms of overdose with FUROSCIX 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 healthy adults, subcutaneous administration of FUROSCIX (80 mg furosemide injection via the ReadyFlow) produced similar diuresis, natriuresis, and kaliuresis to intravenous administration (two 40 mg bolus doses separated by 120 minutes) at 6, 8, and 12 hours post-dose. The duration of diuretic effect with FUROSCIX ReadyFlow was up to 6 hours after initiation of dosing. In adult patients with NYHA Class II and Class III heart failure, subcutaneous administration of FUROSCIX (30 mg furosemide over the first hour followed by 12.5 mg per hour for the subsequent 4 hours, total 80 mg furosemide) produced similar diuresis and natriuresis to intravenous administration (two 40 mg bolus doses separated by 120 minutes) at 8 and 24 hours post-dose.

The duration of diuretic effect with FUROSCIX On-body Infusor was up to 8 hours after initiation of dosing.

12.3Pharmacokinetics Absorption In healthy adults, subcutaneous injection of FUROSCIX (80 mg furosemide injection via the ReadyFlow), the bioavailability was 107.3% (90% CI: 103.9, 110.8) relative to 80 mg intravenous furosemide (two 40‑mg bolus doses separated by 120 minutes) with a median (min-max) T max of 0.75 (0.5-1.5) hours. The pharmacokinetic parameters of FUROSCIX following subcutaneous injection via the ReadyFlow autoinjector are presented in Table 1 below: Table 1: Pharmacokinetic Data of FUROSCIX Following Subcutaneous Injection via the ReadyFlow Autoinjector (n = 19) Dose C max (ng/mL) AUC t (ng×hr/mL) T 1/2 (hr) AUC ∞ (ng×hr/mL) FUROSCIX: 80 mg injection via the ReadyFlow 4,530 ± 1,500 12,500 ± 4,010 2.2 ± 0.3 12,700 ± 4,120 Furosemide administered as 2 x 40 mg bolus doses intravenously, separated by 120 minutes (total dose: 80 mg furosemide) 10,100 ± 2,810 11,700 ± 3,450 1.9 ± 0.4 11,800 ± 3,510 In adult patients with NYHA Class II-III congestive heart failure, subcutaneous infusion of FUROSCIX (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 99.6% (90% CI: 94.8, 104.8) relative to 80 mg intravenous furosemide (two 40-mg bolus doses separated by 120 minutes) with a median T max (min-max) of 4 (1.00 - 5.08) hours.

The pharmacokinetic parameters of FUROSCIX following subcutaneous infusion via the On-body Infusor are presented in Table 2 below: Table 2: Pharmacokinetic Data of FUROSCIX Following Subcutaneous Infusion via the On-body Infusor (n = 15) Dose Cmax (ng/mL) AUCt (ng×hr/mL) T1/2 (hr) AUC∞ (ng×hr/mL) FUROSCIX: 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) 2,040 ± 449 13,000 ± 4,000 3.2 ± 0.9 13,100 ± 4,010 Furosemide administered as 2 x 40 mg bolus doses intravenously, separated by 120 minutes (total dose: 80 mg furosemide) 8,580 ± 2,540 13,000 ± 4,050 2.6 ± 0.3 13,200 ± 4,170 The impact of subcutaneous edema at the administration site of FUROSCIX 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.

Elimination The terminal half-life of furosemide is approximately 2 hours. Metabolism Furosemide glucuronide is the only or at least the major biotransformation product of furosemide in humans. Excretion Significantly more furosemide is excreted in urine following the intravenous injection than after the tablet or oral solution.

Specific Populations Pediatric Patient…

📦 How Supplied / Storage and Handling 145 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING FUROSCIX injection is a sterile, clear, colorless to slightly yellow, non-pyrogenic liquid supplied either in a single-dose autoinjector for subcutaneous injection or in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with the On-body Infusor. Carton containing one 80 mg/mL single-dose prefilled autoinjector NDC 71767-111-01 Carton containing one 80 mg/10 mL (8 mg/mL) prefilled cartridge co-packaged with one On-body Infusor NDC 71767-100-01 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 from light. Do not remove the FUROSCIX ReadyFlow or cartridge for use in the On-body Infusor from carton until it is ready for use.

Do not use if you see particles in the solution or if the solution is discolored or cloudy. Protect the On-body Infusor for FUROSCIX from water.

📋 Description ~1 min read ▾

11 DESCRIPTION FUROSCIX (furosemide injection 80 mg/10 mL or 80 mg/mL) is a loop diuretic which is an anthranilic acid derivative. 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 FUROSCIX ReadyFlow : The ReadyFlow is a disposable, fixed single-dose, mechanical spring driven autoinjector. The ReadyFlow is preloaded with the prefilled syringe containing the drug and delivers 80 mg of furosemide in about 10 seconds.

The single-dose prefilled FUROSCIX ReadyFlow contains 80 mg per 1 mL sterile, clear, colorless to slightly yellow, and non-pyrogenic furosemide solution. The pH of FUROSCIX for administration via the ReadyFlow, 7.7, differs from that of Furosemide Injection, USP. Autoinjector contains 1 mL of FUROSCIX ReadyFlow that contains 80 mg furosemide and the following inactive ingredients: benzyl alcohol (35 mg), hydrochloric acid for pH adjustment if needed, sodium hydroxide for pH adjustment if needed, tromethamine (9.7 mg), and water for injection (q.s.).

On-body Infusor for FUROSCIX : The On-body Infusor for FUROSCIX is a wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of furosemide over 5-hours using a bi-phasic delivery profile. FUROSCIX for administration via the On-body Infusor is provided in a single-dose prefilled cartridge co-packaged with a single-use, On-body Infusor. The single-dose prefilled cartridge contains 80 mg per 10 mL sterile, clear, colorless to slightly yellow, and non-pyrogenic furosemide solution.

The pH of FUROSCIX for administration via the On-body Infusor, 7.4, differs from that of Furosemide Injection, USP. Each 1 mL of FUROSCIX for administration via the On-body Infusor contains the following inactive ingredients: hydrochloric acid for pH adjustment if needed, sodium chloride (5.84 mg), sodium hydroxide for pH adjustment if needed, tris HCl (7.88 mg), and water for injection (q.s.). Structure

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