FUROSCIX - scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation

Manufacturer
scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation
Effective date
2026-07-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
19
Source
daily-update
Hydrated at
2026-07-29 05:10:33

Key Label Information#

Uses

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.

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

Warnings

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

5 WARNINGS AND PRECAUTIONS

Directions And Dosage

2 DOSAGE AND ADMINISTRATION

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.

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.

Other Label Information

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cartridge Carton NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cartridge NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Device Tyvek Lid On-Body Infusor for FUROSCIX® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use

Label Images#

Furosemide Structure
Furosemide Structure
MannKind Logo
MannKind Logo
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Drug Product Cartridge Carton
Drug Product Cartridge Carton
Drug Product Cartridge
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Device
Device
Combination Product Primary Carton
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Autoinjector Carton
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Autoinjector Carton -Inside Flap
Autoinjector
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Autoinjector Carton Sample -Inside Flap
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Autoinjector Sample

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d80d3aff-3a63-4d7b-a2be-fd9388b04330Product name920250806
9061e89f-9c86-4196-b34b-886fc1673cc4Product name120140821

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71767-100-01EA - Each71767-10073c105f1-e6c1-4368-a671-be5c09e2954012022-12-07

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71767-10071767-100-01
71767-11171767-111-01

Ingredients#

Complete SPL Sections#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

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.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

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.).

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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.

17 PATIENT COUNSELING INFORMATION

PATIENT COUNSELING INFORMATION

Advise the patient and/or caregiver to read the FDA-approved patient labeling [see FDA-approved Instructions for Use ] . Advise patients that they should not allow the On-body Infusor to come into contact with water or other fluids. Advise patients and/or caregivers to 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 )] . Advise hypertensive patients to avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms [see Drug Interactions ( 7.1 )] . For more information about FUROSCIX, go to www.FUROSCIX.com or call call 1-877-323-8505 FUROSCIX ® (furosemide injection) for subcutaneous use Manufactured for: MannKind Corporation 25 Mall Road Burlington, MA 01803 Patent: www.mannkindcorp.com/patent-notices FUROSCIX, FUROSCIX READYFLOW, and MANNKIND are trademarks of MannKind Corporation © 2026 MannKind Corporation REG-0018 Rev 05

INSTRUCTIONS FOR USE SECTION

INSTRUCTIONS FOR USE SECTION

INSTRUCTIONS FOR USE Model/REF # FUR-80W5 Instructions For Use On-Body Infusor for FUROSCIX® [fue roe’ six] (furosemide injection) for subcutaneous use Single-Use On-Body Infusor and 80 mg/10 mL (8 mg/mL) Prefilled Cartridge This Instructions for Use contains information about how to prepare and use FUROSCIX On-Body Infusor. Before Starting Read this Instructions for Use before using the FUROSCIX On-Body Infusor for the first time. You or a caregiver should receive training before using the Furoscix On-Body Infusor. Always wash your hands before starting. The FUROSCIX On-Body Infusor will deliver a fixed dose of 80 mg of furosemide over about 5 hours. The FUROSCIX On-Body Infusor delivers the medicine just under the skin (subcutaneously). When the FUROSCIX On-Body Infusor is started, a small needle sticks into the skin to deliver the medicine. The on-body Infusor signals when all the medicine has been delivered. When the on-body Infusor is removed from the skin, a needle cover will extend over the needle to protect from an accidental needle stick. Parts of the FUROSCIX On-Body Infusor and Prefilled Cartridge Important Information The on-body Infusor and prefilled cartridge are not made with natural rubber latex. The infusion will last about 5 hours. During this time, you should limit your activity so that your bending movements are limited. Wearing the Infusor while riding in a car or flying in an airplane is not recommended. You should notice an increase in urine production in about an hour after the infusion is started and may need to make frequent bathroom visits. Be sure you have access to a bathroom for up to 8 hours after starting the infusion. If you do not notice the need to go to the bathroom, call your healthcare provider. The on-body Infusor can only be used with the prefilled FUROSCIX cartridge supplied in the kit. Do not use any other cartridges or medicines inside the on-body Infusor. Do not apply lotions, oils, or ointments to the adhesion area of the abdomen prior to applying the on-body Infusor to the abdomen. Do not use the on-body Infusor if the packaging appears to be opened, or if the on-body Infusor has been dropped or appears to be broken or damaged. Do not use the on-body Infusor within 12 inches of mobile phones, tablets, computers or wireless accessories (for example: TV remote control, Bluetooth computer keyboard or mouse). Do not use the on-body Infusor or prefilled cartridge after the expiration date on the carton. Do not use the prefilled cartridge if the liquid is discolored or cloudy. The liquid in the prefilled cartridge should be clear to slightly yellow in color. Do not use the on-body Infusor in or around an MRI machine. Do not take the on-body Infusor off your skin while it is infusing, unless there is an emergency or a device error. Removing the on-body Infusor before the infusion is done will result in a partial dose. The on-body Infusor will stop infusing and it cannot be restarted. Do not apply a new on-body Infusor unless instructed to do so by your healthcare provider. Do not reuse the on-body Infusor. The on-body Infusor is for single use only. Do not let the on-body Infusor get wet from water or any other liquids. Do not shower, bathe, swim or do activities that may make you sweat while wearing the on-body Infusor. It contains parts that should not get wet. Call your healthcare provider or scPharmaceuticals at 1-855-SCPHARMA (1-855-727-4276) if you have any questions. Storage Information The FUROSCIX On-Body Infusor and prefilled cartridge should be stored at controlled room temperature between 68°F to 77°F (20°C to 25°C) (see Figure B). Do not refrigerate or freeze. Keep the FUROSCIX prefilled cartridge in the original carton to protect from light or physical damage until you are ready to use. Keep the FUROSCIX On-Body Infusor and prefilled cartridge out of the reach of children. Prepare for the Infusion STEP 1 Wash Hands, Check Expiration Date and Remove Supplies from Carton ​ 1.1 Wash your hands before using the on-body Infusor (Figure C). 1.2 Check the expiration date on the FUROSCIX On-Body Infusor carton (see Figure D). Do not use if the expiration date has passed. 1.3 Open the carton and peel away the white paper cover. Remove the plastic cover from the clear tray. Remove supplies from the carton and packaging (see Figure E). Do not use the on-body Infusor or prefilled cartridge if packaging appears to have been previously opened or damaged. 1.4 Gather all materials needed for your injection, on a clean, well-lit work surface (Figure F): On-body Infusor and prefilled cartridge (Included) Instructions For Use (Included) Alcohol wipes (Included) Clippers (if needed) (Not included) Sharps disposal container (Not included) STEP 2 Check On-Body Infusor and Prefilled Cartridge 2.1 Check the on-body Infusor and prefilled cartridge for any damage (see Figure G). Do not use the on-body Infusor or prefilled cartridge if either item appears to be damaged. Do not touch the blue start button until the on-body Infusor is on the skin and you are ready to begin the infusion. Do not touch or fully open the cartridge holder until you are ready to load the cartridge. 2.2 Check the liquid medicine in the prefilled cartridge (see Figure H). The liquid in the prefilled cartridge should be clear to slightly yellow. Do not use the prefilled cartridge if the liquid is discolored or cloudy. Call scPharmaceuticals at: 1-855-SCPHARMA (1-855-727-4276) or call your healthcare provider. STEP 3 Load Prefilled Cartridge into the On-Body Infusor 3.1 Clean the tip (small end) of the prefilled cartridge with an alcohol wipe (see Figure I). Do not continue with the process of opening the cartridge holder all the way or loading the prefilled cartridge until you are ready to begin the infusion. 3.2 Open the cartridge holder all the way to turn on the on-body Infusor. The on-body Infusor “beeps” and the indicator light will begin blinking blue (see Figure J). Note: Complete steps 3.3 through 6.1 within 30 minutes of fully opening the cartridge holder or the Infusor will alarm and cannot restart. 3.3 Insert the prefilled cartridge into the cartridge holder with the tip pointed down (see Figure K). Note: The prefilled cartridge should slide into the cartridge holder easily. If it does not slide in easily, check the prefilled cartridge to make sure the tip is pointed down and try again. Do not press the blue start button until on-body Infusor is applied to skin and you are ready to begin the infusion. 3.4 Close the cartridge holder all the way until it is even with the rest of the on-body Infusor (see Figure L). You may hear a “click” sound when it is closed. Note: If the indicator light blinks red and the on-body Infusor "beeps", the on-body Infusor has experienced an internal error. Do not use the on-body Infusor (see On-Body Infusor Alarm section). Apply the On-Body Infusor STEP 4 Select and Prepare Application Site 4.1 Select one site on the stomach on either side of the belly button (navel). The site should be a flat area below the rib cage and above the belt line (see Figure M). Do not select a site where the skin is irritated or broken. Do not apply lotions, oils or ointments to the adhesion area of the abdomen. Do not select a site where belts, waistbands or other types of clothing may rub against, disturb, or dislodge the on-body Infusor. Note : Rotate application site (side of the stomach) each time if told by your healthcare provider to repeat dose. 4.2 The site should be hairless or nearly hairless. If needed, remove excess hair by clipping or shaving the hair before applying the on-body Infusor (see Figure N). 4.3 Wipe the skin where the on-body Infusor will be applied with an alcohol wipe and allow area to dry (see Figure O). STEP 5 Apply the On-Body Infusor 5.1 Pick up the on-body Infusor. Peel away the adhesive liner by grasping the white tab and pulling it away from the blue tab/adhesive backing (see Figure P). Do not t...

INSTRUCTIONS FOR USE SECTION

INSTRUCTIONS FOR USE SECTION

INSTRUCTIONS FOR USE FUROSCIX ReadyFlow™ [fue roe’ six] (furosemide injection) for subcutaneous use Single-dose autoinjector 80 mg/mL This Instructions for Use contains information on how to use the FUROSCIX ReadyFlow autoinjector to inject an 80 mg dose of furosemide under the skin (subcutaneous). Read this Instructions for Use before using the FUROSCIX ReadyFlow autoinjector. Before using the FUROSCIX ReadyFlow autoinjector, your healthcare provider should show you how to use it the right way. If you have any questions, ask your healthcare provider. INSTRUCTIONS FOR USE Important Information You Need to Know Before Using the FUROSCIX ReadyFlow autoinjector The autoinjector is for single use only. The autoinjector is for subcutaneous (under the skin) injection into the stomach area (abdomen) only. Before injection Do not remove the blue Cap until you are ready to inject (see Step 6). Do not touch or push on the Needle cover. The needle is covered by the grey Needle cover and will not be seen. Do not use in extreme heat or cold. During injection Only inject into the stomach area (abdomen). Do not inject into any other area of the body. Do not lift the autoinjector from your skin before the yellow Plunger rod has stopped moving and fills the Viewing window. If the yellow Plunger rod does not move or does not fill the Viewing window, contact your healthcare provider. If you lift the autoinjector too early or do not press the autoinjector firmly against the skin for the entire injection, the Medicine may appear on the skin or squirt from the needle, and you may not get your full dose of FUROSCIX. If you believe you have not received a full dose, contact your healthcare provider. After injection You should notice an increase in urine production about an hour after the injection and may need to make frequent bathroom visits. Be sure you have access to a bathroom for up to 6 hours after the injection. If you do not notice the need to use the bathroom, contact your healthcare provider. Storing FUROSCIX ReadyFlow autoinjector The autoinjector should be stored at room temperature between 68°F and 77°F (20°C and 25°C). Do not refrigerate or freeze. Keep the autoinjector in the original carton until ready to use to protect from light. Keep the autoinjector and all medicines out of the reach of children. Preparing to Inject Gather supplies Gather all supplies needed for your injection on a clean, well-lit work surface: FUROSCIX ReadyFlow autoinjector Other supplies (not included) ◦ Alcohol wipe ◦ Cotton balls or gauze ◦ Small bandage ◦ Sharps disposal container (see Step 9) Inspect autoinjector Inspect the autoinjector and make sure: the Medicine in the Viewing window is clear and colorless to slightly yellow the Expiration date has not passed there are no signs of cracks or damage Do not use the autoinjector if you see particles in the Medicine. Do not use the autoinjector if the Medicine is discolored or cloudy. Do not use the autoinjector after the Expiration date. Do not use the autoinjector if there are signs of cracks or damage. Wash hands Wash your hands with soap and water before using the autoinjector. Select injection site on the stomach area (abdomen) Select an injection site on the stomach area only , at least two inches away from the belly button (navel). Do not select a site where the skin is irritated or broken. Avoid areas with scars or stretch marks. Make sure you switch areas on the stomach area each time you give an injection. Clean the injection site Wipe the injection site with an alcohol wipe and allow the area to dry. Do not blow on or touch the cleaned area again before injecting. Injecting FUROSCIX Remove Cap Pull the blue Cap straight off and throw away (dispose of) Cap. When the Cap is removed, use the autoinjector right away. Do not put the Cap back onto the autoinjector. Do not touch or push on the grey Needle cover (needle inside). Place autoinjector Hold the autoinjector at 90 degrees with the grey Needle cover flat against the clean stomach area injection site. Make sure you can see the Viewing window. Deliver injection a. Firmly push and hold the autoinjector against stomach area until the yellow Plunger rod stops moving. This may take about 10 seconds. You may or may not hear 2 clicks during the injection. Do not lift the autoinjector while the yellow Plunger rod is moving. If the yellow Plunger rod does not start moving, press the autoinjector more firmly against your skin . b. Check that the yellow Plunger rod has stopped moving and fills the Viewing window. Do not lift the autoinjector before the injection is done. If the Viewing window does not turn completely yellow, or if you see Medicine coming out of the autoinjector, you might not have received a full dose. Contact your healthcare provider. C. When the injection is complete, lift the autoinjector. The grey Needle cover will automatically extend and lock out over the needle. Do not reuse the autoinjector. You cannot stop and restart an injection. It is for single use only. If you see some blood at the injection site, this is normal. Lightly dab with a cotton ball and apply a small bandage. ​ After Injecting Throw away (dispose of) the autoinjector Put your used autoinjector into an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the autoinjector in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that: is made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, is upright and stable during use, is leak-resistant, and is properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal Do not dispose of your sharps disposal container in household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Keep the sharps disposal container out of the reach of children. Expect increased need to urinate Urine production should increase about an hour after the injection for up to 6 hours. If you do not notice the need to use the bathroom, contact your healthcare provider For additional resources call 1-877-323-8505 © 2026 MannKind Corporation, 25 Mall Road, Burlington, MA 01803 USA FUROSCIX READYFLOW is a trademark of MannKind Corporation Patent: www.mannkindcorp.com/patent-notices This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 7/2026 REG-0021 R06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cartridge Carton NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cartridge NDC 71767-100 FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) 10 mL Single Dose Cartridge FOR SUBCUTANEOUS USE ONLY Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Device Tyvek Lid On-Body Infusor for FUROSCIX® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Device (Direct Pad Printing) On-Body Infusor for FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) For subcutaneous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Combination Product Primary Carton NDC 71767-100-01 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Combination Product Physician Sample Primary Carton NDC 71767-100-01 PHYSICIAN SAMPLE ONLY NOT FOR SALE 1 X 10 mL Single Dose Prefilled Cartridge 1 X Single Use On-Body Infusor FUROSCIX ® (furosemide injection) 80 mg/10 mL (8 mg/mL) FOR SUBCUTANEOUS USE ONLY Single Dose Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Autoinjector Carton NDC 71767-111-01 1 Single Dose Prefilled Autoinjector FUROSCIX ReadyFlow™ (furosemide injection) 80 mg/ml For subcutaneous use in the abdomen only Sterile Solution. Do not refrigerate Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Autoinjector NDC 71767-111-01 FUROSCIX ReadyFlow™ (furosemide injection) 80 mg/ml Single dose prefilled autoinjector For subcutaneous use in the abdomen only. Do not refrigerate or freeze. Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Autoinjector Carton for Physician Samples NDC 71767-111-01 1 Single Dose Prefilled Autoinjector FUROSCIX ReadyFlow™ (furosemide injection) 80 mg/ml PHYSICIAN SAMPLE ONLY NOT FOR SALE For subcutaneous use in the abdomen only Sterile Solution. Do not refrigerate Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Autoinjector Sample NDC 71767-111-01 FUROSCIX ReadyFlow™ (furosemide injection) 80 mg/ml SAMPLE NOT FOR SALE Single dose prefilled autoinjector For subcutaneous use in the abdomen only. Do not refrigerate or freeze. Rx Only

Source Document#

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VersionEffective dateSourceHydrated
182025-12-23full-release2026-05-31 21:52:46