FUROSCIX

FUROSCIX is an FDA-registered drug product whose active ingredient is FUROSEMIDE INJECTION 80 MG/ 10 ML. It is labelled by scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 71767-100, application NDA209988, label effective 20260731. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FUROSEMIDE INJECTION 80 MG/ 10 ML are most often described in connection with: treatment edema, pediatric patients, chronic heart, kidney disease, nephrotic syndrome, usage furoscix, ckd including, loop diuretic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 ) 2.1 Recommended 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 )]. 2.2 Important 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.

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 )

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.

What is FUROSCIX used for?
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 …

Who makes FUROSCIX?
scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation is the labeler of record for FUROSCIX.

What form does FUROSCIX come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is FUROSCIX prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has FUROSCIX been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.