MedPath

Furosemide

Generic Name
Furosemide
Brand Names
Furoscix, Lasix
Drug Type
Small Molecule
Chemical Formula
C12H11ClN2O5S
CAS Number
54-31-9
Unique Ingredient Identifier
7LXU5N7ZO5
Background

Furosemide is a potent loop diuretic that acts on the kidneys to ultimately increase water loss from the body. It is an anthranilic acid derivative. Furosemide is used for edema secondary to various clinical conditions, such as congestive heart failure exacerbation, liver failure, renal failure, and high blood pressure. It mainly works by inhibiting electrolyte reabsorption from the kidneys and enhancing the excretion of water from the body. Furosemide has a fast onset and short duration of action and has been used safely and effectively in both pediatric and adult patients. The use of furosemide is particularly beneficial in clinical settings that require a drug with a higher diuretic potential. In addition to oral formulations, the solution for intravenous and intramuscular administration is also available, which is typically limited to patients who are unable to take oral medication or for patients in emergency clinical situations.

Indication

Furosemide is indicated for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome, in adults and pediatric patients.

Oral furosemide is indicated alone for the management of mild to moderate hypertension or severe hypertension in combination with other antihypertensive medications.

Intravenous furosemide is indicated as adjunctive therapy in acute pulmonary edema when a rapid onset of diuresis is desired.

Subcutaneous furosemide is indicated for the treatment of congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure. This drug formulation is not indicated for emergency situations or in patients with acute pulmonary edema.

Associated Conditions
Acute Pulmonary Edema, Ascites, Body Fluid Retention, Edema, Hypertension, Mild to Moderate Hypertension, Chest congestion

FDA Expands Furoscix Approval to Include Edema Treatment in CKD Patients

• The FDA has approved scPharmaceuticals' supplemental New Drug Application for Furoscix, extending its use to treat edema in chronic kidney disease patients, with availability expected in April 2025. • Furoscix becomes the first subcutaneous loop diuretic approved for both heart failure and CKD patients, offering an at-home alternative to traditional IV diuretic therapy. • The approval was granted without requiring additional clinical studies, based on demonstrating adequate pharmacokinetic and pharmacodynamic equivalence to standard furosemide injection.

Advancements in Bronchopulmonary Dysplasia Treatment: A Look into the 2024 Pipeline

The 2024 Bronchopulmonary Dysplasia (BPD) pipeline showcases significant progress with over 12 companies developing therapies. Key developments include Airway Therapeutics, Inc.'s Phase 3 trial for zelpultide alfa and Chiesi Farmaceutici SpA's collaboration with Oak Hill Bio on OHB-607. These efforts aim to address the unmet needs in BPD treatment, particularly for preterm infants.

SQ Innovation's Lasix ONYU Receives Tentative FDA Approval for Congestive Heart Failure Treatment

• SQ Innovation's Lasix ONYU, a combination of furosemide and an on-body device, receives tentative FDA approval for treating fluid overload in congestive heart failure. • The device, developed with Gerresheimer, allows precise, controlled drug administration and is designed for patient comfort and environmental sustainability. • Lasix ONYU aims to reduce healthcare costs by enabling home treatment, potentially decreasing hospital stays for elderly patients with heart failure. • Full FDA approval is expected after October 2025, following the expiration of a competitor's market exclusivity, with product availability anticipated by late 2025.

Regulatory Updates in Cardiometabolic Health: Hypertension, Lipids, and Diabetes Therapies

• The FDA approved an expanded indication for subcutaneous furosemide injection for heart failure patients, offering a convenient self-administration option. • Aprocitentan received FDA approval for hypertension, providing a new treatment option for adults with uncontrolled blood pressure despite other medications. • The FDA cleared a continuous glucose monitoring (CGM) system featuring an implantable sensor lasting up to one year for diabetes management.

FDA Expands Furoscix Indication to Include NYHA Class IV Heart Failure Patients

• The FDA has approved scPharmaceuticals' supplemental New Drug Application (sNDA) for Furoscix, expanding its indication to include NYHA Class IV chronic heart failure patients. • This expansion allows Furoscix to be used in the most symptomatic heart failure patients, who experience the greatest limitations on physical activity, representing approximately 10% of all heart failure patients. • Furoscix offers a potential alternative to hospital admission or readmission for managing congestion due to fluid overload in adult patients with chronic heart failure. • Furoscix is designed for subcutaneous self-administration, offering an outpatient treatment option for heart failure patients.
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