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FDA approved Furoscix (furosemide) for Edema in Heart Failure and CKDFDA approved new diuretic Furoscix for heart and kidney patients

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Key Takeaway
Consider Furoscix for short-term subcutaneous diuresis in adults and children 43 kg+ with edema due to heart failure or CKD.

The FDA has approved Furoscix (furosemide) 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 nephrotic syndrome. Furoscix is a loop diuretic delivered subcutaneously via two devices: the ReadyFlow autoinjector (80 mg dose for adults) and the On-body Infusor (30 mg loading dose followed by 12.5 mg/hour for 4 hours). The approval provides a subcutaneous option for patients who require parenteral diuretic therapy but may not need intravenous access. However, the label emphasizes that Furoscix is not for chronic use and should be transitioned to oral diuretics as soon as clinically feasible.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Furosemide is a loop diuretic that inhibits the Na-K-2Cl symporter in the thick ascending limb of the loop of Henle, reducing sodium and chloride reabsorption and promoting diuresis.

Indication & Patient Population

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, including the nephrotic syndrome.

Dosing & Administration

Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical. Two formulations are available: the ReadyFlow autoinjector delivers 80 mg subcutaneously in about 10 seconds for adults only; the On-body Infusor delivers 30 mg subcutaneously over the first hour then 12.5 mg per hour for the subsequent 4 hours for adults and pediatric patients 43 kg and above. Administer to the abdomen only, rotating sites. In pediatric patients, the On-body Infusor must be administered by a healthcare provider or adult caregiver.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Furoscix provides a subcutaneous loop diuretic option for edema management in patients with heart failure or chronic kidney disease who require parenteral therapy. It is intended for short-term use and should be replaced with oral diuretics as soon as practical.

The FDA has approved a new drug called Furoscix (furosemide) to treat edema, which is swelling caused by extra fluid in the body. It is for adults and children who weigh at least 43 kg and have chronic heart failure or chronic kidney disease, including nephrotic syndrome. Furoscix is a loop diuretic, a type of medicine that helps the kidneys remove extra fluid. It is given as a shot under the skin, not through a vein. There are two ways to take it: a ReadyFlow autoinjector that gives a single 80 mg dose for adults, or an On-body Infusor that gives a 30 mg loading dose followed by 12.5 mg per hour for 4 hours. This approval is important because it offers a subcutaneous option for patients who need diuretic therapy but do not need an IV line. However, the drug label clearly states that Furoscix is not for chronic use. Patients should switch to oral diuretics as soon as their doctor says it is safe. If you have questions about whether Furoscix is right for you, talk to your healthcare provider. They can help you understand the benefits and risks based on your specific health situation.

What this means for you:
Furoscix is a new injectable diuretic for fluid buildup, but it is not for long term use.

Study Details

Study typeFda approval
PublishedOct 2022
View Original Abstract ↓
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 )
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