FDA Approves Furoscix ReadyFlow, First Autoinjector for IV Furosemide

The FDA approved furosemide injection (Furoscix ReadyFlow), an autoinjector from MannKind Corporation, for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD). The approval marks the first autoinjector capable of delivering subcutaneous furosemide with intravenous (IV)-equivalent exposure, based on comparisons of area under the curve (AUC) and pharmacodynamic end points.^1,2

The device delivers a full 80 mg/mL dose in under 10 seconds, with symptom relief that may begin in an hour or less.¹

What Does Furoscix ReadyFlow Offer Patients?

Furoscix ReadyFlow is designed to help adults with HF or CKD address fluid overload earlier, before worsening symptoms lead to emergency department visits, hospitalization, or readmission. The medicine is absorbed into the bloodstream and is intended to extend IV-equivalent furosemide exposure into outpatient, postdischarge, and home-based care settings.^1,2

“Too often, patients living with heart failure or CKD find themselves caught in a cycle of worsening fluid overload that can disrupt daily life and lead to ER visits and hospitalization,” Hunter Champion, MD, PhD, of Emory University Healthcare Network and director of the Heart Failure and Pulmonary Hypertension program at Southeastern Cardiology Associates in Columbus, Georgia, said in the news release.¹ “An at-home option that delivers similar IV-equivalent furosemide exposure through a simple autoinjector gives clinicians an important new tool to intervene as soon as signs and symptoms of fluid overload appear.”

Furosemide injection (Furoscix), delivered via an on-body infuser, was first approved in 2022 for adult patients with edema in HF, followed by an expanded approval for CKD in 2025. That device requires approximately 5 hours to deliver a full dose, and the autoinjector reduces that to 10 seconds or less.^1-3

What Clinical Data Supported the Approval?

The approval is supported by an open-label, single-dose, randomized, 2-way crossover phase 1 trial (NCT06167707) comparing the pharmacokinetics and pharmacodynamics of subcutaneous furosemide with IV furosemide in 21 healthy volunteers aged 45 to 80 years.^1,2,4 Participants were randomly assigned to receive the IV formulation followed by the autoinjector or the reverse sequence.

The autoinjector demonstrated approximately 107.3% bioavailability (90% CI, 103.9-110.8), meeting the 90% CI limit of 80% to 125% for bioequivalence. Participants who received the autoinjector had urine output and urinary sodium and potassium excretion similar to those on IV furosemide at the 6-, 8-, and 12-hour marks and reported a median pain score of 0 across all assessed time points.^1,2

The most common adverse events were localized to the injection site, with systemic adverse events consistent with those in the prescribing information for oral and IV furosemide formulations. The autoinjector is contraindicated in patients with anuria and in those with a history of hypersensitivity to furosemide, any component of the Furoscix formulation, or medical adhesives.²

“The approval of Furoscix ReadyFlow marks an important milestone for patients living with heart failure or chronic kidney disease who experience fluid overload,” Michael Castagna, PharmD, CEO of MannKind Corporation, said in the news release.¹ “By combining IV-equivalent diuretic performance with the simplicity of an autoinjector, Furoscix ReadyFlow has the potential to advance how fluid overload is managed outside traditional care settings.”

What Does This Mean for Pharmacists?

HF affects approximately 6.7 million adults in the United States and is projected to affect more than 8 million by 2030. Fluid overload is a leading driver of HF- and CKD-related emergency visits and hospitalizations, and HF hospitalizations account for approximately 80% of HF-related health care costs, which are projected to reach at least $70 billion annually by 2030.¹

For pharmacists counseling patients on furosemide therapy generally, key safety points include monitoring for dehydration and electrolyte loss (dry mouth, increased thirst, and muscle cramps); low blood pressure with position changes; elevated blood glucose in patients with diabetes; and ototoxicity symptoms such as ringing in the ears.^1,5

Patients should also be counseled that furosemide can increase skin sensitivity to sunlight. With the ReadyFlow autoinjector specifically, pharmacists should reinforce that an incomplete dose—indicated by the viewing window not turning fully yellow or removal from the skin too early—requires contacting a health care provider rather than self-administering a second dose.^1,5

Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026. MannKind's Furoscix Direct program offers dedicated support for patients, caregivers, and health care providers navigating access and coverage questions.¹

REFERENCES

1. MannKind Announces FDA Approval of Furoscix ReadyFlow™, the First and Only Autoinjector Delivering IV-Equivalent Diuretic Therapy for the Treatment of Edema in Adults with Heart Failure or Chronic Kidney Disease. News release. MannKind Corporation. July 24, 2026. Accessed July 24, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-furoscix-readyflowtm-first-and

2. McGovern G. FDA Approves Furosemide Autoinjector for Treatment of Edema in CKD or Heart Failure. Pharmacy Times. July 24, 2026. Accessed July 24, 2026. https://www.pharmacytimes.com/view/fda-approves-furosemide-autoinjector-for-treatment-of-edema-in-ckd-or-heart-failure

3. McGovern G. FDA Approves Expansion for Furosemide Injection to Treat Edema in Patients With CKD. Pharmacy Times. March 6, 2025. Accessed July 24, 2026. https://www.pharmacytimes.com/view/fda-approves-expansion-for-furosemide-injection-to-treat-edema-in-patients-with-ckd

4. Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers. ClinicalTrials.gov identifier: NCT06167707. Updated March 30, 2026. Accessed July 24, 2026. https://clinicaltrials.gov/study/NCT06167707

5. Furosemide (injection route). Mayo Clinic. Portions last updated June 1, 2026. Accessed July 24, 2026. https://www.mayoclinic.org/drugs-supplements/furosemide-injection-route/description/drg-20071261