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Approved by the FDA on October 18, 2024 for the treatment of congestion due to fluid overload in adults with chronic heart failure.

Lasix® ONYU

Lasix ONYU is not yet available for sale.

Lasix ONYU is expected to be available for sale in January 2025. It will be distributed through leading pharmaceutical distributors to allow it to be available at the patient encounter in clinic or Emergency Department.

We partner with heart failure programs to develop workflows to take advantage of this new option for decongestion at home.

Interested in learning more?

Contact us to explore how Lasix ONYU can help you provide effective decongestion at home to more of your patients.

What is Lasix® ONYU (furosemide injection) for subcutaneous use?

Lasix® ONYU is a prescription drug-device combination that treats congestion caused by fluid build-up in a person with heart failure. Lasix® ONYU comes with a special device that delivers the medicine under the skin. Follow the instructions provided by your healthcare provider when using Lasix® ONYU.

What else should you know about Lasix® ONYU?

Lasix® ONYU is a prescription drug-device combination based on a loop diuretic and is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart. Lasix® ONYU comes with a proprietary Infusor for subcutaneous delivery of 80mg furosemide over 5hrs. You should read the FDA-approved patient labeling including the Instructions for Use prior to using.

IMPORTANT SAFETY INFORMATION

Before taking Lasix® ONYU, read the Instructions for Use and tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • have trouble urinating.
  • are allergic to furosemide or any of the ingredients of Lasix® ONYU.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lasix® ONYU and other medicines may affect each other, causing side effects or change how the medicines work.

What are the possible side effects of Lasix® ONYU?

Dehydration: Lasix® ONYU can cause you to lose excess water and electrolytes. Symptoms of excess water and electrolyte loss include dry mouth, increased thirst, muscle pains or cramps, decreased urine output or urine more yellow than normal, headache, dry skin, nausea or vomiting. Your healthcare provider may check your electrolytes while receiving Lasix® ONYU.

Low Blood Pressure: Lasix® ONYU may cause your blood pressure to decrease temporarily. You may feel lightheaded or dizzy, particularly when you stand up. Getting up slowly may help.

High Blood Sugar: If you have diabetes mellitus, Lasix® ONYU may increase blood glucose levels.

Loss of Hearing: Lasix® ONYU can cause ringing in your ears. Tell your healthcare provider if you have trouble hearing while taking Lasix® ONYU.

Your skin may be more sensitive to sunlight while taking Lasix® ONYU.

The most common side effects with Lasix® ONYU are administration site and skin reactions such as: bruising, redness, swelling and infusion site pain.

These are not all the possible side effects of Lasix® ONYU. For more information, including medical advice about side effects, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.You may report side effects to the FDA at 1-800-FDA-1088.

Please see Lasix® ONYU full Prescribing Information and Instructions for Use.

INDICATION & LIMITATION OF USE

Lasix® ONYU is a prescription drug-device combination based on a loop diuretic and is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart. Lasix® ONYU comes with a proprietary Infusor for subcutaneous delivery of 80mg furosemide over 5hrs. Advise the patient and/or caregiver to read the FDA-approved patient labeling including the Instructions for Use.

IMPORTANT SAFETY INFORMATION

Contraindications

Lasix® ONYU is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the Lasix® ONYU formulation, or medical adhesives, and in patients with hepatic cirrhosis or ascites.

Warnings and Precautions
Fluid, Electrolyte, and Metabolic Abnormalities

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Worsening Renal Function

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Ototoxicity

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

Acute Urinary Retention

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Adverse Reactions

The most common adverse reactions with Lasix® ONYU administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see Lasix® ONYU full Prescribing Information and Instructions for Use.