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About the Design of the Lasix ONYU Infusor

The Infusor was designed specifically for the administration of furosemide to patients with heart failure. We considered the needs of the patient, the provider, the payor and the environment.

The Infusor has three components:

  1. Reusable Unit: A personal device that can be used up to 48 times. It contains a small electromotor, battery and electronics. It is charged before each each use, which takes less that 10 minutes.
  2. Disposable Unit: A sterile single use plastic component that includes everything in contact with the drug or body, including a very thin needle for the infusion. The needle comes out when the infusion starts and retracts at completion.

  3. Drug Cartridge: A prefilled glass cartridge containing 80mg furosemide in 2.67mL (30mg/mL).

Read Important Safety Information and the step-by-step instructions in the Instructions for Use before using the Infusor.

Designed for the Patient

The patient is our most important customer. First, we wanted the Infusor to be small and light for comfort during use, and so we could use a more gentle medical tape. This may sound trivial, but the abdominal skin of the elderly is fragile and removing more aggressive tape may hurt and cause bruising or skin damage. We are using a 3M medical tape that has been used since 1980 and is known to be one of the most gentle medical tapes. Unfortunately, some patients may still have a reaction, which in most cases is slight redness that goes away quickly (See Important Safety Information and Prescribing Information).

Designed for the Provider

Treating worsening heart failure and decongestion have clinical workflows. We wanted our new treatment to fit how clinicians want to take care of patients with heart failure. One of the most common workflows is that the patient with congestion due to fluid overload will be seen in the outpatient clinic or Emergency Department. Some patients are too sick or going home is not an option. These patients need to be admitted for treatment. However, there are also patients who have bothersome symptoms due to fluid overload and who just need parenteral diuretic treatment. In other words, there is no other clinical reason for admission and the patient is a good candidate to be treated at home. In many cases, clinicians want to instruct the patient there and then. The best ways of doing this is by preparing the first treatment together. Our design allows training of the patient, preparing and placing the device and then having the patient travel home. Upon arriving home, the patient can press the button and start treatment. Our Infusor allows for 7 hours between placement and starting therapy — more than enough time for almost every patient to reach the comfort of their home.

Designed for the Payor

Money for healthcare is tight. Widespread adoption and easy availability requires that payors also benefit. At home treatment with Lasix ONYU should be one of the most affordable options available when the patient is a good candidate. Electronics are expensive and the materials they use are scarce. Patch pumps like the Infusor contain a motor, controllers (chips), LEDs, and a battery. Our Infusor can be used up to 48 times, after which it can be recycled. The DU is manufactured on a high-capacity robotic line. All combined, this allows Lasix ONYU to be affordable to the benefit of patient and payor. 

Designed for the Planet

Medical waste is incinerated and ends up in landfills. This includes single-use medical products with electronics. This is also an important reason why we selected the two-component design. Our two-component design assures that the electronic components and the battery are not part of the medical waste. First, the electronics can be used for 48 treatments and second, the electronics can be recycled. We also wanted to avoid chemical sterilization. Medical devices with electronic components are commonly sterilized with chemicals, most commonly ethylene oxide, a known carcinogen. Because of these concerns, the FDA, the US Department of Labor and the Environmental Protection Agency all promote alternatives to ethylene-oxide. Because the sterile single use component (DU) does not contain electronics, we can safely sterilize with radiation and avoid the chemicals.

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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.