Lasix ONYU is a loop diuretic indicated for the treatment of edema in adult patients with chronic heart failure. (1.1)

Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure.

• The Infusor is pre-programmed to deliver 30 mg of Lasix ONYU over the first hour then 12.5 mg per hour for the subsequent 4 hours. (2.1)
• Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical. (2.1)
• See Full Prescribing Information for important administration instructions. (2.2)

The Infusor with single-dose prefilled cartridge delivers 30 mg of Lasix ONYU over the first hour followed by 12.5 mg per hour for the subsequent 4 hours [see Clinical Pharmacology (12)]. Administer Lasix ONYU once or twice daily as needed for edema. Lasix ONYU is not for chronic use and should be replaced with oral diuretics as soon as practical.

Lasix ONYU is intended for use in a setting where the patient can limit their activity for the duration of administration [see Warnings and Precautions (5.5)].

The Infusor for Lasix ONYU is not compatible with use in an MRI setting.

Inspect Lasix ONYU prefilled cartridge prior to administration. Lasix ONYU is a clear to slightly yellow solution. Do not use Lasix ONYU if solution is discolored or cloudy [see Description (11)] .

Refer to the Instructions for Use for additional information.

Push the Lasix ONYU prefilled cartridge into Disposable Unit. Slide the Reusable Unit and Disposable Unit together until the Status Light on the Reusable Unit turns on. The Infusor will remain ready to start infusion for 7 hours.

Peel away the paper liner on the Infusor and apply onto a clean, dry area of the abdomen between the top of the beltline and the bottom of the ribcage that is not tender, bruised, red, or indurated. Make sure the Status Lights and the Start/Stop Button are facing up in a horizontal position.

Start the injection by firmly pressing and holding the Start/Stop Button until you hear the motor and see the blue Status Light change to flashing slowly.

Do not remove until the injection is complete which is signaled by the solid blue Status Light and the OK tone (one long beep).

Rotate the site of each subcutaneous administration.

• Lasix ONYU is contraindicated in patients with anuria.
• Lasix ONYU is contraindicated in patients with a history of hypersensitivity to furosemide, any component of the Lasix ONYU formulation, or medical adhesives.

• Anuria. (4)
• Hypersensitivity to furosemide or medical adhesives. (4)

• Fluid, Electrolyte, and Metabolic Abnormalities: Monitor serum electrolytes, CO₂, BUN, creatinine, glucose, and uric acid. (5.1)
• Worsening Renal Function: Monitor for dehydration and azotemia. (5.2)
• Ototoxicity: Avoid higher than recommended doses. (5.3, 7.1)
• Acute Urinary Retention: Monitor patients with symptoms of urinary retention. (5.4)
• Incomplete Dosing: Fluid contact and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms. (5.5)

Furosemide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possible vascular thrombosis and embolism, particularly in elderly patients. Serum electrolytes, CO₂, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide [see Clinical Pharmacology (12.3)].

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. If the physician elects to use high-dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) [see Drug Interactions (7)].

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.

The Lasix ONYU Infusor should not come in contact with water or any other fluids (blood or drug product). Fluid contact with the Infusor circuit board can lead to device errors and premature termination of infusion.
The Lasix ONYU is intended for use in a setting where the patient can limit their activity for the duration of administration. Certain patient movements may cause interruption of device adherence to skin and premature termination of infusion.
Lasix ONYU should only be used in patients who can detect and respond to alarms to ensure a complete dose is administered.

The following important adverse reactions are discussed elsewhere in the labeling:

• Fluid, Electrolyte, and Metabolic Abnormalities [see Warnings and Precautions (5.1)].
• Ototoxicity [see Warnings and Precautions (5.3)]

The following adverse reactions associated with the use of furosemide were identified in clinical trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably, or to establish a causal relationship to drug exposure.

Adverse reactions are categorized below by organ system and listed by decreasing severity.

Gastrointestinal System Reactions: pancreatitis, jaundice (intrahepatic cholestatic jaundice), increased liver enzymes, anorexia, oral and gastric irritation, cramping, diarrhea, constipation, nausea, vomiting.

Systemic Hypersensitivity Reactions: severe anaphylactic or anaphylactoid reactions (e.g., with shock), systemic vasculitis, interstitial nephritis, necrotizing angiitis.

Central Nervous System Reactions: tinnitus and hearing loss, paresthesias, vertigo, dizziness, headache, blurred vision, xanthopsia.

Hematologic Reactions: aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia, anemia, eosinophilia.

Dermatologic Hypersensitivity Reactions: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid, purpura, photosensitivity, rash.

Cardiovascular Reactions: orthostatic hypotension, increase in cholesterol and triglyceride serum levels.

Administration Site and Skin Reactions: erythema, bruising, edema, infusion site pain.

Other Reactions: glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever.

The most common adverse reactions during treatment with the Lasix ONYU Infusor were administration site and skin reactions: erythema, bruising, edema, and infusion site pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact SQ Innovation, at 1-855-452-7496 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.