Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Lasix ONYU injection is a sterile, clear to slightly yellow, non-pyrogenic liquid supplied in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with a Disposable Unit. The Infusor with single-dose prefilled cartridge is designed to deliver 80 mg of Lasix ONYU in 2.67 mL solution over 5 hours. Lasix ONYU Kit: Carton containing one 80 mg/2.67 mL single-dose prefilled cartridge co-packaged with a Disposable Unit and two alcohol pads. NDC 81137‐001‐15 Starter Kit: Carton containing three Lasix ONYU Kits co-packaged with one Reusable Unit and one wall charger. NDC 81137‐001‐35 Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect Lasix ONYU from light. Do not remove the prefilled cartridge from carton until it is ready for use. Do not use if the solution is discolored or cloudy. Protect the Infusor from water.; Treatment Kit Label Artwork Starter Kit Label Artwork treatment-kit starter-kit
- 16 HOW SUPPLIED/STORAGE AND HANDLING Lasix ONYU injection is a sterile, clear to slightly yellow, non-pyrogenic liquid supplied in a single-dose prefilled cartridge for subcutaneous infusion co-packaged with a Disposable Unit. The Infusor with single-dose prefilled cartridge is designed to deliver 80 mg of Lasix ONYU in 2.67 mL solution over 5 hours. Lasix ONYU Kit: Carton containing one 80 mg/2.67 mL single-dose prefilled cartridge co-packaged with a Disposable Unit and two alcohol pads. NDC 81137‐001‐15 Starter Kit: Carton containing three Lasix ONYU Kits co-packaged with one Reusable Unit and one wall charger. NDC 81137‐001‐35 Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect Lasix ONYU from light. Do not remove the prefilled cartridge from carton until it is ready for use. Do not use if the solution is discolored or cloudy. Protect the Infusor from water.
- Treatment Kit Label Artwork Starter Kit Label Artwork treatment-kit starter-kit
Overview
Lasix ONYU (furosemide injection) for subcutaneous use is a loop diuretic. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow crystalline powder. It is sparingly soluble in alcohol, freely soluble in dilute alkali solutions, and insoluble in dilute acids. The structural formula is as follows: Molecular Formula: C 12 H 11 ClN 2 O 5 S Molecular Weight: 330.75 g/mol Lasix ONYU is a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor. The single-dose prefilled cartridge contains 80 mg furosemide in a 2.67 mL sterile, clear to slightly yellow, and nonpyrogenic aqueous solution. The pH of Lasix ONYU, 7.5, differs from that of Furosemide Injection, USP. Each 1 mL dose of Lasix ONYU contains 30 mg of furosemide and the following inactive ingredients: betadex sulfobutyl ether sodium (300 mg), hydrochloric acid for pH adjustment if needed, sodium hydroxide for pH adjustment if needed, tromethamine (3 mg), and water for injection (q.s.). Each single-dose of Lasix ONYU is administered via an electromechanical (battery powered, microprocessor controlled) Infusor, pre-programmed to deliver 80 mg of Lasix ONYU over 5-hours using a bi-phasic delivery profile. The Infusor consists of a custom Reusable Unit which can be used for close to 50 treatments. The Reusable Unit is used with a Disposable Unit and single-dose prefilled cartridge which are provided together for the user as a Lasix ONYU Kit. The Disposable Unit must be discarded after use. image-Structure
Indications & Usage
Lasix ONYU is a loop diuretic indicated for the treatment of edema in adult patients with chronic heart failure. ( 1.1 ) 1.1 Congestion Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure. 1.1 Congestion Lasix ONYU is indicated for the treatment of edema in adult patients with chronic heart failure.
Dosage & Administration
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 ) 2.1 Dosage 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. 2.2 Important Administration Instructions 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. 2.1 Dosage 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. 2.2 Important Administration Instructions 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.
Warnings & Precautions
Fluid, Electrolyte, and Metabolic Abnormalities : Monitor serum electrolytes, CO 2 , 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 ) 5.1 Fluid, Electrolyte, and Metabolic Abnormalities 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, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. 5.2 Worsening Renal Function 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 )]. 5.3 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. 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 )]. 5.4 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. 5.5 Incomplete Dosing 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. 5.1 Fluid, Electrolyte, and Metabolic Abnormalities 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, CO 2 , BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. 5.2 Worsening Renal Function 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 )]. 5.3 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. 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 )]. 5.4 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. 5.5 Incomplete Dosing 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.
Contraindications
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 )
Adverse Reactions
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.
Drug Interactions
Aminoglycoside antibiotics : Increased potential ototoxicity of the antibiotics. Avoid combination. ( 7.1 ) Ethacrynic acid : Risk of ototoxicity. Avoid combination. ( 7.1 ) Salicylates : Risk of salicylate toxicity. ( 7.1 ) Cisplatin and nephrotoxic drugs : Risk of ototoxicity and nephrotoxicity. ( 7.1 ) Lithium : Risk of lithium toxicity. ( 7.1 ) Renin-angiotensin inhibitors : Increased risk of hypotension and renal failure. ( 7.1 ) Adrenergic blocking drugs : Risk of potentiation. ( 7.1 ) Drugs undergoing renal tubular secretion : Risk of toxicity potentiation. ( 7.1 ) 7.1 Effects of Furosemide on Other Drugs Table 1: Effects of Furosemide on Other Drugs Drug/Substance Class or Name Drug Interaction Effect Recommendations Aminoglycoside antibiotics Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function [see Warnings and Precautions ( 5.3 )]. Avoid combination except in life-threatening situations. Ethacrynic acid Possibility of ototoxicity [see Warnings and Precautions ( 5.3 )]. Avoid concomitant use with ethacrynic acid. Salicylates May experience salicylate toxicity at lower doses because of competitive renal excretory sites. Monitor for symptoms of salicylate toxicity. Cisplatin Cisplatin and nephrotoxic drugs There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions ( 5.3 )]. Nephrotoxicity Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function. Paralytic agents Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Monitor for skeletal muscle effect. Lithium Furosemide reduces lithium’s renal clearance and adds a high-risk of lithium toxicity. Avoid concomitant use with lithium. Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers May lead to severe hypotension and deterioration in renal function, including renal failure. Monitor for changes in blood pressure and renal function and interrupt or reduce the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers if needed. Antihypertensive drugs Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Monitor for changes in blood pressure and adjust the dose of other antihypertensive drugs if needed. Adrenergic blocking drugs or peripheral adrenergic blocking drugs Potentiation occurs. Monitor for changes in blood pressure and adjust the dose of adrenergic blocking drugs if needed. Norepinephrine Furosemide may decrease arterial responsiveness (vasoconstricting effect) to norepinephrine. Monitor blood pressure (or mean arterial pressure). Chloral hydrate In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Concomitant use with chloral hydrate is not recommended. Methotrexate and other drugs undergoing renal tubular secretion Furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of furosemide may result in elevated serum levels of these drugs and may potentiate their toxicity. Monitor serum levels of drugs undergoing renal tubular secretion and adjust the dose if needed. Cephalosporin Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment. Monitor for changes in renal function. Cyclosporine Increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. Monitor serum urate levels. Thyroid hormones High doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Monitor the total thyroid hormone levels. 7.2 Effect of Other Drugs on Furosemide Table 2: Effect of Other Drugs on Furosemide Drug/Substance Class or Name Drug Interaction Effect Recommendations Phenytoin Phenytoin interferes directly with renal action of furosemide. Monitor diuretic effects of furosemide and adjust the dose of furosemide if needed. Methotrexate and other drugs undergoing renal tubular secretion May reduce the effect of furosemide. High-dose treatment of methotrexate and these other drugs may result in elevated serum levels of furosemide and may potentiate the toxicity of furosemide. Monitor for enhanced toxicity of furosemide. Indomethacin Coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. 7.1 Effects of Furosemide on Other Drugs Table 1: Effects of Furosemide on Other Drugs Drug/Substance Class or Name Drug Interaction Effect Recommendations Aminoglycoside antibiotics Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function [see Warnings and Precautions ( 5.3 )]. Avoid combination except in life-threatening situations. Ethacrynic acid Possibility of ototoxicity [see Warnings and Precautions ( 5.3 )]. Avoid concomitant use with ethacrynic acid. Salicylates May experience salicylate toxicity at lower doses because of competitive renal excretory sites. Monitor for symptoms of salicylate toxicity. Cisplatin Cisplatin and nephrotoxic drugs There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly [see Warnings and Precautions ( 5.3 )]. Nephrotoxicity Administer furosemide at lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Monitor renal function. Paralytic agents Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Monitor for skeletal muscle effect. Lithium Furosemide reduces lithium’s renal clearance and adds a high-risk of lithium toxicity. Avoid concomitant use with lithium. Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers May lead to severe hypotension and deterioration in renal function, including renal failure. Monitor for changes in blood pressure and renal function and interrupt or reduce the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers if needed. Antihypertensive drugs Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Monitor for changes in blood pressure and adjust the dose of other antihypertensive drugs if needed. Adrenergic blocking drugs or peripheral adrenergic blocking drugs Potentiation occurs. Monitor for changes in blood pressure and adjust the dose of adrenergic blocking drugs if needed. Norepinephrine Furosemide may decrease arterial responsiveness (vasoconstricting effect) to norepinephrine. Monitor blood pressure (or mean arterial pressure). Chloral hydrate In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Concomitant use with chloral hydrate is not recommended. Methotrexate and other drugs undergoing renal tubular secretion Furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of furosemide may result in elevated serum levels of these drugs and may potentiate their toxicity. Monitor serum levels of drugs undergoing renal tubular secretion and adjust the dose if needed. Cephalosporin Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment. Monitor for changes in renal function. Cyclosporine Increased risk of gouty arthritis secondary to furosemide-induced hyperuricemia and cyclosporine impairment of renal urate excretion. Monitor serum urate levels. Thyroid hormones High doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Monitor the total thyroid hormone levels. 7.2 Effect of Other Drugs on Furosemide Table 2: Effect of Other Drugs on Furosemide Drug/Substance Class or Name Drug Interaction Effect Recommendations Phenytoin Phenytoin interferes directly with renal action of furosemide. Monitor diuretic effects of furosemide and adjust the dose of furosemide if needed. Methotrexate and other drugs undergoing renal tubular secretion May reduce the effect of furosemide. High-dose treatment of methotrexate and these other drugs may result in elevated serum levels of furosemide and may potentiate the toxicity of furosemide. Monitor for enhanced toxicity of furosemide. Indomethacin Coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
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