Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with New Concentration

Rhea-AI Summary

Endo (OTCQX: NDOI) has announced the launch of ADRENALIN® 8 mg/250 mL premixed bag, expanding its ready-to-use epinephrine product line. The product will begin shipping on May 19, 2025. ADRENALIN® holds the distinction of being the first FDA-approved and only commercially available manufacturer-prepared epinephrine premixed IV bag. The product offers key benefits including no compounding requirements, single-port IV tubing, and 24-month shelf life at room temperature. The company currently offers 4 mg/250 mL premixed bags and plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations. ADRENALIN® is indicated for increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock.

Positive

• First and only FDA-approved manufacturer-prepared epinephrine premixed IV bag in the market
• Product expansion with new concentration (8 mg/250 mL) and additional concentrations in pipeline
• 24-month shelf life at room temperature, reducing storage complications
• Potential cost reduction and operational efficiency for hospitals by eliminating preparation needs

Negative

• Multiple serious potential adverse reactions including cardiac arrhythmias and pulmonary edema
• Risk of tissue necrosis and gangrene if extravasation occurs
• Significant drug interaction risks with multiple common medications

Endo's products are the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed intravenous (IV) bag

MALVERN, Pa., May 15, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of ADRENALIN^® (epinephrine in 0.9% sodium chloride injection) 8 mg/250 mL premixed bag and will begin shipping the product the week of May 19, 2025. ADRENALIN^® is the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed IV bag.

"Hospital pharmacists and healthcare providers are working harder than ever, and we are committed to supporting them with ready-to-use medicines that help reduce complexity and streamline operations so they can focus on what matters most—patient care," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "With this new ADRENALIN^® premixed bag concentration, plus the additional concentrations in our pipeline, we are proud to offer options and choice through our TruDelivery^® portfolio."

Key product benefits include:

• No compounding or preparation required
• Single-port IV tubing to reduce the risk of inadvertent mixture
• 24-month shelf life at room temperature

The ADRENALIN^® premixed bag is part of Endo Injectable Solutions' TruDelivery^® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care.

In addition to the new 8 mg/250 mL bag, Endo offers ADRENALIN^® 4 mg/250 mL premixed bag and plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations. The company also offers ADRENALIN^® (epinephrine injection, USP) 1 mL single-dose and 30 mL multi-dose vials.

ADRENALIN^® is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

IMPORTANT SAFETY INFORMATION 

WARNINGS AND PRECAUTIONS
Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine.

Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.

Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.

Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough.

Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.

Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment.

ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.

DRUG INTERACTIONS:

• Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids.
• Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines.
• Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias.
• Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.

USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.

Click for Full Prescribing Information.

About Endo
Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product shipments, commercial availability, product benefits, reduction of waste, costs and errors, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and Form 10-Q.

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SOURCE Endo, Inc.

FAQ

What is the new ADRENALIN concentration launched by Endo (NDOI) in May 2025?

Endo launched ADRENALIN® 8 mg/250 mL premixed bag, which will begin shipping the week of May 19, 2025.

What are the key benefits of Endo's ADRENALIN premixed bags?

Key benefits include no compounding or preparation required, single-port IV tubing to reduce inadvertent mixture risk, and 24-month shelf life at room temperature.

What concentrations of ADRENALIN premixed bags does Endo offer or plan to launch?

Endo currently offers 4 mg/250 mL and 8 mg/250 mL premixed bags, with plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations.

What is the primary medical indication for ADRENALIN?

ADRENALIN is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

What are the main safety concerns with ADRENALIN administration?

Main safety concerns include risks of hypertension, pulmonary edema, cardiac arrhythmias, tissue necrosis from extravasation, and potential drug interactions with various medications.