Baxter Announces U.S. FDA Approval and Launch of Ready-To-Use Cardiovascular Medicine Eptifibatide

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DEERFIELD, Ill. - 2019-03-06

Baxter International Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval and launch of ready-to-use eptifibatide. Baxter’s presentation of eptifibatide is the first of its kind available in a flexible container.

"Hospital pharmacists are unsung heroes working behind the scenes to make sure every dose of medication is delivered accurately and on-time to patients," said Robert Felicelli, president, Pharmaceuticals, Baxter. "By adding more essential premix medicines—like eptifibatide—to Baxter's broad portfolio, we can help support pharmacy efficiency, reduce waste and enhance patient safety."

Eptifibatide is a platelet aggregation inhibitor that prevents platelets—specialized blood cells—from sticking together and clotting. Eptifibatide is indicated for medical treatment of acute coronary syndrome (ACS), a broad term that includes heart attack and other emergency conditions in which the blood supply to the heart is suddenly stopped. Eptifibatide is also indicated for treatment of patients undergoing percutaneous coronary intervention (PCI), in which physicians insert a catheter to visualize and open blocked coronary arteries and may, if needed, implant a mesh tube, called a stent, to keep the artery open. 

Like other medicines in Baxter's premix portfolio, eptifibatide uses Baxter’s proprietary GALAXY container technology. GALAXY is a non-PVC and non-DEHP system that enables premixed medicines to have a longer shelf life when stored at room temperature. Premixed formats of standard doses of commonly prescribed drugs offer efficiencies for hospitals by simplifying the preparation process. Premixes may also help enhance patient safety by avoiding potential dosing errors that may occur when medications are compounded, the process of combining different drug agents in specific quantities to fill individualized prescriptions.

Baxter premixed drugs are formulated to adhere to strict Current Good Manufacturing Practice (cGMP) regulations established and monitored by the FDA. Eptifibatide is currently available from Baxter in the United States.

About Baxter Pharmaceuticals

Baxter provides a wide range of high-value generic injectable medicines that help treat some of the most pressing healthcare needs facing patients today, including difficult-to-manufacture oncology drugs and standard-dose, ready-to-use premixed injectable anti-infectives, analgesics and critical care medicines. Baxter has rapidly expanded its pharmaceuticals portfolio through recent acquisitions, strategic partnerships and internal development programs that will help increase access to essential medicines and advance pharmacy efficiency and patient care. Baxter is also the first and only company to offer all three of the most commonly used modern inhaled anesthetics for general anesthesia.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

Rx Only. Please see accompanying full Prescribing Information.

Important Safety Information

Eptifibatide injection is a platelet aggregation inhibitor indicated for treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) and treatment of patients undergoing PCI (including intracoronary stenting).

Important Risk Information for Eptifibatide Injection:

Eptifibatide injection is contraindicated in patients with:

• Bleeding diathesis or bleeding within the previous 30 days
• Severe uncontrolled hypertension
• Major surgery within the preceding 6 weeks
• Stroke within 30 days or any history of hemorrhagic stroke
• Coadministration of another parenteral GP IIb/IIIa inhibitor
• Dependency on renal dialysis
• Known hypersensitivity

Eptifibatide can cause serious bleeding. If bleeding cannot be controlled, discontinue eptifibatide immediately. Minimize vascular and other traumas. If heparin is given concomitantly, monitor aPTT or ACT.

Thrombocytopenia: Discontinue eptifibatide and heparin. Monitor and treat condition appropriately.

Bleeding and hypotension are the most commonly reported adverse reactions.

Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Avoid concomitant use with other glycoprotein (GP) IIb/IIIa inhibitors.

Geriatric Use: Risk of bleeding increases with age.

This release includes forward-looking statements concerning ready-to-use eptifibatide, including expectations with regard to its availability in the U.S., the time thereof, and potential benefits associated with Baxter’s eptifibatide product and its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter and GALAXY are registered trademarks of Baxter International Inc.