Reinforces the company’s efforts to innovate nutrition formulations and delivery mechanisms to meet the needs of patients
PHOENIX, Ariz. - March 26, 2019
Baxter International Inc. (NYSE:BAX), a global leader in clinical nutrition, today announced it will launch Clinolipid (20% Lipid Injectable Emulsion), its proprietary olive oil-based lipid emulsion, in the U.S. later this year — marking the growth of Baxter's lipid portfolio. The announcement was made at the 2019 ASPEN Nutrition Science & Practice Conference, where Baxter featured its diverse portfolio of parenteral nutrition (PN) products to focus on and help improve care for malnourished patients.
Attendees visited booth #601 to see product demonstrations of Baxter's comprehensive clinical nutrition portfolio including PN premix IV solutions, vitamins and lipids in addition to its labeling and compounding technologies. Information was also available regarding Baxter's work to advance educational opportunities for clinicians, including the “Smart PN” collaboration launched with ASPEN last year to help reduce clinical malnutrition.
“Our engagement with ASPEN has one aspiration in mind — reduce clinical malnutrition and find better outcomes for patients so that everyone has a chance for a life full of possibility,” said Jorge Vasseur, general manager of Baxter’s Clinical Nutrition business. “We’re excited to join this year's conference to showcase the latest product innovations that will continue to advance nutritional therapy now and for generations to come.”
For patients who cannot maintain a sufficient source of calories orally or enterally, such as critically ill patients and those who have undergone major surgery, PN is prescribed as an intravenous administration of nourishment. PN may include proteins, carbohydrates, fats, electrolytes, vitamins and other trace elements and plays a critical role in helping reduce malnutrition and achieve stronger health outcomes. To learn more about Baxter’s global clinical nutrition therapies, visit https://www.baxter.com/healthcare-professionals/nutritional-care.
About Baxter's Global Clinical Nutrition Business
Baxter has been assisting clinicians in treating patients' diverse nutrient needs since the 1940s, when the company first introduced liquid proteins in the form of amino acids. Since then, Baxter has continued to advance nutritional therapy. Baxter pioneered the world's first "triple-chamber system" internationally for IV nutrition, which provides many of the essential ingredients of balanced nutrition – protein, carbohydrates, lipids and electrolytes in a single container – simplifying the preparation of parenteral nutrition for patients.
Today, Baxter provides one of the broadest parenteral nutrition portfolios globally, which includes premix IV solutions, vitamins and lipids, as well as pharmacy workflow management, labeling and compounding technology. Baxter's lipid emulsions are available globally in multi-chamber, ready-to-use emulsions, and single-emulsion bags that can be added to a compounded or premixed bag to ensure clinicians can prescribe appropriate well-balanced therapy for their individual patients.
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.
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Important Safety Information for Clinolipid
Clinolipid 20% (Lipid Injectable Emulsion) for Intravenous Use Indication
Clinolipid injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
Clinolipid injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that Clinolipid injection provides sufficient amounts of essential fatty acids in this population.
The omega-3: omega-6 fatty acid ratio in Clinolipid injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
Important Risk Information
The use of Clinolipid injection is contraindicated in patients with the following:
- Known hypersensitivity to egg or soybean proteins, the lipid emulsion and/or excipients.
- Severe hyperlipidemia or severe disorders of lipid metabolism
Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.
Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.
Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.
Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.
Content of vitamin K may counteract anticoagulant activity.
Clinolipid injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.
Reduce dose of Clinolipid injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL.
The most common (5%) adverse drug reactions reported during Clinolipid injection clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
This release includes forward-looking statements concerning Clinolipid, including potential benefits associated with its use and its anticipated launch date. 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 Clinolipid are registered trademarks of Baxter International Inc.