Fresenius Kabi Launches Smoflipid® in the United States

Lake Zurich, Ill., August 18, 2016 – Fresenius Kabi announced today it has launched Smoflipid® for use in adults. Smoflipid is the only intravenous fat emulsion (IVFE) available in the U.S. containing four oils - soybean oil, medium chain triglycerides (MCT), olive oil and fish oil.

Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition. The company received FDA approval for Smoflipid in July 2016.

“Fresenius Kabi is a global leader in clinical nutrition and the introduction of Smoflipid in the U.S. provides the opportunity to grow our clinical nutrition presence and share our expertise,” said John Ducker, president and CEO of Fresenius Kabi USA. “More importantly, Smoflipid is an essential therapy for parenteral nutrition patients and with its availability we have an opportunity to make a meaningful difference in the lives of millions of patients in the U.S.”

“For many years, U.S. clinicians have wanted an alternative to currently available soy-based lipid emulsions,” said Jay M. Mirtallo, M.S., R.Ph, BCNSP, FASHP, a past president and current member, Board of Advisors for the American Society for Parenteral and Enteral Nutrition. “Smoflipid is a new option for clinicians caring for patients requiring parenteral nutrition at a time when leading medical societies have issued guidelines reinforcing the need for alternative oil-based lipids in the U.S.”

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) and the Society of Critical Care Medicine (SCCM) issued updated guidelines in 2016 for nutrition support in critically ill adult patients, which, in part said alternative (oil-based) IVFEs may provide an outcome benefit over soy-based IVFEs and when available, consider the use of alternative IVFEs in critically ill patients who require parenteral nutrition.

“Since its first launch in 2004, Smoflipid has been used in more than six million patients throughout the world. With the introduction to the U.S. market, the product will now be available in more than 65 countries,” said Annemarie Diederich, executive vice president and head of Business Unit Parenteral Nutrition, Colloids & Ketosteril, Pharmaceuticals Division, Fresenius Kabi.

Parenteral nutrition is the intravenous administration of amino acids (protein), carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest or absorb sufficient nutrition via the gastrointestinal tract.

About Smoflipid
Smoflipid is the first and only four-oil lipid emulsion available in the U.S. Its balanced lipid profile contains soybean oil, MCT, olive oil and fish oil. Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

IMPORTANT SAFETY INFORMATION

See full prescribing information for complete boxed warning.

• Deaths in preterm infants have been reported in literature.
• Autopsy findings included intravascular fat accumulation in the lungs.
• Preterm and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

The usual daily dosage is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.

Smoflipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients, severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.

Fresenius Kabi Launches Smoflipid® in the United States
Monitor for signs or symptoms of hypersensitivity reactions, infection, fat overload, hypertriglyceridemia. Monitor laboratory parameters.

To report suspected adverse reactions, contact the Fresenius Kabi Vigilance department at either 1-800-551-7176 or adverse.events.USA@fresenius-kabi.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information and to see the full Prescribing Information for Smoflipid, including Boxed Warning, please visit www.smoflipid.com.

To order Smoflipid call 1-888-386-1300. Health care professionals with questions about Smoflipid can contact Fresenius Kabi medical at 1-800-551-7176 (option 4) or nutrition.medinfo.USA@fresenius-kabi.com.

About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Media Contact
Matt Kuhn
847-550-5751
matt.kuhn@fresenius-kabi.com