Fresenius Kabi Launches Smoflipid® in the United States

First and only four-oil lipid emulsion now available for parenteral
nutrition

LAKE ZURICH, Ill.–(BUSINESS WIRE)–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 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

WARNING: DEATH IN PRETERM INFANTS

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.

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 USA, please visit www.fresenius-kabi.us.

Contacts

Matt Kuhn
Fresenius Kabi
847-550-5751
Matt.kuhn@fresenius-kabi.com