Fresenius Kabi Announces FDA Approval of SMOFlipid® Lipid Injectable Emulsion for Pediatric Patients Requiring Parenteral Nutrition

First and only four-oil lipid injectable emulsion indicated for pediatric parenteral nutrition, including term and preterm neonates

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today it has been granted an expanded indication for SMOFlipid^® Lipid Injectable Emulsion (ILE) for pediatric patients in the United States, including term and preterm neonates, making it the first and only four-oil lipid emulsion for parenteral nutrition patients of every age.¹ SMOFlipid can be used throughout the continuum of care – from the hospital to home care settings.

“The FDA approval of SMOFlipid for pediatric patients represents an important expansion of our parenteral nutrition portfolio and our continued commitment to providing innovative nutrition products to our clinical partners and the patients they serve,” said Gordon Sacks, PharmD., senior director Medical Affairs, Fresenius Kabi USA. “A pediatric indication for SMOFlipid allows clinicians to meet the unique nutritional needs of even our most vulnerable patients at every age.”

Clinical guidelines from ASPEN and ESPEN support the use of alternative-oil ILEs as a source of energy and essential fatty acids.^2-4 A unique blend of four oils, SMOFlipid:

• Has demonstrated safety and tolerability^5,6 in more than 6 million patients worldwide
• Contains soybean oil, medium-chain triglycerides (MCT), olive oil, and fish oil, a good source of omega-3 fatty acids

“There is a genuine need for alternative oil-based injectable lipid emulsions for patients of all ages,” said Pete Allen, senior vice president, Nutrition and Infusion Therapy, Fresenius Kabi USA. “Being able to meet these needs now with SMOFlipid for pediatric patients demonstrates our dedication to innovation when it comes to helping patients thrive on parenteral nutrition.”

Parenteral nutrition is the intravenous administration of amino acids (protein), carbohydrates (dextrose), lipids (fats), electrolytes, vitamins, and other trace elements for patients who cannot digest or absorb sufficient nutrition via the gastrointestinal tract. It can be provided in the hospital, in long-term care facilities, or at home. Because parenteral nutrition products are highly concentrated, they are typically delivered through central veins in the neck or chest. Delivery through peripheral veins in the forearm occurs only for shorter durations of parenteral nutrition.

Indications and Usage

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Important Safety Information

For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration. Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. The recommended dose for pediatrics is shown in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.

Table 1: Recommended Pediatric Dosage

Pediatric Age group	Initial Dose	Maximum Dose	Duration of infusion
Birth to 2 years of age (including preterm and term neonates)	0.5 to 1 g/kg/day	3 g/kg/day	20 to 24 hours for preterm and term neonates
	Increase the dose by 0.5 to 1 g/kg/day		12 to 24 hours for patients 1 month to 2 years
2 to <12 years of age	1 to 2 g/kg/day	3 g/kg/day	12 to 24 hours
	Increase the dose by 0.5 to 1 g/kg/day
12 to 17 years of age	1 to 2 g/kg/day	2.5 g/kg/day	12 to 24 hours

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).

Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur consider discontinuation or dosage reduction.

Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous 100% soybean oil lipid emulsions have been reported in the literature.

Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.

Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.

Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.

Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyl transferase and nosocomial infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, for intravenous use at https://freseniuskabinutrition.com/wp-content/uploads/2022/03/SMOFlipid-PI-3.22.22.pdf.

For more information about SMOFlipid, please visit www.FreseniusKabiNutrition.com/SMOFlipid.

To order SMOFlipid call 1-888-386-1300. Healthcare professionals with questions about SMOFlipid can contact Fresenius Kabi medical at 1-800-551-7176 (option 4) or [e-mail].

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/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. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us.

References: 1. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2022. 2. Vanek VW, Seidner DL, Allen P, et al. Novel Nutrient Task Force, Intravenous Fat Emulsions Workgroup; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. position paper: clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27(2):150-192. 3. Singer P, Blaser AR, Berger MM, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019;38(1):48-79. 4. Weimann A, Braga M, Carli F, et al. ESPEN guideline: clinical nutrition in surgery. Clin Nutr. 2017;36(3):623-650. 5. Klek S, Chambrier C, Singer P, et al. Four-week parenteral nutrition using a third-generation lipid emulsion (SMOFlipid): a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013;32(2):224-231. 6. Mertes N, Grimm H, Fürst P, Stehle P. Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study. Ann Nutr Metab. 2006;50(3):253-259.