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SMOFlipid® Bag

Logo: SMOFlipid

An innovation for adults that delivers 4 oils in 1 lipid emulsion

 

Supply of monounsaturated fatty acids

Mix of fatty acids

Omega-3 fatty acids from fish oil include EPA and DHA

First and only 4-oil lipid emulsion for adult and pediatric patients, including term and preterm neonates1

SMOFlipid is the FIRST and ONLY 4-oil lipid injectable emulsion with a well-established safety and tolerability profile.1 It has been administered to more than 7 million patients worldwide.*

Important safety information>

Full prescribing information>

*Data on file 12/1/23.

Discover the SMOF Difference

 

  • Soybean oil 30%

    (omega-6) Provides essential fatty acids.

  • Medium-chain triglycerides (MCT) 30%

    A source of rapidly available energy.2

  • Olive oil 25%

    (omega-9) Supplies monounsaturated fatty acids.

  • Fish oil 15%

    (omega-3) A source of EPA and DHA.3

Characteristics of the blend

Each oil has characteristics which provide a unique blend. In one clinical study:

There was less of an elevation/increase in liver function tests in patients receiving SMOFlipid vs. 100% soybean oil emulsions.4

Parameters of Liver Function at Baseline and at Week 4

Parameters of Liver Function at Baseline and at Week 4

This randomized, double-blind, multi-center study compared PN containing SMOFlipid or a soybean oil emulsion in intestinal failure patients requiring long-term PN.4 Seventy-three patients (n = 34 in SMOFlipid group and n = 39 in the soybean oil group) received PN with either lipid emulsion and were monitored for 4 weeks.4

PN intake was similar in both groups: 1.3 g/kg/d ILE, 3 g/kg/d dextrose, 1.2 g/kg/d amino acids.4 Infusion occurred 10-24 hr/d, 5-7 days per week.4

After 4 weeks, the mean concentrations of ALT, AST, and total bilirubin were significantly lower in the SMOFlipid group than the comparator group (statistical significance was set at P < 0.05).4

Monitor liver function. If SMOFlipid-treated patients develop liver enzyme abnormalities, consider discontinuation or dose reduction.

Get your quick reference guide for additive compatibility and stability information for SMOFlipid.

Download

 

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Indication

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 when oral or enteral nutrition is not possible, insufficient, or contraindicated.1

Order

ORDERING INFORMATION
NDC Code 63323-820-00 63323-820-74 63323-820-50 63323-820-10
Bag Size 100 mL 250 mL 500 mL 1000 mL
Bags/Case 10 bags/case 10 bags/case 12 bags/case 6 bags/case

KabiCare Patient Support Program for Parenteral Nutrition

Fresenius Kabi’s patient support program, KabiCare, offers online resources for claims appeals and billing as well as coding guides for parenteral nutrition.

Learn more

SMOFlipid resources

Explore additional SMOFlipid materials by visiting our Resource Center.

Download Stability Reference Guide for Adults>

Download Compatibility Tool*>


Learn more
Expand for Important Safety Information

The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.

These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition/SMOFlipidPI.

For Healthcare Professionals

SMOFLIPID (lipid injectable emulsion, USP), for intravenous use

IMPORTANT SAFETY INFORMATION

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 dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. 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 Adult and Pediatric Dosage

Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term
neonates)		 0.5 to 1 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day
Adults 1 to 2 g/kg/day 2.5 g/kg/day

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

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.

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

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-glutamyltransferase, 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 SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.

Expand

The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.

These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition/SMOFlipidPI.

For Healthcare Professionals

SMOFLIPID (lipid injectable emulsion, USP), for intravenous use

IMPORTANT SAFETY INFORMATION

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 dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. 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 Adult and Pediatric Dosage

Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term
neonates)		 0.5 to 1 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day
Adults 1 to 2 g/kg/day 2.5 g/kg/day

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

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.

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

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-glutamyltransferase, 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 SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.

If you still can't find what you're looking for regarding our PN products or Fresenius Kabi Nutrition, let us know and we can help.

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References: 1. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2. Deckelbaum RJ, Hamilton JA, Moser A, et al. Medium-chain versus long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for the mechanisms of lipase action. Biochemistry. 1990;29(5):1136-1142. 3. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388. 4. 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.

* For additional information about the testing results, and for more insights into how to use this information for your PN patients, please contact Fresenius Kabi Medical Affairs via phone at 1-800-551-7176, option 4, or email Nutrition.MedInfo.USA@fresenius-kabi.com.