X
Notice: You have clicked on a link which leaves Fresenius Kabi’s website and you will be redirected to a third-party website. Fresenius Kabi makes no representations nor has any supervision or control over the quality, content, reliability, or security of the third-party website, nor shall Fresenius Kabi be liable for its use.
Continue Cancel

One-of-a-kind blend of 4 oil sources1

Designed to provide a source of calories and essential fatty acids (EFAs) for parenteral nutrition (PN), SMOFlipid is the FIRST and ONLY 4-oil lipid injectable emulsion (ILE) with a well-established safety and tolerability profile.1 It has been administered to more than 7 million patients worldwide.*

*Data on file 4/1/25.

An IV bag filled with images of fish, soybeans, coconuts, and olives, illustrating the nutritional components. Text labels around the bag detail the contents: "Omega-6 (30% soybean oil) Provides EFAs", "Omega-3 (15% fish oil) A source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)", "Medium-chain triglycerides (MCT) (30% MCT) A source of rapidly available energy", and "Omega-9 (25% olive oil) Supplies monounsaturated fatty acids".

A graphic with a central circle containing a four-petal design in yellow, orange, blue, and green. This is encircled by a thick purple ring with the text "DAILY LIPID DOSING" at the top. Below the main circle, curved text reads: "ASPEN recommends following the SMOFlipid PI adult dosing of 1-2 g/kg/day; not to exceed 2.5 g/kg/day."

SMOFlipid is indicated for daily lipid dosing1

Lipids are a key part of a PN regimen, offering EFAs and serving as an alternative energy source to reduce reliance on dextrose, helping to minimize complications from excessive dextrose use, such as5,6:

  • Hepatic steatosis
  • Respiratory insufficiency
  • Hyperglycemia-induced compromised immune function
  • Metabolic stress
  • Fever

SMOFlipid for adults has specific dosing recommendations.1

  • Protect the admixed PN solution from light
  • 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.1

Do not exceed the maximum infusion rate of 0.5 mL/kg/hour in adults.1

Age Nutritional Requirements Direct Infusion Rate
Recommended Initial Dosage and Maximum Dosage Initial Maximum
Adults 1 to 2 g/kg/day
not to exceed 2.5 g/kg/day*		 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.5 mL/kg/hour

*Daily dosage should not exceed a maximum of 60% of total energy requirements.

Effect on liver function parameters7

Each oil has characteristics which provide a unique blend. A clinical study observed SMOFlipid’s effect on liver function parameters7:

Parameters of Liver Function at Baseline and at Week 4

A series of three bar graphs comparing SMOFlipid and Soybean Oil at Baseline and Week 4 for ALT, AST, and Total Bilirubin levels. Each graph shows two bars for "SMOFlipid (n=14)" in blue and "Soybean Oil (n=39)" in light green for both time points. Asterisks indicate a statistically significant difference between groups at Week 4 for ALT, AST, and Total Bilirubin. For ALT, SMOFlipid goes from 38.1 at Baseline to 30.3 at Week 4, while Soybean Oil goes from 45.1 to 48.7. For AST, SMOFlipid goes from 32.0 to 26.5, while Soybean Oil goes from 40.5 to 41.0. For Total Bilirubin, SMOFlipid goes from 10.0 to 9.5, while Soybean Oil goes from 13.8 to 15.7. A footnote states, "*Statistically significant difference between groups at week 4 (P<0.05). Chart adapted from Klek S, et al." and defines ALT and AST.

This randomized, controlled, double-blind, multicenter study compared PN containing SMOFlipid or an soybean oil (SO) emulsion in intestinal failure patients requiring long-term PN. Seventy-three patients (n=34 in SMOFlipid group and n=39 in the SO group) received PN with either lipid emulsion and were monitored for 4 weeks.7

  • 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; infusion occurred 10-24 hr/d, 5-7 days per week7
  • 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); there was no significance for change within treatment groups7

Two on-label adult clinical trials did not show a difference in liver parameters.*

*Data on file.

Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.1

Order
ORDERING INFORMATION
NDC 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 10 12 6

Case Studies

Case Study Small Bowel Obstruction Document preview

Case Study: Small Bowel
Obstruction (SBO)

Download>

Case Study: Home Parenteral Nutrition (HPN) Due to Motility Disorder preview

Case Study: Home Parenteral Nutrition (HPN) Due to Motility Disorder

Download>

Case Study: Home Parenteral Nutrition (HPN) Patient preview

Case Study: Home Parenteral Nutrition (HPN) Patient

Download>

Case Study: Small Bowel Syndrome (SBS) preview

Case Study: Small Bowel
Syndrome (SBS)

Download>

SMOFlipid resources

Explore additional SMOFlipid materials by visiting our Resource Center.

Stability Reference Guide for Adults preview

Download Stability Reference Guide for Adults>

Compatibility Tool preview

Download
Compatibility Tool*>

Adult Sales Aid preview

Download Adult
Sales Aid>

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.

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.

Contact us

References: 1. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388. 3. 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. 4. ASPEN Lipid Injectable Emulsion Safety Recommendations for Adult Patients. ASPEN website. 2021. Accessed March 4, 2025. https://nutritioncare.org/wp-content/uploads/2024/12/ILE-Safety-Recommendations-Adult.pdf 5. Vanek VW, Seidner DL, Allen P, et al. A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27(2):150-192. 6. Calder PC, Jensen GL, Koletzko BV, Singer P, Wanten GJ. Lipid emulsions in parenteral nutrition of intensive care patients: current thinking and future directions. Intensive Care Med. 2010;36(5):735-749. 7. 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.