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

Designed to nourish pediatric patients daily with a proprietary blend of 4 oils, 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".

SMOFlipid helps to nurture growth in pediatric patients1,4-6

  • Infants receiving SMOFlipid experienced adequate growth.1
  • Preterm infants receiving SMOFlipid experienced higher EPA and DHA levels compared to those receiving a soybean oil lipid emulsion.*4,5
  • SMOFlipid is associated with a lower omega-6 to omega-3 polyunsaturated fatty acid ratio compared to soybean oil–based lipid emulsions in preterm neonates.5,6
  • SMOFlipid has a well-established safety and tolerability profile.1

*Based on composition of the product.

Parenteral nutrition-associated cholestasis (PNAC) may develop less frequently in pediatric patients fed a 4-oil ILE vs 100% soybean oil (SO) ILE1

In a randomized clinical trial among neonates and infants expected to be treated with PN for at least 28 days, PNAC, a precursor to parenteral nutrition-associated liver disease (PNALD), developed less frequently in SMOFlipid-treated patients than in 100% SO lipid emulsion-treated patients.1

Pediatric Study 1 also compared the incidence of PNAC (DBIL >2 mg/dL with a second confirmed DBIL >2 mg/dL at least 7 days later) in both groups1:

  • PNAC mostly occurred in patients who received treatment for more than 28 days
  • 2.4% (2/83) of SMOFlipid-treated patients developed PNAC
  • 11.5% (9/78) of SO lipid emulsion-treated patients developed PNAC

There was increasing uncertainty in the estimate of the cumulative incidence of PNAC as fewer patients were at risk.1

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.1

Intravenous lipid use in high-risk neonates requiring PN and associated hepatic outcomes7

Study Purpose and Design:

  • Evaluate effects of SMOFlipid vs. Intralipid® in neonates requiring PN ≥28 days
  • Double-blind, randomized, controlled trial at 14 US study sites
  • Randomization of 161 term and preterm neonates at high risk for IFALD
  • Intervention: Intralipid (n=78), SMOFlipid (n=83), up to 3 g/kg/day as part of PN (mean lipid dose 2.0 ± 0.1 g/kg/day SMOFlipid, 2.6 ± 0.2 g/kg/day Intralipid)

Liver Results:

  • Analysis showed a trend toward a lower risk of cholestasis in the SMOFlipid group (NS due to the low number of events)
  • Significantly lower conjugated bilirubin concentration (P = 0.006) at the end of the initial treatment phase in the SMOFlipid group
  • No new cases of confirmed cholestasis occurred after day 28 in the SMOFlipid group for up to 84 days

Study Limitations:

There was a low incidence of cholestasis in both treatment groups compared to historical data. Additionally, there was a low completion rate (40%) predominantly due to earlier weaning from PN. The use of SMOFlipid in patients with established cholestasis was not assessed.

“Our data supports use of [SMOFlipid] a composite ILE with EPA and DHA from fish oil, for PN in high-risk neonates and infants at risk of IFALD such as those with impaired intestinal function or surgical conditions preventing use of enteral nutrition.”

Consider SMOFlipid as an alternative to Intralipid in high-risk neonates.

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.1

*This trial was funded by Fresenius Kabi Deutschland GmbH upon requirement of a postmarketing study from the United States Food and Drug Administration.

Abbreviations: DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; IFALD, intestinal failure-associated liver disease; ILE, lipid injectable emulsion; NS, not significant; PN, parenteral nutrition.

EPA and DHA (omega-3 fatty acids) are considered to be important for healthy development of infants due to their physiological roles8,9

An outline icon of a classic ring stacker toy, with a dark blue ring on top of progressively larger white rings, all set against a dark green background.

May be considered conditionally essential for growth and development10,11

An icon depicting a cluster of oval shapes outlined in white, each containing a dark blue circle in its center, against a dark green background, resembling a cross-section of cells.

Important structural elements of cell membranes9

An icon featuring two interlocking arrows forming a circular shape, one in dark blue and the other in white, on a dark green background, symbolizing a refresh or continuous cycle.

SMOFlipid contains 1‑3.5% of both EPA and DHA1

Explore the fatty acid pattern of SMOFlipid vs human breast milk12,13

A bar chart showing the percentage by weight of different fatty acids (SFA, MUFA, EFA, EPA, DHA) in Breast Milk at 1 month, Breast Milk at 6 months, and SMOFlipid. The bars are color-coded: dark blue for SFA, a darker blue for MUFA, light blue for EFA, a lighter blue for EPA, and very light blue for DHA. The y-axis ranges from 0 to 70 in increments of 10. The x-axis labels are "Breast Milk (1 month)", "Breast Milk (6 months)", and "SMOFlipid".

Figure adapted with permission from: Goulet O. Nutrients. 2024;16(3):440.12
Fatty acid pattern of lipid emulsions vs. human breast milk. Compiled from
*Koletzko et al., 2016, †Goulet et al., 2010.

In this analysis, SMOFlipid had a fatty acid composition that is similar to breast milk.12,13

Impact on bilirubin in SMOFlipid clinical trials5

Decrease in total bilirubin concentration

A bar chart titled "Total bilirubin pre- and post-treatment (mean ± SEM)" with a y-axis representing concentrations in $\mu$mol/L, ranging from 0 to 160. There are two sets of bars: "Baseline" and "Day 8". Each set has two dark blue bars of slightly different shades, representing two different groups. Error bars are present on top of each bar. A dashed line with an asterisk connects the "Baseline" and "Day 8" bars of one group, indicating a statistically significant difference.

Significantly higher decrease in total bilirubin
concentration in the SMOFlipid group.

Change in direct bilirubin concentration

A bar chart titled "Course of plasma concentrations of direct bilirubin after 8 days (mean ± SD)" with a y-axis representing concentrations in $\mu$mol/L, ranging from 0 to 16. There are four bars in total, divided into two groups by a dashed vertical line. The first two bars, for "Day 0" and "Day 8", are dark blue and represent "SMOFlipid". The next two bars, also for "Day 0" and "Day 8", are a lighter blue and represent "Soybean oil emulsion". An asterisk above the "Day 8" bar for Soybean oil emulsion indicates a significant difference, while "NS" with an arrow points to the difference between Day 0 and Day 8 for SMOFlipid, indicating it is not significant. A legend on the right clarifies the colors for SMOFlipid and Soybean oil emulsion. Below the chart, "NS, not significant." is defined.

The change in direct bilirubin concentration from Day O to Day 8 for the SMOFlipid group compared to the change from Day O to Day 8 in the soybean oil emulsion group was significant between groups.

*P‹0.05 between group difference of changes from baseline to last visit

Prospective, randomized, controlled, double-blind trial in 53 neonates (‹ 34 weeks’ gestation); PN at least 7 days; test group: SMOFlipid, control group: soybean oil emulsion

Significantly higher decrease in total bilirubin
concentration in the SMOFlipid group.

• One on-label submitted study showed no difference in total bilirubin between the two groups14

A circular graphic with a purple outer ring and a white inner circle containing a four-petal design in yellow, orange, blue, and green. The text "DAILY LIPID DOSING" is curved around the top of the purple ring. Below the circle, curved text reads: "The SMOFlipid PI recommends a maximum dosage in pediatric patients of 3 g/kg/day from birth to <12 years of age and 2.5 g/kg/day from 12-17 years of age."

Appropriate daily dosing is vital

The dosing of SMOFlipid varies in pediatrics and neonates; each group has its own specific dosing specifications.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 0.75 mL/kg/hour in pediatric patients.1

Age Nutritional Requirements Direct Infusion Rate
Recommended Initial Dosage and Maximum Dosage Initial Maximum
Birth to 2 years of age (including preterm and term neonates*) Initial 0.5 to 1 g/kg/day
not to exceed 3 g/kg/day**		 0.1 to 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour
Pediatric patients 2 to <12 years of age Initial 1 to 2 g/kg/day
not to exceed 3 g/kg/day**		 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour
Pediatric patients 12 to 17 years of age Initial 1 g/kg/day
not to exceed 2.5 g/kg/day**		 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.75 mL/kg/hour

*The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age).
**Daily dosage should not exceed a maximum of 60% of total energy requirements.

SMOFlipid has 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.

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SMOFlipid resources

Explore additional SMOFlipid materials by visiting our Resource Center.

Preview of Stability Reference Guide for Pediatrics

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A promotional image featuring a young child with bright blue eyes, wearing a blue shirt, looking directly at the viewer. To the left of the child is an illustration of an IV bag with "pn^4" and "SMOFlipid® Lipid Injectable Emulsion, USP 20%" written next to it. Below that text, it reads "Designed with more oil sources for a balanced fatty acid profile." The bottom left corner features the "FRESENIUS KABI" logo, and the bottom right has text saying "Please see Brief Summary of Prescribing Information on pages 5-8." The background is a textured blue.

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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.com/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.com/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. 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. Vlaardingerbroek H, Vermeulen MJ, Carnielli VP, et al. Growth and fatty acid profiles of VLBW infants receiving a multicomponent lipid emulsion from birth. J Pediatr Gastroenterol Nutr. 2014;58(4):417-427. 5. Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012;36(1 Suppl):81S-94S. 6. Ariyawangso U, Puttilerpong C, Ratanachu-ek S, Anuntkosol M. Short-term safety and efficacy of fish-oil emulsions on the prevention of parenteral nutrition-associated liver disease in surgical neonates: a randomized controlled trial. Thai J Pharmac Sci. 2014;38(4):156-209. 7. Abrams SA, Ernst KD, Weitkamp JH, et al. Safety and Efficacy of a Composite Lipid Emulsion with Fish Oil in Hospitalized Neonates and Infants Requiring Prolonged Parenteral Nutrition – A Randomized, Double-Blind, Multicenter, Controlled Trial. J Nutr. 2024;154(12):3615-3625. 8.Agostoni C. Role of long-chain polyunsaturated fatty acids in the first year of life. J Pediatr Gastroenterol Nutr. 2008;47 Suppl 2:S41-44. 9. Cetin I, Koletzko B. Long-chain omega-3 fatty acid supply in pregnancy and lactation. Curr Opin Clin Nutr Metab Care. 2008;11(3):297-302. 10. Lapillonne A, Groh-Wargo S, Gonzalez CH, Uauy R. Lipid needs of preterm infants: updated recommendations. J Pediatr. 2013;162(3 Suppl):S37-47. 11. Bistrian BR. Clinical aspects of essential fatty acid metabolism: Jonathan Rhoads Lecture. JPEN J Parenter Enteral Nutr. 2003;27(3):168-175. 12. Goulet O. An Overview of Parenteral Nutrition from Birth to Adolescence Based on a Composite Fish Oil Containing Lipid Emulsion and a Pediatric Amino Acid Solution. Nutrients. 2024;16(3):440. Published 2024 Feb 1. 13. Koletzko B. Human Milk Lipids. Ann Nutr Metab. 2016;69 Suppl 2:28-40. 14. Tomsits E, Pataki M, Tölgyesi A, Fekete G, Rischak K, Szollár L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010;51(4):514-521.

*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.