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A time—honored lipid emulsion

A long-standing and chosen lipid worldwide: 100% soybean oil–based Intralipid has been administered in more than 200 million infusions since its European approval in 1962.*

Established source of calories and essential fatty acids (EFAs)1: Intralipid contains the EFAs linoleic acid (44% to 62%) and alpha-linolenic acid (4% to 11%).1

*Data on file.

Intralipid 20% composition1

Intralipid 20% Content per L Content per mL
Soybean oil (g) 200 0.2
Osmolality (mOsm/kg water) 350 0.35
Inorganic phosphate (mmol) 15 0.15
Total caloric value (kcal) 2000 2
the medical worker performs the procedure on the patient lying on the bed

Intralipid nourishes with 100% soybean oil1:

  • As a source of essential fatty acids for prevention of essential fatty acid deficiency
  • When other lipid sources are not an option
  • For inpatient use in both adults and children

screen shot of Intralipid fact sheet

It is recommended that the standard intake of nonprotein energy in PN from dextrose be 70%–85% and 15%–30% from lipid.2

Indication and contraindications

INDICATION: Intralipid is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).1

CONTRAINDICATIONS: Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Intralipid. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride > 1,000 mg/dL).1

Order
ORDERING INFORMATION
NDC 65219-531-10 65219-533-25 65219-535-50 65219-539-10 65219-537-50*
Bag Size/
Concentration		 100 mL 20% 250 mL 20% 500 mL 20% 1000 mL 20% 500 mL 30%
Bags/Case 10 10 12 6 12

*Intralipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture program for the preparation of three-in-one or total nutrient admixtures.1

Intralipid resources

Explore additional Intralipid materials by visiting our Resource Center.

Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.

The most common side effects (≥5%) in adult patients include nausea, vomiting and fever and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase), and cholestasis (i.e., reducing or blocking the flow of bile).

These are not all the possible side effects associated with Intralipid. Call your healthcare provider for medical advice regarding Intralipid side effects. You are encouraged to report negative side effects of Intralipid. 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 for Intralipid® 20% (lipid injectable emulsion), for intravenous use and Intralipid® 30% (A 30% I.V. Fat Emulsion) can be found at www.FreseniusKabiNutrition.com/Intralipid20PI and www.FreseniusKabiNutrition.com/Intralipid30PI.

For Healthcare Professionals

Intralipid (lipid injectable emulsion) for intravenous use

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Intralipid 20% (A 20% Intravenous Fat Emulsion), is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).

Intralipid 20% Pharmacy Bulk Package and Intralipid 30% Pharmacy Bulk Package are intended for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for adult and pediatric patients requiring PN and a source of essential fatty acids for prevention of EFAD.

INTRALIPID 20% and 30% PHARMACY BULK PACKAGES ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION.

IMPORTANT SAFETY INFORMATION

INTRALIPID 20% (A 20% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE AND INTRALIPID 30% (A 30% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION OR 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS 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. Protect the admixed PN solution from light. Use a 1.2 micron in-line filter during administration.

Dosage for Intralipid 20%

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

Dosage for Intralipid 30%

Premature infants: initial dose at 0.5 g/kg/24 hours, maximum recommended dosage is 3g fat/kg/24 hours.

Older pediatric patients: daily dose should not exceed 3 of g fat/kg/d.

Adults: The daily dosage should not exceed 2.5 g of fat/kg of body weight

Intralipid is contraindicated in patients with:

  • Known hypersensitivity to egg, soybean, or peanut, or any of the active ingredients or excipients.
  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride > 1,000 mg/dL).
  • Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.

Risk of 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.

Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive PN for extended periods of time, especially preterm neonates. Monitor liver function 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, and Hypertriglyceridemia: 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 pyrexia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis.

Vitamin K Antagonists (e.g., warfarin): Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters.

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 Intralipid safely and effectively. Please see full prescribing information for Intralipid 20% (lipid injectable emulsion), for intravenous use and Intralipid® 30% (A 30% I.V. Fat Emulsion) can be found at www.FreseniusKabiNutrition.com/Intralipid20PI and www.FreseniusKabiNutrition.com/Intralipid30PI.

Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.

The most common side effects (≥5%) in adult patients include nausea, vomiting and fever and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase), and cholestasis (i.e., reducing or blocking the flow of bile).

These are not all the possible side effects associated with Intralipid. Call your healthcare provider for medical advice regarding Intralipid side effects. You are encouraged to report negative side effects of Intralipid. 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 for Intralipid® 20% (lipid injectable emulsion), for intravenous use and Intralipid® 30% (A 30% I.V. Fat Emulsion) can be found at www.FreseniusKabiNutrition.com/Intralipid20PI and www.FreseniusKabiNutrition.com/Intralipid30PI.

For Healthcare Professionals

Intralipid (lipid injectable emulsion) for intravenous use

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Intralipid 20% (A 20% Intravenous Fat Emulsion), is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).

Intralipid 20% Pharmacy Bulk Package and Intralipid 30% Pharmacy Bulk Package are intended for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for adult and pediatric patients requiring PN and a source of essential fatty acids for prevention of EFAD.

INTRALIPID 20% and 30% PHARMACY BULK PACKAGES ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION.

IMPORTANT SAFETY INFORMATION

INTRALIPID 20% (A 20% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE AND INTRALIPID 30% (A 30% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION OR 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS 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. Protect the admixed PN solution from light. Use a 1.2 micron in-line filter during administration.

Dosage for Intralipid 20%

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

Dosage for Intralipid 30%

Premature infants: initial dose at 0.5 g/kg/24 hours, maximum recommended dosage is 3g fat/kg/24 hours.

Older pediatric patients: daily dose should not exceed 3 of g fat/kg/d.

Adults: The daily dosage should not exceed 2.5 g of fat/kg of body weight

Intralipid is contraindicated in patients with:

  • Known hypersensitivity to egg, soybean, or peanut, or any of the active ingredients or excipients.
  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride > 1,000 mg/dL).
  • Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.

Risk of 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.

Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive PN for extended periods of time, especially preterm neonates. Monitor liver function 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, and Hypertriglyceridemia: 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 pyrexia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis.

Vitamin K Antagonists (e.g., warfarin): Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters.

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 Intralipid safely and effectively. Please see full prescribing information for Intralipid 20% (lipid injectable emulsion), for intravenous use and Intralipid® 30% (A 30% I.V. Fat Emulsion) can be found at www.FreseniusKabiNutrition.com/Intralipid20PI and www.FreseniusKabiNutrition.com/Intralipid30PI.

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References: 1. Intralipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2 Mirtallo JM, Ayers P, Boullata J, et al. ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations [published correction appears in Nutr Clin Pract. 2022 Apr;37(2):482]. Nutr Clin Pract. 2020;35(5):769-782.