Version May 2024
Note: For patients receiving other lipid emulsion-based medications (eg, propofol, clevidipine), reduce dosage to avoid fat overload syndrome (ASPEN [Mirtallo 2020]).
Energy/calories: IV: 1 to 2 g/kg/day (ASPEN [Mirtallo 2020]); daily dose may be infused over 12 to 24 hours; maximum daily dose: 2.5 g/kg/day. Note: Lipid injectable emulsion (ILE) should provide 15% to 30% of energy (ASPEN [Mirtallo 2020]) and not exceed 60% of the total daily energy requirements. At the onset of therapy, observe patient for any immediate allergic reactions (eg, dyspnea, cyanosis, fever, pruritus [ASPEN (Mirtallo 2020)]).
Dosage adjustment for increased serum triglycerides: If triglycerides >400 mg/dL, lower dose/infusion rate or stop infusion and advance in smaller increments once triglycerides are <400 mg/dL. Use is contraindicated with triglycerides >1,000 mg/dL (ASPEN [Mirtallo 2020]; Siparsky 2021; manufacturer's labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Energy expenditure and requirements may be lower in these patients; refer to adult dosing.
(For additional information see "Lipid emulsion (soybean, medium-chain triglyceride, olive, and fish oils; [SMOF]): Pediatric drug information")
Parenteral nutrition:
Note: The amount of lipid injectable emulsion needed to prevent essential fatty acid deficiency (EFAD) varies based on age and lipid product; the amount of lipid injectable emulsion (fish oil and plant based) required to prevent EFAD will be higher than the doses of plant-based lipid injectable emulsion (eg, Intralipid); use of restrictive dosing protocol with lipid injectable emulsion (fish oil and plant based) may put patients at risk for EFAD (Carey 2019; ESPGHAN [Lapillonne 2018]). For patients receiving other lipid emulsion–based medications (eg, propofol), take the lipid content provided from these medications into consideration and reduce dosage as needed to avoid adverse effects such as fat overload syndrome (ASPEN [Mirtallo 2020]).
Infants and Children <2 years: IV: Initial: 0.5 to 1 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum daily dose of 3 g/kg/day; generally, lipids should account for ~25% to 50% of nonprotein calories (ESPGHAN [Lapillonne 2018]; Goulet 2020; Martindale 2020; Wassef 2021; manufacturer's labeling).
Children 2 to <12 years: IV: Initial: 1 to 2 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum daily dose of 3 g/kg/day; generally, lipids should account for ~25% to 50% of nonprotein calories (ESPGHAN [Lapillonne 2018]; Goulet 2020; Martindale 2020; Wassef 2021; manufacturer's labeling).
Children ≥12 years and Adolescents: IV: Initial: 1 g/kg/day; maximum daily dose: 2.5 g/kg/day (manufacturer's labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Monitor liver function closely.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in neonates, infants, children, and adults unless otherwise indicated.
>10%: Hematologic & oncologic: Anemia (neonates, infants, children: 18%; adults: 2%)
1% to 10%:
Cardiovascular: Hypertension (≤3%), tachycardia (≤2%), thrombophlebitis (adults: ≤1%)
Dermatologic: Pruritus (adults: ≤1%), skin rash (≤1%)
Endocrine & metabolic: Hyperglycemia (2% to 5%), hypertriglyceridemia (neonates, infants, children: ≤1%), hypervolemia (neonates, infants, children: ≤1%), increased gamma-glutamyl transferase (neonates, infants, children: 6%; adults: ≤1%), metabolic acidosis (neonates, infants, children: ≤1%), nutrition disorder (essential fatty acid deficiency: ≤2%)
Gastrointestinal: Abdominal pain (2% to 4%), cholestasis (≤4%), diarrhea (≤2%), dysgeusia (adults: ≤1%), dyspepsia (adults: 2%), flatulence (adults: 4%), nausea (adults: 9%), vomiting (7% to 9%)
Genitourinary: Urinary tract infection (adults: 2%)
Hematologic & oncologic: C-reactive protein increased (neonates, infants, children: 4%; adults: ≤1%), leukocytosis (adults: ≤1%), thrombocytopenia (neonates, infants, children: 2%)
Hepatic: Abnormal hepatic function tests (≤1%; including increased alanine aminotransferase), hyperbilirubinemia (neonates, infants, children: 3%), increased serum alkaline phosphatase (≤1%)
Infection: Infection (including nosocomial infection; neonates, infants, children: ≤6%), sepsis (2%)
Nervous system: Dizziness (adults: ≤1%), headache (adults: ≤1%)
Respiratory: Dyspnea (adults: ≤1%), pneumonia (adults: ≤1%)
Miscellaneous: Fever (4%)
Postmarketing:
Cardiovascular: Chest pain, palpitations, phlebitis
Dermatologic: Hyperhidrosis
Nervous system: Chills, malaise
Hypersensitivity to fish, egg, soybean, or any other component of the formulation; severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations >1,000 mg/dL). Note: Although the manufacturer's labeling lists hypersensitivity to peanut as a contraindication, the product does not contain peanut; however, a low risk of cross-reactivity between soy and peanuts may exist.
Canadian labeling: Additional contraindications (not in US labeling): Severe hepatic insufficiency; severe blood coagulation disorders; severe renal insufficiency without access to hemofiltration or dialysis; acute shock; acute pulmonary edema; hyperhydration; decompensated cardiac insufficiency; unstable conditions (eg, severe post-traumatic conditions, uncompensated diabetes mellitus, acute MI, CVA, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration).
Concerns related to adverse effects:
• Fat overload syndrome: Although rare, a reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance resulting in a sudden deterioration in the patient's condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and CNS (eg, coma) may occur; usually reversible upon discontinuation.
• Hepatic effects: Although the exact etiology is unknown and likely multifactorial, parenteral nutrition associated liver disease (PNALD) has been reported in patients receiving parenteral nutrition for extended periods of time and can present as cholestasis or steatohepatitis, fibrosis and cirrhosis, possibly leading to hepatic failure; cholecystitis and cholelithiasis have also been observed. Consider discontinuation or dose reduction in patients who develop abnormal LFTs.
• Hypersensitivity: Contains soybean oil, fish oil, and egg phospholipids; hypersensitivity reactions may occur. Cross sensitivity has been observed between soybean and peanut. Discontinue use immediately if a reaction occurs and treat appropriately.
• Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome. In adults with triglycerides >400 mg/dL, reduce dose/infusion rate or stop infusion and monitor triglycerides. In pediatric patients, lower triglyceride levels may be associated with adverse reactions. Assess high-risk patients for their overall energy intake, including other lipid or dextrose sources and medications that may affect lipid and dextrose metabolism, to minimize risk of new or worsening hypertriglyceridemia.
• Infection: Catheter-related bloodstream infections may occur due to lipid emulsions supporting microbial growth; ensure aseptic techniques are used for catheter placement, maintenance, preparation, and administration and frequently assess catheter for signs of infection (eg, discharge, edema, redness).
• Refeeding syndrome: Refeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome (eg, intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic); thiamine deficiency and fluid retention may also develop. Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding.
Disease-related concerns:
• Anemia: The use of fat emulsion has been associated with anemia likely due to hemodilution (Zellner 1967). Use with caution in patients with anemia.
• Bleeding disorders: Use with caution in patients with bleeding disorders.
• Fat embolism: Use with caution in patients who may be at danger for fat embolism.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Pancreatitis: Use with caution in patients with pancreatitis without hyperlipidemia.
• Renal impairment: Use with caution in patients with renal impairment; may contain aluminum, which may accumulate following prolonged administration in patients with renal impairment.
• Respiratory disease: Use with caution in patients with respiratory disease.
Special populations:
• Older adult: Energy expenditure and requirements may be lower in elderly patients.
• Pediatric: Acute respiratory distress, metabolic acidosis, hypertriglyceridemia, and death have been reported in neonates and infants after rapid infusion. Do not exceed recommended daily doses or hourly infusion rates. Preterm infants and low birth weight infants have poor clearance of IV lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
Dosage form specific issues:
• Aluminum: May contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal impairment. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer's labeling.
Other warnings/precautions:
• Administration: The too-rapid administration of lipid emulsion can cause fluid and/or fat overloading, resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity, or metabolic acidosis; hourly infusion rate should be as low as possible.
• Appropriate use: Simultaneous infusion of a carbohydrate/amino acid solution is recommended to minimize the risk of metabolic acidosis.
• Laboratory tests: Lipids in the bloodstream may interfere with some laboratory tests (eg, hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation). Conduct these tests ≥6 hours after stopping the infusion. Products contain vitamin K, which may counteract anticoagulant activity.
• Three-in-one mixtures: Lipid emulsion in a three-in-one mixture may obscure the presence of a precipitate; follow compounding guidelines, especially for calcium and phosphate additions.
Although moderate to severe essential fatty acid deficiency (EFAD) was not seen in short-term (eg, ≤28 days) pediatric clinical trials of lipid injectable emulsion (fish oil and plant based) (eg, Smoflipid), cases of EFAD have been reported in pediatric and adult patients in the postmarketing period, usually occurring after more than 28 days of therapy. Due to the differences in compositions of the available lipid injectable emulsions, the amount of lipid injectable emulsion to prevent EFAD will vary by product; the amount of lipid injectable emulsion (fish oil and plant based) (eg, Smoflipid) required to prevent EFAD will be higher than the doses of plant-based lipid injectable emulsion (eg, Intralipid); use of restrictive dosing protocols with lipid injectable emulsion (fish oil and plant based) may put patients at risk for EFAD (Carey 2019; ESPGHAN [Lapillonne 2018]). Patients should be monitored for signs and symptoms of EFAD (eg, abnormal fatty acid levels, skin manifestations, poor growth); pediatric patients are vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided.
Development of parenteral nutrition–associated liver disease (PNALD), also known as intestinal failure–associated liver disease, has been associated with IV administration of phytosterols contained in plant-based lipid injectable emulsions, including Smoflipid. In a randomized trial (n=161), parenteral nutrition–associated cholestasis (PNAC), a precursor to PNALD, developed less frequently in neonates and infants receiving Smoflipid as part of parenteral nutrition compared to those receiving solely plant-based lipid injectable emulsion (2.4% vs 11.5%); PNAC usually occurred with >28 days of therapy. Closely monitor for PNAC/PNALD; if abnormalities occur consider dose reduction or discontinuation.
Hypertriglyceridemia may occur in patients receiving lipid injectable emulsions. Pediatric patients with serum triglyceride concentrations >200 mg/dL are considered to have hypertriglyceridemia. Hypertriglyceridemia is associated with excess carbohydrate or fat intake, poor glycemic control, and carnitine deficiency. Assess overall energy intake in high-risk patients, including other lipid or dextrose sources and medications that may affect lipid and dextrose metabolism to minimize risk of new or worsening hypertriglyceridemia. Monitor serum triglyceride levels to avoid potential complications of hypertriglyceridemia such as pancreatitis, lipid pneumonitis, and neurologic changes, including kernicterus (ASPEN [Cober 2021]; manufacturer's labeling).
Rapid infusion has been associated with fat overload syndrome in pediatric patients. In a case report, a 2 year old inadvertently received 20 grams (1.75 g/kg) of lipid injectable emulsion (fish oil and plant based) over 30 minutes. The patient developed vomiting, dyspnea, tachypnea, pallor, tachycardia, hypertension, and metabolic acidosis, which was determined to be fat overload syndrome. Treatment included fluids, platelets, albumin, fresh frozen plasma, RBC infusions, and filgrastim; laboratory results slowly returned to normal over a week (Hojsak 2014).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Intravenous [preservative free]:
SMOFlipid: 20% (100 mL, 250 mL, 500 mL, 1000 mL) [contains egg phospholipids (egg lecithin)]
No
Emulsion (SMOFlipid Intravenous)
20% (per mL): $0.12
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Intravenous:
SMOFlipid: 20% (100 mL, 250 mL, 500 mL) [contains egg phospholipids (egg lecithin)]
IV: Administer by IV infusion through a 1.2-micron in-line filter via peripheral line or central venous infusion using DEHP-free administration sets and lines. Initial rate of infusion should be 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase until reaching the required rate after 30 minutes as tolerated. Do not exceed a rate of 0.5 mL/kg/hour. May be simultaneously infused with amino acid and dextrose mixtures by means of Y-connector located near infusion site (flow rates of each solution should be controlled separately by infusion pumps) and infused through a 1.2-micron in-line filter (Worthington 2021). When administered with dextrose and amino acids, the choice of a central or peripheral infusion depends on the osmolarity of the final infusate (osmolarity ≥900 mOsm/L must be infused through a central vein). All lipid emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ISMP 2016; Worthington 2021). To prevent air embolism, use a nonvented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible bags in series, fully evacuate residual gas in the bag prior to administration, do not pressurize the flexible bag to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the bag runs dry.
IV: Prior to opening the overwrap, the integrity indicator should be inspected. If the indicator is black, the overwrap is damaged; do not use. Gently invert bag prior to use. Do not use if discolored or if the emulsion contains a precipitate, phase separation, or there are leaks in the bag.
Experts recommend parenteral nutrition admixtures and lipid emulsions for neonates and infants be protected from light as soon as possible after preparation and through infusion (ASPEN [Robinson 2021]). May be used as part of a parenteral nutrition admixture (3-in-1) or infused simultaneously with amino acid and dextrose mixtures by means of Y-connector located near infusion site (flow rates of each solution should be controlled separately by infusion pumps). All lipid emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ASPEN [Cober 2021]; ASPEN [Worthington 2021]; ISMP 2016). Administration may occur via peripheral line or central venous infusion using di-2-ehtylhexyl phthalate (DEHP)-free administration sets and lines. Infusion sets that contain DEHP, including infusion sets that contain PVC, should not be used. When administered with dextrose and amino acids, the choice of a central or peripheral infusion depends on the osmolarity of the final infusate (osmolarity ≥900 mOsm/L must be infused through a central vein). To prevent air embolism, use a nonvented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible bags in series, fully evacuate residual gas in the bag prior to administration, do not pressurize the flexible bag to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the bag runs dry. Change tubing after each infusion.
Neonates, Infants, and Children <2 years: IV: Initiate at 0.1 to 0.2 mL/kg/hour for 15 to 30 minutes; if no untoward effects occur after 30 minutes, the infusion rate may be gradually increased to 0.75 mL/kg/hour.
Children ≥2 years and Adolescents ≤17 years: IV: Initiate at 0.2 to 0.4 mL/kg/hour for 15 to 30 minutes; if no untoward effects occur after 30 minutes, the infusion rate may be gradually increased to 0.75 mL/kg/hour.
Adolescents >17 years: IV: Initiate at 0.2 mL/kg/hour for 15 to 30 minutes; if no untoward effects occur after 30 minutes, the infusion rate may be gradually increased to 0.5 mL/kg/hour.
Energy/calories: Source of energy/calorie and essential fatty acids (linoleic and alpha-linolenic acids) for pediatric, including term and preterm neonates, and adult patients requiring parenteral nutrition.
Note: The evidence to support lipid emulsion in the treatment of local anesthetic systemic toxicity is based upon the use of 100% soybean oil-based products. Refer to Fat Emulsion (Plant Based) monograph.
Lipid injectable emulsion may be confused with intravenous iron if abbreviated. If abbreviated, use intravenous lipid emulsion (ILE) to avoid confusion (ASPEN 2018; ASPEN [Mirtallo 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Vitamin K Antagonists (eg, warfarin): Lipid Emulsion (Fish Oil and Plant Based) may diminish the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Severe maternal malnutrition may cause adverse events to the fetus/neonate. Indications for fat emulsion therapy in pregnant women are the same as in nonpregnant women. The ASPEN guidelines for parenteral and enteral nutrition state that intravenous fat emulsion may be used safely in pregnant women to provide calories and prevent essential fatty acid deficiency (ASPEN Guidelines 2002).
It is not known if fat emulsion (fish oil based) is excreted in breast milk. The fatty acids found in fat emulsion (eg, linoleic acid, linolenic acid) are endogenous to human milk and concentrations are influenced by maternal diet (IOM 2005). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Caloric content: 2 kcal/mL
Phosphorus: 15 mmol/L
Lipid emulsion should not exceed 60% of the total daily calories.
Monitor for signs and symptoms of essential fatty acid deficiency, fat overload, refeeding syndrome, and/or hypersensitivity reactions.
Monitor triglycerides before initiation of therapy and at least weekly during hospitalization and after changes are made in the dose or rate of the intralipid emulsion administered (ASPEN [Mirtallo 2020]). Monitor more closely in patients with pancreatitis or hepatic disease or in patients receiving other lipid emulsion-based medications (eg, propofol, clevidipine).
When intralipid emulsion is used to prevent essential fatty acid (EFA) deficiency and not as an energy source, monitor for signs and symptoms of EFA deficiency (eg, diffuse, dry scaly rash, alopecia, thrombocytopenia, anemia, impaired wound healing) (Hamilton 2006).
For long-term use (>6 months), monitor for parenteral nutrition–associated liver disease (cholestasis with elevations in serum bilirubin) (ASPEN [Mirtallo 2020]).
Fat overload may be avoided by not exceeding the maximum recommended dose or infusion rate of lipid injectable emulsion. Symptoms include fever, hepatosplenomegaly, icterus, acute respiratory distress syndrome, metabolic acidosis, thrombocytopenia, and bleeding (ASPEN [Mirtallo 2020]).
Monitor for signs and symptoms of infection (including vascular access device complications); fluid and electrolyte status; serum osmolarity; blood glucose; renal function tests; blood counts (including platelets and coagulation parameters).
Lipid emulsion is metabolized and utilized as an energy source; provides fatty acids (linoleic acid, oleic acid, caprylic acid, palmitic acid, capric acid, stearic acid, and alpha linolenic acid) and omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) necessary for normal structure and function of cell membranes.
Metabolism: Fatty acids, phospholipids, and glycerol are metabolized by cells to adenosine triphosphate (ATP), carbon dioxide, and water
Excretion: Biliary (phospholipids)
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