Version May 2024
(For additional information see "Lipid emulsion (fish oil-based): Pediatric drug information")
Parenteral nutrition, patients with intestinal failure-associated liver disease (IFALD) or a history of IFALD (formerly known as parenteral nutrition-associated cholestasis [PNAC]): Note: Initiate as soon as direct or conjugated bilirubin levels are ≥2 mg/dL in patients who are expected to be parenteral nutrition-dependent for ≥2 weeks. Administer until direct or conjugated bilirubin levels are <2 mg/dL, until the patient no longer requires parenteral nutrition, or based on specific institutional protocols (Ref).
Infants, Children, and Adolescents: IV: 1 g/kg/day; if hypertriglyceridemia develops once the infusion has been initiated, consider discontinuing for 4 hours; resume as indicated based on repeat serum triglyceride level. If triglycerides remain elevated, consider a reduced dose of 0.5 to 0.75 g/kg/day with incremental increase up to 1 g/kg/day; if reduced doses are required, monitor patients for essential fatty acid deficiency; usual maximum daily dose: 1 g/kg/day; in rare instances of preexisting malnutrition or when a higher glucose infusion rate cannot be tolerated, doses up to 1.5 g/kg/day have been reported (Ref).
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; however, adjustment is unnecessary as fish oil-based lipid emulsion is indicated for use in patients with cholestasis. Monitor liver function closely.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Bradycardia (35%)
Central nervous system: Agitation (35%)
Dermatologic: Erythema (12%)
Gastrointestinal: Vomiting (46%)
Hematologic & oncologic: Hemorrhage (39%)
Hepatic: Decreased serum bilirubin (60%)
Infection: Viral infection (16%)
Respiratory: Apnea (20%)
1% to 10%:
Central nervous system: Hypertonia (6%)
Dermatologic: Skin rash (8%), catheter-site erythema (6%)
Endocrine & metabolic: Hyperglycemia (7%), hypertriglyceridemia (3%)
Hematologic & oncologic: Neutropenia (7%)
Infection: Abscess (7%)
Hypersensitivity to fish or egg protein or to any component of the formulation; severe hemorrhagic disorders; severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL)
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 manifestations (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, especially preterm infants, and can present as cholestasis or steatohepatitis, fibrosis, and cirrhosis, possibly leading to hepatic failure; cholecystitis and cholelithiasis have also been observed.
• Hypersensitivity: Contains fish oil and egg phospholipids; hypersensitivity reactions may occur. 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. Obtain serum triglycerides before initiating therapy, at the time of each dosage increase, and regularly throughout treatment. In neonates and infants with triglycerides >250 mg/dL and older children with triglycerides >400 mg/dL, consider stopping administration for 4 hours and obtain a repeat serum triglyceride level. Resume therapy based on new result as indicated.
• Infection: Catheter-related bloodstream infections may occur due to lipid emulsions supporting microbial growth; ensure aseptic techniques are used for catheter placement and maintenance, as well as preparation and administration of lipid injectable emulsions; 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: Use with caution in patients with anemia. The use of lipid emulsion has been associated with anemia likely due to hemodilution (Zellner 1967).
• Bleeding disorders: Use with caution in patients with bleeding disorders.
• Renal impairment: Use with caution in patients with renal impairment; may contain aluminum, which may accumulate following prolonged administration in patients with renal impairment.
• Toxicity secondary to highly lipid soluble substances: Hemodynamic and other instability: Successful resuscitation following the administration of lipid emulsion has been reported in animal studies and several human case reports in which cardiovascular toxicity was unresponsive to conventional resuscitation and antidotal measures. Successful resuscitation following the administration of lipid emulsion has been reported in pediatric patients (Fuzaylov 2010; Ludot 2008; Shah 2009; Wong 2010). Additional information is available at http://www.lipidrescue.org. Consider use when toxicity secondary to a highly lipid soluble substance is likely and conventional methods are unsuccessful. Continue CPR throughout treatment with lipid emulsion. Consultation with a medical toxicologist or poison control center is highly recommended.
Special populations:
• 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 an 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. Contains vitamin K, which may counteract anticoagulant activity.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Intravenous:
Omegaven: 5 g/50 mL (50 mL); 10% (100 mL) [latex free; contains egg phospholipids (egg lecithin)]
No
Emulsion (Omegaven Intravenous)
5 gm/50 mL (per mL): $1.40
10 g/100 mL (per mL): $1.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: May be administered 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 injectable emulsion infusions, whether part of an admixture or infused separately, should be filtered using a 1.2-micron in-line filter only (Ref). Administration may occur via peripheral line or central venous infusion using 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). Use a vented infusion set when infused from the bottle, avoid multiple connections, do not connect multiple medications in series, and turn off pump before the bottle runs dry.
Experts recommend parenteral nutrition admixtures and lipid injectable emulsions for neonates and infants be protected from light as soon as possible after preparation and through infusion (Ref).
Rate: Initiate at 0.2 mL/kg/hour (0.02 g/kg/hour) for the first 15 to 30 minutes; if tolerated, gradually increase until reaching the required rate after 30 minutes. Do not exceed a rate of 1.5 mL/kg/hour (0.15 g/kg/hour). The recommended duration of the infusion is 8 to 24 hours, depending upon the clinical situation. Infusion should be completed within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture. In cases where the infusion extends beyond 12 hours, the source container must be changed.
Note: IV compatibility data with one lipid injectable emulsion product does not confer the same IV compatibility data with another lipid injectable emulsion product. Interpret compatibility information carefully (Ref).
Parenteral nutrition-associated cholestasis (treatment): A source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Limitations of use: Not indicated for the prevention of PNAC.
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.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Lipid Emulsion (Fish Oil Based) may enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy
Anticoagulants: Lipid Emulsion (Fish Oil Based) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Animal reproduction studies have not been conducted.
It is not known if fat emulsion (fish oil based) is present in breast milk; however, omega-3 fatty acid concentrations in milk are increased following oral administration of omega-3 fatty acids.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother
Caloric content: 1.12 kcal/mL
Monitor for signs and symptoms of infection (including vascular access device complications); fluid and electrolyte status; serum osmolarity; blood glucose; blood counts (including platelets and coagulation parameters); signs and symptoms of essential fatty acid deficiency, fat overload syndrome, refeeding syndrome, pleural or pericardial effusion, and/or hypersensitivity reactions.
Monitor triglycerides before initiation of lipid injectable emulsion therapy and at least weekly during hospitalization and after changes are made in the amount of lipid emulsion administered; once stable, monitoring frequency may range from weekly to monthly depending on patient clinical status and history; monitor more frequently in patients at risk for hypertriglyceridemia, such as premature infants (especially those that are extremely low birth weight); patients receiving high lipid injectable emulsion or glucose doses; critically ill patients; patients with sepsis, severe thrombocytopenia, or coagulopathy; patients with pancreatitis or liver disease; or in patients receiving other lipid emulsion-based medications (eg, propofol) (ASPEN [Cober 2021]; ASPEN [Mirtallo 2020]; ESPGHAN [Lapillonne 2018]).
Monitor hepatic function (direct bilirubin, ALT/AST, alkaline phosphatase, and gamma-glutamyl transferase) at least weekly during hospitalization and at least every 3 months for patients receiving home parenteral nutrition (Deshpande 2020; ESPGHAN [Lapillonne 2018]). Monitor kidney function periodically.
Lipid emulsion (fish oil based) is metabolized and utilized as an energy source; provides fatty acids (linoleic acid, oleic acid, arachidonic acid, palmitic acid, palmitoleic acid, myristic 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.
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