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Fat Emulsion (Plant Based)

Pronunciation

(fat e MUL shun plant baste)

Index Terms

  • Clinolipid
  • Intravenous Fat Emulsion
  • Lipid Emulsion (Plant Based)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Emulsion, Intravenous:

Intralipid: 20% (100 mL, 250 mL, 500 mL, 1000 mL); 30% (500 mL) [contains egg yolk phospholipids, glycerin]

Liposyn III: 10% (200 mL [DSC], 250 mL [DSC], 500 mL [DSC]); 20% (200 mL [DSC], 250 mL [DSC], 500 mL [DSC])

Liposyn III: 30% (500 mL [DSC]) [contains egg phosphatides]

Nutrilipid: 20% (250 mL, 500 mL, 1000 mL) [contains egg yolk phospholipids, glycerin]

Brand Names: U.S.

  • Intralipid
  • Liposyn III [DSC]
  • Nutrilipid

Pharmacologic Category

  • Caloric Agent

Pharmacology

Fat emulsion is metabolized and utilized as an energy source; provides the essential fatty acids, linoleic acid, and alpha linolenic acid necessary for normal structure and function of cell membranes; in local anesthetic toxicity, lipid emulsion probably extracts lipophilic local anesthesia from cardiac muscle

In toxicity secondary to highly lipid soluble substances, exogenous lipids provide an alternative source of binding (Rowlingson 2008), commonly known as the "lipid sink" effect. High lipid partition constant and large volumes of distribution are good predictors of success when using lipid therapy (French 2011). Lipid administration may also affect the heart in a metabolically advantageous way by improving fatty acid transport (Weinberg 2006).

Metabolism

Fatty acids, phospholipids, and glycerol are metabolized by cells to adenosine triphosphate (ATP), carbon dioxide, and water

Excretion

Biliary (phospholipids)

Half-Life Elimination

0.5 to 1 hour

Use: Labeled Indications

Caloric/fatty acid source: Source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for longer than 5 days) or when oral or enteral nutrition is not possible, insufficient, or contraindicated; to prevent and treat essential fatty acid deficiency (except Clinolipid and Nutrilipid).

Contraindications

Clinolipid, Nutrilipid: Known hypersensitivity to egg or soybean proteins or to any component of the formulation; severe hyperlipidemia (serum triglyceride concentrations above 1,000 mg/dL) or severe disorders of lipid metabolism characterized by hypertriglyceridemia.

Intralipid 20%, 30%: Disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if accompanied by hyperlipidemia; pharmacy bulk package is not intended for direct IV administration.

Liposyn III (10%, 20%, 30%): Disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if accompanied by hyperlipidemia; pharmacy bulk package is not intended for direct IV administration; use of product in which there appears to be an oiling out of the emulsion; partly used containers stored for later use.

Additional contraindications (10% and 20% only): Addition of additives to product bottle (except heparin at 1 to 2 units/mL of fat emulsion); use of a filter. Note: The manufacturer’s labeling states not to use a filter; however, all fat emulsion products should be administered using a 1.2-micron filter (ISMP 2016).

Dosing: Adult

Note: At the onset of therapy, the patient should be observed for any immediate allergic reactions (eg, dyspnea, cyanosis, and fever).

Caloric source: IV: Note: Fat emulsion should not exceed 60% of the total daily calories.

Initial dose: 1-1.5 g/kg/day (not to exceed 500 mL Intralipid 10% or 20% or 330 mL Intralipid 30% [over 4-6 hours] on the first day of therapy); daily dose may be infused over 12-24 hours; maximum daily dose: 2.5 g/kg/day

Essential fatty acid deficiency (EFAD), prevention: IV: Administer at least 2% to 4% of total caloric intake as linoleic acid and 0.25% to 0.5% as alpha linolenic acid (Mirtallo 2004; Mirtallo 2010)

Essential fatty acid deficiency (EFAD), treatment: Intralipid, Liposyn III: IV: Administer 8% to 10% of total caloric intake as fat emulsion; may infuse up to once daily (Riella, 1975). If EFAD occurs with stress, the dosage needed to correct EFAD may be increased.

Serious hemodynamic or other instability secondary to highly lipid soluble substances (off-label use): Note: Continue chest compressions during administration (lipid must circulate): 20%: IV: 1.5 mL/kg administered over 1 to 3 minutes, followed immediately by an infusion of 0.25 mL/kg/minute (recommended infusion durations vary; see below); may repeat the bolus as necessary for persistent cardiovascular collapse or if instability re-emerges (ACMT 2016; AHA [Lavonas 2015]; ASRA [Neal 2012]). Some suggest dosing based on lean body weight (AHA [Lavonas 2015]; ASRA [Neal 2012]). Suggested maximum dose: 10 mL/kg over the first 30 to 60 minutes (AHA [Lavonas 2015]; ASRA [Neal 2012]).

After administration of the initial bolus and continuous infusion, recommendations regarding the continuous infusion vary significantly:

American College of Medical Toxicology: If after the bolus and continuing the infusion for 3 minutes the patient demonstrates a significant response, the infusion rate may be reduced to 0.025 mL/kg/minute (ie, one-tenth the initial rate). If instability re-emerges, the infusion rate may be increased back to 0.25 mL/kg/minute or the bolus may be repeated (ACMT 2016).

American Heart Association recommendations: Continue infusion for 30 to 60 minutes (AHA [Lavonas 2015]).

American Society of Regional Anesthesia and Pain Medicine: Continue infusion for at least 10 minutes after hemodynamic stability has been restored. Increase the infusion rate to 0.5 mL/kg/minute if hemodynamic instability persists or recurs. (ASRA [Neal 2012])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: At the onset of therapy, the patient should be observed for any immediate allergic reactions (eg, dyspnea, cyanosis, and fever).

Caloric source: IV: Note: Fat emulsion should not exceed 60% of the total daily calories.

Infants: Initial dose: 1-2 g/kg/day, increase by 0.5-1 g/kg/day to a maximum of 3 g/kg/day depending on needs/nutritional goals; daily dose may be infused over 24 hours (ASPEN Guidelines 2002; ASPEN Pediatric Nutrition Support Core Curriculum 2010)

Children 1-10 years: Initial dose: 1-2 g/kg/day, increase by 0.5-1 g/kg/day to a maximum of 2-3 g/kg/day depending on needs/nutritional goals; daily dose may be infused over 24 hours (ASPEN Guidelines, 2002; ASPEN Pediatric Nutrition Support Core Curriculum 2010)

Adolescents: Initial dose: 1 g/kg/day (not to exceed 500 mL Intralipid 10% or 20% or 330 mL Intralipid 30% [over 4-6 hours] on the first day of therapy); increase by 1 g/kg/day to a maximum of 2.5 g/kg/day depending upon the needs/nutritional goals; daily dose may be infused over 12-24 hours (ASPEN Guidelines 2002; ASPEN Pediatric Nutrition Support Core Curriculum 2010)

Essential fatty acid deficiency (EFAD), prevention: IV: Children and Adolescents: Refer to adult dosing.

Essential fatty acid deficiency (EFAD), treatment: IV: Intralipid, Liposyn III: Children and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Reconstitution

Do not add additives directly to the fat emulsion. When preparing parenteral nutrition admixture, do not add fat emulsion to the TPN container first; destabilization of the lipid emulsion may occur when other solutions (eg, dextrose) are added. Minimize pH-related problems by ensuring that dextrose solutions, which are typically acidic, are not mixed with lipid emulsions alone. First transfer dextrose solution to the TPN admixture container; then transfer amino acid injection; then transfer lipid emulsion. Amino acid injection, dextrose injection, and lipid emulsions may be simultaneously transferred to the admixture container; use gentle agitation during admixing to minimize localized concentration effects; may shake bags gently after each addition. Do not use administration sets and lines that contain di-2-ehtylhexyl phthalate (DEHP).

Administration

Administer by IV infusion only via peripheral line or by central venous infusion. All fat emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ISMP 2016). At the onset of therapy, the patient should be observed for any immediate allergic reactions such as dyspnea, cyanosis, and fever. Change tubing after each infusion. May be simultaneously infused with carbohydrate/amino acid solutions by means of Y-connector located near infusion site or administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients. Fat emulsions of 30% should only be administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients. Hang fat emulsion higher than other fluids (has low specific gravity and could run up into other lines).

Clinolipid: Prior to opening the overwrap of Clinolipid, check the color of the oxygen indicator and compare to the reference color next to the OK symbol. If the color of the oxygen absorber/indicator does not correspond to the reference color, do not use. After opening the bag, use the contents immediately and do not store for a subsequent infusion. Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. When preparing total parenteral nutrition admixture, do not use the EXACTAMIX Inlet H938173 with an EXACTAMIX compounder to transfer Clinolipid injection; EXACTAMIX Inlet H938174 is recommended.

Intralipid: Prior to opening the overwrap, the integrity indicator should be inspected. If the indicator is black, the overwrap is damaged; do not use.

Nutrilipid: To avoid air embolism, use a nonvented infusion set or close the air vent on a vented set and use a dedicated line without any connections. Prior to opening the overwrap, the oxygen indicator should be inspected; if the indicator is pink or dark pink, do not use. May be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). See prescribing information for detailed administration information.

Caloric source/EFAD:

Children: Initiate infusions of 10% emulsions at ≤0.1 mL/minute for 10 to 15 minutes; if no untoward effects occur, the infusion rate may be increased to 1 mL/kg/hour (maximum rate: 100 mL/hour). Initiate infusions of 20% emulsions at ≤0.05 mL/minute for 10 to 15 minutes; if no untoward effects occur, the infusion rate may be increased to 0.5 mL/kg/hour. Note: Premature and/or septic infants may require reduced infusion rates. Do not exceed 1 g fat/kg in 4 hours in this population.

Adults: Initiate infusions of 10% emulsions at 1 mL/minute for 15 to 30 minutes; if no untoward effects occur, the infusion rate may be increased to 2 mL/minute. Initiate infusions of 20% emulsions at 0.5 mL/minute for 15 to 30 minutes; if no untoward effects occur, the infusion rate may be increased to 1 mL/minute.

Serious hemodynamic or other instability secondary to highly lipid soluble substances (off-label use): Administer initial bolus over 1 to 3 minutes followed by a continuous infusion. Chest compressions should continue during administration if patient is in cardiac arrest. Some experts recommend a decreased infusion rate in patients who respond favorably to the initial bolus and infusion (ACMT 2016); repeat bolus or an increase in the infusion rate may be considered if instability persists or recurs. (ACMT, 2016; AHA [Lavonas 2015]; ASRA [Neal 2012]).

Dietary Considerations

Phosphorus: ~1.5 mMol /100 mL of emulsion

Caloric content: 10% fat emulsion = 1.1 kcal/mL; 20% fat emulsion = 2 kcal/mL; 30% fat emulsion = 3 kcal/mL

Fat emulsion should not exceed 60% of the total daily calories.

Storage

Do not freeze. If accidentally frozen, discard. Do not store partly used containers; fat emulsion can support the growth of various organisms. Do not use if the emulsion appears to be oiling out. Once the closure is penetrated, the contents should be used as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. Admixtures prepared using fat emulsion should be used promptly or stored under refrigeration at 2°C to 8°C (36°F to 46°F) for 24 hours or less and used completely within 24 hours after removal from refrigeration.

Intralipid, Nutrilipid: Store below 25°C (77°F).

Liposyn III: Store at 20°C to 25°C (68°F to 77°F).

Clinolipid: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat. Store in overpouch until ready to use.

Adverse Reactions

1% to 10%:

Endocrine & metabolic: Hyperglycemia, hyperlipidemia

Gastrointestinal: Nausea, vomiting

Hematologic & oncologic: Hypoproteinemia

Hepatic: Abnormal hepatic function tests

Frequency not defined:

Gastrointestinal: Gallbladder disease

Genitourinary: Urinary tract infection

Hepatic: Hepatic abnormality

Infection: Septicemia

Miscellaneous: Fever

<1% (Limited to important or life-threatening): Decreased INR, diarrhea, hypersensitivity reaction (including rash and dyspnea)

ALERT: U.S. Boxed Warning

Deaths in preterm infants:

Deaths in preterm infants after infusion of intravenous (IV) fat emulsions have been reported. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low-birth-weight infants with IV fat emulsion must be based on careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible. Preterm infants and low birth weight infants and small for gestational age infants have poor clearance of IV fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients to decrease the likelihood of IV fat overload. Monitor the infant's ability to eliminate the infused fat from the circulation (such as triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

Warnings/Precautions

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) can occur; usually reversible upon discontinuation.

• Hepatic effects: Parenteral nutrition: 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. Consider discontinuation or dose reduction in patients who develop abnormal LFTs.

• Hypersensitivity: Allergic reactions (eg, tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, vomiting, headache, sweating) to lipid emulsion may occur; discontinue infusion immediately if signs or symptoms of hypersensitivity or allergic reactions occur.

• Refeeding syndrome: Parenteral nutrition: 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; ensure triglyceride levels remain <400 mg/dL.

• Respiratory disease: Use with caution in patients with respiratory disease.

• Renal impairment: Use with caution; some formulations may contain aluminum, which may accumulate following prolonged administration in renally impaired patients.

• Toxicity secondary to highly lipid soluble substances: Hemodynamic and other instability: Successful resuscitation following the administration of fat 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 fat 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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: [US Boxed Warning]: Deaths in preterm infants following administration of fat emulsion have been reported; autopsy findings included intravascular fat accumulation in the lungs. Premature infants, low birth weight infants, and small for gestational age infants clear intravenous fat emulsion poorly and have increased free fatty acid plasma levels following fat emulsion infusion. Strict adherence to proper infusion rates, dosing, and monitoring are necessary; infusion rate should be as slow as possible; strict monitoring of metabolic tolerance and elimination of infused fat from the circulation must occur. To avoid hyperlipidemia and/or fat deposition, do not exceed recommended daily doses and consider administering less than the maximum recommended doses in preterm and small for gestational age infants. Clinolipid is not indicated for use in pediatric patients. Pediatric clinical studies did not establish that Clinolipid provides sufficient amounts of essential fatty acids (EFA) in pediatric patients, which may predispose them to neurologic complications due to EFA insufficiency. Because free fatty acids displace bilirubin from albumin binding sites, the use of lipid infusions in jaundiced or premature infants should be done with caution.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. 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 fat 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.

• 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.

Monitoring Parameters

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, refeeding syndrome, and/or hypersensitivity reactions.

Monitor liver and renal function tests periodically. Monitor triglycerides before initiation of lipid therapy and at least weekly during therapy (or until triglycerides are stable and when changes are made in the amount of fat administered; ASPEN Guidelines, 2002); monitor especially closely in premature infants, septic infants, and patients with pancreatitis or liver disease.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. 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). Medications used for the treatment of cardiac arrest in pregnancy are the same as in the non-pregnant woman. Doses and indications should follow current Advanced Cardiovascular Life Support guidelines. Appropriate medications should not be withheld due to concerns of fetal teratogenicity (Jeejeebhoy [AHA] 2015). Lipid emulsion therapy has been used successfully in the resuscitation of a pregnant female with suspected bupivacaine toxicity (Spence 2007).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of infection, signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), severe nausea, severe vomiting, shortness of breath, angina, dizziness, passing out, blue/gray skin discoloration, tachycardia, headache, sweating a lot, severe loss of strength and energy, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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