Nutrilipid Drug Information
Generic name: SOYBEAN OIL
Lipid Emulsion [EPC]
Uses of Nutrilipid
Nutrilipid ® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated. Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Dosage & Administration of Nutrilipid
| Initial Recommended Dosage | Maximum Dosage |
|---|---|
| Preterm and term infants (<1 year) | 1 to 2 g/kg/day |
| Pediatric patients 1 to 10 years | |
| Pediatric patients 11 to <17 years | 1 g/kg/day |
| Adults | 1 to 1.5 g/kg/day |
Side Effects of Nutrilipid
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia. Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Nutrilipid 20%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions: extravasation, infusion site erythema, infusion site pain, infusion site phlebitis, infusion site pruritus, and infusion site swelling. Immune system disorders: hypersensitivity reactions, including anaphylaxis.
Warnings & Cautions for Nutrilipid
Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and
Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour.
Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation.
Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders Risk of Parenteral Nutrition-Associated
Liver Disease Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including Nutrilipid 20%, have been associated with development of PNALD. Monitor liver tests in patients treated with Nutrilipid 20% and consider discontinuation or dosage reduction if abnormalities occur. Other Hepatobiliary Disorders Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN-treated patients without preexisting liver disease. Monitor liver tests when administering Nutrilipid 20%. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to Nutrilipid 20% use.
Hypersensitivity Reactions Nutrilipid 20% contains soybean oil and egg phospholipids which may
cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following Nutrilipid administration.
Nutrilipid 20% is contraindicated in patients with known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% . If a hypersensitivity reaction occurs, stop infusion of Nutrilipid 20% immediately and initiate appropriate treatment and supportive measures.
Infections Lipid emulsions, such as Nutrilipid 20%, can support microbial growth and
are an independent risk factor for the development of catheter-related bloodstream infections. To decrease the risk of infectious complications, ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of Nutrilipid 20%. Monitor for signs and symptoms of infection, including fever and chills, as well as including laboratory test results (including leukocytosis and hyperglycemia). Perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.
Fat Overload Syndrome Fat overload syndrome is a rare condition that has
been reported with intravenous lipid formulations and is characterized by a sudden deterioration in the patient's condition (e.g., fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations such as coma). A reduced or limited ability to metabolize lipids, accompanied by prolonged plasma clearance (resulting in higher lipid levels), may result in this syndrome. Although fat overload syndrome has been most frequently observed when the recommended lipid dose or infusion rate was exceeded, cases have also been described when the lipid formulation was administered according to instructions. If signs or symptoms of fat overload syndrome occur, stop Nutrilipid 20%. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.
Refeeding Syndrome Administering PN to severely malnourished patients may result in the
refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake.
Hypertriglyceridemia
The use of Nutrilipid 20% is contraindicated in patients with hypertriglyceridemia with serum triglyceride concentrations >1,000 mg/dL. Patients with conditions such as inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes have a higher risk of developing hypertriglyceridemia with the use of Nutrilipid 20%. In addition, patients with hypertriglyceridemia may have worsening of their hypertriglyceridemia with administration of Nutrilipid 20%. Excessive dextrose administration may further increase such risk. Evaluate patients’ capacity to metabolize and eliminate the infused lipid emulsion by measuring serum triglycerides before the start of infusion (baseline value) and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the Nutrilipid 20% infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia such as pancreatitis.
In pediatric patients with hypertriglyceridemia, lower triglyceride levels (i.e., below 400 mg/dL) may be associated with adverse reactions. Monitor serum triglyceride levels to avoid potential complications with hypertriglyceridemia such as pancreatitis, lipid pneumonitis, and neurologic changes, including kernicterus. To minimize the risk of new or worsening of hypertriglyceridemia, assess high-risk patients for their overall energy intake including other sources of lipids and dextrose, as well as concomitant drugs that may affect lipid and dextrose metabolism.
Aluminum Toxicity Nutrilipid 20% contains no more than 25 mcg/L of aluminum.
Prolonged parenteral nutrition administration in patients with renal impairment may result in aluminum reaching toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions that contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration of total parenteral nutrition products.
Monitoring / Laboratory Tests
Monitor fluid status closely in patients with pulmonary edema or heart failure. Throughout treatment, monitor serum triglycerides , fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters. The lipids contained in Nutrilipid may interfere with some laboratory tests (e.g., hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation) if blood is sampled before the lipids have cleared from the bloodstream.
Conduct these tests at least 6 hours after stopping the infusion. Nutrilipid contains Vitamin K that may counteract anticoagulant activity.
Drug Interactions with Nutrilipid
Coumarin and Coumarin Derivatives
The soybean oil in Nutrilipid 20% contains vitamin K1. Vitamin K can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which work by blocking recycling of vitamin K. Monitor laboratory parameters for anticoagulant activity in patients who are on both Nutrilipid 20% and coumarin or coumarin derivatives.
Pregnancy Safety for Nutrilipid
Pregnancy Risk Summary There are no adequate or well controlled studies with Nutrilipid 20% in pregnant women. Additionally, animal reproduction studies have not been conducted with Nutrilipid 20%. It is not known whether Nutrilipid 20% can cause fetal harm when administered to a pregnant woman. Nutrilipid 20% should be given to a pregnant woman only if clearly needed.
Pediatric Use of Nutrilipid
- Preparation Instructions for Nutrilipid 20% Bags for Direct Infusion Caution: Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration.
- Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink. Use only if container and seals are intact.
- Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.
- Step 3: Inspect Nutrilipid 20% bag visually (Figure 2). Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect Nutrilipid 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed.
- Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b). Do not use/penetrate blocked port.
- Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump. Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism. Overwrap Illustration Figure 1 Tear Overwrap Figure 2 Inspect Bag Blocked port illustration Figure 3a and 3b Peel Foil and Insert Spike Do not use blocked port illustration Figure 4 Hang Bag
Contraindications for Nutrilipid
Nutrilipid 20% injection is contraindicated in patients who have: Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20%. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL). Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
Overdosage Information for Nutrilipid
In the event of overdose, serious adverse reactions may result. Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped.
If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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