Category: Intellectual Nourishment
Navigating lipid sources in parenteral nutrition (PN)
Because lipid injectable emulsions (ILEs) are an energy-dense source of calories in PN solutions, choosing a lipid source is important. In this blog post, we’ll discuss various lipid sources and compare 2 mixed-oil ILEs.
Evaluating lipid sources: A variety of lipid sources are available for PN, including medium-chain triglycerides (MCTs), olive oils, and fish oils, which, based on extensive usage in Europe, have an equivalent safety profile to soybean oil.1 These alternative ILEs are metabolized via different pathways.1
Mixed-oil ILEs: While standard soybean oil-based emulsions are commonly used, alternative mixed-oil emulsions containing omega-3s and omega-6s can be a unique blend due to their diverse fatty acid content.
Tailoring nutrition: Recognizing that each patient is unique, it is important to take into consideration the patient’s age, clinical condition, therapeutic objectives, and tolerance when considering a lipid dose.
The role of clinical expertise: The expertise of healthcare professionals is paramount in the selection and management of lipid sources in PN. Ongoing assessment and monitoring of patients is integral to ensure the appropriate choice of lipid for each patient.
An informed approach is critical to incorporating mixed-oil ILEs as a part of the clinical management of patients. Alternative lipid sources containing fish oil are the 4th generation of ILEs. Specifically, a 4-oil ILE was the most recent innovation to the market, receiving approval for adults in 2016 and pediatrics in 2022.
Use this table as a quick reference on the compositional differences between 2 mixed-oil ILEs on the market today.
Expert recommendations suggest an omega-6:omega-3 ratio of 2:1 to 4:1 in ILEs.4-7
At Fresenius Kabi, our dedication to caring also means we’re dedicated to keeping healthcare professionals informed. Staying current with the latest research and news in the field of PN can help you educate patients about the treatments they receive, including the importance of PN and the specific products being used.
Looking for more information?
SMOFlipid® (lipid injectable emulsion, USP), for intravenous use
IMPORTANT SAFETY INFORMATION
What is SMOFlipid?
- Indicated in adult and pediatric patients as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
- The hourly infusion rate in pediatrics should not exceed 0.75 mL/kg/hour and 0.5 mL/kg/hour in adults.
SMOFlipid should not be received by patients who have:
- A known allergy to fish, egg, soybean, or peanut, or to any of the active or inactive ingredients in SMOFlipid.
- Abnormally high levels of lipid (triglycerides) in the blood.
SMOFlipid may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Parenteral nutrition-associated liver disease (PNALD) may progress to liver inflammation and damage caused by a buildup of fat in the liver with scarring and cirrhosis.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.
The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.
These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. 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 can be found at https://www.freseniuskabinutrition.com/SMOFlipidPI.
References: 1. Vanek VW, Seidner DL, Allen P, et al. A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27(2):150-192. 2. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 3. Clinolipid Prescribing Information, Baxter Healthcare Corporation. 2023. 4. Grimble RH. Fatty acid profile of modern lipid emulsions: scientific consideration for creating the ideal composition. Clin Nutr Suppl. 2005;1(3):9-15. 5. Waitzberg DL, Torrinhas RS, Jacintho TM. New parenteral lipid emulsions for clinical use. JPEN J Parenter Enteral Nutr. 2006;30(4):351-367. 6. Mayer K, Schaefer MB, Seeger W. Fish oil in the critically ill: from experimental to clinical data. Curr Opin Clin Nutr Metab Care. 2006;9(2):140-148. 7. Grimm H, Mertes N, Goeters C, et al. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006;45(1):55-60. 8. Deckelbaum RJ, Hamilton JA, Moser A, et al. Medium-chain versus long-chain triacylglycerol emulsion hydrolysis by lipoprotein lipase and hepatic lipase: implications for the mechanisms of lipase action. Biochemistry. 1990;29(5):1136-1142. 9. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388.
Fresenius Kabi: at the forefront of parenteral nutrition (PN)
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies, including clinical nutrition and infusion therapy. Our PN products provide nourishment that helps to care for critically and chronically ill patients all around the world.
Built on years of innovation
Our history begins more than a century ago when Dr. Eduard Fresenius founded the pharmaceutical company Dr. E. Fresenius. There, he offered several pharmaceutical specialty medications, including injectable solutions. Since then, Fresenius Kabi has supported the research needed to drive advancements in clinical nutrition and deliver options to healthcare providers and their patients on PN. We have built on decades of innovation, and our tireless dedication has led to many “firsts” in the field of PN.
A history of “firsts”
In 2014, Fresenius Kabi launched the first and only three-chamber bags for adult PN in the US, Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use and Perikabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use.1,2
In 2016, Fresenius Kabi pioneered the use of fish oil and omega-3s in PN products. During that same year, we brought the benefits of alternative lipid emulsions to market.
In 2018, the FDA approved Omegaven® (fish oil triglycerides) injectable emulsion, the first and only 100% fish oil lipid injectable emulsion (ILE) developed by Fresenius Kabi for pediatric patients with PN-associated cholestasis (PNAC) in the US.3
In 2022, the first four-oil ILE, SMOFlipid® (Lipid Injectable Emulsion, USP 20%), was approved for pediatric patients, including term and preterm neonates.4
In 2023, Fresenius Kabi welcomed Intralipid® (lipid injectable emulsion, USP 20%), a soybean oil-based ILE, back home.5
Fresenius Kabi continues to drive innovation in the world of clinical nutrition.
Caring for life
Fresenius Kabi’s purpose is “caring for life,” and we’re committed to putting lifesaving medicines and technologies in the hands of people who care for patients and finding answers to the challenges they face. We offer an array of PN resources, including detailed product information, case studies, educational videos, and helpful guides. Check them out: www.FreseniusKabiNutrition.com/resources/
Kabiven (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use and Perikabiven (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
IMPORTANT SAFETY INFORMATION
What is Kabiven and Perikabiven?
- Indicated in adult patients as a source of calories, protein, electrolytes and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Kabiven and Perikabiven may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adults.
- Do not exceed the recommended maximum infusion rate of 2.6 mL/kg/hour for Kabiven and 3.7 mL/kg/hour for Perikabiven.
Limitations of Use
Neither Kabiven nor Perikabiven is recommended in pediatric patients less than 2 years old because the fixed amount of the formulations do not meet nutritional needs in this age group.
Do not use Kabiven or Perikabiven in patients who have:
- Simultaneous treatment with ceftriaxone in neonates (28 days of age or younger)
- Known allergy to egg, soybean, peanut or any of the active or inactive ingredients
- Abnormally high levels of lipid (triglycerides) in the blood (with serum triglyceride concentration >1,000 g/dL)
- Inborn errors of amino acid metabolism (a genetic defect in protein metabolism)
- Cardiopulmonary instability (inability for the heart and lungs to function right)
- Hemophagocytic syndrome (a disorder of the immune system)
Kabiven and Perikabiven may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Your healthcare provider will monitor liver tests.
- Pulmonary Embolism (a blockage in a blood vessel in the lung) and Respiratory Distress (increased breathing rate, bluish skin color changes, wheezing) due to Pulmonary Vascular Precipitates (solid substance in the blood vessel of the lungs): If signs of lung issues occur, stop the infusion and start a medical evaluation.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction
- Precipitation (solid substance in the blood vessel) with Ceftriaxone: Do not administer ceftriaxone simultaneously with Kabiven or Perikabiven via a Y-site.
- Infection, fat overload, hyperglycemia (high blood sugar) and refeeding syndrome: Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels
The most common adverse reactions for Kabiven (≥3%) are nausea, fever, high blood pressure, vomiting, decreased blood hemoglobin, decreased blood total protein, low blood potassium, and increased gamma glutamyltransferase (a liver enzyme). The most common adverse reactions for Perikabiven (≥3%) are high blood sugar, low blood potassium, fever and increased blood lipids.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
Tell your doctor if you are taking coumarin and coumarin derivatives, including warfarin: the drug activity may be lessened and your healthcare provider will monitor your blood.
These are not all the possible side effects associated with Kabiven and Perikabiven. Call your healthcare provider for medical advice regarding Kabiven and Perikabiven side effects. You are encouraged to report negative side effects of Kabiven and Perikabiven. 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 can be found at www.freseniuskabinutrition.com/KabivenPI and www.freseniuskabinutrition.com/PeriKabivenPI.
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use OMEGAVEN safely and effectively. To learn more about OMEGAVEN for your child, talk to your child’s healthcare provider. OMEGAVEN is available by prescription only. The FDA-approved product labeling can be found at www.freseniuskabinutrition.com/OmegavenPI.
What is OMEGAVEN?
- A fish oil-based intravenous lipid emulsion that is a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
- Does not prevent PNAC.
- It has not been demonstrated that the clinical outcomes seen in pediatric patients are a result of the omega-6:omega-3 fatty acid ratio of the product.
- The hourly infusion rate should not exceed 1.5 mL/kg/hour
OMEGAVEN should not be received by patients who have:
- a known allergy to fish or egg protein or to any of the ingredients in OMEGAVEN.
- a severe bleeding disorder.
- abnormally high levels of lipid (triglycerides) in the blood.
What important safety information should I know about OMEGAVEN?
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
The most common side effects, (>15%) include: vomiting, agitation, slower than normal heartbeat, interruption of breathing, and viral infection.
These are not all the possible side effects associated with OMEGAVEN. Call your healthcare provider for medical advice regarding OMEGAVEN side effects. You are encouraged to report negative side effects of OMEGAVEN. 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 can be found at www.freseniuskabinutrition.com/OmegavenPI.
SMOFlipid® (lipid injectable emulsion, USP), for intravenous use
IMPORTANT SAFETY INFORMATION
What is SMOFlipid?
- Indicated in adult and pediatric patients as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
- The hourly infusion rate in pediatrics should not exceed 0.75 mL/kg/hour and 0.5 mL/kg/hour in adults.
SMOFlipid should not be received by patients who have:
- A known allergy to fish, egg, soybean, or peanut, or to any of the active or inactive ingredients in SMOFlipid.
- Abnormally high levels of lipid (triglycerides) in the blood.
SMOFlipid may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Parenteral nutrition-associated liver disease (PNALD) may progress to liver inflammation and damage caused by a buildup of fat in the liver with scarring and cirrhosis.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.
The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.
These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. 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 can be found at www.freseniuskabinutrition.com/SMOFlipidPI.
Intralipid (lipid injectable emulsion) for intravenous use
IMPORTANT SAFETY INFORMATION
What is Intralipid?
- 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).
Intralipid should not be received by patients who have:
- A known allergy to egg, soybean, or peanut, or any of the active ingredients or excipients in Intralipid.
- Abnormally high levels of lipid (triglycerides) in the blood.
Intralipid may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly adhere to the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Parenteral nutrition-associated liver disease (PNALD) may progress to liver inflammation and damage caused by a buildup of fat in the liver with scarring and cirrhosis.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides: Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels
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 can be found at www.FreseniusKabiNutrition.com/IntralipidPI.
References: 1. Kabiven Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2. Perikabiven Prescribing Information, Fresenius Kabi USA, LLC. 2023. 3. Omegaven Prescribing Information, Fresenius Kabi USA, LLC. 2023. 4. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 5. Intralipid Prescribing Information, Fresenius Kabi USA, LLC. 2023.
Pediatric malnutrition and the role of parenteral nutrition (PN)
What is pediatric malnutrition?
Malnutrition is a big problem—not just in the U.S. but around the world. According to Dr. Francesco Branca, Director of the Department of Nutrition for Health and Development at the World Health Organization, “Malnutrition is a complex issue, but it is the main cause of death and disease in the world.”1 And it’s no respecter of age. Babies, children, and teenagers can suffer from the detrimental effects of malnutrition.
Some studies have reported that up to 51% of hospitalized pediatric patients suffer from malnutrition due to a disease or injury.2-4
Pediatric malnutrition is defined as “an imbalance between nutrient requirements and intake that results in cumulative deficits of energy, protein, or micronutrients that may negatively affect growth, development, and other relevant outcomes.”5 It may be caused by a disease or injury, which is usually the case in developed countries, and/or it may be caused by environmental, socioeconomic, or behavioral factors that lead to decreased nutrient intake.5 Although pediatric malnutrition is common, “its true prevalence is underreported and not well understood.”6
Babies, children, and teenagers who do not receive the nutrition they need to support adequate growth and development may experience negative consequences. Symptoms may include a thin or bloated appearance or a weakened immune system.7 Patients may also exhibit mood changes, faltering growth, and low energy levels.7,8
What impact does pediatric malnutrition have on patient outcomes?
Malnutrition can lead to adverse outcomes, including longer hospital stays and increased healthcare costs.4,9 Additionally, it can have lasting negative effects on pediatric patients, including stunting, which “often results in delayed mental development, poor school performance, and reduced intellectual capacity.”10
Nourishing pediatric patients with PN
Pediatric patients unable to receive adequate nutrition by mouth or enteral feeding may require PN to meet their nutritional goals.11 PN regimens often include lipid injectable emulsions (ILEs), which provide a noncarbohydrate source of energy and essential fatty acids.12,13
At Fresenius Kabi, we are dedicated to providing more options for patients who need PN.
References: 1. Malnutrition is a world health crisis. World Health Organization website. September 26, 2019. Accessed July 28, 2023. https://www.who.int/news/item/26-09-2019-malnutrition-is-a-world-health-crisis. 2. Hendricks KM, Duggan C, Gallagher L, et al. Malnutrition in hospitalized pediatric patients. Current prevalence. Arch Pediatr Adolesc Med. 1995;149(10):1118-1122. 3. Pawellek I, Dokoupil K, Koletzko B. Prevalence of malnutrition in paediatric hospital patients. Clin Nutr. 2008;27(1):72-76. 4. Secker DJ, Jeejeebhoy KN. Subjective Global Nutritional Assessment for children. Am J Clin Nutr. 2007;85(4):1083-1089. 5. Mehta NM, Corkins MR, Lyman B, et al. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013;37(4):460-481. 6. Goldberg DL, Van Poots, HA. Pediatric and Neonatal Malnutrition: A Collaborative, Family-Centered Approach Improves Outcomes. Pediatr Neonatal Nurs Open J. 2019;6(1):e1-e4. 7. Malnutrition. Johns Hopkins Medicine website. Accessed July 24, 2023. https://www.hopkinsmedicine.org/health/conditions-and-diseases/malnutrition 8. Symptoms Malnutrition. NHS website. Last reviewed May 23, 2023. Accessed July 24, 2023. https://www.nhs.uk/conditions/malnutrition/symptoms/ 9. Gambra-Arzoz M, Alonso-Cadenas JA, Jiménez-Legido M, et al. Nutrition Risk in Hospitalized Pediatric Patients: Higher Complication Rate and Higher Costs Related to Malnutrition. Nutr Clin Pract. 2020;35(1):157-163. 10. Malnutrition in children. World Health Organization website. Accessed July 26, 2023. https://www.who.int/data/nutrition/nlis/info/malnutrition-in-children#:~:text=Stuntingistheresultof,productivityatthenationallevel 11. What Is Parenteral Nutrition. ASPEN website. Accessed July 26, 2023. https://www.nutritioncare.org/About_Clinical_Nutrition/What_is_Parenteral_Nutrition/ 12. Lapillonne A, Fidler Mis N, Goulet O, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Lipids. Clin Nutr. 2018;37(6 Pt B):2324-2336. 13. Cober MP, Gura KM, Mirtallo JM, et al. ASPEN lipid injectable emulsion safety recommendations part 2: Neonate and pediatric considerations. Nutr Clin Pract. 2021;36(6):1106-1125.
Omega-3s in parenteral nutrition (PN)
The role of lipids in PN
People of all ages, from infants to children to adults, may need PN to help them meet their nutritional goals.1 Protein, carbohydrate, and fat are the 3 main components of PN. These 3 macronutrients are important for the provision of adequate nutrition in patients receiving PN.
Intravenous fats, or lipids, provide a good source of energy-dense, non-protein calories, which may lower the amount of carbohydrate needed as part of nutrition support.2,3
“Lipids provide the building blocks for cell membranes and provide essential fatty acids, thereby preventing essential fatty acid deficiency.”3
Lipid source matters when choosing appropriate lipid injectable emulsions (ILEs) for patients on PN. Fish oil-containing ILEs are a source of omega-3 fatty acids. Let’s dive further into some omega-3 properties and explore innovative PN products that contain this alternative energy source.
Introducing an advancement in PN
Fresenius Kabi is dedicated to delivering more options to healthcare providers and their PN patients. So, in 2016, we introduced fish oil and omega-3s into our PN products, representing a development and advancement for critically ill patients.
Meet our innovative omega-3-containing PN products
We understand that lipid source matters when considering appropriate nutrition for patients. We’re proud to offer two innovative ILEs that deliver fish oil and omega-3s to help nourish patients who need PN. Meet SMOFlipid® (Lipid Injectable Emulsion, USP 20%) and Omegaven® (fish oil triglycerides) injectable emulsion.
With SMOFlipid, Fresenius Kabi answered the call from PN and critical care medical societies for an alternative to soy-based ILEs. This unique blend of 4 oils—soybean oil, medium-chain triglycerides, olive oil, and fish oil—is the first lipid advancement for adults in more than 4 decades. In 2022, it received approval for use in pediatric patients, including term and preterm neonates.4 Today, SMOFlipid is recognized all around the world.
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Used for more than a decade worldwide
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Administered to more than 7 million adult and pediatric patients worldwide*
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Safe and well tolerated5,6
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The fatty acid ratio is in line with expert recommendations in adults7-10
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Contains fish oil, which provides a good source of omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)11
Omegaven was previously available only for compassionate care. However, Fresenius Kabi saw the need for the product to be more broadly available to pediatric patients and worked hard to secure the necessary clinical evidence to support FDA approval. In 2018, Omegaven became commercially available for pediatric patients with parenteral nutrition-associated cholestasis (PNAC). It’s the FIRST and ONLY PN innovation with 100% fish oil that nurtures.12
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Patients receiving Omegaven achieved age-appropriate growth12
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Omegaven-treated patients experienced improvement in liver function parameters12
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Direct or conjugated bilirubin levels were effectively lowered12
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Contains the omega-3 fatty acids EPA and DHA
The development of these two products demonstrates our dedication to caring for life. And we will continue to drive advancements for all patients who need PN.
Learn more about SMOFlipid and Omegaven at www.FreseniusKabiNutrition.com/pn-portfolio/.
INDICATIONS AND USAGE
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Limitations of Use
Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients.
It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product.
IMPORTANT SAFETY INFORMATION
Protect the admixed PN solution from light. Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. The recommended nutritional requirements of fat and recommended dosages of Omegaven to meet those requirements for pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.
Table 1: Recommended Pediatric Dosage and Infusion Rate
Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients, severe hemorrhagic disorders due to a potential effect on platelet aggregation, severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL).
Clinical Decompensation with Rapid Infusion of Lipid Injectable Emulsions in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/hour. 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.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
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 infants.
Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency.
The most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.
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 Omegaven safely and effectively. Please see full prescribing information for Omegaven (fish oil triglycerides) injectable emulsion for intravenous use at www.FreseniusKabiNutrition.com/OmegavenPI.
INDICATIONS AND USAGE
SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
IMPORTANT SAFETY INFORMATION
For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during 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. The recommended dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.
Table 1: Recommended Adult and Pediatric Dosage
SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
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.
Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver 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, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: 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 hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and nosocomial infection.
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 SMOFlipid safely and effectively. Please see full prescribing information, for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.
*Data on file.
References: 1. ASPEN. What is parenteral nutrition. ASPEN website. https://www.nutritioncare.org/About_Clinical_Nutrition/What_is_Parenteral_Nutrition/. Accessed June 21, 2023. 2. Raman M, Almutairdi A, Mulesa L, Alberda C, Beattie C, Gramlich L. Parenteral Nutrition and Lipids. Nutrients. 2017;9(4):388. 3. Calder PC, Adolph M, Deutz NE, et al. Lipids in the intensive care unit: Recommendations from the ESPEN Expert Group. Clin Nutr. 2018;37(1):1-18. 4. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 5. Klek S, Chambrier C, Singer P, et al. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)—a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013;32(2):224-231. 6. Mertes N, Grimm H, Fürst P, Stehle P. Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study. Ann Nutr Metab. 2006;50(3):253-259. 7. Grimble RH. Fatty acid profile of modern lipid emulsions: scientific consideration for creating the ideal composition. Clin Nutr Suppl. 2005;1(3):9-15. 8. Waitzberg DL, Torrinhas RS, Jacintho TM. New parenteral lipid emulsions for clinical use. JPEN J Parenter Enteral Nutr. 2006;30(4):351-367. 9. Mayer K, Schaefer MB, Seeger W. Fish oil in the critically ill: from experimental to clinical data. Curr Opin Clin Nutr Metab Care. 2006;9(2):140-148. 10. Grimm H, Mertes N, Goeters C, et al. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006;45(1):55-60. 11. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388. 12. Omegaven Prescribing Information, Fresenius Kabi USA, LLC. 2023.
Nutrition support for the critically ill is critical
How does malnutrition impact critically ill patients?
Several studies have observed a relationship between malnutrition and increased risk of mortality, infections, hospital length of stay.1-8 And unfortunately, many critically ill patients—those with cancer, Crohn’s disease, and short bowel syndrome just to name a few—often become malnourished. These conditions can affect their digestive system or interrupt their bowel function for a long time—or indefinitely. When this happens, clinical nutrition is needed to adequately nourish these patients.
More than 30% of patients in the intensive care unit have been reported to be malnourished.9
PN in critical care
Many critically ill patients cannot tolerate food by mouth or enteral feedings. In these cases, PN plays a crucial role in helping them meet their nutritional goals. In addition to amino acids, lipids, and dextrose, essential fatty acids (EFAs) are…well…essential to providing optimal nutrition.
The good news is that most lipid-based PN products provide EFAs. Lipid sources used in PN include soybean oil, medium-chain triglycerides (MCTs), olive oil, and fish oil. With SMOFlipid® (Lipid Injectable Emulsion, USP 20%), you get all four—each with a unique characteristic.
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What makes SMOFlipid (Lipid Injectable Emulsion, USP 20%) unique?
SMOFlipid is the FIRST and ONLY four-oil lipid injectable emulsion (ILE) with demonstrated safety and tolerability10,11 in more than 7 million patients worldwide.* This unique combination of oils provides a balanced blend for critically ill patients of all ages—from adults to teenagers to preterm neonates.12
*Data on file.
What are the benefits of the blend?
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Soybean oil 30% (omega-6)
Provides essential fatty acids.
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Medium-chain triglycerides 30%
A source of rapidly available energy.13
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Olive oil 25% (omega-9)
Supplies monounsaturated fatty acids.
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Fish oil 15% (omega-3)
A source of EPA
and DHA.14
Studies showed triglyceride levels increased less with SMOFlipid compared to lipid emulsions with higher soybean oil content in adults.15,16
Triglyceride Change After 5 Days
Study Takeaway
In this randomized controlled trial including postoperative surgical ICU adult patients (n=20), SMOFlipid demonstrated a lower triglyceride increase compared to those patients who received a lipid emulsion (1.5 g/kg/d ILE dose in both groups) with a higher soybean oil content.15
Monitor serum triglycerides before and during treatment with SMOFlipid. Company-sponsored studies showed that mean triglyceride levels from baseline values to week 4 were similar in both the SMOFlipid and comparator groups.
In pediatric patients, SMOFlipid has been shown to support growth and provides essential fatty acids.12,17,18
With SMOFlipid, Fresenius Kabi answered the call from PN and critical care medical societies for an alternative to soy-based ILEs.
As pioneers in clinical nutrition, Fresenius Kabi is committed to bringing innovations like SMOFlipid to market. Learn more about this unique 4-oil ILE and how it can help nourish your critically ill patients of any age at www.FreseniuKabiNutrition.com/products/smoflipid-adults/
SMOFLIPID (lipid injectable emulsion), for intravenous use
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.
INDICATIONS AND USAGE
SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
DOSAGE AND ADMINISTRATION
The recommended daily dosage and initial and maximum infusion rates for pediatric and adult patients are provided in Table 1. Do not exceed the recommended maximum infusion rate in Table 1. The recommended duration of infusion for SMOFlipid will vary depending on the clinical situation. Adjust the administration flow rate by taking into account the dose being administered, the daily volume/intake, and the duration of the infusion.
SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion. Prior to administration, transfer to a separate PN container for individual patient use. Use a non-vented, non-DEHP 1.2 micron in-line filter during administration. Protect the admixed PN solution from light.
Table 1: Recommended Pediatric and Adult Dosage and Infusion Rate
| Age | Nutritional Requirements | Direct Infusion Rate | |
|---|---|---|---|
| Recommended Initial Dosage and Maximum Dosage | Initial | Maximum | |
| Birth to 2 years of age (including preterm and term neonates*) | Initial 0.5 to 1 g/kg/day not to exceed 3 g/kg/day** |
0.1 to 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Pediatric patients 2 to <12 years of age | Initial 1 to 2 g/kg/day not to exceed 3 g/kg/day** |
0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Pediatric patients 12 to 17 years of age | Initial 1 g/kg/day not to exceed 2.5 g/kg/day** |
0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Adults | 1 to 2 g/kg/day not to exceed 2.5 g/kg/day** |
0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.5 mL/kg/hour |
*The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age).
** Daily dosage should not exceed a maximum of 60% of total energy requirements
CONTRAINDICATIONS
- Known hypersensitivity to fish, egg, soybean, peanut or to any of the active or inactive ingredients in SMOFlipid.
- Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
WARNINGS AND PRECAUTIONS
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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.
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Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders.
Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD, or Intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic stenosis 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 SMOFlipid, have been associated with development of PNALD.
In a randomized study of neonates and infants expected to be treated with PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed less frequently in SMOFlipid-treated patients than in 100% soybean oil lipid emulsion-treated patients.
Monitor liver tests in patients treated with SMOFlipid and consider discontinuation or dosage reduction if abnormalities occur.
Other Hepatobiliary Disorders
Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some parenteral nutrition-treated patients without preexisting liver disease. Monitor liver tests when administering SMOFlipid. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to SMOFlipid use.
- Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients in SMOFlipid. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and initiate appropriate treatment and supportive measures.
- Infections: Lipid emulsions, such as SMOFlipid, 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 SMOFlipid. Monitor for signs and symptoms of infection including fever and chills, as well as laboratory test results that might indicate infection (including leukocytosis and hyperglycemia). Perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.
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Fat Overload Syndrome: This is a rare condition that has been reported with intravenous lipid emulsions 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 SMOFlipid. 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 refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as patients become anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake.
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Hypertriglyceridemia: The use of SMOFlipid 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 SMOFlipid. In addition, patients with hypertriglyceridemia may have worsening of their hypertriglyceridemia with administration of SMOFlipid. 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 SMOFlipid 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: SMOFlipid contains no more than 25 mcg/L of aluminum. Prolonged PN 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, which 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 can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
- Essential Fatty Acid Deficiency: Treatment-emergent cases of moderate or severe essential fatty acid deficiency (EFAD) (defined as the triene [Mead acid] to tetraene [arachidonic acid] ratio >0.2 and >0.4, respectively) were not observed in pediatric clinical trials of SMOFlipid up to 28 days. However, cases of EFAD have been reported in adults and pediatric patients in the postmarketing period with the use of SMOFlipid. The median time to onset was greater than 28 days among cases that reported time to onset. Monitor patients for laboratory evidence (e.g., abnormal fatty acid levels) and clinical symptoms of EFAD (e.g., skin manifestations and poor growth) because these signs may emerge before laboratory evidence of EFAD is confirmed. Laboratory testing using the triene to tetraene ratio may not be adequate to diagnose EFAD, and assessment of individual fatty acid levels may be needed. Ensure patients are receiving recommended dosages of SMOFlipid to prevent EFAD.
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Monitoring/Laboratory Tests: Throughout treatment monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, coagulation parameters, and complete blood count including platelets.
The lipids contained in SMOFlipid may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream. Conduct these blood tests at least 6 hours after stopping the infusion. SMOFlipid contains vitamin K that may counteract anticoagulant activity.
ADVERSE REACTIONS
Most common adverse drug reactions >1% of adult patients who received SMOFlipid from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia, and device-related infection.
Less common adverse reactions in ≤1% of adult patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash, and thrombophlebitis.
The most common adverse drug reactions in >1% of pediatric patients who received SMOFlipid were anemia, vomiting, gamma-glutamyltransferase increased, nosocomial infection, cholestasis, pyrexia, C-reactive protein increased, hyperbilirubinemia, abdominal pain, bilirubin conjugated increased, diarrhea, tachycardia, thrombocytopenia, hyperglycemia, and sepsis.
Less common adverse reactions in ≤1% of pediatric patients who received SMOFlipid were decreased hematocrit, metabolic acidosis, increased blood triglycerides, infection, increased blood alkaline phosphatase, increased alanine aminotransferase, fluid overload, hypertension, hypertriglyceridemia, and rash.
The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Cardiac disorders: palpitations; General disorders and administration site conditions: chills, chest pain, malaise; Hepatobiliary disorders: cholestasis; Infections and infestations: infection; Metabolism and nutrition disorders: fatty acid deficiency; Respiratory, thoracic and mediastinal disorders: dyspnea; Skin and subcutaneous tissue disorders: hyperhidrosis; Vascular disorders: phlebitis.
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.
DRUG INTERACTIONS
Soybean and olive oils in SMOFlipid contain vitamin K1 which may counteract the anticoagulant activity of vitamin K antagonists such as warfarin. In patients who receive concomitant SMOFlipid and warfarin, increase monitoring of laboratory parameters for anticoagulant activity.
USE IN SPECIFIC POPULATIONS
- Pregnancy and Lactation: Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. Administration of the recommended dose of SMOFlipid is not expected to cause harm to a breastfed infant. There are no data on the presence of SMOFlipid in human or animal milk or its effects on milk production.
- Pediatric Use: The safety and effectiveness of SMOFlipid have been established as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated in pediatric patients, including term and preterm neonates. Use of SMOFlipid in neonates is supported by evidence from short-term (i.e., 1- to 4-week) studies, and one study following neonates beyond 4 weeks. Use of SMOFlipid in older pediatric patients is supported by evidence from a short-term (i.e., <28 days) study in pediatric patients 28 days to 12 years of age and additional evidence from studies in adults. The most common adverse reactions in SMOFlipid-treated pediatric patients were anemia, vomiting, gamma-glutamyltransferase increased, and nosocomial infection. PNALD, also referred to as IFALD, has been reported in pediatric patients who received SMOFlipid for more than 2 weeks. PNAC (a precursor to PNALD) was reported less frequently in SMOFlipid-treated patients compared to soybean oil lipid emulsion-treated patients in Pediatric Study 1. Although clinically significant cases of EFAD were not observed during short-term use in pediatric clinical studies, cases of EFAD have been reported with the use of SMOFlipid in the postmarketing setting. Monitor pediatric patients for laboratory evidence of EFAD because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided. In the post marketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal has been reported. Because of immature renal function, preterm infants receiving prolonged treatment with SMOFlipid may be at risk for aluminum toxicity.
- Geriatric Use: Energy expenditure and requirements may be lower for older adults than younger patients. Of the 354 adult patients in clinical studies of SMOFlipid, 35% were >65 years of age and 10% were >75 years of age. No overall differences in the safety and efficacy of SMOFlipid were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity in some older patients cannot be ruled out.
OVERDOSAGE
In the event of an overdose, serious adverse reactions may result. Stop the SMOFlipid infusion until triglyceride levels have normalized and symptoms have abated. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from plasma.
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