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lipid sources

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.

Table: Alternative ILEs for Parenterally Fed Adult Patients


Expert recommendations suggest an omega-6:omega-3 ratio of 2:1 to 4:1 in ILEs.4-7

Table: Alternative ILEs for Parenterally Fed Adult Patients


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?

Button: Go to resources

 

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.

a healthcare worker adjusts an IV

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”

Icon: three-chamber bag

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

Icon: Fish

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.

Icon: toy bear

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

Icon: toy cubes

In 2022, the first four-oil ILE, SMOFlipid® (Lipid Injectable Emulsion, USP 20%), was approved for pediatric patients, including term and preterm neonates.4

Icon: lipid injectable emulsion

In 2023, Fresenius Kabi welcomed Intralipid® (lipid injectable emulsion, USP 20%), a soybean oil-based ILE, back home.5

Icon: flask

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/

Want to stay informed and up to date? Follow us on social media.

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.

The doctor is talking to a boy

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.

Golden fish

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.

 

Logo: SMOFlipid

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.

 

  • Icon: calendar

    Used for more than a decade worldwide

  • Icon: Globe

    Administered to more than 7 million adult and pediatric patients worldwide*

  • Safe and well tolerated5,6

  • Icon: adults

    The fatty acid ratio is in line with expert recommendations in adults7-10

  • Icon: Fish

    Contains fish oil, which provides a good source of omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)11

Logo: Omegaven

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

  • Icon: growth

    Patients receiving Omegaven achieved age-appropriate growth12

  • Icon: liver

    Omegaven-treated patients experienced improvement in liver function parameters12

  • Direct or conjugated bilirubin levels were effectively lowered12

  • 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.

Newborn baby being examined with text overlay "Nutrition In NEC"

Nutrition in NEC: what are your options?

Babies who are born too soon are vulnerable to the development of serious health conditions like necrotizing enterocolitis (NEC), an intestinal disease that affects babies during their first weeks and months of life.1,2 It’s a complicated disease in which the tissues of the intestines become necrotic, potentially leading to peritonitis, sepsis, and even death.3

“NEC affects 2% to 5% of all premature infants and is responsible for nearly 8% of all NICU admissions.”3

What causes NEC?

When the intestinal lining is damaged and torn, the bacteria that’s inside the intestine can enter the peritoneum and bloodstream, resulting in infection.2,3 Preemies, very low birth weight babies, and formula-fed babies are especially at risk for developing NEC; however, the disease can also affect full-term babies, particularly those who are born with a hypoxic medical condition such as a cyanotic congenital heart defect.3

While many babies fully recover from the disease without any further complications, some may face long-term challenges with cognition, muscle function, and intestinal function.3,4 And unfortunately, death can occur in 10-50% of babies who develop this devastating disease.1,3

 

What are the signs that a baby may have NEC?

A baby may present with the following nonspecific signs and symptoms3:

  • Swollen belly
  • Decreased activity
  • Appetite loss
  • Vomiting
  • Diarrhea
  • Bloody stools

As NEC gets worse, a baby can experience respiratory and circulatory problems and may even become unresponsive.3

 

How is NEC treated?

Treatment of NEC involves stopping all feedings by mouth and maintaining NPO status, or “nothing by mouth.”3 A nasogastric tube is placed to decompress the dilated bowels and intravenous (IV) broad-spectrum antibiotics are started.3 Some babies may require surgical removal of the affected portion of the intestine.3

When babies with NEC are unable to receive nutrition by mouth, parenteral nutrition (PN) should be initiated to help nourish these vulnerable patients.3

 


Nourishing tiny patients with PN

As the U.S. market leader in lipid injectable emulsions (ILEs),* we have two solutions that are approved for use in even the youngest PN patients to help them meet their nutritional needs. What’s unique about these two solutions is that they both contain fish oil that provides omega-3 fatty acids.

Logo: SMOFlipid

Our FIRST and ONLY 4-oil lipid injectable emulsion (ILE), SMOFlipid, has demonstrated safety and tolerability5,6 in more than 7 million adult and pediatric patients worldwide.* SMOFlipid is the only PN innovation with a unique blend of 4 oils to nourish patients of all ages, including the smallest patients.7

 

SMOFlipid helps to nurture growth in pediatric patients.7-10

Logo: Omegaven

Parenteral nutrition-associated cholestasis (PNAC) is a significant complication that develops among pediatric patients who require long-term PN,11 which can be the case for some patients who have NEC.3 In addition, premature birth, low birth weight, intestinal failure secondary to NEC, and active recovery from surgical NEC can increase a baby’s risk for developing PNAC.11-15

Omegaven is the FIRST and ONLY PN innovation with 100% fish oil that nurtures pediatric patients with PNAC.16 It was previously available only for compassionate care, but Fresenius Kabi saw the need for the product to be more broadly available to pediatric patients and worked hard to secure FDA approval in 2018.

 


The omega-3 fatty acids EPA and DHA are considered to be important for the healthy development of infants due to their special physiological roles.17,18

A tireless dedication to driving advancements in clinical nutrition has allowed us to deliver more options to you and your most delicate PN patients. We will continue to build on our history of innovation in clinical nutrition to further the field for all patients on PN. Learn more about our innovations that nourish pediatric patients 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 daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.

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).

Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of soybean oil-based intravenous lipid emulsions have been reported in medical literature. Autopsy findings in these preterm infants included intravascular lipid accumulation in the lungs. The risk of pulmonary lipid accumulation with Omegaven is unknown. 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. This risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions. Monitor patients receiving Omegaven for signs and symptoms of pleural or pericardial effusion.

Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.

Risk of 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 daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. The recommended dose for pediatrics is shown in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour. 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 Pediatric Dosage 

Table showing Recommended Pediatric Dosage.

 

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).

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.

Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous 100% soybean oil lipid emulsions have been reported in the literature.

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. NEC Awareness Month. NEC Society. Accessed April 12, 2023. https://necsociety.org/nec-awareness-month/ 2. What is necrotizing enterocolitis (NEC)?. NEC Society. Accessed April 19, 2023. https://necsociety.org/wp-content/uploads/2023/03/WHAT-IS-NEC-for-families-2023-1.pdf 3. Ginglen JG, Butki N. Necrotizing Enterocolitis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; August 8, 2022. 4. Rees CM, Pierro A, Eaton S. Neurodevelopmental outcomes of neonates with medically and surgically treated necrotizing enterocolitis. Arch Dis Child Fetal Neonatal Ed. 2007;92(3):F193-F198. 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. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2023. 8. Vlaardingerbroek H, Vermeulen MJ, Carnielli VP, Vaz FM, van den Akker CH, van Goudoever JB. Growth and fatty acid profiles of VLBW infants receiving a multicomponent lipid emulsion from birth. J Pediatr Gastroenterol Nutr. 2014;58(4):417-427. 9. Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012;36(1 Suppl):81S-94S. 10. Ariyawangso U, Puttilerpong C, Ratanachu-ek S, Anuntkosol M. Short-term safety and efficacy of fish-oil emulsions on the prevention of parenteral nutrition-associated liver disease in surgical neonates: a randomized controlled trial. Thai J Pharmac Sci. 2014;38(4):156-209. 11. Lauriti G, Zani A, Aufieri R, et al. Incidence, prevention, and treatment of parenteral nutrition-associated cholestasis and intestinal failure-associated liver disease in infants and children: a systematic review. JPEN J Parenter Enteral Nutr. 2014;38(1):70-85. 12. Lacaille F, Gupte G, Colomb V, et al. Intestinal failure-associated liver disease: a position paper of the ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. J Pediatr Gastroenterol Nutr. 2015;60(2):272-283. 13. Wales PW, Allen N, Worthington P, et al. A.S.P.E.N. clinical guidelines: support of pediatric patients with intestinal failure at risk of parenteral nutrition-associated liver disease. JPEN J Parenter Enteral Nutr. 2014;38(5):538-557. 14. Orso G, Mandato C, Veropalumbo C, Cecchi N, Garzi A, Vajro P. Pediatric parenteral nutrition-associated liver disease and cholestasis: Novel advances in pathomechanisms-based prevention and treatment. Dig Liver Dis. 2016;48(3):215-222. 15. Satrom K, Gourley G. Cholestasis in Preterm Infants. Clin Perinatol. 2016;43(2):355-373. 16. Omegaven Prescribing Information, Fresenius Kabi USA, LLC. 2023. 17. Agostoni C. Role of long-chain polyunsaturated fatty acids in the first year of life. J Pediatr Gastroenterol Nutr. 2008;47 Suppl 2:S41-44. 18. Cetin I, Koletzko B. Long-chain omega-3 fatty acid supply in pregnancy and lactation. Curr Opin Clin Nutr Metab Care. 2008;11(3):297-302.

4127-OMEG-08-05/23

illustration of a hospital next to a house with a PN IV bag in the middle.

Parenteral nutrition (PN): from hospital to home

Transforming the delivery of healthcare

Many people, especially those living in rural areas, must drive long distances to receive care at their nearest medical clinic or hospital. This has been an issue for years—one that has forced thinking to become more consumer-centric.1 Then, the pandemic in 2020 accelerated this way of thinking into action. Telehealth—or telemedicine—has been around for years but not widely used. Now, telehealth is becoming increasingly available, forever transforming the delivery of healthcare.

According to an Issue Brief by the Assistant Secretary for Planning and Evaluation, nearly half of Medicare primary care visits were provided via telehealth in April 2020, compared with less than 1% in February 2020.2

Use of telehealth in rural areas

Telehealth changes the equation for so many people, as they now have access to healthcare no matter where they live. It also brings forth the opportunity to transform the economics of rural hospitals and remote communities.1 How?

Before the turn of the decade, 120 rural hospitals were forced to close their doors while a quarter of the survivors remained at high risk for closing.3

Specialists, including neonatologists, neurologists, and cardiologists, are available to rural hospitals via telehealth; this allows patients to receive care without being transferred to a larger facility that’s located farther away.1 In turn, the rural hospital receives most of the compensation, which strengthens its economy.1

Telehealth’s impact on home PN (HPN) patients

Telehealth services have been utilized by patients for years, including those receiving PN at home. It allows for one-on-one visits with a provider who can obtain a thorough history and observe a patient’s home environment.4 Home supplies and equipment setup for HPN may also be evaluated, which has the potential to prevent readmissions and infections.5 Telehealth also allows for easy coordination of group visits and continued group education.4

One study showed that remote video consultations saved time and miles traveled for patients living far from their medical center, which allowed for improved visit attendance.6 And a quality improvement initiative of early post-discharge telemedicine visits involving 26 pediatric HPN patients showed that a telehealth provider helped families recognize early challenges associated with learning or harmful situations.5

Barriers to receiving telehealth care at home

While telehealth visits provide additional services that may be missed in traditional outpatient visits, there are some challenges to receiving care at home, including fragmented insurance coverage, in-state medical licensure requirements, established in-person physician-patient relationships, completion of telemedicine-specific informed consent forms, and reliable internet and communications devices.7,8 In the opinion of Raphael et al, despite these challenges, more hospitals, payers, accreditors, and families are looking to telehealth visits for managing PN at home.5

Nourishing PN patients—from hospital to home

As pioneers in clinical nutrition, our innovations nourish at every age and stage of life—from hospital to home. We are proud to have developed the first and only three-chamber bag for adult PN in the U.S., which can be conveniently stored and dispensed by a pharmacy anytime, including nights and weekends. Learn more about how we can help you help your HPN patients flourish with our innovations that nourish at www.FreseniusKabiNutrition.com/pn-portfolio/.

References: 1. Harrison M. 5 Critical Priorities for the U.S. Health Care System. Harvard Business Review. December 15, 2021. Accessed February 8, 2023. https://hbr.org/2021/12/5-critical-priorities-for-the-u-s-health-care-system. 2. Assistant Secretary for Planning and Evaluation. Issue Brief – Medicare Beneficiary Use of Telehealth Visits: Early Data from the start of the COVID-19 Pandemic. ASPE website. July 28, 2020. Accessed February 8, 2023. https://aspe.hhs.gov/sites/default/files/private/pdf/263866/hp-issue-brief-medicare-telehealth.pdf. 3. Topchik M, Gross K, Pinette M, et al. The Rural Health Safety Net Under Pressure: Rural Hospital Vulnerability. The Chartis Group. Published 2022. Accessed March 13, 2023. https://www.chartis.com/sites/default/files/documents/Rural%20Hospital%20Vulnerability-The%20Chartis%20Group.pdf. 4. Mehta P, Stahl MG, Germone MM, et al. Telehealth and Nutrition Support During the COVID-19 Pandemic. J Acad Nutr Diet. 2020;120(12):1953-1957. 5. Raphael BP, Schumann C, Garrity-Gentille S, et al. Virtual Telemedicine Visits in Pediatric Home Parenteral Nutrition Patients: A Quality Improvement Initiative. Telemed J E Health. 2019;25(1):60-65. 6. Cloutier A, Bond A, Taylor MI, et al. Successful implementation of remote video consultations for patients receiving home parenteral nutrition in a national UK Centre. Frontline Gastroenterol. 2019;11(4):280-284. Published 2019 Oct 14. 7. Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016 Jul 14;375(2):154-61. 8. Thomas L, Capistrant G. State Telemedicine Gaps Analysis: Coverage & Reimbursement. American Telemedicine Association. February 2017. Accessed March 14, 2023. https://www.globalmed.com/wp-content/uploads/2019/07/2017-NEW_50-State-Telehealth-Gaps-Analysis-Reimbursement_FINAL.pdf.

3806-NP-08-02/23

Nurse attaching monitor to patient in bed.

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.

  • 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?
  • Soybean oil 30% (omega-6)

    Provides essential fatty acids.

  • Medium-chain triglycerides 30%

    A source of rapidly available energy.13

  • Olive oil 25% (omega-9)

    Supplies monounsaturated fatty acids.

  • 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

  • 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 (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.
  • 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.
  • 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.
  • 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.

References: 1. Mogensen KM, Horkan CM, Purtle SW, et al. Malnutrition, Critical Illness Survivors, and Postdischarge Outcomes: A Cohort Study. JPEN J Parenter Enteral Nutr. 2018;42(3):557-565. 2. Havens JM, Columbus AB, Seshadri AJ, et al. Malnutrition at Intensive Care Unit Admission Predicts Mortality in Emergency General Surgery Patients. JPEN J Parenter Enteral Nutr. 2018;42(1):156-163. 3. National Alliance for Infusion Therapy and the American Society for Parenteral and Enteral Nutrition Public Policy Committee and Board of Directors. Disease-related malnutrition and enteral nutrition therapy: a significant problem with a cost-effective solution. Nutr Clin Pract. 2010;25(5):548-554. 4. Jensen GL, Bistrian B, Roubenoff R, Heimburger DC. Malnutrition syndromes: a conundrum vs continuum. JPEN J Parenter Enteral Nutr. 2009;33(6):710-716. 5. Jensen GL, Mirtallo J, Compher C, et al. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010;34(2):156-159. 6. Jensen GL. Inflammation as the key interface of the medical and nutrition universes: a provocative examination of the future of clinical nutrition and medicine. JPEN J Parenter Enteral Nutr. 2006;30(5):453-463. 7. Stratton RJ, King CL, Stroud MA, Jackson AA, Elia M. ‘Malnutrition Universal Screening Tool’ predicts mortality and length of hospital stay in acutely ill elderly. Br J Nutr. 2006;95(2):325-330. 8. Mogensen KM, Robinson MK, Casey JD, et al. Nutritional Status and Mortality in the Critically Ill. Crit Care Med. 2015;43(12):2605-2615. 9. Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review. JPEN J Parenter Enteral Nutr. 2017;41(5):744-758. 10. 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. 11. 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. 12. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2022. 13. 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. 14. Kalish BT, Fallon EM, Puder M. A tutorial on fatty acid biology. JPEN J Parenter Enteral Nutr. 2012;36(4):380-388. 15. Antébi H, Mansoor O, Ferrier C, et al. Liver function and plasma antioxidant status in intensive care unit patients requiring total parenteral nutrition: comparison of 2 fat emulsions. JPEN J Parenter Enteral Nutr. 2004;28(3):142-148. 16. Donoghue V, Schleicher GK, Spruyt MGL, et al. Four-oil intravenous lipid emulsion effect on plasma fatty acid composition, inflammatory markers and clinical outcomes in acutely ill patients: A randomised control trial (Foil fact). Clin Nutr. 2019;38(6):2583-2591. 17. Vlaardingerbroek H, Vermeulen MJ, Carnielli VP, et al. Growth and fatty acid profiles of VLBW infants receiving a multicomponent lipid emulsion from birth. J Pediatr Gastroenterol Nutr. 2014;58(4):417-427. 18. Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012;36(1 Suppl):81S-94S.

3673-SMF-08-06/23

The first FDA-approved lipid emulsion comes back home

A short history of Intralipid®

Created by Professor Arvid Wretlind, Intralipid was the first FDA-approved lipid injectable emulsion (ILE). Since its 1962 approval in Europe, it has been given in more than 200 million infusions1 in patients of every age, including premature babies, pregnant women, and trauma, cancer, and burn patients. In 1975, it was approved by the FDA and made available to patients in the U.S., offering them intravenous clinical nutrition support that minimizes the dependence on dextrose as a major source of non-protein calories.2

What’s next for Intralipid?

Beginning in 2023, Intralipid will be distributed and sold by the U.S. Fresenius Kabi team. As the U.S. market leader in ILEs3, we’re dedicated to providing healthcare providers with a complete portfolio of lipid emulsions for every age and stage. That’s why we’re bringing Intralipid home.

Access the full Prescribing Information for Intralipid.

How Intralipid is used

Intralipid is a soybean oil-based ILE that was created to provide a clinical nutrition option to patients requiring parenteral nutrition (PN). While Intralipid is a proven ILE that has been in use for decades, subsequent generations of ILEs have evolved, such as the one-of-a-kind 4-oil lipid emulsion, SMOFlipid® (lipid injectable emulsion), and the only 100% fish oil ILE, Omegaven® (fish oil triglycerides) injectable emulsion.

 

If you have any questions about Intralipid sales and distribution, send your inquiry to: nutrition.us@fresenius-kabi.com

References: 1. Data on File 2. Raman M, Almutairdi A, Mulesa L, Alberda C, Beattie C, Gramlich L. Parenteral Nutrition and Lipids. Nutrients. 2017;9(4):388. 3. Data on File; 10/1/22; calculation includes all ILEs approved in the U.S.

3397-INT-08-07/23

INDICATIONS AND USAGE
Intralipid 20% (A 20% Intravenous Fat Emulsion), is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).

Intralipid 20% Pharmacy Bulk Package and Intralipid 30% Pharmacy Bulk Package are intended for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for adult and pediatric patients requiring PN and a source of essential fatty acids for prevention of EFAD.

INTRALIPID 20% and 30% PHARMACY BULK PACKAGES ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION.

IMPORTANT SAFETY INFORMATION
INTRALIPID 20% (A 20% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE AND INTRALIPID 30% (A 30% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION OR 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS 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. Protect the admixed PN solution from light. Use a 1.2 micron in-line filter during administration.

Dosage for Intralipid 20%
Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term neonates) 0.5 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 2.5 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2 g/kg/day
Adults 1 g/kg/day (stable)
≤1 g/kg/day (critically ill)
2.5 g/kg/day

Dosage for Intralipid 30%
Premature infants: initial dose at 0.5 g/kg/24 hours, maximum recommended dosage is 3g fat/kg/24 hours.
Older pediatric patients: daily dose should not exceed 3 of g fat/kg/d.
Adults: The daily dosage should not exceed 2.5 g of fat/kg of body weight
 

Intralipid is contraindicated in patients with:

  • Known hypersensitivity to egg, soybean, or peanut, or any of the active ingredients or excipients.
  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride > 1,000 mg/dL).
  • Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.

 

Risk of 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.

Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive PN for extended periods of time, especially preterm neonates. Monitor liver function 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, and Hypertriglyceridemia: 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 pyrexia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis.

Vitamin K Antagonists (e.g., warfarin): Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters.
 

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 Intralipid safely and effectively. Please see full prescribing information, for intravenous use at www.FreseniusKabiNutrition.com/IntralipidPI.

Graphic of 2022 with stars and sparkles. The 0 has IV nozzles on the bottom of it.

Cheers to a fulfilling year

With 2022 coming to a close, we thought we’d look back at a PN year in review. It was a year of guidance updates, product approvals, supply and demand news, reimbursement changes, and so much more…

 

A Taste of 2022 for Fresenius Kabi

 

2022 was a big year for all of us here at Fresenius Kabi Nutrition and for the thousands of patients who require parenteral nutrition (PN). With more than 25,000 pediatric and adult patients requiring PN at home and more than 127,000 receiving PN in hospitals across the United States,1,2 providers have more options than ever for their patients, including soybean oil, fish oil, and multiple oil sources. We’re proud to have not just fulfilled the need for alternative lipid emulsions in 2022, but for the past year of growth in peer-to-peer interaction, partnerships, education, and social community.

  • Icon: compass

    Guidance and PN

    Further guidance on the use of PN in patients with pediatric acute liver failure (PALF) were released this year, giving physicians and caregivers more definitive counsel on the best management for their youngest patients. A 2022 NASPGHAN Position Paper on the Diagnosis and Management of PALF states that “lipids should be utilized [in PN] unless a disorder of fatty acid oxidation or mitochondrial disease is suspected.”3

  • Icon: Newspaper

    SMOFlipid: Oh baby, we’ve got news

    SMOFlipid® (Lipid Injectable Emulsion, USP 20%), our one-of-a-kind, 4-oil ILE that has been used for years in adults, was approved for children 17 and under this year!4 Not only that but the FDA removed the boxed warning and limitations of use from the prescribing information. “The FDA doesn’t often remove warnings, but when it does, it requires clinical evidence proving that the drug’s risks are less severe than previous studies show.”5

“As the only provider of fish oil-containing ILEs, the pediatric indication for SMOFlipid represents an important expansion of our parenteral nutrition portfolio and allows clinicians to meet the unique nutritional needs of even our most vulnerable patients at every age.”

Gordon Sacks, PharmD, Senior Director Medical Affairs, Fresenius Kabi USA, LLC

Read more about the role omega-3s play in ILEs.

  • Icon: IV Bag

    SMOFlipid is back in stock

    Due to ongoing COVID-related supply chain issues and increased demand, the last few years have witnessed a shortage of PN products this year, including SMOFlipid. The good news is that it’s back in stock and available for order through your wholesaler. Or you can click here to order SMOFlipid.

  • Icon Headphones with microphone and speech bubble

    Addressing the challenges of reimbursement with KabiCare

    Fresenius Kabi Nutrition is also dedicated to helping patients get access to innovative PN products. That’s why the KabiCare Patient Support Program for Nutrition was created—to guide healthcare providers through the challenges of PN reimbursement and simplify the treatment journey for their patients on PN. Providers can contact a live representative at 1-833-KABICARE or visit kabicare.us to help them navigate the landscape of PN reimbursement with insurance benefit investigation, billing and coding support, prior authorization, and claims appeals.

  • Icon: group of people with one highlighted

    It was great to SEE you in 2022

    We’re so thankful that we could gather in-person again at ASPEN, NASPGHAN, Hot Topics, and many other conferences, educational sessions, and speaker programs. We look forward to seeing you in the future! If you want to learn more about our clinical nutrition offerings or would like to schedule something for your team, reach out to us or your PN Sales Specialist.

What’s next?

In 2023, we’re welcoming one of our original PN products back to the Fresenius Kabi family. In the meantime, we’ll continue driving advancements that will help nourish patients at every age and stage of life. Stay tuned!

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

Age Nutritional Requirements
Initial Recommended Dosage Maximum Dosage
Birth to 2 years of age (including preterm and term neonates) 0.5 to 1 g/kg/day 3 g/kg/day
Pediatric patients 2 to <12 years of age 1 to 2 g/kg/day 3 g/kg/day
Pediatric patients 12 to 17 years of age 1 g/kg/day 2.5 g/kg/day
Adults 1 to 2 g/kg/day 2.5 g/kg/day

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.

References: 1. Mundi MS, Pattinson A, McMahon MT, Davidson J, Hurt RT. Prevalence of home parenteral and enteral nutrition in the United States. Nutr Clin Pract. 2017;32(6):799-805. 2. Guenter P, Blackmer A, Malone JM, et al. Update on use of enteral and parenteral nutrition in hospitalized patients with a diagnosis of malnutrition in the United States. Nutr Clin Pract. 2022;37:94-101. 3. Squires JE, Alonso EM, Ibrahim SH, et al. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the Diagnosis and Management of Pediatric Acute Liver Failure. J Pediatr Gastroenterol Nutr. 2022;74(1):138-158. 4. SMOFlipid Prescribing Information, Fresenius Kabi USA, LLC. 2022. 5. Llamas M. Black box warnings. Drugwatch. https://www.drugwatch.com/fda/black-box-warnings. Accessed November 2, 2022.

3577-SMF-08-06/23

closeup of man in lab coat using a mortar and pestle.

Pharmacists: integral members of the nutrition care team

Pharmacists are on the frontlines of healthcare as advocates for their patients and are among the most accessible members of the healthcare team.1 In fact, according to investigators in a nationwide geographic information systems analysis, “nearly 90% of Americans live within five miles of a community pharmacy.”2

The face of neighborhood healthcare

Patients come to know and trust their local pharmacist with their health and medication management. That’s why pharmacies are often recognized as “the face of neighborhood healthcare.”3 But pharmacists are also critical healthcare members in hospitals, community health centers, and long-term care facilities. Let’s take a “behind-the-scenes” look at the many roles these pharmacists play in caring for their patients.

Pharmacists in clinical practice are tasked with verifying and dispensing medication orders, recommending appropriate dose adjustments, and communicating with other members of the healthcare team to help ensure patient safety. And some are involved in the management of clinical nutrition, including parenteral nutrition (PN). In order to prepare and compound PN, pharmacists must undergo special training that includes competency assessments and the completion of a learning program associated with PN ordering and preparation.4 Some pharmacists become Board Certified Nutrition Support Pharmacists (BCNSP) and must become recertified every seven years by passing the BPS Nutrition Support Pharmacy Recertification Exam or by earning 100 hours of continuing education credit through Purdue University College of Pharmacy.5

Pharmacists in clinical practice are tasked with verifying and dispensing medication orders, recommending appropriate dose adjustments, and communicating with other members of the healthcare team to help ensure patient safety.

An integral part of the multidisciplinary nutrition care team

“Pharmacists with adequate clinical training and expertise in PN therapy can have pivotal roles in the care of patients receiving PN therapy.”6 They’re “an integral part of the multidisciplinary nutrition care team.”4 They play a central role in the final stages of the PN process and are responsible for reviewing, transcribing, preparing, and compounding PN.4,7 PN is compounded manually or with the use of an automated compounding device (ACD) using sterile compounding techniques.4,7 Manual compounding is often labor-intensive and requires multiple manipulations of infusion equipment that can contaminate the final admixture.8 Though not guaranteed to be error-free, using an ACD is associated with improved compounding accuracy and reduced contamination.8 Beyond these responsibilities, a pharmacist’s roles can also include monitoring patients’ response to PN therapy; supervising home parenteral nutrition (HPN) programs; educating patients, caregivers, and other healthcare professionals on nutrition support; and conducting PN-related research and quality improvement activities.6

“The ultimate goal is to reduce PN-related medication errors”4

PN is a complex, high-alert medication with the potential to cause errors that can lead to patient harm.9-11 The gap analysis by Boullata et al estimated that monthly PN-related medication errors were reported by nearly 53% of respondents; however, 44% of respondents reported not knowing about these errors or that their organization doesn’t track these errors.11 Further, 58% did not know where in the process errors may be happening.11 That’s why pharmacists are crucial to the PN process. In their review of the PN prescription, they can prevent errors by ensuring appropriate dosing, stability, and compatibility of PN ingredients.

As a leader in clinical nutrition, Fresenius Kabi is proud to support clinicians and their patients on PN by delivering innovations that nourish at every age and stage of life. To explore our comprehensive portfolio of PN products, visit: www.FreseniusKabiNutrition.com/pn-portfolio/

References: 1. National Center for Chronic Disease Prevention and Health Promotion. A Program Guide for Public Health: Partnering with Pharmacists in the Prevention and Control of Chronic Diseases. CDC website. Published August 2012. Accessed September 23, 2022. https://www.cdc.gov/dhdsp/programs/spha/docs/pharmacist_guide.pdf. 2. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis [published online ahead of print, 2022 Jul 15]. J Am Pharm Assoc (2003). 2022;S1544-3191(22)00233-3. 3. National Association of Chain Drug Stores. Pharmacies: The Face of Neighborhood Healthcare. NACDS website. Accessed September 23, 2022. https://nacds.morningconsultintelligence.com. 4. Boullata JI, Holcombe B, Sacks G, et al. Standardized Competencies for Parenteral Nutrition Order Review and Parenteral Nutrition Preparation, Including Compounding: The ASPEN Model. Nutr Clin Pract. 2016;31(4):548-555. 5. Pharmacy Students. Board Certified Nutrition Support Pharmacist (BCNSP). Pharmacy Students website. Accessed October 13, 2022. https://www.pharmacystudents.org/pharmacist-certification/board-certified-nutrition-support-pharmacist-bcnsp. 6. Katoue MG. Role of pharmacists in providing parenteral nutrition support: current insights and future directions. Integr Pharm Res Pract. 2018;7:125-140. 7. Boullata JI. Overview of the parenteral nutrition use process. JPEN J Parenter Enteral Nutr. 2012;36(2 Suppl):10S-13S. 8. Iredell B, Mourad H, Nickman NA, et al. ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures. Am J Health Syst Pharm. 2022;79(10):730-735. 9. Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations; 2016. 10. Guenter P, Ayers P, Boullata JI, Gura KM, Holcombe B, Sacks GS. Parenteral Nutrition Errors and Potential Errors Reported Over the Past 10 Years. Nutr Clin Pract. 2017;32(6):826-830. 11. Boullata JI, Guenter P, Mirtallo JM. A parenteral nutrition use survey with gap analysis. JPEN J Parenter Enteral Nutr. 2013;37(2):212-222.

3411-NP-08-10/22

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References: 1. National Center for Chronic Disease Prevention and Health Promotion. A Program Guide for Public Health: Partnering with Pharmacists in the Prevention and Control of Chronic Diseases. CDC website. Published August 2012. Accessed September 23, 2022. https://www.cdc.gov/dhdsp/programs/spha/docs/pharmacist_guide.pdf. 2. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis [published online ahead of print, 2022 Jul 15]. J Am Pharm Assoc (2003). 2022;S1544-3191(22)00233-3. 3. National Association of Chain Drug Stores. Pharmacies: The Face of Neighborhood Healthcare. NACDS website. Accessed September 23, 2022. https://nacds.morningconsultintelligence.com. 4. Boullata JI, Holcombe B, Sacks G, et al. Standardized Competencies for Parenteral Nutrition Order Review and Parenteral Nutrition Preparation, Including Compounding: The ASPEN Model. Nutr Clin Pract. 2016;31(4):548-555. 5. Pharmacy Students. Board Certified Nutrition Support Pharmacist (BCNSP). Pharmacy Students website. Accessed October 13, 2022. https://www.pharmacystudents.org/pharmacist-certification/board-certified-nutrition-support-pharmacist-bcnsp. 6. Katoue MG. Role of pharmacists in providing parenteral nutrition support: current insights and future directions. Integr Pharm Res Pract. 2018;7:125-140. 7. Boullata JI. Overview of the parenteral nutrition use process. JPEN J Parenter Enteral Nutr. 2012;36(2 Suppl):10S-13S. 8. Iredell B, Mourad H, Nickman NA, et al. ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures. Am J Health Syst Pharm. 2022;79(10):730-735. 9. Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations; 2016. 10. Guenter P, Ayers P, Boullata JI, Gura KM, Holcombe B, Sacks GS. Parenteral Nutrition Errors and Potential Errors Reported Over the Past 10 Years. Nutr Clin Pract. 2017;32(6):826-830. 11. Boullata JI, Guenter P, Mirtallo JM. A parenteral nutrition use survey with gap analysis. JPEN J Parenter Enteral Nutr. 2013;37(2):212-222.