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Premature infants with parenteral nutrition-associated cholestasis (PNAC) require careful nourishment. Omegaven is the first and only 100% fish oil lipid emulsion in the US for pediatric patients with PNAC.1

  • Omegaven is a source of calories and fatty acids in pediatric patients with PNAC1
  • Fish oil is the newest type of lipid to be introduced into PN products1
  • Fish oil is rich in omega-3s1

EPA and DHA (omega-3 fatty acids) are considered to be important for healthy development of infants due to their physiological roles3,4

An outline icon of a classic ring stacker toy, with a dark blue ring on top of progressively larger white rings, all set against a dark green background.

May be considered conditionally essential for growth and development5,6

An icon depicting a cluster of oval shapes outlined in white, each containing a dark blue circle in its center, against a dark green background, resembling a cross-section of cells.

Important structural elements of cell membranes4

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The mean content of the two major fatty acid components in 10 g/100 mL of Omegaven are 2.0 g EPA and 1.9 g DHA1

Indications and limitations of use

Indication:
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).1

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.1

Understanding PNAC

PNAC is the onset of liver disease in the context of the administration of PN in patients with temporary or permanent intestinal failure.7 It is most commonly defined as direct or conjugated bilirubin greater than 2 mg/dL in patients who receive PN >2 weeks.8-11 Other terms commonly used include intestinal failure-associated liver disease (IFALD) and parenteral nutrition-associated liver disease (PNALD).

Incidence of PNAC increases with longer exposure to PN.12 The average incidence rate of PNAC in neonates and infants is 29.9%.11

PNAC risk factors may include prematurity, low birth weight, lack of enteral feeding, necrotizing enterocolitis, recurrent sepsis, and factors relevant to PN.11-13

 

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Bottle Size 50 mL 100 mL
Bottles/Case 10 10

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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.

For Healthcare Professionals

OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use

IMPORTANT SAFETY INFORMATION

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

Nutritional Requirements Direct Infusion Rate
Initial Maximum
1 g/kg/day; this is also the maximum daily dose 0.2 mL/kg/hour for the first 15 to 30 minutes;
gradually increase to the required rate after 30 minutes		 1.5 mL/kg/hour

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.

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.

For Healthcare Professionals

OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use

IMPORTANT SAFETY INFORMATION

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

Nutritional Requirements Direct Infusion Rate
Initial Maximum
1 g/kg/day; this is also the maximum daily dose 0.2 mL/kg/hour for the first 15 to 30 minutes;
gradually increase to the required rate after 30 minutes		 1.5 mL/kg/hour

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.

If you still can't find what you're looking for regarding our PN products or Fresenius Kabi Nutrition, let us know and we can help.

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References: 1. Omegaven Prescribing Information, Fresenius Kabi USA, LLC. 2023. 2. Data on file. 3. Agostoni C. Role of long-chain polyunsaturated fatty acids in the first year of life. J Pediatr Gastroenterol Nutr. 2008;47 Suppl 2:S41-S44. 4. 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. 5. Lapillonne A, Groh-Wargo S, Gonzalez CH, Uauy R. Lipid needs of preterm infants: updated recommendations. J Pediatr. 2013;162(3 Suppl):S37-47. 6. Bistrian BR. Clinical aspects of essential fatty acid metabolism: Jonathan Rhoads Lecture. JPEN J Parenter Enteral Nutr. 2003;27(3):168-175. 7. Cahova M, Bratova M, Wohl P. Parenteral Nutrition-Associated Liver Disease: The Role of the Gut Microbiota. Nutrients. 2017;9(9):987. 8. 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. 9. Gupta K, Wang H, Amin SB. Parenteral Nutrition-Associated Cholestasis in Premature Infants: Role of Macronutrients. JPEN J Parenter Enteral Nutr. 2016;40(3):335-341. 10. Hojsak I, Colomb V, Braegger C, et al. ESPGHAN Committee on Nutrition Position Paper. Intravenous Lipid Emulsions and Risk of Hepatotoxicity in Infants and Children: a Systematic Review and Meta-analysis. J Pediatr Gastroenterol Nutr. 2016;62(5):776-792. 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. Tillman EM, Helms RA. Omega-3 Long Chain Polyunsaturated Fatty Acids for Treatment of Parenteral Nutrition-Associated Liver Disease: A Review of the Literature. J Pediatr Pharmacol Ther. 2011;16(1):31-38. 13. Rangel SJ, Calkins CM, Cowles RA, et al. Parenteral nutrition–associated cholestasis: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2012;47(1):225-240.

*For additional information about the testing results, and for more insights into how to use this information for your parenteral nutrition (PN) patients, please contact Fresenius Kabi Medical Affairs via phone at 1-800-551-7176, option 4, or email Nutrition.MedInfo.USA@fresenius-kabi.com.