SMOFLIPID 20%

The plasma concentrations of EPA and DHA, the major fatty acids in Omegaven, as well as linoleic acid and alpha-linolenic acid (essential fatty acids) were measured along with the markers of essential fatty acid status in 58 pediatric patients with PNAC after an intravenous infusion of 1 mg/kg/day of Omegaven over 10 weeks. Five patients received Omegaven as the exclusive lipid source, and all others received concurrent enteral or oral nutrition. Figure 1: Mean Plasma Concentrations of Fatty Aci...

The efficacy of Omegaven was evaluated in two open-label single-center clinical trials (

Study 1NCT00910104, and

Study 2NCT00738101) in pediatric patients with PNAC (defined as direct or conjugated bilirubin [DBil] equal to or greater than 2 mg/dL) who required PN for at least 14 days. Although Study 1 and Study 2 were not adequately designed to demonstrate noninferiority or superiority of Omegaven to the soybean oil-based lipid emulsion comparator, the data from these studies support Omegaven as a source of calories in pediatric patients with PNAC. Nutritional efficacy was assessed by biom...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )]
• Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )]
• Infections [see Warnings and Precautions ( 5.3 )]
• Fat overload syndrome [see Warnings and Precautions ( 5.4 )]
• Refeeding syndrome [see Warnings and Precautions ( 5.5 )]
• Hypertriglyceridemia...

Use of Omegaven is contraindicated in patients with:

• Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients [see Warnings and Precautions ( 5.2 )].
• Severe hemorrhagic disorders due to a potential effect on platelet aggregation.
• Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,...

• 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. ( 5.1 )
• Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs. ( 5.2 )
• Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia : Monitor for signs and symptoms; monitor laboratory paramete...

7 DRUG INTERACTIONS Antiplatelet Agents and Anticoagulants : Prolonged bleeding time has been reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving Omegaven and concomitant antiplatelet agents or anticoagulants. ( 7.1 ) 7.1 Antiplatelet Agents and Anticoagulants Some published studies have demonstrat...