Overview
11 DESCRIPTION Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9).
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Omegaven provides a biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression. 12.3 Pharmacokinetics 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...
Indications
- 1 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 [see Clinical Studies ( 14 )]. • 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 [see Clinical Studies ( 14 )].
Common Doses
- 1 g
- 2 mg
- 0.30 mg
- 250 mg
Dosage
2 DOSAGE AND ADMINISTRATION • For infusion into a central or peripheral vein. ( 2.1 ) • See full prescribing information for administration and admixing instructions. ( 2.1 , 2.2 ) • Protect the admixed PN solution from light. ( 2.2 ) • Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy sources given to the patient. The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. ( 2.
Contraindications
- 4 CONTRAINDICATIONS 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 1,000 mg/dL) [see Warnings and Precautions ( 5.6 )]. • Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients.
Side Effects
- 6 ADVERSE REACTIONS 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 [see Warnings and Precautions ( 5.
Interactions
- 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 demonstrated prolongation of bleeding time in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids.