HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OMEGAVEN safely and effectively. See full prescribing information for OMEGAVEN.
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
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. (1)
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)
DOSAGE AND ADMINISTRATION
For infusion into a central or peripheral vein. (2.1)
May be infused directly from the bottle or admixed in a parenteral nutrition (PN) container. (2.1, 2.2)
Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. (2.3)
Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. (2.3)
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. (2.3)
The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. (2.3)
For information on infusion rate when initiating dosing and in patients with elevated triglyceride levels, see the full prescribing information. (2.3)
The recommended duration for infusion is between 8 and 24 hours, depending on the clinical situation. (2.3)
Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN. (2.3)
DOSAGE FORMS AND STRENGTHS
Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) in a single-dose bottle. (3)
CONTRAINDICATIONS
Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. (4)
Severe hemorrhagic disorders. (4)
Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides greater than 1,000 mg/dL. (4, 5.6)
WARNINGS AND PRECAUTIONS
Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous soybean oil-based lipid emulsions have been reported in literature, and autopsy findings included intravascular lipid accumulation in the lungs. Risk with Omegaven is unknown. Monitor for signs and symptoms of pleural or pericardial effusion. (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 parameters. (5.3, 5.4, 5.5, 5.6)
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. (5.7)
Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency. (5.8)
ADVERSE REACTIONS
Most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection. (6.1)
To report SUSPECTED ADVER |
