se, take into account the energy supplied by dextrose and amino acids from PN, as well as energy from oral or enteral nutrition. Energy provided from lipid-based medications must also be taken into account (e.g., propofol).
Omegaven contains 0.15 to 0.30 mg/mL of dl-alpha-tocopherol. Take into account the amount of alpha-tocopherol in Omegaven when determining the need for additional supplementation of vitamin E.
Recommended Pediatric Dosing
The recommended Omegaven dosage for pediatric patients is 1 g/kg/day; this is also the maximum daily dose.
The initial rate of infusion should not exceed 0.05 mL/minute for the first 15 to 30 minutes of infusion. If tolerated, gradually increase until reaching the required rate after 30 minutes. The maximum infusion rate should not exceed 1.5 mL/kg/hour, corresponding to 0.15 g/kg/hour.
If hypertriglyceridemia (triglycerides greater than 250 mg/dL in neonates and infants or greater than 400 mg/dL in older children) develops once Omegaven has been initiated at the recommended dosage, consider stopping the administration of Omegaven for 4 hours and obtain a repeat serum triglyceride level. Resume Omegaven based on new result as indicated.
In patients with elevated triglyceride levels, consider other reasons for hypertriglyceridemia (e.g., renal disease, other drugs). If triglycerides remain at elevated levels, consider a reduced dose of 0.5 g to 0.75 g/kg/day with an incremental increase to 1 g/kg/day.
Monitor triglyceride levels during treatment [see Warnings and Precautions (5.6, 5.8)].
The recommended duration for infusion of Omegaven is between 8 and 24 hours, depending on the clinical situation.
Administer Omegaven until DBil levels are less than 2 mg/dL or until the patient no longer requires PN.
3 DOSAGE FORMS AND STRENGTHS
Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) sterile, white, homogenous emulsion in a 50-mL and 100-mL single-dose bottle.
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 hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL) [see Warnings and Precautions (5.6)].
5 WARNINGS AND PRECAUTIONS
5.1 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.
5.2 Hypersensitivity Reactions
Omegaven contains fish oil and egg phospholipids, which may cause hypersensitivity reactions. Signs or symptoms of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, |
