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Omegaven Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose bottles (50mL, 100mL)—10
Manufacturer
Generic Availability
Mechanism of Action
Omegaven provides a biologically utilizable source of calories and essential fatty acids. 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.
Omegaven Indications
Indications
Limitations of Use
Omegaven Dosage and Administration
Adult
Children
Individualize. May give alone or as part of PN admixture. Initiate therapy as soon as direct or conjugated bilirubin (DBil) levels ≥2mg/dL in patients expected to be PN-dependent for ≥2 weeks. Determine dose based on energy requirements, age, body wt, tolerance, clinical status, ability to eliminate/metabolize lipids, energy supplied from parenteral, oral, or enteral nutrition, and lipid-based medications. Administer by IV infusion via a central or peripheral vein. Initial and max dose: 1g/kg/day. Initiate rate at 0.2mL/kg/hr for first 15–30mins; increase gradually to required rate after 30mins; max 1.5mL/kg/hr. Usual infusion duration: 8–24hrs based on patients' clinical status. Can administer until DBil <2mg/dL or until PN no longer required. Hypertriglyceridemia: see full labeling. If TGs remain elevated, consider 0.5–0.75g/kg/day with incremental increase to 1g/kg/day.
Omegaven Contraindications
Contraindications
Omegaven Boxed Warnings
Not Applicable
Omegaven Warnings/Precautions
Warnings/Precautions
Clinical decompensation with rapid IV infusion in neonates/infants. Correct severe fluid and electrolyte disorders prior to initiating. Measure serum triglycerides at baseline and periodically during treatment. If hypertriglyceridemia (TG >250mg/dL [infants] or >400mg/dL [older children]) develops; consider interrupting for 4hrs and repeat serum TG levels; resume as indicated. Discontinue immediately and treat if hypersensitivity reaction occurs. Increased risk of infection with malnutrition-associated immunosuppression, long-term use, poor catheter maintenance, immunosuppressive effects of other conditions or drugs; monitor and ensure aseptic technique. Severely malnourished: monitor closely for refeeding syndrome. Increased risk of aluminum toxicity (esp. in renal impairment, preterm infants). Monitor fluid and electrolyte status, serum osmolarity, blood glucose, hepatic and renal function, CBCs, and coagulation parameters during treatment. Monitor for essential fatty acid deficiency (EFAD). Pulmonary edema or heart failure: monitor fluid status closely. Pregnancy. Nursing mothers.
Omegaven Pharmacokinetics
See Literature
Omegaven Interactions
Interactions
Omegaven Adverse Reactions
Adverse Reactions
Omegaven Clinical Trials
See Literature
Omegaven Note
Not Applicable
Omegaven Patient Counseling
See Literature
