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Omegaven Generic Name & Formulations
Legal Class
Rx
General Description
Fish oil triglycerides 5g/50mL, 10g/100mL; emulsion for IV infusion; contains aluminum.
Pharmacological Class
Fatty acids.
How Supplied
Single-dose bottles (50mL, 100mL)—1, 10
Manufacturer
Generic Availability
NO
Omegaven Indications
Indications
To provide a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Limitations of Use
Not for prevention of PNAC. Not demonstrated that clinical outcomes with Omegaven are a result of omega-6:omega-3 fatty acid ratio.
Omegaven Dosage and Administration
Adult
Not indicated.
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, and additional energy supplied from parenteral, oral, or enteral nutrition. Administer by IV infusion via a central or peripheral vein. Usual dose: max 1g/kg/day. Initiate rate at max 0.05mL/min for first 15–30mins; if tolerated, increase gradually to required rate after 30mins; max 1.5mL/kg/hr (0.15g/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
Fish or egg protein allergy. Severe hemorrhagic disorder due to potential effect on platelet aggregation. Severe hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia (serum triglyceride [TG] >1000mg/dL).
Omegaven Boxed Warnings
Not Applicable
Omegaven Warnings/Precautions
Warnings/Precautions
Risk of death in preterm infants: see full labeling. Monitor for pleural or pericardial effusion. 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, blood glucose, hepatic and renal function, coagulation parameters, and CBC during treatment. Monitor for essential fatty acid deficiency (EFAD). Pregnancy. Nursing mothers.
Omegaven Pharmacokinetics
See Literature
Omegaven Interactions
Interactions
Concomitant antiplatelets or anticoagulants: monitor bleeding time periodically. May interfere with lab blood tests (eg, hemoglobin, lactate dehdyrogenase, bilirubin, oxygen saturation).
Omegaven Adverse Reactions
Adverse Reactions
Vomiting, agitation, bradycardia, apnea, viral infection, erythema, rash, abscess, neutropenia, hypertonia, incision site erythema; fat overload syndrome, hypertriglyceridemia.
Omegaven Clinical Trials
See Literature
Omegaven Note
Not Applicable
Omegaven Patient Counseling
See Literature
