fish oil triglycerides (Rx)

Brand and Other Names:Omegaven
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Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

injectable emulsion, single-dose emulsion

  • 5g/50mL
  • 10g/100mL

Nutrition-associated Cholestasis

Indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

Recommended dose: 1 g/kg/day IV (maximum daily dose)

Initial rate of IV infusion should not exceed 0.05 mL/minute for the first 15-30 minutes of infusion

If tolerated, gradually increase until reaching the required rate after 30 minutes; maximum infusion rate should not exceed 1.5 mL/kg/hr, corresponding to 0.15 g/kg/hr

Clinical trial efficacy and safety

  • Effectiveness was established in 2 open-label clinical trials of 82 pediatric patients (aged 3 to 42 weeks), including preterm neonates with estimated gestational age of >24 weeks at birth
  • Safety was established in 189 pediatric patients (aged 19 days to 15 years); the most common adverse reactions were vomiting, agitation, and bradycardia

Dosage Modifications

Hypertriglyceridemia

  • If hypertriglyceridemia (triglycerides >250 mg/dL [neonates and infants] or >400 mg/dL [older children]) develops once fish oil triglycerides has been initiated at the recommended dosage, consider stopping the administration for 4 hr and obtain a repeat serum triglyceride level
  • Resume based on new result as indicated In patients with elevated triglyceride levels, consider other reasons for hypertriglyceridemia (eg, renal disease, other drugs)
  • If triglycerides remain at elevated levels, consider a reduced dose of 0.5-0.75 g/kg/day with an incremental increase to 1 g/kg/day; monitor triglyceride levels during treatment
  • Recommended duration for infusion is between 8-24 hr, depending on the clinical situation
  • Administer until direct bilirubin levels are <2 mg/dL or until the patient no longer requires PN

Dosing Considerations

Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level

Initiate dosing as soon as direct or conjugated bilirubin (DBil) levels are ≥2 mg/dL in pediatric patients who are expected to be PN-dependent for at least 2 weeks

Dosing depends on each patient’s energy requirements, which may be influenced by age, body weight, tolerance, clinical status, and ability to metabolize and eliminate lipids

When determining dose, 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 (eg, propofol); contains 0.15-0.30 mg/mL of dl-alpha-tocopherol

Take into account the amount of alpha-tocopherol in fish oil triglyceride when determining the need for additional supplementation of vitamin E

Limitations of use

  • Not indicated for the prevention of PNAC; it is not been demonstrated that fish oil triglycerides prevents PNAC in parenteral nutrition (PN)-dependent patients
  • It has not been demonstrated that the clinical outcomes observed in patients treated with fish oil triglycerides are a result of the omega-6:omega-3 fatty acid ratio of the product
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Interactions

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            Adverse Effects

            >10%

            Vomiting (46%)

            Agitation (35%)

            Bradycardia (35%)

            Apnea (20%)

            Viral infection (16%)

            Erythema (12%)

            1-10%

            Rash (8%)

            Abscess (7%)

            Neutropenia (7%)

            Hypertonia (6%)

            Incision site erythema (6%)

            Postmarketing Reports

            Life-threatening hemorrhage following a central venous catheter change reported in a 9-month-old infant with intestinal failure who received PN with fish oil triglyceride as the sole lipid source; infant had no prior history of bleeding, coagulopathy, or portal hypertension

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            Warnings

            Contraindications

            Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients

            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 >1000 mg/dL)

            Cautions

            Fat overload syndrome reported with IV lipid emulsions; reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in this syndrome, which is characterized by a sudden deterioration in the patient's condition including fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations (eg, coma); syndrome is usually reversible when the lipid infusion discontinued

            Administering PN to severely malnourished patients may result in refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic; thiamine deficiency and fluid retention may also develop; closely monitor severely malnourished patients and slowly increase their nutrient intake Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome; serum triglyceride levels >1000 mg/dL have been associated with an increased risk of pancreatitis; measure serum triglycerides before the start of infusion (baseline value), and regularly throughout treatment (see Dosage Modifications)

            Fish oil triglyceride contains no more than 25 mcg/L of aluminum; aluminum may reach toxic levels with prolonged IV administration if kidney function is impaired; patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4-5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity

            Monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, coagulation parameters, and complete blood count throughout treatment

            Monitor patients for laboratory evidence of essential fatty acid deficiency (EFAD) is recommended; consider laboratory tests determining serum fatty acids levels values to help determine adequacy of essential fatty acid status; increasing essential fatty acid intake (enterally or parenterally) is effective in treating and preventing EFAD

            Lipids contained in fish oil triglyceride may interfere with some laboratory blood tests (eg, hemoglobin, lactate dehydrogenase, bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream; lipids are normally cleared after a period of 5-6 hr once the lipid infusion is stopped

            Infections

            • Lipid emulsions, such as fish oil triglyceride, can support microbial growth and are an independent risk factor for the development of bloodstream infections; risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of IV catheters, or immunosuppressive effects of other conditions or concomitant drugs; monitor for signs and symptoms of early infections including fever and chills, laboratory tests results indicating possible infection (including leukocytosis and hyperglycemia), and frequently inspect IV catheter site for edema, redness, and discharge
            • Ensure aseptic technique in catheter placement and maintenance, as well as in the preparation and administration of the drug to decrease risk of infection

            Hypersensitivity Reactions

            • Drug contains fish oil and egg phospholipids, which may cause hypersensitivity reactions
            • Signs or symptoms of a hypersensitivity reaction include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, fever, or chills
            • If a hypersensitivity reaction occurs, stop infusion immediately and initiate appropriate treatment and supportive measures

            Pulmonary lipid accumulation

            • Deaths in preterm infants after infusion of soybean oil-based IV lipid emulsions have been reported in medical literature; risk of pulmonary lipid accumulation with fish oil triglycerides is unknown
            • Preterm and small-for-gestational-age infants have poor clearance of IV lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion; consider this risk due to poor lipid clearance when administering IV lipid emulsions
            • Monitor for signs and symptoms of pleural or pericardial effusion

            Drug interaction overview

            • Prolonged bleeding time in patients reported with oral omega-3 fatty acids taking antiplatelet agents or anticoagulants
            • Clinical trials of IV fish oil triglycerides did not observe bleeding times that exceeded normal limit or clinically significant bleeding episodes; however, the prescribing information recommends periodic monitor of bleeding time in patients receiving fish oil triglycerides receiving concomitant antiplatelet agents or anticoagulants
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            Pregnancy

            Pregnancy

            There are no available data on use in pregnant women to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal reproduction studies have not been conducted with fish oil triglycerides

            Lactation

            No data are available regarding the presence of fish oil triglycerides from fish oil triglycerides in human milk, the effects on the breastfed infant, or the effects on milk production

            Lactating women receiving oral omega-3 fatty acids have been shown to have higher levels of fatty acids in their milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Fish oil triglycerides provides a biologically utilizable source of calories and essential fatty acids

            Fatty acids serve as an important substrate for energy production

            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

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            Administration

            IV Administration

            Administer alone or as part of a PN admixture for central or peripheral IV infusion

            When administered with dextrose and amino acids, choosing central or peripheral venous route depends on the osmolarity of the final infusate; solutions with osmolarity of >900 mOsm/L (central vein) Use a 1.2 micron in-line filter during administration

            Use a dedicated line for PN Infused concurrently into the same vein as dextrose-amino acid solutions (as part of PN) by a Y-connector located closest to the infusion site; flow rates of each solution should be controlled separately by infusion pumps

            Avoid multiple connections; do not connect multiple medications in series

            Turn off pump before the bottle runs dry

            Use a vented infusion set when infusing from the bottle; do not use infusion sets and lines that contain di-2-ethylhexyl phthalate (DEHP) Infusion sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer

            Prior to infusion, visually inspect for particulate matter and discoloration

            Discard the bottle if any particulates or discoloration are observed

            Gently invert the bottle before use

            Use only if the emulsion is homogeneous and the container is undamaged; strict aseptic techniques must be followed; hang the bottle using the attached hanger and start infusion

            Also see Storage

            Storage

            Unused bottle

            • Store <25°C (77°F); avoid excessive heat; do not freeze
            • If accidentally frozen, discard product

            Opened bottle

            • Once the bottle is connected to the infusion set, use immediately
            • Complete infusion within 12 hr when using a Y-connector
            • Infuse admixtures containing fish oil triglycerides immediately
            • If not used immediately, store up to 6 hr at room temperature or up to 24 hr under refrigeration
            • Complete the infusion within 24 hours after removal from storage
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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