Fish oil triglycerides

What is Fish oil triglycerides?

Fish oil triglycerides (Omegaven) is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

What are the uses of this medicine?

• This medicine is used as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

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.
• 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.

How does this medicine work?

• Omegaven provides a biologically utilizable source of calories and essential fatty acids.
• Fatty acids serve as an important substrate for energy production.
• 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.

Who Should Not Use this medicine ?

• This medicine cannot be used in patients:
• 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 greater than 1,000 mg/dL).

What drug interactions can this medicine cause?

• Prolonged bleeding time has been reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids.
• Periodically monitor bleeding time in patients receiving Omegaven and concomitant antiplatelet agents or anticoagulants.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

• 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.
• The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day.
• 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.
• Administer Omegaven until DBil levels are less than 2 mg/dL or until the patient no longer requires PN.

Administration

• For infusion into a central or peripheral vein.
• May be infused directly from the bottle or admixed in a parenteral nutrition (PN) container.
• Protect the admixed PN solution from light.
• Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level.
• Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater.
• The recommended duration for infusion is between 8 and 24 hours, depending on the clinical situation.
• Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) in a single-dose bottle

This medicine is available in fallowing brand namesː

• Omegaven

What side effects can this medication cause?

The most common side effects of this medicine include:

• vomiting
• agitation
• bradycardia
• apnea
• viral infection

What special precautions should I follow?

• Deaths in preterm infants after infusion of intravenous soybean oil-based lipid emulsions have been reported in literature. Monitor for signs and symptoms of pleural or pericardial effusion.
• 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, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, fever, or chills. If a hypersensitivity reaction occurs, stop infusion of Omegaven immediately and initiate appropriate treatment and supportive measures.
• Lipid emulsions, such as Omegaven, can support microbial growth and are an independent risk factor for the development of bloodstream infections.
• Fat overload syndrome is a rare condition that has been reported with intravenous lipid emulsions.
• Aluminum Toxicity may occur. Increased risk in patients with renal impairment, including preterm infants.
• Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency.

What to do in case of emergency/overdose?

In the event of an overdose, fat overload syndrome may occur.

Management for overdosage:

• Stop the infusion of Omegaven until triglyceride levels have normalized and any symptoms have abated.
• The effects are usually reversible by stopping the lipid infusion.
• If medically appropriate, further intervention may be indicated.
• Lipids are not dialyzable from serum.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

• The effectiveness of Omegaven was established in two open-label clinical trials of 82 pediatric patients, 3 to 42 weeks of age.
• The safety of Omegaven was established in 189 pediatric patients (19 days to 15 years of age).
• Deaths in preterm infants after infusion of intravenous soybean oil-based lipid emulsion have been reported in literature.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Fish oil

Inactive ingredients 150 mg tablets:

• alpha.-tocopherol
• egg phospholipids
• sodium oleate
• glycerin
• sodium hydroxide
• water

Who manufactures and distributes this medicine?

• Packager: Fresenius Kabi USA, LLC

What should I know about storage and disposal of this medication?

• Store below 25°C (77°F). Avoid excessive heat.
• Do not freeze.
• If accidentally frozen, discard product.
• Once the bottle is connected to the infusion set, use Omegaven immediately.
• Complete infusion within 12 hours when using a Y-connector.
• Infuse admixtures containing Omegaven immediately.
• If not used immediately, admixtures can be stored for up to 6 hours at room temperature or up to 24 hours under refrigeration.
• Complete the infusion within 24 hours after removal from storage.

• Dailymed label info on Fish oil triglycerides
• FDA Fish oil triglycerides

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