Omegaven

OMEGAVEN- fish oil injection, emulsion
Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE

Omegaven is indicated 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 [see Clinical Studies (14)].
  • 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 [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

  • Omegaven can be administered alone or as part of a PN admixture.
  • Omegaven is for central or peripheral intravenous infusion. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central vein.
  • Use a 1.2 micron in-line filter during administration.
  • Use a dedicated line for PN. Omegaven should be 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 the pump before the bottle runs dry.
  • Use a vented infusion set when Omegaven is infused 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 Omegaven for particulate matter and discoloration. Discard the bottle if any particulates or discoloration are observed.
  • Gently invert the bottle before use. Use Omegaven 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.
  • After connecting the infusion set, start infusion of Omegaven immediately. Complete the infusion within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.
  • For single use only. Discard unused portion.

2.2 Admixing Instructions

If Omegaven is administered as part of a PN admixture, follow the instructions below.

  • Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
  • Do not add Omegaven directly to the empty PN container; destabilization of the lipid emulsion may occur.
  • When Omegaven is administered with other infusion solutions (e.g., amino acids, dextrose), the compatibility of the solutions used must be ensured. Questions related to compatibility may be directed to Fresenius Kabi USA, LLC, at 1-800-551-7176.
  • The following proper mixing sequence must be followed to minimize pH-related problems by ensuring that typically acidic dextrose solutions are not mixed with lipid emulsions alone:
    1. Transfer dextrose solution to the PN container.
    2. Transfer amino acid solution to the PN container.
    3. Transfer Omegaven to the PN container.

      Simultaneous transfer of amino acid solution, dextrose solution, and Omegaven using an automated compounding device is also permitted; follow automated compounding device instructions as indicated.

      Use gentle agitation during admixing to minimize localized concentration effects; shake container gently after each addition.

  • The prime destabilizers of emulsions are excessive acidity (such as a pH less than 5) and inappropriate electrolyte content. Care should be taken if adding divalent cations (e.g., Ca++ and Mg++), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that can protect the emulsion from destabilization.
  • Inspect the admixture to ensure that precipitates have not formed during preparation of the admixture and the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixture. Discard the admixture if any of these are observed.

Stability and Storage

  • Protect the admixed PN solution from light.
  • Start infusion of admixtures containing Omegaven immediately. If not used immediately, admixtures may 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.
  • Any remaining contents of a partly used PN container must be discarded.
  • Follow the instructions of each product included in the admixture.

2.3 Dosing Information

Dosing Considerations

  • Prior to administration of Omegaven, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level.
  • Initiate Omegaven dosing as soon as direct or conjugated bilirubin (DBil) levels are 2 mg/dL or greater in pediatric patients who are expected to be PN-dependent for at least 2 weeks.
  • The dosing of Omegaven 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 (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.

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