Intralipid Dosage

Important Preparation and Administration Instructions

• Intralipid 30% Pharmacy Bulk Package is for admixing use only and is not intended for direct intravenous administration.
• Admixtures containing Intralipid 30% are prepared and administered by a healthcare provider in the inpatient setting [see Dosage and Administration (2.2)].
• Patients and caregivers may administer admixtures containing Intralipid for home use after appropriate training by a trained healthcare provider [see Patient Counseling Information (17)].
• Intralipid 30% must be combined with other PN fluids so that the resulting admixture has a final lipid concentration of no more than 20% (0.2 g lipid per mL of admixture). Refer to Admixture Preparation Instructions [see Dosage and Administration (2.2)].
• When Intralipid 30% is diluted to 20%, strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.125 g/kg/hour for neonates and infants [see Warnings and Precautions (5.1)].
• Intralipid admixtures with osmolarity
  • Greater than or equal to 900 mOsm/L must be infused through a central vein.
  • Less than 900 mOsm/L may be administered either through a central or peripheral vein.
• Use a 1.2 micron in-line filter during admixture administration.
• PN admixtures should use a dedicated infusion line without any connections. Do not connect multiple medications in series.
• To prevent air embolism, use a non-vented infusion set or close the vent on a vented set and fully evacuate residual gas in the bag prior to admixture administration.
• The flow rate of the admixture should be controlled with an infusion pump. Do not pressurize the flexible bag to increase flow rates, and if administration is controlled by a pumping device, turn off the pump before the bag runs dry.
• Do not use infusion sets and lines that contain di-2-ethylhexyl phthalate (DEHP), including infusion sets that contain polyvinyl chloride (PVC) components, because they contain DEHP as a plasticizer.
• After connecting the infusion set, start infusion of PN admixture with Intralipid immediately. Complete the infusion within 24 hours.

Admixture Preparation Instructions

Use the following instructions to prepare the Intralipid 30% Pharmacy Bulk Package for transfer to a compounding bag:

	1. Inspect Bag Inspect the integrity indicator (Oxalert®) (A) before removing the overpouch. Discard the product if the indicator is black, overpouch is opened or damaged, emulsion color is not white, or seals of bag are broken.
	2. Remove Overpouch Place the bag on a clean, flat surface. Tear the overpouch at notch and pull down. Discard the Oxalert sachet (A) and the oxygen absorber (B). Visually inspect the bag and contents for particulate matter and discoloration prior to administration. The lipid emulsion should be a homogenous liquid with a milky white appearance. If the mixture is not white or the emulsion has separated (noted by discoloration, phase separation, or oily droplets), or if particulates and/or leakage are observed, discard the bag.
	3. Spike Bag Identify the infusion port (blue cap with the arrow pointing away from the bag). Immediately before inserting the compounding set, break off the blue infusion port cap. Use a suitable sterile transfer device or dispensing set with an external spike diameter of 5.5 to 5.7 mm. Hold the base of the infusion port. Insert the spike through the infusion port by rotating your wrist slightly until the spike is inserted. Do not pierce the infusion port more than once.
	4. Transfer to the Compounding Bag Hang the bag using the hanger cut and start transfer to the compounding bag. Discard unused portion.

• Use the Intralipid 30% immediately for admixing after removal from the overpouch. If not used immediately, the product can be stored for no longer than 24 hours at 2°C to 8°C (36°F to 46°F). After removal from storage, and once the closure is penetrated, use Pharmacy Bulk Package contents within 4 hours.
• Diluting Intralipid 30% to a 10% or 20% concentration with an intravenous fluid such as normal saline or other diluent does not produce a dilution that is equivalent in composition to Intralipid 10% or 20% intravenous lipid emulsions. Therefore, diluents other than dextrose and amino acids should not be used to prepare admixtures for direct intravenous administration.

Admixing Instructions

• Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
• Do not add Intralipid 30% Pharmacy Bulk Package to the PN container first; destabilization of the lipid may occur. The prime destabilizers of emulsions are excessive acidity (such as a pH <5) and inappropriate electrolyte content. Amino acid solutions exert buffering effects that protect the emulsion from destabilization. Give careful consideration to the addition of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability.
• Do not inject additives directly into Intralipid.
• Intralipid 30% may be mixed with amino acid and dextrose injections to produce “all-in-one” PN admixtures. The mixing sequence below must be followed for manual compounding to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsions alone; shake bags gently after each addition.
  • Transfer dextrose injection to the PN container.
  • Transfer amino acid injection.
  • Transfer Intralipid 30%.
• Simultaneous transfer of amino acid injection, dextrose injection, and Intralipid to the PN container is also permitted; follow automated compounding device instructions as indicated. Use gentle agitation during admixing to minimize localized concentration effects.
• Additions to the PN admixtures should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi.
• Inspect the admixture to ensure that precipitates have not formed during preparation of the admixture and the emulsion has not separated. Discard the admixture if any of the above are observed.
• Infuse admixtures containing Intralipid immediately. If not used immediately, store admixtures under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. Infusion must be complete within 24 hours after removal from refrigeration. Discard any remaining admixture.
• Protect the admixed PN solution from light.

​2.3 Recommended Dosage and Administration

• ​The recommended nutritional requirements of lipid and recommended dosages of Intralipid to be administered to meet those requirements for adults and pediatric patients are provided in Table 1.
• ​The dosing of Intralipid depends on the patient's individual energy requirements influenced by age, body weight, tolerance, clinical status, and the ability to metabolize and eliminate lipids.
• ​When determining dose, energy supplied by dextrose and amino acids from PN, as well as energy from oral or enteral nutrition, has to be taken into account. Energy and lipid provided from lipid-based medications should also be taken into account (e.g., propofol).
• ​Prior to administration of admixtures with Intralipid, correct severe fluid and electrolyte disorders and measure serum triglyceride levels to establish a baseline value. In patients with elevated triglyceride levels, initiate Intralipid at a lower dosage and titrate in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.7)].