Fish oil, medium-chain triglycerides, olive oil, and soybean oil
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Lipid Emulsion
Dosing in kidney impairment
Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8 , 8.4 ) 5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions.
Prolonged PN administration in patients with renal impairment may result in aluminum reaching toxic levels. Preterm neonates are at greater risk because their kidneys are immature and they require large amounts of calcium and phosphate solutions that contain aluminum. Patients with impaired kidney function, including preterm neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity.
Laboratory testing using the triene to tetraene ratio may not be adequate to diagnose EFAD, and assessment of individual fatty acid levels may be needed. Ensure patients are receiving recommended dosages of SMOFlipid to prevent EFAD [see Dosage and Administration, Description] . 5.10 Monitoring/Laboratory Tests Throughout treatment, monitor serum triglycerides [see Warnings and Precautions] , fluid and electrolyte status, blood glucose, liver and kidney function, coagulation parameters, and complete blood count including platelets.
Preparation and administration
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Important Administration Instructions
SMOFlipid is prepared and administered by a healthcare provider in the inpatient setting. Patients and caregivers may prepare and administer SMOFlipid for home use after appropriate training by a trained healthcare provider.
SMOFlipid is for intravenous infusion into a central or peripheral vein.
Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration and Warnings and Precautions].
SMOFlipid 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 administration.
Use a dedicated infusion line without any connections. Do not connect multiple medications in series.
To prevent air embolism, use a nonvented infusion set or close the vent on a vented set and fully evacuate residual gas in the bag prior to administration.
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.
SMOFlipid can be infused concurrently into the same vein as dextrose-amino acid solutions (as part of PN) by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps.
After connecting the infusion set, start infusion of SMOFlipid immediately. Complete the infusion within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.
Preparation Instructions Use the following instructions to prepare single-dose SMOFlipid 100 mL, 250 mL, and 500 mL Flexible Containers for administration: [See table below.] SMOFlipid 100 mL, 250 mL and 500 mL single-dose Flexible Containers
After removing the overpouch, infuse immediately. If not used immediately, the product should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. After removal from storage, infuse within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture. SMOFlipid 1000 mL Pharmacy Bulk Package
For admixing use only and not for direct intravenous infusion . Prior to administration, transfer to a separate PN container for individual patient use.
Transfer the contents through the blue infusion port using a suitable sterile transfer device or dispensing set. Discard any unused contents.
Use the Pharmacy Bulk Package immediately for admixing after removal from 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. Admixing Instructions
Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
Do not add SMOFlipid 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 SMOFlipid.
SMOFlipid 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 SMOFlipid.
Simultaneous transfer of amino acid injection, dextrose injection, and SMOFlipid 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 USA, LLC.
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 SMOFlipid 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. smofl-img-01.jpg smofl-img-02.jpg smofl-img-03.jpg smofl-img-04.jpg smofl-img-05.jpg
Recommended Dosage and Administration
The recommended nutritional requirements of lipid and recommended dosages of SMOFlipid to be administered to meet those requirements for pediatric and adult patients are provided in Table 1 , along with recommendations for the initial and maximum infusion rates.
The recommended duration of infusion for SMOFlipid will vary depending on the clinical situation. Adjust the administration flow rate by taking into account the dose being administered, the daily volume/intake, and the duration of the infusion [see Overdosage].
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 SMOFlipid, correct severe fluid and electrolyte disorders and measure serum triglyceride levels to establish a baseline value. In patients with elevated triglyceride levels, initiate SMOFlipid at a lower dosage and titrate in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions] .
SMOFlipid contains 0.162 to 0.225 mg/mL of all-rac-alpha-tocopherol. Take into account the amount of all-rac-alpha-tocopherol in SMOFlipid when determining the need for additional supplementation. [See table below.]
| *The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age). | |||
| ** Daily dosage should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)]. | |||
| Age | Nutritional Requirements | Direct Infusion Rate | |
| Recommended Initial Dosage and Maximum Dosage | Initial | Maximum | |
| Birth to 2 years of age (including preterm and term neonates*) [see Warnings and Precautions (5.1)] | Initial 0.5 to 1 g/kg/day not to exceed 3 g/kg/day** | 0.1 to 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Pediatric patients 2 to <12 years of age | Initial 1 to 2 g/kg/day not to exceed 3 g/kg/day** | 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Pediatric patients 12 to 17 years of age | Initial 1 g/kg/day not to exceed 2.5 g/kg/day** | 0.2 to 0.4 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.75 mL/kg/hour |
| Adults | 1 to 2 g/kg/day not to exceed 2.5 g/kg/day** | 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes | 0.5 mL/kg/hour |
Drug interactions
Check fish oil, medium-chain triglycerides, olive oil, and soybean oil against a medication listLabel text (1 paragraph)
Soybean and olive oils in SMOFlipid contain vitamin K 1 which may counteract the anticoagulant activity of vitamin K antagonists such as warfarin. In patients who receive concomitant SMOFlipid and warfarin, increase monitoring of laboratory parameters for anticoagulant activity. Vitamin K Antagonists (e.g., warfarin) : Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters. ( 7 )
Contraindications
Use of SMOFlipid is contraindicated in patients with: • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients in SMOFlipid [see Warnings and Precautions ( 5.3 )] • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions ( 5.7 )] • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients. ( 4 ) • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL). ( 4 , 5.7 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. There are risks to the fetus associated with severe malnutrition during pregnancy ( see Clinical Considerations ) . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality. Parenteral nutrition should be considered if the pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.