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SMOFLIPID (lipid injectable emulsion), for intravenous use
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SMOFLIPID safely and effectively. See full prescribing information for SMOFLIPID. SMOFLIPID (lipid injectable ...
These highlights do not include all the information needed to use SMOFLIPID safely and effectively. See full prescribing information for SMOFLIPID.
SMOFLIPID (lipid injectable emulsion), for intravenous use
Initial U.S. Approval: 2016
WARNING: DEATH IN PRETERM INFANTS
See full prescribing information for complete boxed warning.
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Deaths in preterm infants have been reported in literature. (5.1, 8.4)
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Autopsy findings included intravascular fat accumulation in the lungs. (5.1,8.4)
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Preterm and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. (5.1, 8.4)
INDICATIONS AND USAGE
Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.(1)
Limitations of Use
The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. (1)
DOSAGE AND ADMINISTRATION
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For intravenous infusion only into a peripheral or central vein. (2.1)
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Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient. (2.4)
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The usual daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day (2.4)
DOSAGE FORMS AND STRENGTHS
Smoflipid is a lipid injectable emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 mL. (3)
CONTRAINDICATIONS
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Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients. (4)
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Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides > 1,000 mg/dL. (4, 5.8)
WARNINGS AND PRECAUTIONS
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Hypersensitivity Reactions:Monitor for signs or symptoms. Discontinue infusion if reactions occur. (5.2)
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Infection, Fat Overload, Hypertriglyceridemia, and Refeeding Complications: Monitor for signs and symptoms; monitor laboratory parameters. (5.3,5.4, 5.5, 5.8)
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Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. (5.6, 8.4)
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Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. (5.7, 8.4)
ADVERSE REACTIONS
Most common adverse drug reactions (>1%) from clinical trials were nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, increased blood triglycerides, hypertension, sepsis, dyspepsia, urinary tract infection, anemia and device related infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters. (7.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
Table of Contents
1 INDICATIONS AND USAGE
Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or ...
Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Limitations of Use
The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions [See Clinical Studies (14)]
2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions - Smoflipid is for central or peripheral intravenous infusion. When administered with dextrose and amino acids, the choice of a ...
2.1 Administration Instructions
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Smoflipid 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 must be infused through a central vein.
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Use a 1.2 micron in-line filter.
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Use a dedicated line for parenteral nutrition (PN). 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.
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To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible bags in series, 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 pump before the bag runs dry.
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Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
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