2. Clinical Information
  3. All Smoflipid® Clinical Information

All Smoflipid® Clinical Information


Liver Function

Levels of AST/ALT in patients receiving Smoflipid® were significantly lower versus soybean oil emulsions7,18

liver functions

STUDY TAKEAWAY
Smoflipid® showed lower concentrations of liver enzymes (ALT, AST) compared to soybean oil lipid emulsions, indicating an improvement in the patient's liver function.7

Monitor liver function. If Smoflipid® treated patients develop liver enzyme abnormalities, consider discontinuation or dose reduction.


Triglyceride Data

Studies showed triglyceride levels increased less with Smoflipid® compared to lipid emulsions with higher soybean oil content.8,18

triglyceride data

STUDY TAKEAWAY
In postoperative surgical patients, Smoflipid® demonstrated a lower triglyceride increase compared to those patients who received a lipid emulsion with a higher soybean oil content.18

Monitor serum triglycerides before and during treatment with Smoflipid®. Company-sponsored studies showed that mean triglyceride levels from baseline values to week 4 were similar in both the Smoflipid® and comparator groups.11


Fatty Acid Profile

Smoflipid® has a 2.5:1 ω-6:ω-3 fatty acid ratio11

triglyceride data
  • The fatty acid ratio in Smoflipid® is in line with expert recommendations.12-15
  • The ω-6:ω-3 fatty acid ratio in Smoflipid® has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

  • Smoflipid® has a lower amount of ω-6 fatty acids compared to 100% soybean oil emulsion11, 16, 17

  • Smoflipid® meets the essential fatty acid requirements of adults11


Fatty Acid Composition of Current ILEs

current IVLEs

a Data on file. Fresenius Kabi. 2016.

The ω-6:ω-3 fatty acid ratio in Smoflipid® has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.



EPA/DHA

  • Smoflipid® has been shown to improve EPA and DHA levels in adult patients7,23
    – ESPEN states, "Addition of EPA and DHA to lipid emulsions has demonstrable effects on cell membranes and inflammatory processes." (Grade B)21

α-tocopherol

  • An additive in Smoflipid® that prevents the oxidation of lipids in the formulation (~200 mg/L)7,18,23
    – In clinical studies, Smoflipid® has been shown to increase plasma α-tocopherol levels7,18,23

References

  1. Klek S, et al. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid): a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013;32(2):224-231.
  1. Wu MH, et al. Randomized clinical trial of new intravenous lipid (SMOFlipid 20%) versus medium-chain triglycerides/long-chain triglycerides in adult patients undergoing gastrointestinal surgery. JPEN J Parenter Enteral Nutr. 2014;38(7):800-808.
  1. Smoflipid [prescribing information].
  2. Grimble RH. Fatty acid profile of modern lipid emulsions: scientific consideration for creating the ideal composition. Clin Nutr Suppl. 2005;1(3):9-15.
  3. Waitzberg DL, et al. New parenteral lipid emulsions for clinical use. JPEN J Parenter Enteral Nutr. 2006;30(4):351-367.
  4. Mayer K, et al. Fish oil in the critically ill: from experimental to clinical data. Curr Opin Clin Nutr Metab Care. 2006;9(2):140-148.
  5. Grimm H, et al. Immunonutrition-supplementary amino acids and fatty acids ameliorate immune deficiency in critically ill patients. Arch Surg. 2001;386(5):369-376.
  6. Intralipid [prescribing information].
  7. Nutrilipid [prescribing information].
  1. Antébi H, et al. Liver function and plasma antioxidant status in intensive care unit patients requiring total parenteral nutrition: comparison of 2 fat emulsions. JPEN J Parenter Enteral Nutr. 2004;28(3):142-148.
  1. Singer P, et al. ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr. 2009;28(4):387-400.
  1. Grimm H, et al. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006;45(1):55-60.

BRIEF SUMMARY OF PRESCRIBING INFORMATION:

These highlights do not include all the information needed to use Smoflipid safely and effectively. See full prescribing information, including Boxed Warning, for Smoflipid available at www.smoflipid.com

SMOFLIPID (lipid injectable emulsion), for intravenous use

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.

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.

DOSAGE AND ADMINISTRATION

  • For intravenous infusion only into a peripheral or central vein.
  • Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient.
  • The usual daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.

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.

WARNING: DEATH IN PRETERM INFANTS

See full prescribing information for complete boxed warning.

  • Deaths in preterm infants have been reported in literature.
  • Autopsy findings included intravascular fat accumulation in the lungs.
  • Preterm and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

CONTRAINDICATIONS

  • Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients.
  • Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.

WARNINGS AND PRECAUTIONS (also see BOXED WARNING)

  • Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
  • Infection, Fat Overload Syndrome, Refeeding Complications, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters including serum triglycerides.
  • Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
  • 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.

ADVERSE REACTIONS (also see Warnings and Precautions)

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.

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.