Parenteral Nutrition

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Fresenius Kabi is a global leader in clinical nutrition focused on improving patient care. Our expanding U.S. portfolio of parenteral nutrition products brings innovation and advancements to U.S. clinicians and patients.

Featured Products


Smoflipid Product Photo

Smoflipid®

With Smoflipid®, Fresenius Kabi answered the call from parenteral nutrition and critical care medical societies for an alternative to soy-based lipid injectable emulsion. It's the first four-oil lipid emulsion in the U.S. -- A blend of soybean oil, medium chain triglycerides, olive oil, and fish oil -- and the first and only advancement in lipid emulsions in more than 40 years. Safe, well tolerated,1,2 and administered to over 6 million patients, Smoflipid® provides energy and essential fatty acids. With this innovative product, you now have an alternative option for adult patients requiring parenteral nutrition.

Reference:
1. Klek S, et al. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid); a double, randomised, multicentre study in adults. Clin Nutr. 2013;32(2):224-231.
2. Mertes N, et al. Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study. Ann Nutr Metab. 2006;50(3):253-259

For more information visit the Smoflipid® website

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

Smoflipid Black Box Warning

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 recommended 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.

 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.


Kabiven Product Image

Kabiven®

Kabiven® is the first and only three-chamber bag for parenteral nutrition. It efficiently delivers dextrose, amino acids and electrolytes, and lipids, components clinicians have relied upon for years. The unique design streamlines the delivery of nutrition therapy to the patient by simplifying calculations, prescription writing, compounding, and administration, all the while supporting PN safety by minimizing the risk of contamination.1,2

1. Ayers P, et al. ASPEN parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014;38:296-333
2. ISMP. www.ismp.org/Tools/guidelines/IVsummit/IVCGuidelines.pdf. Published 2013, revised 2016, access Oct 3, 2016

For more information visit the Kabiven® website

BRIEF SUMMARY OF PRESCRIBING INFORMATION

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

KABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
Initial U.S. Approval: 2014

PERIKABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
Initial U.S. Approval: 2014

Kabiven Black Box Warning

INDICATIONS AND USAGE

Kabiven and Perikabiven are each indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Kabiven and Perikabiven may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.

Limitation of Use:

Not recommended for use in pediatric patients <2 years, including preterm infants, because the fixed content of the formulation does not meet nutritional requirements in this age group.

DOSAGE AND ADMINISTRATION

  • Kabiven is for intravenous infusion only into a central vein
  • Perikabiven is for intravenous infusion into a central or peripheral vein
  • Recommended dosage depends on clinical status, body weight and nutritional requirement
  • Kabiven adult dosage: 19 to 38 mL/kg/day (0.63 to 1.26 g/kg/day of protein, 1.85 to 3.71 g/kg/day of dextrose, 0.74 to 1.48 g/kg/day of lipid)
  • The maximum infusion rate for Kabiven is 2.6 mL/kg/hour (corresponding to 0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose, the limiting factor, and 0.1 g/kg/hour of lipid
  • Perikabiven adult dosage: 27 to 40 mL/kg/day (0.64 to 0.94 g/kg/day of protein, 1.83 to 2.71 g/kg/day of dextrose, 0.95 to 1.4 g/kg/day of lipid)
  • The maximum infusion rate for Perikabiven is 3. 7 ml/kg/hour (corresponding to 0.09 g/kg/hour of amino acids, 0.25 g/kg/hour of dextrose, the limiting factor, and 0.13 g/kg/hour lipid)
  • The recommended infusion period is 12 to 24 hours

DOSAGE FORMS AND STRENGTHS

  • Kabiven and Perikabiven are sterile, hypertonic emulsions in a three-chamber container. The individual chambers contain one of the following: amino acids and electrolytes, dextrose, or lipid injectable emulsion, respectively
  • Kabiven is available in four sizes 2566 mL, 2053 mL, 1540 ml and 1026 mL
  • Perikabiven is available in three sizes 2400 mL, 1920 mL and 1440 mL

CONTRAINDICATIONS

  • Known hypersensitivity to egg, soybean proteins, peanut proteins, corn or corn products, or to any of the active substances or excipients
  • Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1000 mg/dL
  • Inborn errors of amino acid metabolism
  • Cardiopulmonary instability
  • Hemophagocytic syndrome

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur
  • Infection, fat overload, hyperglycemia and refeedinq complications:  Monitor for signs and symptoms; monitor laboratory parameters

ADVERSE REACTIONS

The most common adverse reactions to Kabiven (>3%) are nausea, pyrexia, hypertension, vomiting, decreased hemoglobin, decreased total protein, hypokalemia, decreased potassium and increased gamma glutamyltransferase.

The most common adverse reactions to Perikabiven (>3%) are hyperglycemia, hypokalemia, pyrexia and increased blood triglycerides.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC,  at 1-800-551-7176 or FDA at 1-800-FDA-1 088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters

USE IN SPECIFIC POPULATIONS

Renal Impairment: Patients on hemodialysis or continuous renal replacement therapy may require additional protein supplementation to meet nutritional requirements. If required, adjust the volume of Kabiven or Perikabiven administered based on serum electrolyte levels and fluid balance.