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 soybean oil-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 worldwide, 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

This brief summary does not include all the information needed to use SMOFlipid safely and effectively. Please see full Prescribing Information at www.smoflipid.com

SMOFLIPID (lipid injectable emulsion), for intravenous use

INDICATIONS AND USAGE

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

IMPORTANT SAFETY INFORMATION

For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration.  Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, 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. The recommended dose for pediatrics is shown in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour.  SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures.  Protect the admixed PN solution from light.

Smoflipid Black Box Warning

SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).
 
Parenteral Nutrition-Associated Liver Disease:  Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests, if abnormalities occur consider discontinuation or dosage reduction.  
Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous 100% soybean oil lipid emulsions have been reported in the literature.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. 
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty
Acid Deficiency
:  Monitor for signs and symptoms; monitor laboratory parameters.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates. 

Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia.  Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase and nosocomial infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, for intravenous use by clicking here.

 


 

Omegaven

Omegaven®

Omegaven is the first and only fish oil lipid emulsion for pediatric patients with parenteral nutrition-associated cholestasis (PNAC)1 in the U.S.

Available in more than 40 countries worldwide, it has been marketed in Germany since 1998 for adults and has been available in the U.S. since 2007 for pediatric patients under FDA’s compassionate use program. The U.S. is the only country with a specific indication as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

  • Patients receiving Omegaven achieved age appropriate growth1
  • Omegaven-treated patients experienced improvement in liver function parameters1
  • Fish oil is rich in Omega-3s

Reference:
1. Omegaven Prescribing Information, Fresenius Kabi USA, LLC. 2018

For more information visit the Omegaven® website

INDICATIONS AND USAGE

Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). 

Limitations of Use:
Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients. 
It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product. 

IMPORTANT SAFETY INFORMATION

Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.

Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients, severe hemorrhagic disorders due to a potential effect on platelet aggregation, severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL).

  • Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of soybean oil-based intravenous lipid emulsions have been reported in medical literature. Autopsy findings in these preterm infants included intravascular lipid accumulation in the lungs. The risk of pulmonary lipid accumulation with Omegaven is unknown. Preterm and small-for-gestational-age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. This risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions. Monitor patients receiving Omegaven for signs and symptoms of pleural or pericardial effusion.
     
  • Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
     
  • Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters.
     
  • Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
     
  • Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency.
     
  • The most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Omegaven safely and effectively. Please see full prescribing information for Omegaven (fish oil triglycerides) injectable emulsion for intravenous use here.
 


 

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.