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


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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, including Boxed Warning for SMOFlipid (lipid injectable emulsion), for intravenous use 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 (PN) 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

The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion. Prior to administration, transfer to a separate PN container.

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

  • Death in Preterm Infants: (see BLACK BOX WARNING)
     
  • Hypersensitivity Reactions: SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut oil. Signs or symptoms of a hypersensitivity reaction may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, or chills. If a hypersensitivity reaction occurs, stop infusion of SMOFlipid immediately and undertake appropriate treatment and supportive measures.
     
  • Risk of Catheter-Related Infections: Lipid emulsions, such as SMOFlipid, can support microbial growth and is an independent risk factor for the development of catheter-related bloodstream infections. The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions or drugs.
     
  • Fat Overload Syndrome: This is a rare condition that has been reported with intravenous lipid emulsions. A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in a syndrome characterized by a sudden deterioration in the patient’s condition including fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, fatty liver infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma).
     
  • Refeeding Syndrome: Reintroducing calories and protein to severely undernourished patients with PN may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop.
     
  • Aluminum Toxicity: SMOFlipid contains no more than 25 mcg/L of aluminum. During prolonged PN administration in patients with renal impairment, the aluminum levels in the patient may reach toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral intakes of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of PN products.
     
  • Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): PNALD has been reported in patients who receive PN for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. Intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development of PNALD, although a causal relationship has not been established. If SMOFlipid-treated patients develop liver test abnormalities, consider discontinuation or dose reduction.
     
  • Hypertriglyceridemia: Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, and metabolic syndrome.
     
  • Monitoring/Laboratory Tests: Routinely monitor serum triglycerides, fluid and electrolyte status, blood glucose, liver and kidney function, blood count including platelets, and coagulation parameters throughout treatment. Monitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended.
     
  • Interference with Laboratory Tests: Content of vitamin K may counteract anticoagulant activity. The lipids contained in this emulsion may interfere with some laboratory blood tests (e.g., hemoglobin, lactate dehydrogenase [LDH], bilirubin, and oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream.

ADVERSE REACTIONS

Most common adverse drug reactions in >1% of patients who received SMOFlipid 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.

Less common adverse reactions in ≤1% of patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis.

The following adverse reactions have been identified during post-approval use of SMOFlipid in countries where it is registered. Infections and Infestations: infection. Respiratory, Thoracic and Mediastinal Disorders: dyspnea.

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.

DRUG INTERACTIONS

Coumarin and Coumarin Derivatives, Including Warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters.

USE IN SPECIFIC POPULATIONS

  • Pregnancy and Lactation: There are no available data on risks associated with SMOFlipid when used in pregnant or lactating women.
     
  • Pediatric Use: The safety and effectiveness of SMOFlipid have not been established in pediatric patients.
     
  • Hepatic Impairment: Parenteral nutrition should be used with caution in patients with hepatic impairment. Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive PN, including cholestasis, hepatic steatosis, fibrosis and cirrhosis (PN associated liver disease), possibly leading to hepatic failure.

OVERDOSAGE

In the event of an overdose, fat overload syndrome may occur. Stop the SMOFlipid infusion until triglyceride levels have normalized. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from serum.
 


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.