Fresenius Kabi
A Leader in Parenteral Nutrition Innovation

FK Parenteral Nutrition Product Family

Please see below for Important Safety Information, including Boxed Warning for Smoflipid and Kabiven.

For a full product catalog, please contact your Sales Rep, or go to:
https://www.fresenius-kabi.com/us/documents/Fresenius_Kabi_Pharmaceutical_Products_Catalog_Aug_2019_s.pdf

Smoflipid®
Lipid Injectable Emulsion, USP 20%

4-oil Lipid Emulsion for Adults


Smoflipid Bag

Kabiven/Perikabiven®
(Amino Acids, Electrolytes, Dextrose and Lipid
Injectable Emulsion), for intravenous use

3-chamber bag delivering dextrose, amino acids, electrolytes and lipids for Adults


Kabiven Bag

Omegaven®
(fish oil triglycerides) injectable emulsion

Fish Oil Triglycerides for Pediatric Patients with PNAC


Omegaven Bottle




SMOFLIPID
IMPORTANT SAFETY INFORMATION

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.

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.
  • The usual daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.

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

Monitor for signs or symptoms of:

  • Hypersensitivity Reactions: Discontinue infusion if reactions occur.
  • Infection, Fat Overload Syndrome, Hypertriglyceridemia and Refeeding Syndrome: Monitor laboratory parameters.
  • 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.

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.

This Important Safety Information does not include all the information needed to use Smoflipid safely and effectively. Please see full Prescribing Information, including Boxed Warning, for Smoflipid at www.smoflipid.com.

Full Prescribing Information

KABIVEN
IMPORTANT SAFETY INFORMATION

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.

Kabiven and Perikabiven three-chamber bags must be mixed prior to infusion. For admixing instructions see INSTRUCTIONS FOR USE in the prescribing information.

INDICATIONS AND LIMITATIONS OF USE

  • 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.
  • Kabiven is indicated for intravenous infusion into a central vein.
  • Perikabiven is indicated for intravenous infusion into a peripheral or central vein.
  • Neither Kabiven nor Perikabiven is recommended for use in pediatric patients < 2 years, including preterm infants because the fixed content of the formulations do not meet the nutritional requirements in this age group.

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

  • Kabiven is hypertonic and may cause vein irritation, vein damage and even thrombosis if infused in a peripheral vein. Only infuse Kabiven into a central vein.
  • Monitor for signs or symptoms of hypersensitivity reactions and discontinue infusion if reactions occur.
  • Monitor patient closely for signs and symptoms of infection, hypertriglyceridemia, hyperglycemia and refeeding complications.
  • Monitor laboratory parameters for alterations in electrolytes, liver and renal impairment, fluid status and coagulation parameters. Adjust rate and dose of Kabiven and Perikabiven according to clinical status.

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.

Please see full Prescribing Information, including Boxed Warning, for Kabiven and Perikabiven available at www.KabivenUSA.com.

Full Prescribing Information

OMEGAVEN
IMPORTANT SAFETY INFORMATION

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.

Full Prescribing Information