Kabiven / Perikabiven

Generic Name: Date of Approval: August 25, 2014
Company: Fresenius Kabi USA

Treatment for: Parenteral Nutrition

FDA Approves Kabiven and FDA Approves Perikabiven

The U.S. Food and Drug Administration has approved Kabiven and Perikabiven (amino acids, electrolytes, dextrose and lipid injectable emulsion) parenteral nutrition (PN) products in a three-chamber bag. The unique three-chamber bag simplifies the delivery of parenteral nutrition by providing a premixed solution that is shelf-stable until activated for patient use.

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.

Important Safety Information

  • 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 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, Vigilance & Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Please see full Prescribing Information, including Boxed Warning, for Kabiven and Perikabiven.

Patient Counseling Information for Kabiven

  • Kabiven is given by infusion through a central vein catheter only.
  • Allergic reactions may occur.
  • There is a risk of infection and sepsis associated with formulations administered intravenously.
  • Kabiven may cause adverse reactions such as nausea and vomiting, excess fat (lipids) in the blood, high blood sugar, abnormally increased transaminase and bilirubin, or abnormally high or low blood electrolyte levels.
  • Contact their healthcare provider if they develop symptoms of an allergic reaction, infection, high blood sugar, low blood sugar, nausea, vomiting, or fluid retention occurs.
  • Have periodic laboratory tests and routinely follow-up with their healthcare provider.
  • Inform their healthcare provider about any changes in prescription or over the counter medications and supplements to avoid potential drug interactions and side effects.
  • When patients self-administer Kabiven injection at home, inform patients of the following:
    • Patients and/or caregiver must be trained in how to inspect, activate and administer Kabiven.
    • Follow the Kabiven inspection, activation and administration instructions.
    • Do not deviate from the administration instructions.
    • Inspect product before using for evidence of damage, particulate matter, and/or discoloration.
    • Discard the bag in the following situations:
      • Evidence of damage to the bag
      • More than one chamber is white
      • Solution is yellow
    • Any seal is already broken
  • Prior to activation, store Kabiven between 20° to 25°C (68° to 77°F).
  • Activate bag just prior to use or refrigerate activated bag at 2 to 8°C (36 to 46°F) for up to 24 hours. Discard any unused portion.
  • After activation and prior to administration carefully inspect bag for separation of the lipid emulsion, which can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the bag if this occurs.

Patient Counseling Information for Perikabiven

  • Perikabiven is given by infusion through a peripheral or central vein catheter.
  • Allergic reactions may occur.
  • There is a risk of infection and sepsis associated with formulations administered intravenously.
  • Perikabiven may cause adverse reactions such as nausea and vomiting, excess fat (lipids) in the blood, high blood sugar, abnormally increased transaminase and bilirubin, or abnormally high or low blood electrolyte levels.
  • Contact their healthcare provider if they develop symptoms of an allergic reaction, infection, high blood sugar, low blood sugar, nausea, vomiting, or fluid retention occurs.
  • Have periodic laboratory tests and routinely follow-up with their healthcare provider.
  • Inform their healthcare provider about any changes in prescription or over the counter medications and supplements to avoid potential drug interactions and side effects.
  • When patients self-administer Perikabiven injection at home, inform patients of the following:
    • Patients and/or caregiver must be trained in how to inspect, activate and administer Perikabiven.
    • Follow the Perikabiven inspection, activation and administration instructions.
    • Do not deviate from the administration instructions.
    • Inspect product before using for evidence of damage, particulate matter, and/or discoloration.
    • Discard the bag in the following situations:
      • Evidence of damage to the bag
      • More than one chamber is white
      • Solution is yellow
    • Any seal is already broken
  • Prior to activation, store Perikabiven between 20° to 25°C (68° to 77°F).
  • Activate bag just prior to use or refrigerate activated bag at 2 to 8°C (36 to 46°F) for up to 24 hours. Discard any unused portion.
  • After activation and prior to administration carefully inspect bag for separation of the lipid emulsion, which can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the bag if this occurs.

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