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.

• 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.