Fresenius Kabi announced the availability of Omegaven (fish oil triglycerides) injectable emulsion as a source of calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Omegaven, the first approved fish oil lipid emulsion for this condition, was previously available only for compassionate use in the US.
Fatty acids are an important part of energy production; the most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids also serve an important role for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.
Clinical data showed pediatric patients treated with Omegaven attained and maintained age-appropriate growth. An improvement in liver function parameters and an increase in plasma platelet concentrations were also seen with Omegaven.
Omegaven is not indicated to prevent PNAC. It should not be used in patients with a known fish or egg protein hypersensitivity, severe hemorrhagic disorders due to a potential effect on platelet aggregation, severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia.
“Previously, clinicians had no options for the provision of lipids for these vulnerable children, who because of PNAC, are at serious risk of liver failure,” said Gordon S. Sacks, PharmD, BCNSP, FASPEN, FCCP, senior director, medical affairs for parenteral nutrition at Fresenius Kabi USA. “Fresenius Kabi is pleased Omegaven is now widely available to meet the short and long-term calorie and fatty acid needs of PNAC pediatric patients that were previously unmet.”
Omegaven is available as a 5g/50mL and 10g/100mL strength injectable emulsions in 50mL and 10-count single-dose bottles.
For more information call (800) 551-7176 or visit Fresenius-Kabi.com.