![]() Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to SMOFlipid use. Monitor liver tests when administering SMOFlipid. Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some parenteral nutrition-treated patients without preexisting liver disease. Monitor liver tests in patients treated with SMOFlipid and consider discontinuation or dosage reduction if abnormalities occur. In a randomized study of neonates and infants expected to be treated with PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed less frequently in SMOFlipid-treated patients than in 100% soybean oil lipid emulsion-treated patients. The etiology of PNALD is multifactorial however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including SMOFlipid, have been associated with development of PNALD. Risk of Parenteral Nutrition-Associated Liver Disease (PNALD) and Other Hepatobiliary Disorders: PNALD, or Intestinal failure associated liver disease (IFALD) can present as cholestasis or hepatic stenosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure).Table 1: Recommended Pediatric Dosage Pediatric Age groupīirth to 2 years of age (including preterm and term neonates*)Ģ0 to 24 hours for preterm and term neonatesġ2 to 24 hours for patients 1 month to 2 years Protect the admixed PN solution from light. Use a non-vented, non-DEHP 1.2 micron in-line filter during administration. Prior to administration, transfer to a separate PN container for individual patient use. SMOFlipid 1000 mL is supplied as a Pharmacy Bulk Package for admixing only and is not for direct infusion. Pediatric dosage is in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour. 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 is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Please see full prescribing information for intravenous use at INDICATIONS AND USAGE This brief summary does not include all the information needed to use SMOFlipid safely and effectively. SMOFLIPID (lipid injectable emulsion), for intravenous useīRIEF SUMMARY OF PRESCRIBING INFORMATION FOR HEALTHCARE PROVIDERS
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