Smoflipid (Page 2 of 6)

2.3 Recommended Dosage and Administration

  • The dosing of SMOFlipid depends on the patient’s individual energy requirements influenced by age, body weight, tolerance, clinical status, and the ability to metabolize and eliminate lipids.
  • When determining dose, energy supplied by dextrose and amino acids from PN, as well as energy from oral or enteral nutrition, has to be taken into account. Energy and lipid provided from lipid-based medications should also be taken into account (e.g., propofol).
  • Prior to administration of SMOFlipid, correct severe fluid and electrolyte disorders and measure serum triglyceride levels to establish a baseline value. In patients with elevated triglyceride levels, initiate SMOFlipid at a lower dosage and titrate in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.7)]. SMOFlipid contains 0.162 to 0.225 mg/mL of all-rac-alpha-tocopherol. Take into account the amount of all-rac-alpha-tocopherol in SMOFlipid when determining the need for additional supplementation.

Recommended Adult Dosage

  • The recommended dosage of SMOFlipid for adult patients is 1 to 2 g/kg/day and should not exceed 2.5 g/kg/day. The initial rate of infusion should be 0.1 g/minute for the first 15 to 30 minutes of infusion. If tolerated, gradually increase until reaching the required rate after 30 minutes. Maximum infusion rate should not exceed 0.1 g/kg/hour. The daily dose should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)].
  • The recommended duration of infusion for SMOFlipid is between 12 and 24 hours, depending on the clinical situation. The administration flow rate is determined by dividing the volume of lipid by the duration of the infusion.

Recommended Pediatric Dosage

  • The recommend dosage of SMOFlipid for pediatric patients is shown in Table 1.
  • The duration of infusion will vary depending on the clinical situation, but infuse SMOFlipid over a longer duration in neonates as shown in Table 1.
  • Do not exceed an infusion rate of 0.15 g/kg/hour.
  • The administration flow rate is determined by dividing the volume of lipid by the duration of the infusion.
Table 1: Recommended Pediatric Dosage

* The neonatal period is defined as including term, post-term, and preterm newborn infants. The neonatal period for term and post-term infants is the day of birth plus 27 days. For preterm infants, the neonatal period is defined as the day of birth through the expected age of delivery plus 27 days (i.e., 44 weeks post-menstrual age).

Pediatric Age group Initial Dose Maximum Dose Duration of infusion
Birth to 2 years of age (including preterm and term neonates*) 0.5 to 1 g/kg/dayIncrease the dose by 0.5 to 1 g/kg/day 3 g/kg/day 20 to 24 hours for preterm and term neonates12 to 24 hours for patients1 month to 2 years
2 to <12 years of age 1 to 2 g/kg/dayIncrease the dose by 0.5 to 1 g/kg/day 3 g/kg/day 12 to 24 hours
12 to 17 years of age 1 to 2 g/kg/day 2.5 g/kg/day 12 to 24 hours

3 DOSAGE FORMS AND STRENGTHS

SMOFlipid is a sterile, homogenous lipid injectable emulsion in Flexible Containers supplied as:

  • 20 g of lipid/100 mL in 100 mL single-dose Flexible Container
  • 50 g of lipid/250 mL in 250 mL single-dose Flexible Container
  • 100 g of lipid/500 mL in 500 mL single-dose Flexible Container
  • 200 g of lipid/1000 mL in 1000 mL Pharmacy Bulk Package

4 CONTRAINDICATIONS

Use of SMOFlipid is contraindicated in patients with:

  • Known hypersensitivity to fish, egg, soybean, peanut protein, or to any of the active or inactive ingredients in SMOFlipid [see Warnings and Precautions (5.3)]
  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7)]

5 WARNINGS AND PRECAUTIONS

5.1 Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders

Risk of Parenteral Nutrition-Associated Liver Disease

Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure- associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). 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.

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 [see Adverse Reactions (6.1), Use in Specific Populations (8.4)].

Monitor liver tests in patients treated with SMOFlipid and consider discontinuation or dosage reduction if abnormalities occur.

Other Hepatobiliary Disorders

Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN- treated patients without preexisting liver disease.

Monitor liver tests when administering SMOFlipid. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to SMOFlipid use.

5.2 Death in Preterm Neonates

Deaths in preterm neonates after infusion of lipid injectable emulsions containing only soybean oil have been reported in the medical literature. Autopsy findings in these preterm neonates included intravascular lipid accumulation in the lungs. Preterm and small-for-gestational-age neonates 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 SMOFlipid for signs and symptoms of pleural or pericardial effusion.

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