INDICATIONS AND USAGE
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.
IMPORTANT SAFETY INFORMATION
For intravenous infusion only into a central or peripheral vein. Use a non-vented non-DEHP 1.2 micron in-line filter set during administration. Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. The recommended daily dosage in adults is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day. The recommended dose for pediatrics is shown in Table 1, and do not exceed an infusion rate of 0.15 g/kg/hour. SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. Protect the admixed PN solution from light.
Table 1: Recommended Pediatric Dosage
| Pediatric Age group/th> |
Initial Dose |
Maximum Dose |
Duration of infusion |
| Birth to 2 years of age (including preterm and term neonates) |
0.5 to 1 g/kg/day
Increase the dose by 0.5 to 1 g/kg/day |
3 g/kg/day |
20 to 24 hours for preterm and term neonates
12 to 24 hours for patients 1 month to 2 years |
| 2 to <12 years of age |
1 to 2 g/kg/day
Increase 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 |
SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides > 1,000 mg/dL).
Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who received parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests, if abnormalities occur consider discontinuation or dosage reduction.
Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous 100% soybean oil lipid emulsions have been reported in the literature.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.
Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and hyperglycemia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase and nosocomial infection.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use SMOFlipid safely and effectively. Please see full prescribing information, for intravenous use at www.freseniuskabinutrition.com.
INDICATIONS AND USAGE
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
Limitations of Use:
Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients.
It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6: omega-3 fatty acid ratio of the product.
IMPORTANT SAFETY INFORMATION
Protect the admixed PN solution from light. Prior to administration, correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.
Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients, severe hemorrhagic disorders due to a potential effect on platelet aggregation, severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dL).
Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of soybean oil-based intravenous lipid emulsions have been reported in medical literature. Autopsy findings in these preterm infants included intravascular lipid accumulation in the lungs. The risk of pulmonary lipid accumulation with Omegaven is unknown. Preterm and small-for-gestational-age infants 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 Omegaven for signs and symptoms of pleural or pericardial effusion.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended, including monitoring for essential fatty acid deficiency.
The most common adverse drug reactions (>15%) are: vomiting, agitation, bradycardia, apnea and viral infection.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Omegaven safely and effectively. Please see full prescribing information for Omegaven (fish oil triglycerides) injectable emulsion for intravenous use at www.freseniuskabinutrition.com.
WARNING: DEATH IN PRETERM INFANTS
- Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
- Autopsy findings included intravascular fat accumulation in the lungs.
- Preterm infants and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
INDICATIONS AND USAGE
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.
Limitations of Use:
Neither KABIVEN nor PERIKABIVEN is recommended for use in pediatric patients < 2 years including preterm infants because the fixed content of the formulation does not meet nutritional requirements in this age group.
KABIVEN is indicated for intravenous infusion into a central vein. PERIKABIVEN is indicated for intravenous infusion into a peripheral or central vein. It is recommended to mix the contents thoroughly by inverting the bags upside down to ensure a homogenous admixture. Ensure the vertical seals between chambers are broken and the contents of all three chambers for KABIVEN and PERIKABIVEN are mixed together prior to infusion. The dosage of KABIVEN and PERIKABIVEN should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids, dextrose and lipids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to administration of KABIVEN and PERIKABIVEN, correct severe fluid, electrolyte and acid-base disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. The recommended dosage of KABIVEN in adults is 19 to 38 mL/kg/day. The recommended dosage of PERIKABIVEN in adults is 27 to 40 mL/kg/day. The maximum daily dosage of KABIVEN and PERIKABIVEN in adults should not exceed 40 mL/kg/day.
Kabiven and Perikabiven is contraindicated in patients with 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 characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 g/dL). Inborn error of amino acid metabolism. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support). Hemophagocytic syndrome.
Hypersensitivity reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur.
Infection, fat overload, hyperglycemia and refeeding complications: Monitor for signs and symptoms; monitor laboratory parameters.
The most common adverse reactions for Kabiven (≥3%) are nausea, pyrexia, hypertension, vomiting, decreased hemoglobin, decreased total protein, hypokalemia, decreased potassium, and increased gamma glutamyltransferase. The most common adverse reactions for Perikabiven (≥3%) are hyperglycemia, hypokalemia, pyrexia, and increased blood triglycerides.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use KABIVEN and PERIKABIVEN safely and effectively. Please see full prescribing information, including Boxed Warning for KABIVEN and PERIKABIVEN (amino acids, electrolytes, dextrose and lipid injectable emulsion), for intravenous use at www.freseniuskabinutrition.com.
Insurance Support