Beyond parenteral nutrition (PN):
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Comprehensive reimbursement resources have been developed following the latest Centers for Medicare & Medicaid Services (CMS) guidelines regarding reimbursement for PN products.
Explore the latest Billing and Coding Guides for our PN products
SMOFlipid® (lipid injectable emulsion), for intravenous use
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Omegaven® (fish oil triglycerides) injectable emulsion, for intravenous use
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Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
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Full prescribing information>
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Explore user-friendly tools that help aid in insurance processing
Insurance processing becomes more efficient with our easy-to-use templates for the Letter of Medical Necessity and Letter of Appeal for each product.
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For Consumers
SMOFLIPID® (lipid injectable emulsion USP), for intravenous use
IMPORTANT SAFETY INFORMATION
What is SMOFlipid?
- Indicated in adult and pediatric patients as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
- The hourly infusion rate in pediatrics should not exceed 0.75 mL/kg/hour and 0.5 mL/kg/hour in adults.
SMOFlipid should not be received by patients who have:
- A known allergy to fish, egg, soybean, or peanut, or to any of the active or inactive ingredients in SMOFlipid.
- Abnormally high levels of lipid (triglycerides) in the blood.
SMOFlipid may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Parenteral nutrition-associated liver disease (PNALD) may progress to liver inflammation and damage caused by a buildup of fat in the liver with scarring and cirrhosis.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.
The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.
These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition/SMOFlipidPI.
For Healthcare Professionals
SMOFLIPID (lipid injectable emulsion, USP), for intravenous use
IMPORTANT SAFETY INFORMATION
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 dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. 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 Adult and Pediatric Dosage
| Age | Nutritional Requirements | |
|---|---|---|
| Initial Recommended Dosage | Maximum Dosage | |
| Birth to 2 years of age (including preterm and term neonates) |
0.5 to 1 g/kg/day | 3 g/kg/day |
| Pediatric patients 2 to <12 years of age | 1 to 2 g/kg/day | 3 g/kg/day |
| Pediatric patients 12 to 17 years of age | 1 g/kg/day | 2.5 g/kg/day |
| Adults | 1 to 2 g/kg/day | 2.5 g/kg/day |
SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
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.
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 SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.
For Consumers
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use OMEGAVEN safely and effectively. To learn more about OMEGAVEN for your child, talk to your child’s healthcare provider. OMEGAVEN is available by prescription only. The FDA-approved product labeling can be found at www.freseniuskabinutrition.com/OmegavenPI.
What is OMEGAVEN?
- A fish oil-based intravenous lipid emulsion that is a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
- Does not prevent PNAC.
- It has not been demonstrated that the clinical outcomes seen in pediatric patients are a result of the omega-6:omega-3 fatty acid ratio of the product.
- The hourly infusion rate should not exceed 1.5 mL/kg/hour
OMEGAVEN should not be received by patients who have:
- a known allergy to fish or egg protein or to any of the ingredients in OMEGAVEN.
- a severe bleeding disorder.
- abnormally high levels of lipid (triglycerides) in the blood.
What important safety information should I know about OMEGAVEN?
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
The most common side effects, (>15%) include: vomiting, agitation, slower than normal heartbeat, interruption of breathing, and viral infection.
These are not all the possible side effects associated with OMEGAVEN. Call your healthcare provider for medical advice regarding OMEGAVEN side effects. You are encouraged to report negative side effects of OMEGAVEN. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at www.FreseniusKabiNutrition.com/OmegavenPI.
For Healthcare Professionals
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
IMPORTANT SAFETY INFORMATION
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 nutritional requirements of fat and recommended dosages of Omegaven to meet those requirements for pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.
Table 1: Recommended Pediatric Dosage and Infusion Rate
| Nutritional Requirements | Direct Infusion Rate | |
|---|---|---|
| Initial | Maximum | |
| 1 g/kg/day; this is also the maximum daily dose | 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes |
1.5 mL/kg/hour |
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).
Clinical Decompensation with Rapid Infusion of Lipid Injectable Emulsions in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/hour. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
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/OmegavenPI.
For Consumers
KABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
PERIKABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
IMPORTANT SAFETY INFORMATION
What is Kabiven and Perikabiven?
- Indicated in adult patients as a source of calories, protein, electrolytes and essential fatty acids for 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 adults.
- Do not exceed the recommended maximum infusion rate of 2.6 mL/kg/hour for Kabiven and 3.7 mL/kg/hour for Perikabiven.
Limitations of Use
Neither Kabiven nor Perikabiven is recommended in pediatric patients less than 2 years old because the fixed amount of the formulations do not meet nutritional needs in this age group.
Do not use Kabiven or Perikabiven in patients who have:
- Simultaneous treatment with ceftriaxone in neonates (28 days of age or younger)
- Known allergy to egg, soybean, peanut or any of the active or inactive ingredients
- Abnormally high levels of lipid (triglycerides) in the blood (with serum triglyceride concentration >1,000 g/dL)
- Inborn errors of amino acid metabolism (a genetic defect in protein metabolism)
- Cardiopulmonary instability (inability for the heart and lungs to function right)
- Hemophagocytic syndrome (a disorder of the immune system)
Kabiven and Perikabiven may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Your healthcare provider will monitor liver tests.
- Pulmonary Embolism (a blockage in a blood vessel in the lung) and Respiratory Distress (increased breathing rate, bluish skin color changes, wheezing) due to Pulmonary Vascular Precipitates (solid substance in the blood vessel of the lungs): If signs of lung issues occur, stop the infusion and start a medical evaluation.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction
- Precipitation (solid substance in the blood vessel) with Ceftriaxone: Do not administer ceftriaxone simultaneously with Kabiven or Perikabiven via a Y-site.
- Infection, fat overload, hyperglycemia (high blood sugar) and refeeding syndrome: Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels
The most common adverse reactions for Kabiven (≥3%) are nausea, fever, high blood pressure, vomiting, decreased blood hemoglobin, decreased blood total protein, low blood potassium, and increased gamma glutamyltransferase (a liver enzyme). The most common adverse reactions for Perikabiven (≥3%) are high blood sugar, low blood potassium, fever and increased blood lipids.
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.
Tell your doctor if you are taking coumarin and coumarin derivatives, including warfarin: the drug activity may be lessened and your healthcare provider will monitor your blood.
These are not all the possible side effects associated with Kabiven and Perikabiven. Call your healthcare provider for medical advice regarding Kabiven and Perikabiven side effects. You are encouraged to report negative side effects of Kabiven and Perikabiven. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling for KABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use and PERIKABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use can be found at www.FreseniusKabiNutrition.com/KabivenPI and www.FreseniusKabiNutrition.com/PerikabivenPI.
For Healthcare Professionals
KABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
PERIKABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
IMPORTANT SAFETY INFORMATION
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.
IMPORTANT SAFETY INFORMATION
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. Do not exceed the recommended maximum infusion rate of 2.6 mL/kg/hour for KABIVEN and 3.7 mL/kg/hour for PERIKABIVEN.
KABIVEN and PERIKABIVEN are contraindicated in:
- Concomitant treatment with ceftriaxone in neonates (28 days of age or younger)
- Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
- Severe disorders of lipid metabolism characterized by hypertriglyceridemia (with serum triglyceride concentration >1,000 g/dL).
- Inborn errors of amino acid metabolism.
- Cardiopulmonary instability
- Hemophagocytic syndrome
Clinical Decompensation with Rapid Infusion of Lipid Injectable Emulsions in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.
Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
Hypersensitivity reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur.
Precipitation with Ceftriaxone: Do not administer ceftriaxone simultaneously with KABIVEN or PERIKABIVEN via a Y-site.
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.
Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters
This Important Safety Information does not include all the information needed to use KABIVEN and PERIKABIVEN safely and effectively. Please see full prescribing information for KABIVEN and PERIKABIVEN (amino acids, electrolytes, dextrose and lipid injectable emulsion), for intravenous use at www.FreseniusKabiNutrition.com/KabivenPI and www.FreseniusKabiNutrition.com/PerikabivenPI.
For Consumers
SMOFLIPID® (lipid injectable emulsion USP), for intravenous use
IMPORTANT SAFETY INFORMATION
What is SMOFlipid?
- Indicated in adult and pediatric patients as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
- The hourly infusion rate in pediatrics should not exceed 0.75 mL/kg/hour and 0.5 mL/kg/hour in adults.
SMOFlipid should not be received by patients who have:
- A known allergy to fish, egg, soybean, or peanut, or to any of the active or inactive ingredients in SMOFlipid.
- Abnormally high levels of lipid (triglycerides) in the blood.
SMOFlipid may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Parenteral nutrition-associated liver disease (PNALD) may progress to liver inflammation and damage caused by a buildup of fat in the liver with scarring and cirrhosis.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
Monitoring/Laboratory Tests: The content of vitamin K may interfere with blood clotting activity of medications.
The most common side effects (>1%) in adult patients include nausea, vomiting, and high levels of glucose in the blood and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase) and hospital-acquired infections.
These are not all the possible side effects associated with SMOFlipid. Call your healthcare provider for medical advice regarding SMOFlipid side effects. You are encouraged to report negative side effects of SMOFlipid. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at https://www.FreseniusKabiNutrition/SMOFlipidPI.
For Healthcare Professionals
SMOFLIPID (lipid injectable emulsion, USP), for intravenous use
IMPORTANT SAFETY INFORMATION
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 dose for adults and pediatrics is shown in Table 1. For information on age-appropriate infusion rate, see the full prescribing information. 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 Adult and Pediatric Dosage
| Age | Nutritional Requirements | |
|---|---|---|
| Initial Recommended Dosage | Maximum Dosage | |
| Birth to 2 years of age (including preterm and term neonates) |
0.5 to 1 g/kg/day | 3 g/kg/day |
| Pediatric patients 2 to <12 years of age | 1 to 2 g/kg/day | 3 g/kg/day |
| Pediatric patients 12 to 17 years of age | 1 g/kg/day | 2.5 g/kg/day |
| Adults | 1 to 2 g/kg/day | 2.5 g/kg/day |
SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut, or any of the active or inactive ingredients, and severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
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.
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 SMOFlipid (lipid injectable emulsion, USP), for intravenous use at www.FreseniusKabiNutrition.com/SMOFlipidPI.
For Consumers
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
IMPORTANT SAFETY INFORMATION
These highlights do not include all the information needed to use OMEGAVEN safely and effectively. To learn more about OMEGAVEN for your child, talk to your child’s healthcare provider. OMEGAVEN is available by prescription only. The FDA-approved product labeling can be found at www.freseniuskabinutrition.com/OmegavenPI.
What is OMEGAVEN?
- A fish oil-based intravenous lipid emulsion that is a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC).
- Does not prevent PNAC.
- It has not been demonstrated that the clinical outcomes seen in pediatric patients are a result of the omega-6:omega-3 fatty acid ratio of the product.
- The hourly infusion rate should not exceed 1.5 mL/kg/hour
OMEGAVEN should not be received by patients who have:
- a known allergy to fish or egg protein or to any of the ingredients in OMEGAVEN.
- a severe bleeding disorder.
- abnormally high levels of lipid (triglycerides) in the blood.
What important safety information should I know about OMEGAVEN?
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction.
- Fat Overload Syndrome, Refeeding Syndrome, Elevated Triglycerides (Hypertriglyceridemia): Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels.
The most common side effects, (>15%) include: vomiting, agitation, slower than normal heartbeat, interruption of breathing, and viral infection.
These are not all the possible side effects associated with OMEGAVEN. Call your healthcare provider for medical advice regarding OMEGAVEN side effects. You are encouraged to report negative side effects of OMEGAVEN. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling can be found at www.FreseniusKabiNutrition.com/OmegavenPI.
For Healthcare Professionals
OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous use
IMPORTANT SAFETY INFORMATION
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 nutritional requirements of fat and recommended dosages of Omegaven to meet those requirements for pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates. Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.
Table 1: Recommended Pediatric Dosage and Infusion Rate
| Nutritional Requirements | Direct Infusion Rate | |
|---|---|---|
| Initial | Maximum | |
| 1 g/kg/day; this is also the maximum daily dose | 0.2 mL/kg/hour for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes |
1.5 mL/kg/hour |
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).
Clinical Decompensation with Rapid Infusion of Lipid Injectable Emulsions in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 1.5 mL/kg/hour. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs.
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/OmegavenPI.
For Consumers
KABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
PERIKABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
IMPORTANT SAFETY INFORMATION
What is Kabiven and Perikabiven?
- Indicated in adult patients as a source of calories, protein, electrolytes and essential fatty acids for 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 adults.
- Do not exceed the recommended maximum infusion rate of 2.6 mL/kg/hour for Kabiven and 3.7 mL/kg/hour for Perikabiven.
Limitations of Use
Neither Kabiven nor Perikabiven is recommended in pediatric patients less than 2 years old because the fixed amount of the formulations do not meet nutritional needs in this age group.
Do not use Kabiven or Perikabiven in patients who have:
- Simultaneous treatment with ceftriaxone in neonates (28 days of age or younger)
- Known allergy to egg, soybean, peanut or any of the active or inactive ingredients
- Abnormally high levels of lipid (triglycerides) in the blood (with serum triglyceride concentration >1,000 g/dL)
- Inborn errors of amino acid metabolism (a genetic defect in protein metabolism)
- Cardiopulmonary instability (inability for the heart and lungs to function right)
- Hemophagocytic syndrome (a disorder of the immune system)
Kabiven and Perikabiven may cause serious side effects including:
- Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly follow the recommended total daily dosage and do not exceed the maximum infusion rate. If poor clearance of fats occurs, the infusion should be stopped, and a medical evaluation started.
- Risk of Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Your healthcare provider will monitor liver tests.
- Pulmonary Embolism (a blockage in a blood vessel in the lung) and Respiratory Distress (increased breathing rate, bluish skin color changes, wheezing) due to Pulmonary Vascular Precipitates (solid substance in the blood vessel of the lungs): If signs of lung issues occur, stop the infusion and start a medical evaluation.
- Allergic Reactions: Contact your healthcare provider immediately if you are experiencing an allergic reaction
- Precipitation (solid substance in the blood vessel) with Ceftriaxone: Do not administer ceftriaxone simultaneously with Kabiven or Perikabiven via a Y-site.
- Infection, fat overload, hyperglycemia (high blood sugar) and refeeding syndrome: Your healthcare provider will monitor you for signs and symptoms of early infection and blood levels
The most common adverse reactions for Kabiven (≥3%) are nausea, fever, high blood pressure, vomiting, decreased blood hemoglobin, decreased blood total protein, low blood potassium, and increased gamma glutamyltransferase (a liver enzyme). The most common adverse reactions for Perikabiven (≥3%) are high blood sugar, low blood potassium, fever and increased blood lipids.
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.
Tell your doctor if you are taking coumarin and coumarin derivatives, including warfarin: the drug activity may be lessened and your healthcare provider will monitor your blood.
These are not all the possible side effects associated with Kabiven and Perikabiven. Call your healthcare provider for medical advice regarding Kabiven and Perikabiven side effects. You are encouraged to report negative side effects of Kabiven and Perikabiven. Contact Fresenius Kabi USA, LLC at: 1-800-551-7176 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. The FDA-approved product labeling for KABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use and PERIKABIVEN® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use can be found at www.FreseniusKabiNutrition.com/KabivenPI and www.FreseniusKabiNutrition.com/PerikabivenPI.
For Healthcare Professionals
KABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
PERIKABIVEN (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
IMPORTANT SAFETY INFORMATION
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.
IMPORTANT SAFETY INFORMATION
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. Do not exceed the recommended maximum infusion rate of 2.6 mL/kg/hour for KABIVEN and 3.7 mL/kg/hour for PERIKABIVEN.
KABIVEN and PERIKABIVEN are contraindicated in:
- Concomitant treatment with ceftriaxone in neonates (28 days of age or younger)
- Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
- Severe disorders of lipid metabolism characterized by hypertriglyceridemia (with serum triglyceride concentration >1,000 g/dL).
- Inborn errors of amino acid metabolism.
- Cardiopulmonary instability
- Hemophagocytic syndrome
Clinical Decompensation with Rapid Infusion of Lipid Injectable Emulsions in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.
Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
Hypersensitivity reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur.
Precipitation with Ceftriaxone: Do not administer ceftriaxone simultaneously with KABIVEN or PERIKABIVEN via a Y-site.
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.
Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters
This Important Safety Information does not include all the information needed to use KABIVEN and PERIKABIVEN safely and effectively. Please see full prescribing information for KABIVEN and PERIKABIVEN (amino acids, electrolytes, dextrose and lipid injectable emulsion), for intravenous use at www.FreseniusKabiNutrition.com/KabivenPI and www.FreseniusKabiNutrition.com/PerikabivenPI.