Fresenius Kabi: at the forefront of parenteral nutrition (PN)

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies, including clinical nutrition and infusion therapy. Our PN products provide nourishment that helps to care for critically and chronically ill patients all around the world.

Built on years of innovation

Our history begins more than a century ago when Dr. Eduard Fresenius founded the pharmaceutical company Dr. E. Fresenius. There, he offered several pharmaceutical specialty medications, including injectable solutions. Since then, Fresenius Kabi has supported the research needed to drive advancements in clinical nutrition and deliver options to healthcare providers and their patients on PN. We have built on decades of innovation, and our tireless dedication has led to many “firsts” in the field of PN.

A history of “firsts”

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

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 orwww.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 can be found at www.freseniuskabinutrition.com/KabivenPI and www.freseniuskabinutrition.com/PeriKabivenPI.

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.

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 www.freseniuskabinutrition.com/SMOFlipidPI.

Intralipid (lipid injectable emulsion) for intravenous use

IMPORTANT SAFETY INFORMATION

What is Intralipid?

• Indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).

Intralipid should not be received by patients who have:

• A known allergy to egg, soybean, or peanut, or any of the active ingredients or excipients in Intralipid.
• Abnormally high levels of lipid (triglycerides) in the blood.

Intralipid may cause serious side effects including:

• Serious Adverse Reactions with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Strictly adhere to 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: 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 (≥5%) in adult patients include nausea, vomiting and fever and in pediatric patients include low levels of red blood cells, vomiting, increased levels of liver enzymes (i.e., gamma-glutamyltransferase), and cholestasis (i.e., reducing or blocking the flow of bile).

These are not all the possible side effects associated with Intralipid. Call your healthcare provider for medical advice regarding Intralipid side effects. You are encouraged to report negative side effects of Intralipid. 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/IntralipidPI.