Intralipid: Package Insert / Prescribing Info

2.1 Important Preparation and Administration Instructions

• Intralipid 30% Pharmacy Bulk Package is for admixing use only and is not intended for direct intravenous administration.
• Admixtures containing Intralipid 30% are prepared and administered by a healthcare provider in the inpatient setting [see Dosage and Administration (2.2)].
• Patients and caregivers may administer admixtures containing Intralipid for home use after appropriate training by a trained healthcare provider [see Patient Counseling Information (17)].
• Intralipid 30% must be combined with other PN fluids so that the resulting admixture has a final lipid concentration of no more than 20% (0.2 g lipid per mL of admixture). Refer to Admixture Preparation Instructions [see Dosage and Administration (2.2)].
• When Intralipid 30% is diluted to 20%, strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.125 g/kg/hour for neonates and infants [see Warnings and Precautions (5.1)].
• Intralipid admixtures with osmolarity
  • Greater than or equal to 900 mOsm/L must be infused through a central vein.
  • Less than 900 mOsm/L may be administered either through a central or peripheral vein.
• Use a 1.2 micron in-line filter during admixture administration.
• PN admixtures should use a dedicated infusion line without any connections. Do not connect multiple medications in series.
• To prevent air embolism, use a non-vented infusion set or close the vent on a vented set and fully evacuate residual gas in the bag prior to admixture administration.
• The flow rate of the admixture should be controlled with an infusion pump. Do not pressurize the flexible bag to increase flow rates, and if administration is controlled by a pumping device, turn off the pump before the bag runs dry.
• Do not use infusion sets and lines that contain di-2-ethylhexyl phthalate (DEHP), including infusion sets that contain polyvinyl chloride (PVC) components, because they contain DEHP as a plasticizer.
• After connecting the infusion set, start infusion of PN admixture with Intralipid immediately. Complete the infusion within 24 hours.

2.2 Admixture Preparation Instructions

Use the following instructions to prepare the Intralipid 30% Pharmacy Bulk Package for transfer to a compounding bag:

	1. Inspect Bag Inspect the integrity indicator (Oxalert®) (A) before removing the overpouch. Discard the product if the indicator is black, overpouch is opened or damaged, emulsion color is not white, or seals of bag are broken.
	2. Remove Overpouch Place the bag on a clean, flat surface. Tear the overpouch at notch and pull down. Discard the Oxalert sachet (A) and the oxygen absorber (B). Visually inspect the bag and contents for particulate matter and discoloration prior to administration. The lipid emulsion should be a homogenous liquid with a milky white appearance. If the mixture is not white or the emulsion has separated (noted by discoloration, phase separation, or oily droplets), or if particulates and/or leakage are observed, discard the bag.
	3. Spike Bag Identify the infusion port (blue cap with the arrow pointing away from the bag). Immediately before inserting the compounding set, break off the blue infusion port cap. Use a suitable sterile transfer device or dispensing set with an external spike diameter of 5.5 to 5.7 mm. Hold the base of the infusion port. Insert the spike through the infusion port by rotating your wrist slightly until the spike is inserted. Do not pierce the infusion port more than once.
	4. Transfer to the Compounding Bag Hang the bag using the hanger cut and start transfer to the compounding bag. Discard unused portion.

• Use the Intralipid 30% immediately for admixing after removal from the overpouch. If not used immediately, the product can be stored for no longer than 24 hours at 2°C to 8°C (36°F to 46°F). After removal from storage, and once the closure is penetrated, use Pharmacy Bulk Package contents within 4 hours.
• Diluting Intralipid 30% to a 10% or 20% concentration with an intravenous fluid such as normal saline or other diluent does not produce a dilution that is equivalent in composition to Intralipid 10% or 20% intravenous lipid emulsions. Therefore, diluents other than dextrose and amino acids should not be used to prepare admixtures for direct intravenous administration.

Admixing Instructions

• Prepare the admixture in PN containers using strict aseptic techniques to avoid microbial contamination.
• Do not add Intralipid 30% Pharmacy Bulk Package to the PN container first; destabilization of the lipid may occur. The prime destabilizers of emulsions are excessive acidity (such as a pH <5) and inappropriate electrolyte content. Amino acid solutions exert buffering effects that protect the emulsion from destabilization. Give careful consideration to the addition of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability.
• Do not inject additives directly into Intralipid.
• Intralipid 30% may be mixed with amino acid and dextrose injections to produce “all-in-one” PN admixtures. The mixing sequence below must be followed for manual compounding to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsions alone; shake bags gently after each addition.
  • Transfer dextrose injection to the PN container.
  • Transfer amino acid injection.
  • Transfer Intralipid 30%.
• Simultaneous transfer of amino acid injection, dextrose injection, and Intralipid to the PN container is also permitted; follow automated compounding device instructions as indicated. Use gentle agitation during admixing to minimize localized concentration effects.
• Additions to the PN admixtures should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi.
• Inspect the admixture to ensure that precipitates have not formed during preparation of the admixture and the emulsion has not separated. Discard the admixture if any of the above are observed.
• Infuse admixtures containing Intralipid immediately. If not used immediately, store admixtures under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. Infusion must be complete within 24 hours after removal from refrigeration. Discard any remaining admixture.
• Protect the admixed PN solution from light.

2.3 Recommended Dosage and Administration

• The recommended nutritional requirements of lipid and recommended dosages of Intralipid to be administered to meet those requirements for adults and pediatric patients are provided in Table 1.
• The dosing of Intralipid 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 admixtures with Intralipid, correct severe fluid and electrolyte disorders and measure serum triglyceride levels to establish a baseline value. In patients with elevated triglyceride levels, initiate Intralipid at a lower dosage and titrate in smaller increments, monitoring the triglyceride levels with each adjustment [see Warnings and Precautions (5.7)].

5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsions in Neonates and Infants

In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported.

Intralipid 30% Pharmacy Bulk Package is not intended for direct infusion. When it is diluted to 20%, strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.125 g/kg/hour.

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.

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 or poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions (5.5, 5.7) and Overdosage (10)].

5.2 Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders

5.3 Hypersensitivity Reactions

Intralipid contains soybean oil and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. Intralipid is contraindicated in patients with known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients in Intralipid. If a hypersensitivity reaction occurs, stop infusion of admixtures containing Intralipid immediately and initiate appropriate treatment and supportive measures.

5.4 Infections

Parenteral nutrition, such as Intralipid, can support microbial growth and is an independent risk factor for the development of catheter-related bloodstream infections. To decrease the risk of infectious complications, ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of admixtures containing Intralipid.

Monitor for signs and symptoms of infection including fever and chills, as well as laboratory test results that might indicate infection (including leukocytosis and hyperglycemia). Perform frequent checks of the intravenous catheter insertion site for edema, redness, and discharge.

5.5 Fat Overload Syndrome

Fat overload syndrome is a rare condition that has been reported with intravenous lipid injectable emulsions and is characterized by a sudden deterioration in the patient's condition (e.g., fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, hepatomegaly, deteriorating liver function, and central nervous system manifestations such as coma). A reduced or limited ability to metabolize lipids, accompanied by prolonged plasma clearance (resulting in higher lipid levels), may result in this syndrome. Although fat overload syndrome has been most frequently observed when the recommended lipid dose or infusion rate was exceeded, cases have also been described when the lipid formulation was administered according to instructions.

If signs or symptoms of fat overload syndrome occur, stop the infusion of admixtures containing Intralipid. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.

5.6 Refeeding Syndrome

Administering PN to severely malnourished patients may result in refeeding syndrome, which is characterized by the intracellular shift of potassium, phosphorus, and magnesium as patients become anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, closely monitor severely malnourished patients and slowly increase their nutrient intake.

5.7 Hypertriglyceridemia

The use of Intralipid is contraindicated in patients with hypertriglyceridemia with serum triglyceride concentrations >1,000 mg/dL.

Patients with conditions such as inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes have a higher risk of developing hypertriglyceridemia with the use of Intralipid. In addition, patients with hypertriglyceridemia may have worsening of their hypertriglyceridemia with administration of Intralipid. Excessive dextrose administration may further increase such risk.

Evaluate patients' capacity to metabolize and eliminate the infused lipid emulsion by measuring serum triglycerides before the start of infusion (baseline value) and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the Intralipid infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia such as pancreatitis. In pediatric patients with hypertriglyceridemia, lower triglyceride levels (i.e., below 400 mg/dL) may be associated with adverse reactions. Monitor serum triglyceride levels to avoid potential complications with hypertriglyceridemia such as pancreatitis, lipid pneumonitis, and neurologic changes, including kernicterus.

To minimize the risk of new or worsening of hypertriglyceridemia, assess high-risk patients for their overall energy intake including other sources of lipids and dextrose, as well as concomitant drugs that may affect lipid and dextrose metabolism.

5.8 Aluminum Toxicity

Intralipid contains no more than 25 mcg/L of aluminum. Prolonged PN administration in patients with renal impairment may result in aluminum reaching toxic levels. Preterm neonates are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions that contain aluminum.

Patients with impaired kidney function, including preterm neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading in these patients may occur at even lower rates of administration.

5.9 Monitoring/Laboratory Tests

Monitor fluid status closely in patients with pulmonary edema or heart failure.

Throughout treatment, monitor serum triglycerides [see Warnings and Precautions (5.7)], essential fatty acids, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count (including platelets), and coagulation parameters.

The lipids contained in Intralipid may interfere with some laboratory tests (e.g., hemoglobin, lactate dehydrogenase, bilirubin, oxygen saturation) if blood is sampled before lipids have cleared from the bloodstream. Conduct these tests at least 6 hours after stopping the infusion.

Intralipid contains vitamin K that may counteract anticoagulant activity [see Drug Interactions (7)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Intralipid 20% or equivalent soybean oil lipid emulsions functioned as the comparator in trials of the 4-oil mixed lipid emulsion [see Clinical Studies (14)]. The adverse reactions from these studies are included to present the clinical experience with Intralipid because Intralipid 30% is to be diluted down to 20% or lower for PN admixture.

The safety database for Intralipid or equivalent soybean oil lipid emulsion exposure in these studies include 393 patients (230 adults; 163 pediatric) in 9 clinical trials. Adult patients were exposed for 5 days to 4 weeks in 5 clinical trials. Intralipid or equivalent soybean oil lipid emulsion was used as a component of PN which also included dextrose, amino acids, vitamins, and trace elements. Two of the 5 studies in adults were performed with Intralipid as a component of PN delivered in a 3-chamber bag.

Less common adverse reactions occurring in ≤1% of adult patients who received Intralipid or equivalent soybean oil lipid emulsion were dyspepsia, urinary tract infection, anemia, infection, dyspnea, cholestasis, dysgeusia, increased blood alkaline phosphatase, tachycardia, liver function test abnormalities, dizziness, rash, and thrombophlebitis.

The 163 patients treated with Intralipid in four pediatric trials consisted of 147 patients <28 days of age, 9 patients 28 days to <2 years of age, and 7 patients 2 to 7 years of age; the duration of exposure was 7 to 84 days. Fifty-six percent of the pediatric patients were female, and 85% were Caucasian. Most pediatric patients were preterm neonates with feeding intolerance or other conditions requiring short-term (<29 days) PN.

Less common adverse reactions occurring in ≤1% of pediatric patients who received Intralipid were hyperglycemia, sepsis, increased blood triglycerides, infection, fluid overload, hypertension, hypertriglyceridemia, rash, and hyperlipidemia.

In a randomized active-controlled, double-blind, parallel-group, multi-center study that included 152 neonates and 9 patients ranging in age from 29 to 153 days who were expected to require PN for at least 28 days, PNAC, a precursor to PNALD, developed more frequently in Intralipid-treated patients than in patients treated with a comparator 4-oil mixed lipid emulsion.

PNAC (defined as direct bilirubin >2 mg/dL with a second confirmed elevation >2 mg/dL at least 7 days later) occurred in 11.5% (9/78) in Intralipid-treated patients and 2.4% (2/83) of patients treated with a 4-oil mixed lipid emulsion. Most PNAC events occurred in patients who were treated for longer than 28 days.

The estimated cumulative incidence of PNAC is shown in the Kaplan-Meier cumulative incidence curve in Figure 1 [see Pediatric Clinical Studies (14.2)].

Figure 1: Cumulative Incidence Curve of Time to Parenteral Nutrition-Associated Cholestasis (PNAC) with Standard Error Bars

6.2 Postmarketing Experience

The following adverse reactions from voluntary reports have been reported with Intralipid. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: palpitations
Gastrointestinal disorders: vomiting, nausea
General disorders and administration site conditions: chills, chest discomfort, pyrexia
Nervous system disorders: dizziness
Respiratory, thoracic, and mediastinal disorders: dyspnea
Immune system disorders: hypersensitivity
Vascular disorders: phlebitis
Blood and lymphatic system disorders: hypercoagulability

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

Intralipid is contraindicated in pediatric patients with severe disorders of lipid metabolism [(see Contraindications (4)].

The safety and effectiveness of Intralipid have been established as a source of calories and essential fatty acids for PN in pediatric patients, including term and preterm neonates. Use of Intralipid in neonates is supported by evidence from short-term (i.e., 1- to 4- week) studies, and one study following neonates beyond 4 weeks [see Clinical Studies (14.2)]. Use of Intralipid in older pediatric patients is supported by evidence from short-term (i.e., <28 days) studies in pediatric patients 28 days to 12 years of age and additional evidence from studies in adults [see Clinical Studies (14)]. The most common adverse reactions in Intralipid-treated pediatric patients were anemia, vomiting, gamma-glutamyltransferase increased, and cholestasis. PNAC, a precursor to PNALD, developed more frequently in Intralipid-treated patients than in patients treated with a comparator 4-oil mixed lipid emulsion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1)]. Because of immature renal function, preterm neonates receiving prolonged treatment with Intralipid may be at risk for aluminum toxicity [see Warnings and Precautions (5.8)].

8.5 Geriatric Use

Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

12.1 Mechanism of Action

Intralipid provides a biologically utilizable source of calories and essential fatty acids.

Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

12.2 Pharmacodynamics

The pharmacodynamic effects of Intralipid have not been fully characterized.

12.3 Pharmacokinetics

Intralipid provides fatty acids in the form of triglycerides which are hydrolyzed by lipoprotein lipase to release free fatty acids. Linoleic acid and alpha-linolenic acid are metabolized within a common biochemical pathway through a series of desaturation and elongation steps.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with Intralipid.

14.1 Adult Clinical Studies

The efficacy of Intralipid or equivalent soybean oil lipid emulsion compared to a 4-oil mixed lipid emulsion was evaluated in 3 clinical studies in adult patients. Nutritional efficacy in adult studies was assessed by changes in anthropometric indices (body weight, height, and body mass index [BMI]), changes in lipid and protein metabolism (albumin), and fatty acid parameters. Of the 354 adult patients (178 Intralipid; 176 comparator), 62% were male, 99% were Caucasian, and ages ranged from 19 to 96 years. All patients received Intralipid/equivalent soybean oil lipid emulsion or the comparator as part of a PN regimen. Although Adult Study 1, Adult Study 2, and Adult Study 3 were not designed for formal statistical comparisons between Intralipid/equivalent soybean oil lipid emulsion and the comparator, they support Intralipid as a source of calories and essential fatty acids in adults. The lipid dosage was variable in these studies and adjusted to the patient's nutritional requirements.

Adult Study 1 was a double-blind, randomized, active-controlled, parallel-group, multicenter study in patients who required PN for at least 28 days. Seventy-five patients were enrolled, and 73 patients were treated with either Intralipid or the comparator. Changes in mean triglyceride levels from baseline values to Week 4 were similar in both the Intralipid and comparator groups. Mean albumin levels demonstrated a comparable decrease in both groups. Mean changes in body weight (kg) and BMI (kg/m2) were similar in both the Intralipid and the comparator groups.

Adult Study 2 was a phase 3, randomized, double-blind, active-controlled, multicenter study. A total of 249 postoperative adult patients were randomized to receive either an equivalent soybean oil lipid emulsion to Intralipid or the comparator for at least 5 days as part of their total parenteral nutrition (TPN) regimen. From baseline to Day 6, mean triglyceride levels increased similarly in both the soybean oil lipid emulsion and the comparator groups.

Adult Study 3 was a double-blind randomized, active-controlled, parallel-group, single-center study in 32 adult patients who required TPN for 10 to 14 days. Patients were treated with either an equivalent soybean oil lipid emulsion to Intralipid or the comparator. The increase in mean triglyceride levels from baseline to the final assessment was similar in both the soybean oil lipid emulsion and the comparator groups.

14.2 Pediatric Clinical Studies

The efficacy of Intralipid compared to a 4-oil mixed lipid emulsion in pediatric patients of all age groups, including term and preterm neonates, was evaluated in 333 patients in 4 randomized active-controlled, double-blind, parallel-group controlled clinical studies. Although Pediatric Studies 1, 2, 3, and 4 were not designed for formal statistical comparisons between Intralipid and the comparator, they support Intralipid as a source of calories and essential fatty acids in pediatric patients. The 333 pediatric patients (163 Intralipid; 170 comparator) consisted of 296 patients who were <28 days old, 22 patients 29 days to <2 years old, and 15 patients 2 to <12 years old. Fifty percent of the pediatric patients were male and 87% were Caucasian. All patients received Intralipid or the comparator as part of a PN regimen. Nutritional efficacy in neonates was assessed by changes in anthropometric indices (body weight, height, head circumference). Nutritional efficacy in pediatric patients, 28 days to 12 years of age, was assessed by changes in triglyceride concentrations and fatty acid parameters.

Pediatric Study 1 enrolled 152 preterm and term neonates (birth up to 28 days) and 9 patients ranging in age from 29 to 153 days. Patients were treated with either Intralipid (n=78) or the comparator (n=83). A total of 119 patients (58 Intralipid; 61 comparator) received study treatment for ≥14 days. A total of 27 patients received Intralipid for ≥29 days; 5 patients received Intralipid for the maximum study duration of 78-84 days.

Pediatric Studies 2 and 3 enrolled 60 and 84 preterm neonates, respectively, who were treated with either Intralipid or the comparator (72 neonates in each group). The median treatment duration for Intralipid group was 9 days in Pediatric Study 2 and 6 days in Pediatric Study 3.

Pediatric Study 4 enrolled 28 patients 5 months to <2 years of age and 15 patients 2 to 11.5 years of age. Patients were treated with either Intralipid (n=13) or the comparator (n=15) with a median treatment duration of 27 days.

In Pediatric Studies 1, 2 and 3, which enrolled neonates, Intralipid-treated patients showed increases in the median body weight, height/length, and head circumference (which was measured in Studies 1 and 3) comparable to the comparator-treated patients. Mean triglyceride levels from baseline to the final assessment in Pediatric Studies 1, 2, and 3 were variable in these neonates, but overall differences between groups were not considered clinically relevant. Mean triglyceride levels in Pediatric Study 4 were variable but remained within the normal range.

Admixtures

Infuse admixtures containing Intralipid immediately. If admixtures are not used immediately, admixtures should be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours. After removal from storage, infuse within 24 hours [see Dosage and Administration (2.2)].

Protect the admixed PN solution from light [see Dosage and Administration (2.2)].

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants

Inform caregivers that acute respiratory distress and death may occur in neonates and infants after rapid infusion of intravenous lipid emulsions. If Intralipid is infused at home, instruct caregivers not to exceed the maximum infusion rate [see Warnings and Precautions (5.1)].

Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders

Inform patients and caregivers that use of parenteral nutrition may result in parenteral nutrition- associated liver disease and/or other hepatobiliary disorders [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Inform patients and caregivers that Intralipid may cause hypersensitivity reactions. If admixtures containing Intralipid are infused at home, instruct patients or caregivers to stop the infusion of admixtures containing Intralipid immediately and seek medical attention if a hypersensitivity reaction occurs, [see Warnings and Precautions (5.3)].

Infections

Inform patients and caregivers that patients who receive admixtures containing Intralipid are at risk of infection. If admixtures containing Intralipid are infused at home, instruct patients or caregivers to ensure aseptic techniques are used for the preparation and administration of admixtures containing Intralipid and to monitor for signs and symptoms of infection [see Warnings and Precautions (5.4)].

Fat Overload Syndrome

Inform patients and caregivers that fat overload syndrome has been reported with the use of intravenous lipid emulsions. If admixtures containing Intralipid are infused at home, instruct patients or caregivers to stop the infusion of admixtures containing Intralipid if signs or symptoms of fat overload syndrome occur [see Warnings and Precautions (5.5)].

Refeeding Syndrome

If the patient is severely malnourished, inform patients and caregivers that administering parenteral nutrition including Intralipid may result in refeeding syndrome [see Warnings and Precautions (5.6)].

Hypertriglyceridemia

Inform patients and their caregivers about the risks of hypertriglyceridemia with Intralipid use [see Warnings and Precautions (5.7)].

Aluminum Toxicity

Inform patients and their caregivers that prolonged PN administration in patients with renal impairment, including preterm neonates, may result in aluminum reaching toxic levels associated with central nervous system and bone toxicity [see Warnings and Precautions (5.8)].

Preparation and Administration Instructions

If it is acceptable for a patient or caregiver to administer admixtures containing Intralipid at home, then provide recommendations on how to inspect and prepare, add compatible additives (when appropriate), administer, and store admixtures containing Intralipid [see Dosage and Administration (2.1, 2.2)]. Inform patients or caregivers not to deviate from the administration instructions given by the healthcare provider.

Manufactured by:

Uppsala, Sweden
Intralipid is a registered trademark of Fresenius Kabi AB.
www.fresenius-kabi.com/us
451715C