NutriLipid I.V. Fat Emulsion Soybean Oil 20 g/100mL Injection, Solution — NDC 0264-4460-10 (Billing 00264-4460-10)

1 INDICATIONS AND USAGE Nutrilipid ® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated. Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.

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2 DOSAGE AND ADMINISTRATION Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. ( 2.1 ) For intravenous infusion through a peripheral or central line ( 2.1 ) Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient. ( 2.4 ) For information on the age-appropriate infusion rate, see the full prescribing information.

( 2.4 , 5.1 ) Age Nutritional Requirements Initial Recommended Dosage Maximum Dosage Preterm and term infants (<1 year) 1 to 2 g/kg/day 3 g/kg/day Pediatric patients 1 to 10 years Pediatric patients 11 to <17 years 1 g/kg/day 2.5 g/kg/day Adults 1 to 1.5 g/kg/day 2.5 g/kg/day

2.1Administration Instructions Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid 20% is for intravenous infusion through a peripheral or central line. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.

Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Use a non-vented infusion set or close the air vent on a vented set. Use of a vented intravenous administration set with the vent in the open position could result in air embolism.

Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Use a 1.2 micron in-line filter.

Nutrilipid 20% can be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP as a plasticizer.

2.2Preparation Instructions for Nutrilipid 20% Bags for Direct Infusion Caution: Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink.

Use only if container and seals are intact. Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.

Step 3: Inspect Nutrilipid 20% bag visually (Figure 2). Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Inspect Nutrilipid 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed. Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b).

Do not use/penetrate blocked port. Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump.

Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.

Overwrap Illustration Figure 1 Tear Overwrap Figure 2 Inspect Bag Blocked port illustration Figure 3a and 3b Peel Foil and Insert Spike Do not use block… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion supplied as: 20% (50 g/250 mL) (0.2 g/mL) of lipid in 250 mL single-dose flexible bag 20% (100 g/500 mL) (0.2 g/mL) of lipid in 500 mL single-dose flexible bag 20% (200 g/1,000 mL) (0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk Package Injectable emulsion: 20% (50 g/250 mL)(0.2 g/mL) of lipid in 250 mL single-dose flexible bag ( 3 ) 20% (100 g/500 mL)(0.2 g/mL) of lipid in 500 mL single-dose flexible bag ( 3 ) 20% (200 g/1,000 mL)(0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk Package ( 3 )

17 PATIENT COUNSELING INFORMATION When initiating Nutrilipid 20% administration, discuss the following information with the patient or caregiver: 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 Nutrilipid is infused at home, instruct caregivers not to exceed 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 Nutrilipid 20% may cause hypersensitivity reactions, including anaphylaxis. If Nutrilipid 20% is infused at home, instruct patients and caregivers to stop the infusion of Nutrilipid 20% immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills [see Warnings and Precautions (5.3) ].

Infections Inform patients and caregivers that patients who receive Nutrilipid 20% are at risk of infection. If Nutrilipid 20% is infused at home, instruct patients and caregivers to ensure aseptic techniques are used for the preparation and administration of Nutrilipid 20% 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 Nutrilipid 20% is infused at home, instruct patients and caregivers to stop Nutrilipid 20% 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 Nutrilipid 20% may result in refeeding syndrome [see Warnings and Precautions (5.6) ]. Hypertriglyceridemia Inform patients and caregivers about the risks of hypertriglyceridemia with Nutrilipid 20% use [see Warnings and Precautions (5.7) ].

Aluminum Toxicity Inform patients and 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 and caregiver to administer Nutrilipid 20% at home, then provide recommendations on how to prepare, administer, and store Nutrilipid 20% [see Dosage and Administration (2.1, 2.2) ].

2.4Dosing Considerations The dosing of Nutrilipid 20% depends on the patient’s individual energy requirements, influenced by body weight, tolerance, clinical status, age-related growth rate in pediatric patients and the ability to eliminate and metabolize fat. For partial parenteral nutrition, energy supply by oral or enteral nutrition has to be taken into account. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary.

Prior to administration of Nutrilipid 20%, correct severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. Recommended Adult and Pediatric Dosing The recommended nutritional requirements of lipid and recommended dosages of Nutrilipid 20% to be administered to meet those requirements for adults and pediatric patients are provided in Table 1, along with recommendations for the initial and maximum infusion rates.

The recommended duration of infusion for Nutrilipid 20% is between 12 and 24 hours, depending on the clinical situation. Adjust the administration flow rate by taking into account the dose being administered, the daily volume/intake, and the duration of the infusion [see Overdosage (10) ]. Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition.

In patients with elevated triglyceride levels, initiate Nutrilipid 20% injection at a lower dose, and advance in smaller increments, monitoring the triglyceride levels with each adjustment [ see Warnings and Precautions (5.7) and (5.9) ] . When Nutrilipid 20% is administered to correct essential fatty acid deficiency, 8% to 10% of the caloric input should be supplied by Nutrilipid 20% in order to provide adequate amounts of linoleic and linolenic acids. Table 1: Recommended Pediatric and Adult Dosage and Infusion Rate Age Nutritional Requirements Direct Infusion Rate Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration.

Recommended Initial Dosage and Maximum Dosage Initial Maximum Preterm and term infants (less than 1 year of age) [see Warnings and Precautions (5.1) ] Initial 1 to 2 g/kg/day not to exceed 3 g/kg/day Daily dosage should also not exceed a maximum of 60% of total energy requirements [see Overdosage (10)]. 0.05 mL/min for the first 10 to 15 minutes; gradually increase to the required rate after 15 minutes 0.75 mL/kg/hour Pediatric patients 1 to 10 years of age Initial 1 to 2 g/kg/day not to exceed 3 g/kg/day 0.75 mL/kg/hour Pediatric patients 11 to <17 years of age Initial 1 g/kg/day not to exceed 2.5 g/kg/day 0.5 mL/kg/hour Adults 1 to 1.5 g/kg/day not to exceed 2.5 g/kg/day 0.5 mL/min for the first 15 to 30 minutes; gradually increase to the required rate after 30 minutes 0.5 mL/kg/hour