Smoflipid 6 g/100mL; 6 g/100mL; 5 g/100mL; 3 g/100mL Injection, Emulsion
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 7QWA1RIO01
A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
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UNII 1Z74184RGV
Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 399SL044HN
Sodium oleate is a salt derived from oleic acid, a natural fatty acid. In medicines, it acts as an emulsifier and surfactant, helping mix oil and water ingredients together and improving how the drug dissolves and spreads in the body.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.2947 | $294.70 / 1000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Smoflipid 6 g/100mL; 6 g/100mL; 5 g/100mL; 3 g/100mLthis 63323-0820-00 | Fresenius | 100 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0820-00 You're viewing this | 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) | 2016-07-13 | Active |
| 63323-0820-10 | 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) | 2019-05-27 | Active |
| 63323-0820-12 | 20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) | 2016-07-13 | Active |
| 63323-0820-50 | 12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) | 2016-07-13 | Active |
| 63323-0820-74 | 10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) | 2016-07-13 | Active |
This pack accounts for about 4.0% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 63323-0820-00?
What NDC number is used to bill for this package of Smoflipid 6 g/100mL; 6 g/100mL; 5 g/100mL; 3 g/100mL Injection, Emulsion?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 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. 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 when oral or enteral nutrition is not possible, insufficient, or contraindicated.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • For intravenous infusion into a central or peripheral vein. ( 2.1 ) • SMOFlipid Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. ( 2.2 ) • Protect the admixed PN solution from light.
( 2.2 ) • 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. ( 2.3 ) • For information on the age-appropriate infusion rate, see the full prescribing information ( 2.3 , 5.1 ) 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
2.1Important Administration Instructions • SMOFlipid is prepared and administered by a healthcare provider in the inpatient setting. Patients and caregivers may prepare and administer SMOFlipid for home use after appropriate training by a trained healthcare provider. • SMOFlipid is for intravenous infusion into a central or peripheral vein. • Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.1 )]. • SMOFlipid 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 administration. • Use a dedicated infusion line without any connections.
Do not connect multiple medications in series. • To prevent air embolism, use a nonvented infusion set or close the vent on a vented set and fully evacuate residual gas in the bag prior to administration. • 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. • SMOFlipid can be infused concurrently into the same vein as dextrose-amino acid solutions (as part of PN) by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. • After connecting the infusion set, start infusion of SMOFlipid immediately.
Complete the infusion within 12 hours when using a Y-connector and within 24 hours when used as part of an admixture.
2.2Preparation Instructions Use the following instructions to prepare single-dose SMOFlipid 100 mL, 250 mL, and 500 mL Flexible Containers for administration: 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 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 infusion set, break off the blue infusion port cap. • Use infusion sets according to ISO Number 8536-4 with an external spike diameter of 5.5 to 5.7 mm and use a no…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SMOFlipid is a sterile, homogenous lipid injectable emulsion in Flexible Containers supplied as: • 20 g of lipid/100 mL in 100 mL single-dose Flexible Container • 50 g of lipid/250 mL in 250 mL single-dose Flexible Container • 100 g of lipid/500 mL in 500 mL single-dose Flexible Container • 200 g of lipid/1000 mL in 1000 mL Pharmacy Bulk Package SMOFlipid is a sterile, homogenous lipid injectable emulsion supplied as 20 g of lipid/100 mL in 100 mL single-dose Flexible Container, 50 g of lipid/250 mL in 250 mL single-dose Flexible Container, 100 g of lipid/500 mL in 500 mL single-dose Flexible Container, and 200 g of lipid/1000 mL in 1000 mL Pharmacy Bulk Package.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Use of SMOFlipid is contraindicated in patients with: • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients in SMOFlipid [see Warnings and Precautions ( 5.3 )] • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions ( 5.7 )] • Known hypersensitivity to fish, egg, soybean, peanut or any of the active or inactive ingredients. ( 4 ) • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).
( 4 , 5.7 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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. ( 5.1 , 8.4 ) • Parenteral Nutrition-Associated Liver Disease: Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.
( 5.2 , 6.1 , 8.4 ) • Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. ( 5.3 ) • Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency: Monitor for signs and symptoms; monitor laboratory parameters.
( 5.4 , 5.5 , 5.6 , 5.7 , 5.9 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8 , 8.4 )
5.1Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion 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. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour [see Dosage and Administration ( 2.3 )].
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 of 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 )].
5.2Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders Risk of Parenteral Nutrition-Associated Liver Disease Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure- associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including SMOFlipid, have been associated with development of PNALD.
In a randomized study of neonates and infants expected to be treated with PN for at least 28 days, parenteral nutrition-associated cholestasis (PNAC), a precursor to PNALD, developed less frequently in SMOFlipid-treated patients than in 100% soybean oil lipid emulsion-treated patients [see Adverse Reactions ( 6.1 ), Use in Specific Populations ( 8.4 )] . Monitor liver tests in patients treated with SMOFlipid and consider discontinuation or dosage reduction if abnormalities occur. Other Hepatobiliary Disorders Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN- treated patients without preexisting liver disease.
Monitor liver tests when administering SMOFlipid. Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to SMOFlipid use.
5.3Hypersensitivity Reactions SMOFlipid contains soybean oil, fish oil, and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following SMOFlipid administration [see Adverse Reactions ( 6.2 )] .
SMOFlipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, peanut or any of the active or inacti…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Adverse reactions described elsewhere in this Prescribing Information are: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )] • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Infections [see Warnings and Precautions ( 5.4 )] • Fat Overload Syndrome [see Warnings and Precautions ( 5.5 )] • Refeeding Syndrome [see Warnings and Precautions ( 5.6 )] • Hypertriglyceridemia [see Warnings and Precautions ( 5.7 )] • Aluminum Toxicity [see Warnings and Precautions ( 5.8 )] • Essential Fatty Acid Deficiency [see Warnings and Precautions ( 5.9 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. The safety database for SMOFlipid includes exposure in 399 patients (229 adults; 170 pediatric) in 9 clinical trials. Adult patients were exposed for 5 days to 4 weeks in 5 clinical trials.
The pooled population exposed to SMOFlipid was adult patients up to 89 years old (20 to 89 years of age), 43% female and 99% Caucasian. The most frequently reported medical histories in the SMOFlipid group were surgical and medical procedures (84%), neoplasms (57%), gastrointestinal disorders (53%), vascular disorders (37%), and infections and infestations (20%). SMOFlipid 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 SMOFlipid as a component of PN delivered in a 3- chamber bag. Table 2: Adverse Reactions in >1% of Adult Patients Treated with SMOFlipid Adverse Reaction Number of Patients in SMOFlipid Group (N=229) Number of Patients in Soybean Oil lipid emulsion Comparator Group (N=230) Nausea 20 (9%) 26 (11%) Vomiting 15 (7%) 12 (5%) Hyperglycemia 12 (5%) 5 (2%) Flatulence 10 (4%) 4 (2%) Pyrexia 9 (4%) 11 (5%) Abdominal pain 8 (4%) 5 (2%) Blood triglycerides increased 6 (3%) 4 (2%) Hypertension 6 (3%) 9 (4%) Sepsis 5 (2%) 4 (2%) Dyspepsia 5 (2%) 1 (0%) Urinary tract infection 4 (2%) 3 (1%) Anemia 4 (2%) 2 (1%) Device related infection 4 (2%) 2 (1%) Less common adverse reactions occurring in ≤1% of adult patients who received SMOFlipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritus, dizziness, rash and thrombophlebitis.
The 170 patients treated with SMOFlipid in four pediatric trials consisted of 149 patients <28 days of age, 13 patients 28 days to <2 years of age, and 8 patients 2 to 7 years of age; the duration of exposure was 7 to 84 days. Forty five percent of the pediatric patients were female, and 89% were Caucasian. Most pediatric patients were preterm neonates with feeding intolerance or other conditions requiring short-term (<29 days) PN.
Table 3: Adverse Reactions in >1% of Pediatric Patients Treated with SMOFlipid Adverse Reaction Number of Patients in SMOFlipid Group (N=170) Number of Patients in Soybean Oil lipid emulsion Comparator Group (N=163) Anemia 30 (18%) 33 (20%) Vomiting 16 (9%) 16 (10%) Gamma-glutamyltransferase increased 10 (6%)…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Soybean and olive oils in SMOFlipid contain vitamin K 1 which may counteract the anticoagulant activity of vitamin K antagonists such as warfarin. In patients who receive concomitant SMOFlipid and warfarin, increase monitoring of laboratory parameters for anticoagulant activity. Vitamin K Antagonists (e.g., warfarin) : Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. There are risks to the fetus associated with severe malnutrition during pregnancy ( see Clinical Considerations ) .
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality. Parenteral nutrition should be considered if the pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.
8.2Lactation Risk Summary Administration of the recommended dose of SMOFlipid is not expected to cause harm to a breastfed infant. There are no data on the presence of SMOFlipid in human or animal milk or its effects on milk production. Available published literature includes fewer than five reported cases of breastfed infants exposed to various lipid emulsions via lactation, and these cases did not report adverse events.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SMOFlipid and any potential adverse effects of SMOFlipid on the breastfed infant, or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of SMOFlipid have been established as a source of calories and essential fatty acids for PN when oral or enteral nutrition is not possible, insufficient, or contraindicated in pediatric patients, including term and preterm neonates. Use of SMOFlipid 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 SMOFlipid in older pediatric patients is supported by evidence from a short-term (i.e., <28 days) study 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 SMOFlipid-treated pediatric patients were anemia, vomiting, gamma-glutamyltransferase increased, and nosocomial infection [see Adverse Reactions ( 6.1 )]. PNALD, also referred to as IFALD, has been reported in pediatric patients who received SMOFlipid for more than 2 weeks. PNAC (a precursor to PNALD) was reported less frequently in SMOFlipid- treated patients compared to soybean oil lipid emulsion-treated patients in Pediatric Study 1 [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )].
Although clinically significant cases of EFAD were not observed during short-term use in pediatric clinical studies, cases of EFAD have been reported with the use of SMOFlipid in the postmarketing setting [ see Warnings and Precautions ( 5.9 ), Adverse Reactions ( 6.1 )]. Monitor pediatric patients for laboratory evidence of EFAD because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided [see Warnings and Precautions ( 5.9 )]. 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 infants receiving prolonged treatment with SMOFlipid may be at risk for aluminum toxicity [see Warnings and Precautions ( 5.8 )].
8.5 Geriatric Use Energy…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Administration of the recommended dose of SMOFlipid is not expected to cause major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with SMOFlipid. There are risks to the fetus associated with severe malnutrition during pregnancy ( see Clinical Considerations ) .
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality. Parenteral nutrition should be considered if the pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SMOFlipid have been established as a source of calories and essential fatty acids for PN when oral or enteral nutrition is not possible, insufficient, or contraindicated in pediatric patients, including term and preterm neonates. Use of SMOFlipid 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 SMOFlipid in older pediatric patients is supported by evidence from a short-term (i.e., <28 days) study 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 SMOFlipid-treated pediatric patients were anemia, vomiting, gamma-glutamyltransferase increased, and nosocomial infection [see Adverse Reactions ( 6.1 )]. PNALD, also referred to as IFALD, has been reported in pediatric patients who received SMOFlipid for more than 2 weeks. PNAC (a precursor to PNALD) was reported less frequently in SMOFlipid- treated patients compared to soybean oil lipid emulsion-treated patients in Pediatric Study 1 [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )].
Although clinically significant cases of EFAD were not observed during short-term use in pediatric clinical studies, cases of EFAD have been reported with the use of SMOFlipid in the postmarketing setting [ see Warnings and Precautions ( 5.9 ), Adverse Reactions ( 6.1 )]. Monitor pediatric patients for laboratory evidence of EFAD because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided [see Warnings and Precautions ( 5.9 )]. 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 infants receiving prolonged treatment with SMOFlipid may be at risk for aluminum toxicity [see Warnings and Precautions ( 5.8 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Energy expenditure and requirements may be lower for older adults than younger patients. Of the 354 adult patients in clinical studies of SMOFlipid, 35% were >65 years of age and 10% were >75 years of age. No overall differences in the safety and efficacy of SMOFlipid were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity in some older patients cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of an overdose, serious adverse reactions may result [see Warnings and Precautions ( 5.1 , 5.5 )] . Stop the infusion of SMOFlipid until triglyceride levels have normalized and symptoms have abated. The effects are usually reversible by stopping the lipid infusion. If medically appropriate, further intervention may be indicated. Lipids are not dialyzable from plasma.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action SMOFlipid 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.
12.2Pharmacodynamics The pharmacodynamic effects of SMOFlipid have not been fully characterized.
12.3Pharmacokinetics SMOFlipid provides fatty acids in the form of triglycerides which are hydrolyzed by lipoprotein lipase to release free fatty acids. Alpha-linolenic acid and linoleic acid are metabolized within a common biochemical pathway through a series of desaturation and elongation steps. Downstream products of alpha-linolenic acid are EPA and DHA, and linoleic acid is converted to arachidonic acid.
🧬 Mechanism of Action ▾
12.1Mechanism of Action SMOFlipid 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING SMOFlipid is a sterile lipid injectable emulsion with a lipid content of 0.2 gram/mL available in Flexible Containers in the following sizes: Product Code Unit of Sale Strength Each 830307310 NDC 63323-820-00 Unit of 10 20 grams/100 mL (0.2 grams/mL) NDC 63323-820-01 100 mL single-dose Bag 830307312 NDC 63323-820-12 Unit of 20 20 grams/100 mL (0.2 grams/mL) NDC 63323-820-02 100 mL single-dose Bag 830570310 NDC 63323-820-74 Unit of 10 50 grams/250 mL (0.2 grams/mL) NDC 63323-820-04 250 mL single-dose Bag 830820310 NDC 63323-820-50 Unit of 12 100 grams/500 mL (0.2 grams/mL) NDC 63323-820-03 500 mL single-dose Bag 830920310 NDC 63323-820-10 Unit of 6 200 grams/1000 mL (0.2 grams/mL) NDC 63323-820-05 1000 mL Pharmacy Bulk Package Bag Store below 25°C (77°F).
Avoid excessive heat. Do not freeze. If accidentally frozen, discard container.
Store in overpouch until ready for use. SMOFlipid 100 mL, 250 mL and 500 mL single-dose Flexible Containers. After removing the overpouch, infuse immediately.
If not used immediately, the product 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 12 hours when using a Y-connector or within 24 hours if used as part of an admixture [see Dosage and Administration ( 2.2 )] . SMOFlipid 1000 mL Pharmacy Bulk Package Use the Pharmacy Bulk Package immediately for admixing after removal from overpouch.
If not used immediately, the product should 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 [see Dosage and Administration ( 2.2 )] . Admixtures Infuse admixtures containing SMOFlipid immediately.
If 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 )].
📋 Description ▾
11 DESCRIPTION SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.2 g/mL, and comprises a mixture of soybean oil, MCTs, olive oil, and fish oil. The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35 mg/mL (range of 28 to 50 mg/mL), and alpha-linolenic acid (an omega-3 essential fatty acid) is 4.5 mg/mL (range of 3 to 7 mg/mL).
The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L. Each 100 mL of SMOFlipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all-rac-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9).
SMOFlipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L). The oils included in SMOFlipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure: where , , and are saturated and unsaturated fatty acid residues. The major components of the fatty acids in SMOFlipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%), alpha-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%).
Oleic Acid C 18 H 34 O 2 Linoleic Acid C 18 H 32 O 2 Caprylic Acid C 8 H 16 O 2 Capric Acid C 10 H 20 O 2 Stearic Acid C 18 H 36 O 2 Palmitic Acid C 16 H 32 O 2 Linolenic Acid C 18 H 30 O 2 EPA C 20 H 30 O 2 DHA C 22 H 32 O 2 SMOFlipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. smofl-struc-01.jpg Figure Figure Figure smofl-struc-02.jpg smofl-struc-03.jpg smofl-struc-04.jpg smofl-struc-05.jpg smofl-struc-06.jpg smofl-struc-07.jpg smofl-struc-08.jpg smofl-struc-09.jpg smofl-struc-10.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION When initiating SMOFlipid administration, discuss the following information: 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 SMOFlipid 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 SMOFlipid may cause hypersensitivity reactions, including anaphylaxis. If SMOFlipid is infused at home, instruct patients or caregivers to stop the infusion of SMOFlipid 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 SMOFlipid are at risk of infection. If SMOFlipid is infused at home, instruct patients or caregivers to ensure aseptic techniques are used for the preparation and administration of SMOFlipid 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 SMOFlipid is infused at home, instruct patients or caregivers to stop SMOFlipid 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 SMOFlipid may result in refeeding syndrome. [see Warnings and Precautions ( 5.6 )] . Hypertriglyceridemia Inform patients and caregivers about the risks of hypertriglyceridemia with SMOFlipid 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 )] . Essential Fatty Acid Deficiency Inform patients and caregivers that cases of EFAD with the use of SMOFlipid have been reported in adults and pediatric patients in the postmarketing period [see Warnings and Precautions ( 5.9 )] . Preparation and Administration Instructions If it is acceptable for a patient or caregiver to administer SMOFlipid at home, then provide recommendations on how to prepare, add compatible additives (when appropriate), administer, and store SMOFlipid [see Dosage and Administration ( 2.1 , 2.2 )].
Manufactured by: Uppsala, Sweden Fresenius Kabi, Oxalert, and SMOFlipid are registered trademarks of Fresenius Kabi, www.fresenius-kabi.com/us 451418F smofl-logo-01.jpg