Home › Drugs › Smoflipid

Smoflipid

FDA Drug Information • Also known as: Smoflipid

Brand Names
Smoflipid
Drug Class
Lipid Emulsion [EPC]
Route
INTRAVENOUS
Dosage Form
INJECTION, EMULSION
Product Type
HUMAN PRESCRIPTION DRUG

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...

What Is Smoflipid Used For?

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 2.1 Important 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. 2.2 Preparation 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)...

    • Side Effects (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. 6.1 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. 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...

    • 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 )

    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 )

    • Pregnancy and Breastfeeding

    8.1 Pregnancy 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.

    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.

    How Supplied

    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...

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.