What is Perikabiven and how is it used?Perikabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion is a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Perikabiven may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Show
What are the possible side effects of Perikabiven?Perikabiven may cause serious side effects including:
Get medical help right away, if you have any of the symptoms listed above. The most common side effects of Perikabiven include:
Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Perikabiven. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. WARNING DEATH IN PRETERM INFANTS
DESCRIPTIONPERIKABIVEN® is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN® when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6•H2O) and has the following structure: Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:
Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:Linoleic acid C18H32O2 Oleic acid C18H34O2 Palmitic acid C16H32O2 Linolenic acid C18H30O2 Stearic acid C18H36O2 Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure: Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). INDICATIONSPERIKABIVEN® is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteralnutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN® may be used to prevent essential fattyacid deficiency or treat negative nitrogen balance in adult patients. Limitations Of UsePERIKABIVEN® is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed contentof the formulation does not meet the nutritional requirements of this age group [see WARNINGS AND PRECAUTIONS and Use In Specific Populations] . DOSAGE AND ADMINISTRATIONAdministration
Important Preparation Instructions
Instructions For Use
INSPECT BAG TO CONFIRM ACTIVATION.
IDENTIFY CORRECT PORT.
WARNING: Ensure additives are compatible.
NOTE: The membrane of Additive Port is sterile at first use. Use aseptic technique for subsequent additions. The septum can be pierced up to 10 times with the recommended needle size 18 to 23 G11/2 inches (40mm).
NOTE: The membrane of infusion Port is sterile at first use. Use infusion sets (according to ISO Number 8536-4) with an external spike diameter of 5.5 to 5.7 mm. FOR SINGLE USE ONLY.
Dosing ConsiderationsThe dosage of PERIKABIVEN® should be individualized based on the patient’s clinical condition (ability to adequately metabolize aminoacids, dextrose and lipids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. PERIKABIVEN® is a combination of amino acids, electrolytes, dextrose, and lipids in a fixed volume and concentration. The dosage selectionis based upon fluid requirements which can be used in conjunction with the nutritional requirements to determine final dosage [see Table 1]. PERIKABIVEN® meets the total nutritional requirements for protein, dextrose and lipids in stable patients, and can be individualized to meetspecific needs with the addition of nutrients. The maximum infusion rate is based upon the dextrose component. Prior to administration of PERIKABIVEN® , correct severe fluid, electrolyte and acid-base disorders. Before starting the infusion, obtain serumtriglyceride levels to establish the baseline value. Recommended Adult DosageThe recommended dosage of PERIKABIVEN® in adults is 27 to 40 mL/kg/day. The recommended daily nutritional requirements for protein,dextrose and lipids compared to the amount of nutrition provided by PERIKABIVEN® are shown in Table 1. The maximum daily dosage of PERIKABIVEN® in adults should not exceed 40 mL/kg/day. In patients with serum triglyceride concentrations above 400 mg/dL, stop the PERIKABIVEN® infusion and monitor serum triglyceride levels. Once the triglycerides are <400 mg/dL, restart PERIKABIVEN® at a lower infusion rate and advance rate in smaller increments towards targetdosage, checking the triglyceride levels prior to each adjustment [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS] . Table 1: Nutritional Comparison
Treatment with PERIKABIVEN® may be continued for as long as is required by the patient’s condition. Dosing In Renal ImpairmentIn patients with renal impairment, the dosage of PERIKABIVEN® should be the recommended adult dosage (see above). Prior toadministration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume ofPERIKABIVEN® administered as required [see WARNINGS AND PRECAUTIONS]. Renal patients not needing dialysis require 0.6 to 0.8 g of protein/kg/day. Patients on dialysis or continuous renal replacement therapy shouldreceive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses . ThePERIKABIVEN® dosage can be adjusted based on the treatment for the renal impairment, supplementing protein as indicated. Additionalprotein may be added to PERIKABIVEN® bag or infused separately. If required, additional amino acids may be added to the PERIKABIVEN® bag or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Fresenius KabiUSA, LLC. Infusion Duration And RateThe recommended duration of infusion for PERIKABIVEN® is between 12 and 24 hours, depending on the clinical situation. The maximum infusion rate of PERIKABIVEN® is 3.7 mL/kg/hour. This corresponds to 0.09 g/kg/hour of amino acids, 0.25 g/kg/hour ofdextrose (the rate limiting factor) and 0.13 g/kg/hour of lipid. Dosing Instructions
HOW SUPPLIEDDosage Forms And StrengthsPERIKABIVEN® is a sterile, hypertonic emulsion in a three chamber container. The individual chambers contain one of the followingrespectively: amino acids and electrolytes, dextrose, or lipid injectable emulsion. Table 2 describes the individual components ofPERIKABIVEN® . Table 2: Contents of PERIKABIVEN when mixed
Storage And HandlingPERIKABIVEN® is a sterile emulsion available in the following 3 sizes:
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. If accidentally frozen, discardthe bag. It is recommended that the product be stored at 5°C to 25°C (41°F to 77°F).Do not remove container from overpouch until intended foruse. After breaking the vertical seals, chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 24 hoursat 25°C (77°F). The product should be used immediately after the introduction of additives. If not used immediately, the storage time and conditions prior to useshould not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage at 2° to 8°C (36° to 46°F), the admixture should beinfused within 24 hours. Any mixture remaining must be discarded. REFERENCES 1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123. 2. Mueller CM ed. The A.S.P.E.N. Nutrition Support Core Curriculum 2nd ed. 2012. Chapter 29 Wolk R, Foulks C. Renal Disease., pg. 500 Manufactured by: FRESENIUS KADI, Uppsala, Sweden. Revised: Feb 2022. SLIDESHOWDigestive Disorders: Common Misconceptions See SlideshowSide Effects & Drug Interactions SIDE EFFECTSThe following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical data described for PERIKABIVEN® reflects exposure in 93 patients exposed for 5 to 7 days in 4 active-controlled trials. Thepooled population exposed to PERIKABIVEN® was 18 to 87 years old, 48% female, 73% Caucasian. The enrolled patients had variedunderlying conditions such as gastrointestinal disorders (55%), vascular disorders (30%), metabolism and nutrition disorders (28%), respiratory,thoracic, and mediastinal disorders (22%), and psychiatric disorders (20%). Most patients received peripheral intravenous infusion doses of≥80% of their target mean daily exposure. Adverse reactions occurring in at least 2% of patients who received PERIKABIVEN® are shown in Table 3. Table 3: Adverse Reactions in >2% of Patients Treated with PERIKABIVEN®
Less common adverse reactions in ≤1% of patients who received PERIKABIVEN® were hyperkalemia, hypomagnesaemia, hypernatremia,tachycardia, hypertension, thrombophlebitis, vomiting, jaundice, rash and increased blood bilirubin. Post-Marketing ExperienceThe following additional adverse reactions have been identified during post-approval use of PERIKABIVEN® in countries where it isregistered. Because these reactions are reported voluntarily post-approval from a population of uncertain size, it is not always possible toreliably estimate their frequency or establish a causal relationship to product exposure.
DRUG INTERACTIONSCoumarin And Coumarin DerivativesThe soybean oil present in PERIKABIVEN® has vitamin K1. Vitamin K1 can reverse the anticoagulant activity of coumarin and coumarinderivatives, which work by blocking recycling of vitamin K1. Monitoring for anticoagulant activity is recommended in patients who are on bothPERIKABIVEN® and coumarin or coumarin derivatives. WARNINGSIncluded as part of the "PRECAUTIONS" Section PRECAUTIONSDeath In Preterm InfantsDeaths in preterm infants after infusion of intravenous lipid emulsions have been reported. Autopsy findings included intravascular lipidaccumulation in the lungs. Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levelsfollowing lipid emulsion infusion. The safe and effective use of PERIKABIVEN® injection in pediatric patients, including preterm infants, has not been established. PERIKABIVEN® is not recommended for use in pediatric patients under the age of 2 years including preterm infants. Hypersensitivity ReactionsStop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop. Signs orsymptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache,sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia and chills. InfectionsPatients who require parenteral nutrition are at high risk of infections due to malnutrition and their underlying disease state. Infection and sepsismay occur as a result of the use of intravenous catheters to administer parenteral nutrition, poor maintenance of catheters, orimmunosuppressive effects of illness, drugs, and parenteral formulations. Decrease the risk of septic complications with heightened emphasis on aseptic technique in catheter placement and maintenance, as well asaseptic technique in the preparation of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis andhyperglycemia) and frequent checks of the parenteral access device. Fat Overload SyndromeFat overload syndrome is a rare condition that has been reported with intravenous lipid formulations. A reduced or limited ability to metabolizethe lipid contained in PERIKABIVEN® accompanied by prolonged plasma clearance may result in a syndrome characterized by a suddendeterioration in the patient's condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia,liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). The cause of the fatoverload syndrome is unclear. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped. Although it has been mostfrequently observed when the recommended lipid dosage was exceeded, cases have also been described where the lipid formulation wasadministered according to instructions. Refeeding SyndromeRefeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome, characterized by the intracellularshift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop.Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent thesecomplications. Diabetes/HyperglycemiaPERIKABIVEN® should be used with caution in patients with diabetes mellitus or hyperglycemia. With the administration ofPERIKABIVEN® , hyperglycemia and hyperosmolar syndrome may result. Administration of dextrose at a rate exceeding the patient'sutilization rate may lead to hyperglycemia, coma and death. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levelswhile infusing PERIKABIVEN® . Insulin may be administered or adjusted to maintain optimal blood glucose levels during PERIKABIVEN® administration. Monitoring/Laboratory TestsRoutine Monitoring
Essential Fatty AcidsMonitoring patients for signs and symptoms of essential fatty acid deficiency (EFAD) is recommended. Laboratory tests are available todetermine serum fatty acids levels. Reference values should be consulted to help determine adequacy of essential fatty acid status. Increasingessential fatty acid intake (enterally or parenterally) is effective in treating and preventing EFAD. In PERIKABIVEN® , the mean composition of linoleic acid (an omega-6 essential fatty acid) is 19 mg/mL (range 17 to 20 mg/mL) and alpha-linolenic acid (an omega-3 essential fatty acid) is 2.3 mg/mL (range 1.8 to 3.8 mg/mL). There are insufficient long-term data to determinewhether PERIKABIVEN® can supply essential fatty acids in adequate amounts in patients who may have increased requirements. ThrombophlebitisPERIKABIVEN® is indicated for peripheral administration, or may be infused into a central vein. Peripheral catheters should not be used forsolutions with osmolarity of ≥ 900 mOsm/L. The primary complication of peripheral access is venous thrombophlebitis, which manifests aspain, erythema, tenderness or a palpable cord. The catheter should be removed as soon as thrombophlebitis develops. Precipitation With CeftriaxonePrecipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such asPERIKABIVEN® in the same intravenous administration line. Ceftriaxone must not be administered simultaneously with PERIKABIVEN® via a Y-site. However, ceftriaxone and PERIKABIVEN® may be administered sequentially if the infusion lines are thoroughly flushed betweeninfusions with a compatible fluid [ see DOSAGE AND ADMINISTRATION] . Hepatobiliary DisordersHepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, includingcholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of thesedisorders is thought to be multifactorial and may differ between patients. Increase of blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions. In some patients this mayindicate hepatic insufficiency or the presence of an inborn error of amino acid metabolism [see CONTRAINDICATIONS] or hepatic insufficiency. Monitor liver function parameters and ammonia. Patients developing signs of hepatobiliary disorders should be assessed early by a clinicianknowledgeable in liver diseases in order to identify causative and contributory factors, and possible therapeutic and prophylactic interventions. Electrolyte Imbalance And Fluid Overload In Renal ImpairmentPatients with renal impairment, such as pre-renal azotemia, renal obstruction and protein-losing nephropathy may be at increased risk ofelectrolyte and fluid volume imbalance. PERIKABIVEN® should be used with caution in patients with renal impairment.PERIKABIVEN® dosage may require adjustment with specific attention to fluid, protein and electrolyte content in these patients. Monitor renal function parameters. Patients developing signs of renal impairment should be assessed early by a clinician knowledgeable inrenal disease in order to determine the appropriate PERIKABIVEN® dosage and other treatment options. HypertriglyceridemiaTo evaluate the patient’s capacity to eliminate and metabolize the infused lipid emulsion, measure serum triglycerides before the start ofinfusion (baseline value), with each increase in dosage, and regularly throughout treatment. Reduce dose of PERIKABIVEN® and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL toavoid the clinical consequences associated with hypertriglyceridemia. Serum triglyceride levels above 1,000 mg/dL have been associated withan increased risk of pancreatitis. Impaired lipid metabolism with hypertriglyceridemia may occur in conditions such as inherited lipid disorders, obesity, diabetes mellitus, andmetabolic syndrome. In these cases, increased triglycerides can also be increased by dextrose and/or overfeeding. Monitor overall energy intakeand other sources of lipid and dextrose, as well as drugs that may interfere with lipid and dextrose metabolism. Aluminum ToxicityPERIKABIVEN® contains no more than 25 mcg/L of aluminum. The aluminum contained in PERIKABIVEN® may reach toxic levels with prolonged parenteral administration in patients with impaired kidneyfunction. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphatesolutions that contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminumat greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading mayoccur at even lower rates of administration of total parenteral nutrition products. Interference With Laboratory TestsHigh levels of lipids in plasma may interfere with some laboratory blood tests such as hemoglobin, triglycerides, bilirubin, LDH, and oxygensaturation, if blood is sampled before lipid has been cleared from the bloodstream. Lipids are normally cleared after a lipid-free interval of 5 to 6hours in most patients. PERIKABIVEN® contains Vitamin K1 which may interfere with anticoagulant activity [see DRUG INTERACTIONS] . Risk Of Parenteral Nutrition Associated Liver DiseaseParenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods oftime, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial.Intravenously administered phytosterols (plant sterols) contained in plant-derived lipid formulations have been associated with development ofPNALD although a causal relationship has not been established. If PERIKABIVEN® treated patients develop liver test abnormalities considerdiscontinuation or dosage reduction. Nonclinical ToxicologyCarcinogenesis, Mutagenesis, Impairment Of FertilityLong-term animal studies have not been conducted to evaluate carcinogenic potential of PERIKABIVEN® or its effect on fertility. Genotoxicitystudies have not been conducted with PERIKABIVEN® to assess its mutagenic potential. Use In Specific PopulationsPregnancyRisk SummaryThe limited available data on the use of PERIKABIVEN® in pregnant women are not sufficient to inform a drug-associated risk. However,there are clinical considerations if PERIKABIVEN® is used in pregnant women [see Clinical Considerations]. Animal reproduction studieshave not been conducted with PERIKABIVEN® . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. 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 ConsiderationsDisease-Associated Maternal and/or Embryofetal Risk Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenitalmalformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot befulfilled by oral or enteral intake. LactationRisk SummaryThere are no data available to assess the presence of PERIKABIVEN® and/or its active metabolite(s) in human milk, the effects on the breastfedchild or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’sclinical need for PERIKABIVEN® , and any potential adverse effects of PERIKABIVEN® on the breastfed child or from the underlyingmaternal condition. Pediatric UseThe safety and effectiveness of PERIKABIVEN® in pediatric patients has not been established. Deaths in preterm infants after infusion ofintravenous lipid emulsion have been reported [see WARNINGS AND PRECAUTIONS] . Patients, particularly preterm infants, are at risk foraluminum toxicity [see WARNINGS AND PRECAUTIONS] . PERIKABIVEN® is not recommended for use in pediatric patients under the age of two years, including preterm infants, as the fixed content ofthe formulation does not meet the nutritional requirements of this age group due to the following reasons:
Patients, including pediatric patients, may be at risk for PNALD [see WARNINGS AND PRECAUTIONS] . Newborns – especially those born premature and with low birth weight – are at increased risk of developing hypo – or hyperglycemia andtherefore need close monitoring during treatment with intravenous dextrose solutions to ensure adequate glycemic control in order to avoidpotential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity,necr Geriatric UseClinical studies of PERIKABIVEN® did not include sufficient numbers of patients aged 65 and over to determine whether they responddifferently from other younger patients. Other reported clinical experience has not identified differences in responses between the elderly andyounger 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. Hepatic ImpairmentIn patients with impaired liver function PERIKABIVEN® should be administered with caution. Frequent clinical evaluation and laboratorytests to monitor liver function such as bilirubin and liver function parameters should be conducted [ see WARNINGS AND PRECAUTIONS] . Renal ImpairmentIn patients with impaired renal function, PERIKABIVEN® should be administered with caution. Frequent clinical evaluation and laboratorytests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] . Overdosage & Contraindications OVERDOSEIn the event of overdose, fat overload syndrome may result [see WARNINGS AND PRECAUTIONS] . Stop the infusion of PERIKABIVEN® toallow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, furtherintervention may be indicated. The lipid administered and fatty acids produced are not dialyzable. CONTRAINDICATIONSThe use of PERIKABIVEN® is contraindicated in patients with the following:
CLINICAL PHARMACOLOGYMechanism Of ActionPERIKABIVEN® is used as a supplement or as the sole source of nutrition in patients, providing macronutrients (amino acids, dextrose andlipids) and micronutrients (electrolytes) parenterally. The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized tourea and carbon dioxide as a source of energy. The administered dextrose is oxidized to carbon dioxide and water, yielding energy. Intravenously administered lipids provide a biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an importantsubstrate for energy production. The most common mechanism of action for energy derived from fatty acid metabolism is beta- oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators ofgene expression. PharmacokineticsThe infused lipid particles provided by PERIKABIVEN® are expected to be cleared from the blood stream in a manner thought to becomparable to the clearing of chylomicrons. In healthy volunteers, the maximum clearance rate of the triglycerides after fasting overnight hasbeen found to be 3.8 ± 1.5 g/kg per 24 hours. Both elimination and oxidation rates are dependent on the patient's clinical condition; elimination is faster and utilization is increased inpostoperative patients, in sepsis, burns and trauma, while patients with renal impairment and hypertriglyceridemia may show lower utilizationof exogenous lipid emulsions. Due to differences in elimination, patients with these conditions should be closely monitored duringPERIKABIVEN® administration [see WARNINGS AND PRECAUTIONS] . The disposition of infused amino acids, dextrose and electrolytes are essentially the same as those supplied by ordinary food. A clinical study in healthy volunteers employing high intravenous doses (80 mmol) of either sodium glycerophosphate used inPERIKABIVEN® or reference, inorganic sodium phosphate demonstrated that both compounds resulted in comparable serum inorganicphosphate concentrations after a single intravenous dose. Changes from baseline in the serum levels of sodium, potassium and total calciumwere comparable across the two phosphate sources in this study. PATIENT INFORMATIONTo ensure the safe and effective use of PERIKABIVEN® , this information should be discussed with the patient. Inform Patients Of The Following
When Patients Self-Administer PERIKABIVEN® Injection At Home, Inform Patients Of The Following
Additional information is available at www.KabivenUSA.com. The brand names mentioned in this document are the trademarks of their respective owners. FromReport Problems to the Food and Drug AdministrationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. What is the purpose of administering intravenous fat emulsion to a patient?Fat emulsions are used for nutritional support in patients who are unable to get enough fat in their diet, usually because of certain illnesses (eg, parenteral nutrition-associated cholestasis) or recent surgery. Fats are used by the body for energy and to form substances needed for normal body functions.
Can emulsions be given IV?Intravenous fat emulsion (IVFE) is an important source of calories and essential fatty acids for patients receiving parenteral nutrition (PN). Administered as an individual infusion or combined with PN, the fats provided by IVFE are vital for cellular structural function and metabolism.
How are lipid emulsions administered?Lipid emulsions given alone can be administered through either a peripheral or a central venous line. Central venous access is preferred if lipid infusion is ordered for more than 48 hours and is required if it accompanies hypertonic parenteral nutrition solution.
Why is lipid emulsion important?The infusion of lipid emulsions allows a high energy supply, facilitates the prevention of high glucose infusion rates and is indispensable for the supply with essential fatty acids.
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