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Parenteral nutrition: Drug information

Parenteral nutrition: Drug information
(For additional information see "Parenteral nutrition: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Deaths in preterm infants (Kabiven, Perikabiven)

Deaths in preterm infants after infusion of lipid injectable emulsions have been reported in the medical literature. Autopsy findings included intravascular lipid accumulation in the lungs. Preterm infants and low-birth-weight infants have poor clearance of lipid injectable emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

Brand Names: US
  • Kabiven;
  • Perikabiven
Brand Names: Canada
  • Olimel;
  • Olimel E;
  • PeriOlimel;
  • SmofKabiven
Pharmacologic Category
  • Caloric Agent;
  • Intravenous Nutritional Therapy
Dosing: Adult
Nutritional supplementation

Nutritional supplementation:

Fixed-combination solutions: Note: Dosage should be individualized based on patient status. These products contain a fixed combination of amino acids, dextrose, lipids, and electrolytes. Continue therapy for as long as required based on patient status. Correct severe fluid, electrolyte, or acid-base disorders prior to infusion. Also refer to the American Society for Parenteral and Enteral Nutrition for more detailed information.

Kabiven (central line use only): IV: 19 to 38 mL/kg/day infused over 12 to 24 hours; maximum daily dose: 40 mL/kg/day.

Macronutrient Content of Kabiven Based on Recommended Dosage

Nutrition provided by Kabiven recommended dosage

Fluid (mL/kg/day)

19 to 38

Protein (amino acids) (g/kg/day)

0.6 to 1.3

Nitrogen (g/kg/day)

0.1 to 0.2

Dextrose (g/kg/day)

2.1 to 4.1

Lipids (g/kg/day)

0.7 to 1.5

Total calories (kcal/kg/day)

16 to 32

Perikabiven (peripheral or central line): IV: 27 to 40 mL/kg/day infused over 12 to 24 hours; maximum daily dose: 40 mL/kg/day.

Macronutrient Content of Perikabiven Based on Recommended Dosage

Nutrition provided by Perikabiven recommended dosage

Fluid (mL/kg/day)

27 to 40

Protein (amino acids) (g/kg/day)

0.64 to 0.94

Nitrogen (g/kg/day)

0.1 to 0.15

Dextrose (g/kg/day)

2.03 to 3

Lipids (g/kg/day)

0.95 to 1.4

Total calories (kcal/kg/day)

18 to 27

Dosage adjustment for increased serum triglycerides: Stop infusion and monitor if triglycerides >400 mg/dL; restart at a lower infusion rate and advance in smaller increments once triglycerides are <400 mg/dL. Use is contraindicated with triglycerides >1,000 mg/dL.

Dosing: Kidney Impairment: Adult

Kabiven, Perikabiven: Use with caution in patients with kidney impairment; dosage adjustment may be necessary. Correct severe fluid or electrolyte imbalances prior to administration. Closely monitor electrolytes and adjust administered volume as necessary. Supplement protein as indicated for patients with acute or chronic kidney impairment or those requiring frequent dialysis or CRRT (ASPEN 2019). Additional amino acid solution may be added to the premixed solutions or infused separately.

Dosing: Hepatic Impairment: Adult

There is no dosage adjustment provided in the manufacturer's labeling; use with caution; dosage adjustments may be necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Intravenous:

Kabiven: (1026 mL,1540 mL, 2053 mL, 2566 mL) [sulfite free; lipid chamber contains egg phospholipids (egg lecithin)]

Perikabiven: (1440 mL,1920 mL, 2400 mL) [sulfite free; lipid chamber contains egg phospholipids (egg lecithin)]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Intravenous:

Olimel 4.4% E: (1000 mL, 1500 mL, 2000 mL) [lipid chamber contains egg phosphatide]

Olimel 5.7% and Olimel 5.7% E: (1000 mL, 1500 mL, 2000 mL) [lipid chamber contains egg phosphatide]

Olimel 7.6% E: (650 mL, 1000 mL, 1500 mL, 2000 mL) [lipid chamber contains egg phosphatide]

PeriOlimel 2.5% E: (1000 mL, 1500 mL, 2000 mL, 2500 mL) [lipid chamber contains egg phosphatide]

SmofKabiven: (986 mL, 1477 mL, 1970 mL, 2463 mL) [contains egg phospholipids]

Administration: Adult

IV: Parenteral nutrition may be administered as a continuous 24-hour infusion or as a cyclic infusion (generally, over 8 to 12 hours) in selected stable patients (eg, expected to have a longer course or home infusion) (Kumpf 2006; Stout 2010). All parenteral nutrition should be infused through a 1.2-micron filter (Worthington 2021). ASPEN suggests that parenteral nutrition with an osmolarity up to 900 mOsm/L may be administered peripherally; monitor closely for extravasation (ASPEN [Ayers 2014]; ASPEN [Boullata 2014]). Abrupt discontinuation may cause hypoglycemia; infusion tapering may decrease this risk (Stout 2010).

Kabiven and Perikabiven are fixed combinations of amino acids, dextrose, lipids, and electrolytes and come in several sizes; selection will be based on fluid requirements and duration of infusion. Note: Always check compatibility with parenteral nutrition before simultaneously administering any drug via Y-site; contact manufacturer for product-specific compatibility as most databases (eg, Trissel's) only provide parenteral nutrition containing soybean oil lipid emulsion (Mirtallo 2020). If patient is receiving ceftriaxone, do not administer ceftriaxone simultaneously via Y-site due to precipitation (Kabiven and Perikabiven contain calcium); if the infusion line is thoroughly flushed between infusions with a compatible fluid, may sequentially administer ceftriaxone and Kabiven or Perikabiven.

Kabiven: Infuse over 12 to 24 hours via central vein only using a 1.2-micron inline filter (Worthington 2021). Maximum infusion rate: 2.6 mL/kg/hour (corresponds to amino acids 0.09 g/kg/hour; dextrose 0.25 g/kg/hour [rate-limiting component]; lipids 0.1 g/kg/hour). Administer through a dedicated line without any connections. Do not use administration lines and sets containing DEHP (sets containing PVC components have DEHP as a plasticizer). Vein irritation, damage, and/or thrombosis may occur if administered via peripheral vein.

Perikabiven: Infuse over 12 to 24 hours via peripheral or central vein using a 1.2-micron inline filter (Worthington 2021). Maximum infusion rate: 3.7 mL/kg/hour (corresponds to amino acids 0.09 g/kg/hour; dextrose 0.25 g/kg/hour [rate-limiting component]; lipids 0.13 g/kg/hour). Administer through a dedicated line without any connections. Do not use administration lines and sets containing DEHP (sets containing PVC components have DEHP as a plasticizer).

Vesicant; ensure proper needle or catheter placement prior to and during IV infusion. Avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave needle/cannula in place). Gently aspirate extravasated solution (do NOT flush the line), initiate hyaluronidase antidote, remove needle/cannula, and apply dry cold compresses (Hurst 2004; Reynolds 2014). Elevate extremity.

Hyaluronidase: Intradermal or SubQ: Inject a total of 1 to 1.7 mL (15 units/mL) as 5 separate 0.2 to 0.3 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Reynolds 2014; Zenk 1981). May also inject hyaluronidase through the catheter that caused the infiltration (Reynolds 2014).

Alternative to hyaluronidase: Nitroglycerin topical 2% ointment (based on limited data): Apply a 1-inch strip to site of ischemia; may repeat after 8 hours if necessary (Reynolds 2014).

Use: Labeled Indications

Nutritional supplementation:

Kabiven, Perikabiven: 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; prevention of essential fatty acid deficiency or treatment of negative nitrogen balance in adult patients.

Limitations of use: These fixed-content formulations are not recommended for use in children <2 years of age, including preterm infants, because they do not meet nutritional requirements for this age group.

Guideline recommendations:

According to the American Society for Parenteral and Enteral Nutrition, parenteral nutrition conditions that are likely to require parenteral nutrition include: impaired absorption or loss of nutrients (eg, short bowel syndrome, intestinal atresia, gastroschisis, volvulus, necrotizing enterocolitis, high output intestinal fistula, neutropenic colitis, small bowel mucosal disease), mechanical bowel obstruction (eg, intrinsic or extrinsic blockage of intestinal lumen as occurs with inflammatory bowel disease, peritoneal carcinomatosis, stenosis or strictures), need to restrict oral or enteral intake (eg, ischemic bowel, severe pancreatitis, chylous fistula), motility disorders (eg, prolonged ileus, pseudo-obstruction, severe adhesive disease), inability to achieve or maintain enteral access. The indication in these conditions is dependent on the patient's nutrition status, clinical condition, and whether enteral nutrition is feasible or contraindicated (Worthington 2017).

Medication Safety Issues
Sound-alike/look-alike issues:

TPN abbreviation should not be used when ordering this medication; had been mistaken for tPA (alteplase). Parenteral nutrition (PN) is the preferred nomenclature (ASPEN 2018).

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%: Gastrointestinal: Nausea (2% to 15%)

1% to 10%:

Cardiovascular: Hypertension (≤8%), phlebitis (2%), tachycardia (≤1%), thrombophlebitis (≤1%)

Dermatologic: Eczema (≤1%), pruritus (1% to 2%), skin rash (≤1%)

Endocrine & metabolic: Decreased serum calcium (1%), decreased serum total protein (4%), hyperglycemia (2% to 5%), hyperkalemia (≤1%), hypernatremia (≤1%), hypertriglyceridemia (≤1%), hypoalbuminemia (2%), hypokalemia (4%), hypomagnesemia (≤1%)

Gastrointestinal: Dysgeusia (≤1%), vomiting (≤6%)

Hematologic & oncologic: C-reactive protein increased (2%), decreased hemoglobin (6%), prolonged prothrombin time (1%)

Hepatic: Increased gamma-glutamyl transferase (2% to 4%), increased serum alanine aminotransferase (2%), increased serum alkaline phosphatase (1% to 2%), increased serum bilirubin (≤1%), jaundice (≤1%)

Nervous system: Dizziness (≤1%), headache (≤1%)

Renal: Increased blood urea nitrogen (2%)

Miscellaneous: Fever (4% to 9%)

Postmarketing:

Cardiovascular: Chest tightness, facial flushing

Gastrointestinal: Abdominal distension, abdominal pain, cholestasis

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Infection: Infection

Nervous system: Intracranial hemorrhage (subependymal)

Contraindications

Kabiven, Perikabiven: Hypersensitivity to egg, soybean proteins, peanut proteins, or any component of the formulation; severe hyperlipidemia or severe disorders of lipid metabolism with hypertriglyceridemia (serum triglycerides >1,000 mg/dL); inborn errors of amino acid metabolism; cardiopulmonary instability, including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis, and hemodynamic instability requiring significant vasopressor support; hemophagocytic syndrome; neonates (≤28 days of age) receiving concurrent treatment with ceftriaxone, even if separate lines are used.

Canadian labeling: Additional contraindications (not in US labeling): Note: Contraindications may vary by product; also refer to product labeling: Severe liver or kidney insufficiency (not on dialysis or hemofiltration); hepatic coma; severe blood coagulation disorders; uncontrolled hyperglycemia; elevated serum electrolyte levels of any of the included electrolytes; unstable conditions (eg, severe posttraumatic conditions, uncompensated diabetes mellitus, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration, hyperosmolar coma); hypertriglyceridemia-associated acute pancreatitis.

Note: Contraindications for peripheral parenteral nutrition regardless of formulation (premixed or patient-specific formulations) include significant malnutrition, severe metabolic stress, large nutrient or electrolyte needs, fluid restriction, need for prolonged parenteral nutrition (ie, >2 weeks), and kidney or liver impairment (ASPEN [Mueller 2017]). Central parenteral nutrition in these conditions is recommended (Worthington 2017).

Warnings/Precautions

Concerns related to adverse effects:

• Catheter occlusion: Recognized when unable to infuse due to resistance or unable to aspirate blood due to resistance. May be due to thrombotic (most common) or nonthrombotic causes; treat as appropriate (ASPEN [Mueller 2017]).

• Lipid overload syndrome: A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may rarely occur. Lipid overload syndrome may result in a sudden deterioration in patient condition along with anemia, coagulation disorders, CNS manifestations (eg, coma), deteriorating liver function and hepatomegaly, fever, hyperlipidemia, leukopenia, or thrombocytopenia; usually reversible upon discontinuation.

• Hyperglycemia: Use with caution in patients with diabetes mellitus or insulin resistance. Hyperglycemia and hyperosmolar syndrome may occur with therapy. Hyperglycemia may also occur in patients without diabetes; risk factors include age, severity of illness, and rate of infusion (Clement 2004). Monitor administration rate as well as serum glucose; insulin may be required for optimal glucose control.

• Hypersensitivity: Allergic or hypersensitivity reactions (eg, altered mentation, bronchospasm, cyanosis, flushing, dyspnea, headache, hypotension, hypoxia, rash, sweating, tachycardia, tachypnea, vomiting) may occur; discontinue infusion immediately if signs or symptoms of hypersensitivity or allergic reactions occur.

• Hypertriglyceridemia: May occur in patients with impaired lipid metabolism (eg, diabetes mellitus, metabolic syndrome, obesity) or those being overfed with dextrose, receiving high-dose lipid-based medications. Monitor triglycerides closely (eg, baseline and weekly). Reduce dose of fixed combination solutions or eliminate lipid injectable emulsion from the parenteral nutrition regimen with serum triglycerides >400 mg/dL (>1,000 mg/dL is associated with pancreatitis); may reinitiate lipid injectable emulsion when <400 mg/dL. Monitor all sources of lipids, dextrose, and medications that may interfere with their metabolism (ASPEN [Mueller 2017]; Mirtallo 2020).

• Infection: Patients requiring parenteral nutrition may be at high risk of infection, including sepsis, due to malnutrition, the underlying disease state, or catheters required for administration. Proper aseptic technique should be followed; monitor for signs of early infection. Diabetic patients are at a greater risk of developing catheter-related infections compared with nondiabetic patients (McMahon 1996).

• Intestinal failure–associated liver disease: Has been reported in patients receiving parenteral nutrition for extended periods of time, especially preterm infants. Intestinal failure–associated liver disease may present as cholestasis or hepatic steatosis progressing to steatohepatitis with fibrosis and cirrhosis. Cholecystitis and cholelithiasis have also occurred. Consider discontinuation or dose reduction in patients who develop LFT abnormalities (Mirtallo 2020).

• Refeeding syndrome: Use with caution in patients at risk for refeeding syndrome (eg, severely malnourished). Refeeding syndrome may occur in severely undernourished patients and is due to the intracellular shift of magnesium, phosphorus, and potassium resulting in generalized fatigue, muscle weakness, edema, hemolysis, and cardiac arrhythmia (may result in cardiopulmonary arrest); thiamine deficiency may also develop. In patients at risk, initiate and advance caloric intake slowly (ASPEN [Mueller 2017]; da Silva 2020).

• Respiratory effects: Pulmonary embolism, including fatalities, and respiratory distress have occurred in patients developing pulmonary vascular precipitates due to receiving parenteral nutrition. Risk is increased with excessive addition of calcium and phosphates. The prepared solution, infusion set, and catheters should be inspected for precipitates prior to administration. Discontinue therapy and initiate medical evaluation in patients who develop signs of pulmonary embolism or respiratory distress.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with hepatic impairment. Hepatobiliary disorders (eg, cholecystitis, cholelithiasis, cholestasis, cirrhosis, hepatic steatosis, fibrosis) may occur in patients without liver disease and may lead to hepatic failure. If hepatobiliary complications occur during treatment, among other strategies for treatment, consider reducing dextrose or lipid injectable emulsion component, providing a balance between dextrose and lipid injectable emulsion, or cycling parenteral nutrition (ASPEN [Mueller 2017]). Increased blood ammonia and hyperammonemia may occur with amino acid therapy; evaluate patients for hepatic insufficiency or an unknown inborn error of amino acid metabolism.

• Kidney impairment: Use with caution in patients with kidney impairment; risk of electrolyte and fluid volume imbalance may be increased.

Dosage form specific issues:

• Aluminum: Kabiven, Perikabiven: May contain aluminum; toxic aluminum concentrations may be seen with prolonged use or kidney dysfunction. Premature neonates are at higher risk due to immature kidney function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity in patients with kidney dysfunction (including premature infants); tissue loading may occur at lower doses.

Other warnings/precautions:

• Abrupt withdrawal: If parenteral nutrition is discontinued abruptly, rebound hypoglycemia may occur. Infuse dextrose 10% at same rate and monitor capillary blood glucose for hypoglycemia at 30 minutes to 1 hour after parenteral nutrition is discontinued. To reduce the risk of rebound hypoglycemia in susceptible patients (eg, patients requiring large doses of insulin), taper down the infusion rate for 1 to 2 hours or half the infusion rate (ASPEN [Mueller 2017]).

• Concurrent ceftriaxone administration: Kabiven, Perikabiven: Avoid simultaneous administration via Y-site with ceftriaxone; may administer sequentially after proper flushing of IV lines between infusions for patients other than neonates. Avoid concurrent administration in neonates, even if separate IV lines are used.

• Multivitamins: Multivitamins and potentially trace elements must be added to Kabiven and Perikabiven to provide balanced, complete parenteral nutrition and to avoid micronutrient deficiency.

Reproductive Considerations

Optimization of parenteral nutrition is recommended prior to conception for patients who may become pregnant (Bond 2017).

Pregnancy Considerations

Outcome data following short-term (eg, hyperemesis gravidarum) and long-term (eg, chronic intestinal failure) use of parenteral nutrition during pregnancy are available. Adequate weight gain of the mother and, in general, normal-weight infants have been reported (ASPEN [Mueller 2017]; Billiauws 2017; Bond 2017; Buchholz 2015; Russo-Stieglitz 1999; Theilla 2017). Long-term adverse developmental effects in infants and children have not been observed (Billiauws 2017; Theilla 2017).

Severe malnutrition is associated with adverse pregnancy outcomes, including congenital malformations, intrauterine growth restriction, preterm delivery, perinatal mortality, and low birth weight infants.

Indications for parenteral nutrition are the same in pregnant patients as in nonpregnant patients. Parenteral nutrition should not be withheld when otherwise indicated. Pregnancy-specific parenteral nutrition risks should be considered, including the significant adverse effects of hyperglycemia. Increased maternal and fetal monitoring by a multidisciplinary team is recommended to ensure adequate nutrition as pregnancy progresses and the avoidance of complications (ASPEN [Mueller 2017]; Wolk 1990).

In patients with nausea and vomiting of pregnancy, parenteral nutrition should be used as a last option for patients who cannot maintain their weight because of vomiting; enteral nutrition is preferred (ACOG 2018).

Breastfeeding Considerations

Amino acid, dextrose, and electrolyte disposition is the same as supplied by ordinary food; lipid clearance is dependent on clinical status.

According to the manufacturer of the premixed solution, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. However, successful breastfeeding with adequate infant weight gain has been reported in postpartum patients requiring chronic parenteral nutrition (ASPEN [Mueller 2017]; Borbolla Foster 2016; Buchholz 2015). Close monitoring is recommended to ensure adequate nutrition for the mother and infant (ASPEN [Mueller 2017]; Wolk 1990).

Monitoring Parameters

Serum triglycerides (baseline, with each dose change, and regularly during therapy), fluid and electrolytes, blood glucose, serum osmolarity, hepatic and kidney function, blood ammonia, blood count (including platelets and coagulation factors). Fluid status should be closely monitored in patients with heart failure, kidney impairment, or pulmonary edema. Signs and symptoms of infection (especially catheter-related infection), hypersensitivity reactions, essential fatty acid deficiency, lipid overload syndrome, refeeding syndrome.

ASPEN recommendations (ASPEN [Mueller 2017 ]):

At baseline and daily: Weight (in stable patients, 2 to 3 times per week); intake and output (in stable patients, daily unless fluid status assessed by physical exam)

At baseline and weekly: CBC with differential; PT/INR, PTT; serum triglycerides (upon initiation also measure on day 1); ALT/AST, alkaline phosphatase, total bilirubin (also measure on day 1; in stable patients, these may be measured monthly)

At baseline and 1 to 2 times per week in stable patients/daily in critically ill patients: Electrolytes (sodium, potassium, chloride, carbon dioxide, magnesium, calcium, phosphorus) (upon initiation, daily × 3); BUN, creatinine; serum glucose (upon initiation, daily × 3)

As needed: Capillary glucose (in critically ill patients, measure 3 times daily until consistently <150 mg/dL); nitrogen balance

Note: In patients receiving long-term parenteral nutrition, obtain bone mineral density testing annually, monitor for iron deficiency periodically, and monitor serum levels of trace elements biannually.

Mechanism of Action

Combination of amino acids, dextrose, lipids, and electrolytes to provide parenteral nutrition.

Pricing: US

Emulsion (Kabiven Intravenous)

3.3-9.8-3.9-0.7% (per mL): $0.04

Emulsion (Perikabiven Intravenous)

2.4-6.8-3.5-0.5% (per mL): $0.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Nutriflex Omega Special (AT, BG, CH, CZ, DE, DK, EE, ES, GB, IE, NL, NO);
  • Nutriflex Omega Special Emulsion for Infusion (SG);
  • Nutriflex Omega Sprecial (PT);
  • Smofkabiven (AR, BE, BG, CZ, DE, DK, EE, ES, FR, HK, HR, HU, IL, IS, KR, LT, LU, LV, NL, NO, PL, PT, RO, SA, SI, SK);
  • Smofkabiven Electrolyta Free Amino Acids (BE);
  • Smofkabiven Electrolyte Free Amino Acids (AU)


For country code abbreviations (show table)
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