Version May 2024
Hypovolemia, plasma volume expansion: Note: Discontinue use at the first sign of kidney injury. With severe dehydration, administer crystalloid first. Do not use in critically ill patients (including those with sepsis or septic shock), or patients with preexisting kidney dysfunction, receiving renal replacement therapy, preexisting bleeding disorders, intracranial bleeding, or severe hepatic dysfunction (SSC [Evans 2021]; manufacturer's labeling).
IV: 250 to 1,000 mL once; may repeat over several days as needed based on assessment of intravascular volume status. Initial, total volume, and rate of infusion based on clinical situation and individual patient needs; maximum total daily dose: up to 50 mL/kg/day (or up to 3,500 mL/day in a 70 kg patient) (Futier 2020; Guidet 2012; Myburgh 2012; Perner 2012; manufacturer’s labeling).
Avoid use in patients with preexisting kidney dysfunction. Use is contraindicated in oliguric/anuric kidney failure unrelated to hypovolemia or patients receiving renal replacement therapy. Discontinue use at the first sign of kidney injury.
There are no dosage adjustments provided in the manufacturer’s labeling; use is contraindicated in severe hepatic disease.
Refer to adult dosing. Use with caution.
(For additional information see "Tetrastarch (Hydroxyethyl starch 130/0.4; Voluven): Pediatric drug information")
Note: With severe dehydration, administer crystalloid first. Dose and rate of infusion dependent on amount of blood lost, on maintenance or restoration of hemodynamics, and on amount of hemodilution. Titrate to individual colloid needs, hemodynamics, and hydration status. Do not use in critically ill patients, those undergoing open heart surgery with cardiopulmonary bypass, or those with preexisting kidney dysfunction. Critical Care Medicine societies (ACCM, SCCM) recommend against the use of hydroxyethyl starch (HES) solutions for fluid resuscitation of severe sepsis and septic shock in neonatal and pediatric patients (ACCM [Davis 2017]; SCCM [Dellinger 2013]).
Volume expansion:
Infants and Children <2 years: IV infusion: Usual range: 7 to 25 mL/kg/dose; mean reported dose: 16 ± 9 mL/kg/dose; maximum daily dose: 50 mL/kg/day; in clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported (Chong Sung 2006; Osthaus 2009; Witt 2008).
Children 2 to 12 years: IV infusion: Usual range: 25 to 47 mL/kg/dose; mean reported dose: 36 ± 11 mL/kg/dose; maximum daily dose: 50 mL/kg/day; in clinical trials of intraoperative use, a dose of 10 mL/kg/dose has been reported (Chong Sung 2006; Osthaus 2009; Van der Linden 2013; Witt 2008).
Adolescents: IV Infusion: Administer up to 50 mL/kg/day (or up to 3,500 mL daily in a 70 kg patient); may administer repetitively over several days.
Avoid use in patients with pre-existing renal dysfunction; use is contraindicated in oliguric/anuric renal failure unrelated to hypovolemia or patients receiving dialysis. Discontinue use at the first sign of renal injury.
There are no dosage adjustments provided in manufacturer’s labeling; use is contraindicated in severe impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Pruritus (dose dependent; may be delayed), skin rash
Gastrointestinal: Increased serum amylase
Hematologic & oncologic: Anemia, coagulation time increased, decreased clotting factors, decreased hematocrit, prolonged prothrombin time, wound hemorrhage
<1%, postmarketing, and/or case reports: Acute kidney injury, anaphylactoid reaction, anaphylaxis, bradycardia, bronchospasm, circulatory shock, flu-like symptoms, hemorrhage (perioperative) (Rasmussen 2014), hypersensitivity reaction, hypotension, non-cardiogenic pulmonary edema, shock, tachycardia
Hypersensitivity to hydroxyethyl starch or any component of the formulation; critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy; kidney failure with oliguria or anuria (not related to hypovolemia); dialysis; any fluid overload condition (eg, pulmonary edema, congestive heart failure); severe hypernatremia; severe hyperchloremia; patients with intracranial bleeding; severe liver disease; preexisting coagulation or bleeding disorders.
Canadian labeling: Additional contraindications (not in US labeling): Volulyte only: Severe hyperkalemia.
Concerns related to adverse effects:
• Anaphylactoid reactions: Anaphylactoid reactions (eg, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch; discontinue use immediately with signs of hypersensitivity reaction and administer appropriate therapy.
• Bleeding/coagulopathy: Discontinue use of hydroxyethyl starch (HES) at the first sign of coagulopathy. Monitor the coagulation status in patients undergoing open heart surgery in association with cardiopulmonary bypass. HES solutions have been associated with excess bleeding in these patients. Use is contraindicated in patients with preexisting coagulation or bleeding disorders.
• Fluid overload: Administration may cause fluid overload; avoid use in patients at risk from overexpansion of blood volume (eg, very young patients, elderly patients). Use is contraindicated in patients with any preexisting condition where volume overload is a potential concern (eg, heart failure, kidney impairment, or renal replacement therapy).
• Hemodilution: Large volumes may cause a reduction in hematocrit, coagulation factors and other plasma proteins due to hemodilution; coagulation may be impaired (eg, prolonged PT, PTT, and clotting times) and a transient prolongation of bleeding time may be observed.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor hepatic function. Use is contraindicated in patients with severe hepatic disease; may result in further reduction of coagulation factors, increasing the risk of bleeding.
• Kidney impairment: Avoid use in patients with preexisting kidney impairment; fluid status including urine output should be monitored closely; discontinue use at the first sign of kidney injury. Use is contraindicated with oliguria or anuria unrelated to hypovolemia or in patients receiving hemodialysis.
Special populations:
• Critically ill patients: HES solutions have been associated with mortality and renal injury requiring renal replacement therapy in critically ill patients, including patients with sepsis; avoid use in critically ill adult patients, including those with sepsis. Avoid use in patients admitted to the ICU (Brunkhorst 2008; Perel 2012; Perner 2012; SSC [Evans 2021]). Crystalloids (eg, sodium chloride and balanced solutions) are recommended as the fluid of choice for initial resuscitation and ongoing resuscitation (SSC [Evans 2021]). If used in patients who are not critically ill, avoid use in patients with preexisting kidney dysfunction and discontinue use at the first sign of kidney injury. Since the need for renal replacement therapy has been reported up to 90 days after HES administration, continue to monitor kidney function in all patients for at least 90 days.
Dosage form specific issues:
• Volulyte [CAN]: Contains sodium, magnesium, acetate and potassium; use with caution in situations where electrolyte and/or acid-base disturbances may be exacerbated.
Other warnings/precautions:
• Appropriate use: Not a substitute for red blood cells or coagulation factors. Severely dehydrated patients should be resuscitated with a sufficient volume of crystalloid solution before consideration of tetrastarch administration.
HES use has also been associated with acute kidney injury in pediatric patients (Reinhart 2012).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Voluven: 6% (500 mL [DSC]) [dehp free, latex free, pvc free]
No
Solution (Voluven Intravenous)
6-0.9% (per mL): $0.12
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Volulyte: 6% (250 mL, 500 mL)
Voluven: 6% (250 mL, 500 mL)
IV: Administer IV only; may be administered via infusion pump or pressure infusion. Infuse the initial 10 to 20 mL slowly while observing for possible anaphylactoid reaction; have epinephrine and resuscitative equipment available. Initial and total volume and rate of infusion is based on clinical situation and individual patient needs. Do not use if crystalline precipitate forms or is turbid deep brown. Change IV tubing at least every 24 hours.
IV: Administer IV only; may be administered via infusion pump or pressure infusion; if administered by pressure infusion, air should be withdrawn or expelled from bag prior to infusion to prevent air embolus. Infuse the first 10 to 20 mL slowly to observe for anaphylaxis; have epinephrine and resuscitative equipment available. Do not use if crystalline precipitate forms or is turbid deep brown. Change IV tubing at least once every 24 hours.
Hypovolemia, plasma volume expansion: Blood volume expander used in treatment and prevention of hypovolemia.
Note: Not a substitute for red blood cells or coagulation factors in plasma.
Voluven may be confused with VoLumen
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Arbekacin: Tetrastarch may enhance the nephrotoxic effect of Arbekacin. Risk X: Avoid combination
Adverse events have been observed in animal reproduction studies.
It is not known if tetrastarch is excreted in breast milk. The manufacturer recommends that caution be exercised when administering tetrastarch to nursing women.
BP, heart rate, fluid balance, urine output, kidney function (continue to monitor for at least 90 days after administration), urine output, hemodynamic parameters where appropriate, hemoglobin, hematocrit, coagulation parameters, liver function (at baseline and periodically during treatment), acid-base balance.
Produces plasma volume expansion by virtue of its highly colloidal starch structure.
Duration: ≥6 hours.
Distribution: Vd: 5.9 L.
Metabolism: Molecules >50,000 daltons are metabolized by plasma α-amylase.
Half-life elimination: 12 hours.
Excretion: Urine (smaller hydroxyethyl starch molecules [<50,000 daltons] unchanged, metabolites).
Clearance: 31.4 mL/minute.
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