Dosing and uses of Voluven (tetrastarch)
Adult dosage forms and strengths
IV solution
- 6% hydroxyethyl starch 130/0.4 in 0.9% NaCl
Hypovolemia
Plasma volume substitute indicated for treatment and prophylaxis of hypovolemia
Daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics, and on the hemodilution
Administer up to 50 mL/kg/day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq Na per kg of body weight)
This dose is equivalent to 3500 mL for a 70 kg patient
Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction
Pediatric dosage forms and strengths
IV solution
- 6% hydroxyethyl starch 130/0.4 in 0.9% NaCl
Hypovolemia
Plasma volume substitute indicated for treatment and prophylaxis of hypovolemia
Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status
Newborns and infants
<2 yr: Mean dose of 16 mL/kg IV
2-12 years: Mean dose of 36 mL/kg IV
Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction
Voluven (tetrastarch) adverse (side) effects
1-10%
Pruritus
Increased serum amylase
Decreased coagulation factors
Decreased hematocrit
<1%
Anaphylactoid reactions
Warnings
Black box warnings
Do not use hydroxyethyl starch (HES) in critically ill adults (including sepsis)
Use of HES increases risk of mortality and renal replacement therapy in critically ill adults
Contraindications
Critically ill adults, including those with sepsis (see Black box warnings)
Severe liver disease
Hypersensitivity
Clinical conditions with volume overload
Pre-existing coagulation or bleeding disorders
Renal failure with oliguria or anuria not related to hypovolemia
Patients receiving dialysis treatment
Severe hypernatremia or hyperchloremia
Intracranial bleeding
Cautions
Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, noncardiac pulmonary edema) reported
Avoid use with pre-existing renal dysfunction; discontinue at the first sign of renal injury
Monitor renal function for at least 90 days following administration
Monitor coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with HES solutions in this population; discontinue at the first sign of coagulopathy
Avoid fluid overload; adjust dosage with cardiac or renal dysfunction
In cases of severe dehydration, a crystalloid solution should be given first
Monitor fluid balance, serum electrolytes, renal and hepatic function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or when warranted
Interference with laboratory tests
- Elevated serum amylase levels may be observed and can interfere with the diagnosis of pancreatitis
- High doses may result in dilutional effects (eg, decreased levels of coagulation factors and other plasma proteins, decreased hematocrit)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Voluven (tetrastarch)
Mechanism of action
Colloidal solution volume expander that contains hydroxyethyl starch 130/0.4
130 refers to the molecular weight (130,000 daltons)
0.4 refers to the low molar substitution by hydroxyethyl groups
Absorption
Peak plasma time: At end of infusion
Peak plasma time (75%): 30 min post-infusion
Peak plasma time (14%): 6 hr post-infusion
Distribution
Vd: 5.9 L
Elimination
Half-life: 12 hr
Plasma clearance: 31.4 mL/min
Excretion: 62-70% in urine over 72 hr
