Used for plasma volume expansion in the treatment of hypovolemia. Not a substitute for whole blood or plasma.
Comparable with human albumin 5% as a plasma volume expander.
Leukapheresis
6% hetastarch in 0.9% sodium chloride injection: Adjunct in leukapheresis to enhance the yield of granulocytes by centrifugal means.
Dosage and Administration
Administration
Leukapheresis: Add citrate anticoagulant to 250–700 mL of 6% hetastarch in 0.9% sodium chloride injection and mix thoroughly; add to the input line of the centrifugation apparatus in a hetastarch-to-venous whole blood ratio of 1:8 to 1:13.
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV infusion.
6% Hetastarch in lactated electrolye injection (Hextend®): Do not administer simultaneously with blood through the same administration set. Hextend® contains calcium; risk of coagulation.
Rate of Administration
Determine rate of infusion based on amount of fluid (e.g., blood) lost, resultant hemoconcentration, and patient’s age, weight, and clinical condition.
Dosage
Adults
Hypovolemia
IV
Determine dosage based on amount of fluid lost, resultant hemoconcentration, and patient’s age, weight, and clinical condition.
Usually, 500–1000 mL (30–60 g).
Prescribing Limits
Adults
Hypovolemia
IV
Total daily dose >20 mL/kg (1.2 g/kg) or 1500 mL (90 g) for a typical 70-kg patient usually not needed.
Dosages >1500 mL daily have been used in postoperative and trauma patients with severe blood loss, generally in conjunction with blood and blood products.
Special Populations
Geriatric Patients
Select dosage with caution. (See Geriatric Use under Cautions.)
CHF, renal disease with oliguria or anuria not related to hypovolemia, or other clinical conditions exacerbated by volume overload.
Known hypersensitivity to hydroxyethyl starch or any ingredient in the formulation.
Warnings/Precautions
Warnings
Therapy Limitations
Hypovolemia: Safety established only for treatment of hypovolemia in elective surgery.
Do not use as a cardiac bypass pump prime, while patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued.
6% Hetastarch in lactated electrolyte injection (Hextend®): Not indicated for use in leukapheresis.
Hemodilution
Risk of excessive hemodilution (e.g., decreased hematocrit and plasma protein concentrations) following administration of volumes >25% of blood volume in <24 hours. Consider administering packed red cells, platelets, or fresh frozen plasma if excessive hemodilution occurs. Avoid excessive hemodilution, particularly in patients at risk of CHF or pulmonary edema.
Modest decreases in platelet counts and hemoglobin concentrations reported in donors undergoing repeated leukapheresis procedures; hemoglobin concentration returns to normal within 24 hours.
Hematologic Effects
In patients with hypovolemia, risk of altered coagulation and bleeding (due to hemodilution and direct inhibition of factor VIII); increased risk with higher dosages. (See Therapy Limitations and also Patient Evaluation and Laboratory Monitoring under Cautions.)
Safety of prolonged use (i.e., over several days) not established in situations other than leukapheresis. Prolonged use associated with coagulation abnormalities, von Willebrand’s-like syndrome, and/or Factor VIII deficiency; intracranial bleeding resulting in death reported. Consider replacement therapy if severe factor VIII deficiency or von Willebrand’s disease occurs. Coagulopathy may take several days to resolve.
Sensitivity Reactions
Hypersensitivity Reactions
Death, life-threatening anaphylactic/anaphylactoid reactions (e.g., rash, urticaria, pruritus, angioedema, flushing, severe hypotension, tachycardia, bradycardia, ventricular fibrillation, cardiac arrest, wheezing, shortness of breath, stridor, tachypnea, chest pain, pulmonary edema, laryngeal edema, bronchospasm) reported rarely. Hypersensitivity reactions can occur even after therapy is discontinued.
Possible hypersensitivity reaction in patients allergic to corn; use with caution in such patients.
Discontinue immediately and institute appropriate therapy (e.g., antihistamines, epinephrine, corticosteroids) and supportive measures (e.g., maintenance of adequate airway, oxygen) if a hypersensitivity reaction occurs. Continued supportive care needed until manifestations have resolved.
Major Toxicities
Hepatic Effects
Elevated indirect bilirubin concentration reported following multiple infusions; concentrations return to normal 96 hours after final infusion; total bilirubin concentrations remained within normal limits.
Transient elevation of serum amylase concentration reported; no association with pancreatitis demonstrated.
General Precautions
Electrolyte Components of Hetastarch Preparation
Observe the usual precautions and contraindications associated with the electrolyte components in Hextend® (potassium, sodium, lactate).
Observe the usual precautions and contraindications associated with the sodium in 6% hetastarch in 0.9% sodium chloride.
Leukapheresis: Perform clinical evaluation regularly. Monitor CBC. If frequency of leukapheresis exceeds guidelines for whole blood donation, consider monitoring total leukocyte and platelet counts, leukocyte differential count, hemoglobin and hematocrit, PT, and aPTT.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether hetastarch is distributed into human milk. Use with caution.
Pediatric Use
Safety and efficacy not established. Use with caution.
In a limited number of pediatric patients (1–15.5 years of age) receiving Hespan® at dosages ≤20 mL/kg, no differences in coagulation parameters or in amount of required replacement fluid reported compared with pediatric patients receiving albumin; increased PT reported in those receiving hetastarch dosages >20 mL/kg.
Geriatric Use
No substantial differences in efficacy relative to younger adults, but increased sensitivity cannot be ruled out. Use with caution.
Substantially eliminated by kidneys; monitor renal function periodically since geriatric patients are more likely to have decreased renal function. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use with caution in patients with history of liver disease.
Renal Impairment
More prolonged elevation of serum amylase concentration relative to otherwise healthy adults.
Patients with renal glomerular damage: Possible leakage of larger hetastarch molecules into urine, resulting in an elevated specific gravity, which can obscure diagnosis of renal failure.
Maximum plasma volume expansion in hypovolemic patients reached within several minutes after the end of IV infusion.
Duration
Effective plasma volume expansion may persist for ≥24 hours and diminish 24–36 hours following IV infusion.
Elimination
Elimination Route
Hetastarch molecules with molecular weight <50,000 are excreted rapidly in urine; approximately 33% of a single 500-mL (30-g) dose is excreted in urine within 24 hours. Molecules with molecular weight ≥50,000 are slowly degraded to molecules small enough to excrete. Hydroxyethylated glucose units are excreted intact; substantial quantities of glucose are not produced.
Intravascular concentration of the drug is <10% of the total dose after 2 weeks.
Biliary excretion accounts for <1% of total dose.
Not removed by hemodialysis. Not known if removed by other extracorporeal elimination techniques.
Stability
Storage
Parenteral
Injection
25°C (up to 40°C). Do not freeze; protect from excessive heat.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Hespan®
Drug Compatibility
Compatible with citrate concentrations up to 2.5% for 24 hours at room temperature.
Synthetic colloid derived from a waxy starch composed mainly of amylopectin. Approximately 75% of glucose units of the starch are hydroxyethylated (to retard degradation by serum amylase) to form polymers resembling glycogen; average molecular weight is approximately 600,000–670,000 (range: 450,000–800,000).
Exhibits colloidal osmotic effect. Retains intravascular fluid, resulting in plasma volume expansion slightly in excess of volume of solution infused.
Colloidal properties resemble those of human albumin, dextran 70, and dextran 75.
Causes temporary increase in arterial and venous pressures, cardiac index, stroke work index, and pulmonary wedge pressure in hypovolemic patients.
Increases erythrocyte sedimentation rate when added to whole blood; improves granulocyte collection by centrifugal leukopharesis.
Advice to Patients
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., CHF).
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
