Hetastarch

Class: Replacement Preparations
VA Class: BL800
CAS Number: 9005-27-0
Brands: Hespan, Hextend

Introduction

Plasma volume expander; a nonprotein synthetic colloid.^{a b}

Uses for Hetastarch

Hypovolemia

Used for plasma volume expansion in the treatment of hypovolemia.^{b c} Not a substitute for whole blood or plasma.¹⁰⁰

Comparable with human albumin 5% as a plasma volume expander.^{b c}

Leukapheresis

6% hetastarch in 0.9% sodium chloride injection: Adjunct in leukapheresis to enhance the yield of granulocytes by centrifugal means.¹⁰⁰

Hetastarch 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.^{100 b}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹⁰⁰

6% Hetastarch in lactated electrolye injection (Hextend): Do not administer simultaneously with blood through the same administration set.^c Hextend contains calcium; risk of coagulation.^c

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.^{100 b c}

Dosage

Adults

Hypovolemia

IV

Determine dosage based on amount of fluid lost, resultant hemoconcentration, and patient’s age, weight, and clinical condition.^{100 b c}

Usually, 500–1000 mL (30–60 g).¹⁰⁰

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.^{b c}

Dosages >1500 mL daily have been used in postoperative and trauma patients with severe blood loss, ^{100 b} generally in conjunction with blood and blood products.^c

Special Populations

Geriatric Patients

Select dosage with caution.^c (See Geriatric Use under Cautions.)

Cautions for Hetastarch

Contraindications

• 
  

  Coagulation or bleeding disorders.^{b c}

  
  


• 
  

  CHF, renal disease with oliguria or anuria not related to hypovolemia, or other clinical conditions exacerbated by volume overload.^{b c}

  
  


• 
  

  Known hypersensitivity to hydroxyethyl starch or any ingredient in the formulation.^{b c}

  
  

Warnings/Precautions

Warnings

Therapy Limitations

Hypovolemia: Safety established only for treatment of hypovolemia in elective surgery.^{b c}

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.^b

6% Hetastarch in lactated electrolyte injection (Hextend): Not indicated for use in leukapheresis.^c

Hemodilution

Risk of excessive hemodilution (e.g., decreased hematocrit and plasma protein concentrations) following administration of volumes >25% of blood volume in <24 hours.^{b c} Consider administering packed red cells, platelets, or fresh frozen plasma if excessive hemodilution occurs.^{b c} Avoid excessive hemodilution, particularly in patients at risk of CHF or pulmonary edema.^{b c}

Modest decreases in platelet counts and hemoglobin concentrations reported in donors undergoing repeated leukapheresis procedures; hemoglobin concentration returns to normal within 24 hours.^b

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.^{b c} (See Therapy Limitations and also see Patient Evaluation and Laboratory Monitoring under Cautions.)

Safety of prolonged use (i.e., over several days) not established in situations other than leukapheresis.^b Prolonged use associated with coagulation abnormalities, von Willebrand’s-like syndrome, and/or Factor VIII deficiency; intracranial bleeding resulting in death reported.^{b c} Consider replacement therapy if severe factor VIII deficiency or von Willebrand’s disease occurs.^{b c} Coagulopathy may take several days to resolve.^{b c}

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.^{b c} Hypersensitivity reactions can occur even after therapy is discontinued.^{b c}

Possible hypersensitivity reaction in patients allergic to corn; use with caution in such patients.^{b c}

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.^{a b c} Continued supportive care needed until manifestations have resolved.^{b c}

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.^{b c}

Transient elevation of serum amylase concentration reported; no association with pancreatitis demonstrated.^{b c}

General Precautions

Electrolyte Components of Hetastarch Preparation

Observe the usual precautions and contraindications associated with the electrolyte components in Hextend (potassium, sodium, lactate).^c

Observe the usual precautions and contraindications associated with the sodium in 6% hetastarch in 0.9% sodium chloride.^b

Patient Evaluation and Laboratory Monitoring

Hypovolemia: Closely monitor vital signs, fluid balance, electrolyte concentrations, acid-base balance, hemoglobin, hematocrit, platelet count, PT, and aPTT.^{b c}

Leukapheresis: Perform clinical evaluation regularly.^b Monitor CBC.^b 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.^b

Specific Populations

Pregnancy

Category C.^{b c}

Lactation

Not known whether hetastarch is distributed into human milk.^{b c} Use with caution.^{b c}

Pediatric Use

Safety and efficacy not established.^{b c} Use with caution.^a

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.^{b c}

Geriatric Use

No substantial differences in efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^c Use with caution.^a

Substantially eliminated by kidneys; monitor renal function periodically since geriatric patients are more likely to have decreased renal function.^c (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in patients with history of liver disease.^{b c}

Renal Impairment

More prolonged elevation of serum amylase concentration relative to otherwise healthy adults.^{b c}

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.^{b c}

Use with caution.^{b c}

Common Adverse Effects

Circulatory overload, bleeding, metabolic acidosis, vomiting, peripheral edema, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headache, muscle pain.^{b c}

Interactions for Hetastarch

Anticoagulants

Caution in patients receiving anticoagulants.^{b c}

Hetastarch Pharmacokinetics

Absorption

Onset

Maximum plasma volume expansion in hypovolemic patients reached within several minutes after the end of IV infusion.^a

Duration

Effective plasma volume expansion may persist for ≥24 hours^a and diminish 24–36 hours following IV infusion.^c

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.^{b c} Molecules with molecular weight ≥50,000 are slowly degraded to molecules small enough to excrete.^a Hydroxyethylated glucose units are excreted intact; substantial quantities of glucose are not produced.^{a b c}

Intravascular concentration of the drug is <10% of the total dose after 2 weeks.^{b c}

Biliary excretion accounts for <1% of total dose.^{b c}

Not removed by hemodialysis.^{b c} Not known if removed by other extracorporeal elimination techniques.^{b c}

Stability

Storage

Parenteral

Injection

25°C (up to 40°C).^{b c} Do not freeze; protect from excessive heat.^{b c}

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.^b

Admixture CompatibilityHID

Compatible
Fosphenytoin sodium

Y-site CompatibilityHID

Compatible
Cimetidine HCl
Diltiazem HCl
Enalaprilat
Eratapenem
Nicardipine HCl
Incompatible
Amikacin sulfate
Cefotaxime sodium
Cefoxitin sodium
Gentamicin sulfate
Theophylline
Tobramycin sulfate
Variable
Ampicillin sodium
Cefazolin sodium
Doxycycline hyclate
Ranitidine HCl

Hextend

Solution Compatibility

Do not administer simultaneously with blood through the same administration set; risk of coagulation due to calcium in Hextend.^c

Drug Compatibility

Y-site CompatibilityHID

Compatible
Alfentanil HCl
Amikacin sulfate
Aminophylline
Amiodarone HCl
Ampicillin sodium
Ampicillin sodium–sulbactam sodium
Atracurium besylate
Azithromycin
Aztreonam
Bumetanide
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Cefepime HCl
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Chlorpromazine HCl
Cimetidine HCl
Ciprofloxacin
Clindamycin phosphate
Co-trimoxazole
Dexamethasone sodium phosphate
Digoxin
Diltiazem HCl
Diphenhydramine HCl
Dobutamine HCl
Dolasetron mesylate
Dopamine HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Ephedrine sulfate
Epinephrine HCl
Erythromycin lactobionate
Esmolol
Famotidine
Fenoldopam mesylate
Fentanyl citrate
Fluconazole
Furosemide
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium succinate
Hydromorphone HCl
Hydroxyzine HCl
Inamrinone lactate
Isoproterenol HCl
Ketorolac tromethamine
Labetalol HCl
Levofloxacin
Lidocaine HCl
Lorazepam
Magnesium sulfate
Mannitol
Meperidine HCl
Methylprednisolone sodium succinate
Metoclopramide HCl
Metronidazole
Midazolam HCl
Milrinone lactate
Mivacurium chloride
Morphine sulfate
Nalbuphine HCl
Nitroglycerin
Norepinephrine bitartrate
Ofloxacin
Ondansetron HCl
Pancuronium bromide
Phenylephrine HCl
Piperacillin sodium–tazobactam sodium
Potassium chloride
Procainamide HCl
Prochlorperazine edisylate
Promethazine HCl
Ranitidine HCl
Rocuronium bromide
Sodium nitroprusside
Succinylcholine chloride
Sufentanil citrate
Theophylline
Thiopental sodium
Ticarcillin disodium–clavulanate potassium
Tobramycin sulfate
Vancomycin HCl
Vecuronium bromide
Verapamil HCl
Incompatible
Amphotericin B
Diazepam
Sodium bicarbonate

ActionsActions

• 
  

  Synthetic colloid derived from a waxy starch composed mainly of amylopectin.^{b c} 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).^{a b c}

  
  


• 
  

  Exhibits colloidal osmotic effect.^a Retains intravascular fluid,^c resulting in plasma volume expansion slightly in excess of volume of solution infused.^a

  
  


• 
  

  Colloidal properties resemble those of human albumin, dextran 70, and dextran 75.^a

  
  

  Does not have antigenic properties; generally does not interfere with blood-typing or cross-matching.^a

  
  


• 
  

  Causes temporary increase in arterial and venous pressures, cardiac index, stroke work index, and pulmonary wedge pressure in hypovolemic patients.^a

  
  


• 
  

  Increases erythrocyte sedimentation rate when added to whole blood; improves granulocyte collection by centrifugal leukopharesis.^{b c}

  
  

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).^{b c}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{b c}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{b c} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hetastarch in Sodium Chloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion only	6% Hetastarch in 0.9% Sodium Chloride*	Hespan	Braun
			6% Hetastarch in 0.9% Sodium Chloride Injection	Baxter, Hospira

Hetastarch in Lactated Electrolyte

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion only	6% Hetastarch in Lactated Electrolyte	Hextend	Abbott

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Du Pont Pharmaceuticals. Hespan (6% hetastarch in 0.9% sodium chloride injection) prescribing information. In: Huff BB, ed. Physicians’ desk reference. 43rd ed. Oradell, NJ: Medical Economics Company Inc; 1989:904-5.

101. Damon L, Adams M, Stricker RB et al. Intracranial bleeding during treatment with hydroxyethyl starch. N Engl J Med. 1987; 317:964-5. [IDIS 234727] [PubMed 2442613]

102. Bianchine JR. Intracranial bleeding during treatment with hydroxyethyl starch. N Engl J Med. 1987; 317:965.

103. Symington BE. Hetastarch and bleeding complications. Ann Intern Med. 1986; 105:627-8. [IDIS 221752] [PubMed 2428275]

a. AHFS drug information 2003. McEvoy GK, ed. Hetastarch. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2516-7.

b. B. Braun Medical Inc. Hespan (6% hetastarch in 0.9% sodium chloride injection) prescribing information. Irvine, CA; 2003 Apr.

c. Abbott Laboratories. Hextend (6% hetastarch in lactated electrolyte injection) prescribing information. North Chicago, IL; 2003 Oct.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:867-75.

More Hetastarch resources

• Hetastarch Side Effects (in more detail)
• Hetastarch Use in Pregnancy & Breastfeeding
• Hetastarch Support Group
• 0 Reviews for Hetastarch - Add your own review/rating

• Hetastarch Prescribing Information (FDA)


• hetastarch Concise Consumer Information (Cerner Multum)


• Hespan MedFacts Consumer Leaflet (Wolters Kluwer)


• Hespan Prescribing Information (FDA)

Compare Hetastarch with other medications

• Blood Disorders