hetastarch

Hetastarch, with the chemical name of hydroxyethyl starch, is a starch derived from corn, used to increase the fluid volume of blood when other adequate treatments are not available.

Hetastarch cannot be used as a substitute for blood or plasma, the fluid component of blood. Hetastarch is also used in leukapheresis, a process by which white cells (granulocytes) are collected from donors by passing their blood through a medical device. Hetastarch facilitates the separation of granulocytes from red blood cells and improves the yield of granulocytes.

Hetastarch is a synthetic colloid derived from amylopectin, a starch commonly present in many foods. Hetastarch solution increases the oncotic pressure within the blood vessels, which draws the fluid from the interstitial spaces into the intravascular space, expanding the plasma volume. In leukapheresis, hetastarch increases the sedimentation rate of red cells (erythrocytes) which facilitates the extraction of granulocytes from donor blood.

Hetastarch solution is administered by intravenous infusion to patients with low plasma volume (hypovolemia) due to severe blood loss from trauma or surgery. Some formulations of hetastarch solution also contain electrolytes in the proportions that blood normally contains. The degree of plasma volume expansion depends on the patient’s intravascular status, and the volume decreases in the following 24 to 36 hours.

• Do not use hetastarch when alternate treatments are available.
• Do not use hetastarch in patients with hypersensitivity to hetastarch, corn starch or any of the components of the formulation.
• Do not use hetastarch in the following conditions:
  • Severe congestive heart failure (CHF)
  • Severe bleeding disorders
  • Severe kidney failure
• Use with caution in patients with:
  • Liver disease
  • Low platelet count (thrombocytopenia)
  • Kidney impairment
• Hetastarch use increases the risk of acute kidney injury and mortality in the following conditions:
  • Critically ill patients, including those with sepsis
  • Surgery patients
  • Blunt trauma patients
• Avoid using hetastarch products in patients with pre-existing kidney function impairment. Discontinue use at the first sign of kidney injury. Monitor the patient’s kidney function for at least 90 days after administration of hetastarch.
• Hetastarch can interfere with the blood clotting process and cause bleeding disorders (coagulopathy):
  • Do not use in patients undergoing open heart surgery with cardiopulmonary bypass or immediately post-procedure, because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired.
  • Monitor coagulation status of patients, particularly surgery patients.
  • Discontinue hetastarch at the first sign of coagulopathy.
• There have been rare reports of anaphylactic reactions including death, possibly to corn starch from which hetastarch is made. Discontinue hetastarch at the first sign of hypersensitivity symptoms and institute appropriate treatment. Hypersensitivity reactions can occur even after discontinuation of hetastarch.
• Exercise caution to avoid excessive volume expansion that can result in circulatory overload and excessive dilution of the blood (hemodilution), especially in patients with a risk for congestive heart failure and pulmonary edema.
• Hemodilution can reduce the levels of hemoglobin, coagulation factors, and plasma proteins. Consider administration of packed red cells, platelets, or fresh frozen plasma, if indicated. Monitor the patient’s vital signs and hemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time.
• Monitor liver function in patients receiving hetastarch.
• Hextend brand of hetastarch contains calcium, potassium, and lactate. Use with caution in patients with electrolyte or acid/base disturbances such as metabolic acidosis, respiratory alkalosis, or kidney impairment. Avoid use in lactic acidosis.
• Do not use Hextend in leukapheresis.

Common side effects of hetastarch include:

• Hypersensitivity reactions including:
  • Rash
  • Hives (urticaria)
  • Itching (pruritus)
  • Erythema multiforme, a type of severe skin reaction
  • Coughing
  • Sneezing
  • Flushing
  • Chills
  • Fever
  • Restlessness
  • Swelling in the face and around eyes (facial and periorbital edema)
  • Swelling under the skin and in mucous tissue (angioedema)
  • Swelling of the voice box (laryngeal edema)
  • Non-cardiac pulmonary edema
  • Bronchospasm
  • Wheezing
  • Whistling sound while breathing (stridor)
  • Rapid breathing (tachypnea)
  • Shortness of breath (dyspnea)
  • Chest pain
  • Abnormally rapid or slow heart rate (tachycardia or bradycardia)
  • Severely low blood pressure (hypotension)
  • Rapid and irregular ventricular contraction (ventricular fibrillation)
  • Cardiac arrest
  • Life-threatening allergic reaction (anaphylaxis)
  • Death
• Circulatory overload
• Congestive heart failure
• Pulmonary edema
• Intracranial bleeding
• Bleeding or anemia due to hemodilution and/or clotting factor VIII deficiency
• Acquired von-Willebrand’s like syndrome, a clotting disorder (coagulopathy)
• Disseminated intravascular coagulopathy
• Destruction of red blood cells (hemolysis)
• Excessive acidity of body fluids (metabolic acidosis)
• Vomiting
• Headache
• Muscle pains
• Influenza-like symptoms
• Peripheral edema of lower extremities
• Submaxillary and parotid glandular enlargement

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Injectable solution

• 6% hydroxyethyl starch in 0.9% NaCl (Hespan)
• 6% hydroxyethyl starch in lactated electrolyte solution (Hextend)

Adult:

Hypovolemia

• 500-1000 mL (30-60 g) intravenous (IV)
• Not to exceed 1500 mL/day (20 mL/kg)
• Monitor: Complete blood count (CBC) with differential, hemoglobin (Hgb), hematocrit (Hct), prothrombin time (PT), partial thromboplastin time (PTT)

Leukapheresis

• 250-700 mL Hespan to which citrate anticoagulant has been added
• Ratio of 1:8 to 1:13 to venous whole blood
• Monitor: CBC with differential, Hgb, Hct, PT, PTT

Renal Impairment

• Creatinine clearance (CrCl) below 10 mL/min: Following a regular initial dose, reduce subsequent doses by 20-50% of normal

Pediatric:

Hypovolemia (Off-label)

• 10 mL/kg/dose
• Not to exceed 20 mL/kg

Leukapheresis (Off-label)

• 250-700 mL Hespan
• Infused at a ratio of 1:8 to 1:13 to venous whole blood.

Other Information

• Monitor: CBC with differentials, Hgb, Hct, PT, PTT

Overdose

• Hetastarch is typically administered under clinical conditions in the intensive care unit where the patient’s vital signs are continuously monitored and overdose is unlikely.
• Excessive administration of hetastarch can increase the plasma volume too much and cause circulatory overload and hemodilution.
• Hetastarch interferes with the function of platelets and clotting (coagulation) factors and can increase the risk of bleeding.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of hetastarch include:
  • Arbekacin
• Hetastarch has no known serious, mild or moderate interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the safety of hetastarch use in pregnant women, however, animal reproductive studies show it can cause fetal harm. Hetastarch should be used with caution in pregnancy only if clearly needed and potential benefits to the mother outweigh potential fetal risks.
• It is not known if hetastarch is present in breastmilk. Hetastarch should be administered with caution in nursing mothers because many drugs are excreted in breastmilk.