Hetastarch

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Usual Adult Dose for Hypovolemia:

Dosage for Acute Use in Plasma Volume Expansion: 500 to 1000 mL by intravenous infusion
Maintenance dose: Total dosage and rate of infusion depends on the amount of blood or plasma lost and the resultant hemoconcentration
Maximum dose: Doses of more than 1500 mL per day (approximately 20 mL per kg of body weight) are usually not required although higher doses have been used in postoperative and trauma patients.

Dosage in Leukapheresis: 250 to 700 mL to which citrate anticoagulant has been added and administered to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood.

Comments:
-Hetastarch and citrate should be thoroughly mixed to assure effective anticoagulation.
-Hetastarch admixtures of 500 to 560 mL with citrate concentrations up to 2.5% are compatible for 24 hours at room temperature.

• Synthetic colloid derived from a waxy starch composed mainly of amylopectin.100 106 Approximately 75% of glucose units of the starch are hydroxyethylated to form polymers resembling glycogen; average molecular weight is approximately 600–670 (range: 450–800).100 106

• Exhibits colloidal oncotic effect.106 Retains intravascular fluid,106 resulting in plasma volume expansion.100 106

• 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 leukapheresis.100

• If you have an allergy to hetastarch or any other part of hetastarch.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bleeding problems, blood clotting problems, high blood volume, heart failure, kidney disease, or liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take hetastarch with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take hetastarch or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hetastarch. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Single-use container:

Renal Dysfunction

Coagulopathy

6% Hetastarch in 0.9% Sodium Chloride Injection has not been adequately evaluated to establish its safety in uses over extended periods other than leukapheresis. 6% Hetastarch in 0.9% Sodium Chloride Injection has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand’s-like syndrome and/or Factor VIII deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve. Certain conditions may affect the safe use of 6% Hetastarch in 0.9% Sodium Chloride Injection on a chronic basis. For example, in patients with subarachnoid hemorrhage where 6% Hetastarch in 0.9% Sodium Chloride Injection is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur. Intracranial bleeding resulting in death has been reported.3

Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using 6% Hetastarch in 0.9% Sodium Chloride Injection due to the volume expanding effects of Hetastarch and to the collection of platelets and erythrocytes. Hemoglobin levels usually return to normal within 24 hours. Hemodilution by 6% Hetastarch in 0.9% Sodium Chloride Injection may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels. Regular and frequent clinical evaluation and complete blood counts (CBC) are necessary for proper monitoring of 6% Hetastarch in 0.9% Sodium Chloride Injection use during leukapheresis. If the frequency of leukapheresis is to exceed the guidelines for whole blood donation, you may wish to consider the following additional tests: total leukocyte and platelet counts, leukocyte differential count, hemoglobin and hematocrit, prothrombin time (PT), and partial thromboplastin time (PTT).

Hypersensitivity Reactions

Life threatening anaphylactic/anaphylactoid reactions including death have been rarely reported with 6% Hetastarch in 0.9% Sodium Chloride Injection. Patients may develop hypersensitivity reaction to corn starch from which this product is made. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved.

Circulatory Overload

6% Hetastarch in 0.9% Sodium Chloride Injection has not been adequately evaluated to establish its safety in situations other than treatment of hypovolemia in elective surgery.

Large volumes of 6% Hetastarch in 0.9% Sodium Chloride Injection may transiently alter the coagulation mechanism due to hemodilution and a direct inhibitory action on Factor VIII. Administration of volumes of 6% Hetastarch in 0.9% Sodium Chloride Injection that are greater than 25% of the blood volume in less than 24 hours may cause significant hemodilution reflected by lower hematocrit and plasma protein values. Administration of packed red cells, platelets, or fresh frozen plasma should be considered if clinically indicated.

When using 6% Hetastarch in 0.9% Sodium Chloride Injection for plasma volume expansion, caution should be taken to avoid excessive hemodilution and circulatory overload especially in those patients at risk for developing congestive heart failure and pulmonary edema. 6% Hetastarch in 0.9% Sodium Chloride Injection is primarily excreted via the kidneys so caution should be exercised in patients who have impaired renal function. Although the risk of circulatory overload is largely dependent on the clinical circumstances, use of doses higher than 20 mL/kg/24h will increase the risk significantly. Increased risk of coagulation abnormalities and bleeding is also associated with higher doses. Monitor patients’ vital signs and hemoglobin, hematocrit, platelet count, prothrombin time and partial thromboplastin time.

Liver Function Test

Drug/Laboratory Test Interactions

Bilirubin Levels

Indirect bilirubin levels of 8.3 mg/L (normal 0.0-7.0 mg/L) have been reported in 2 out of 20 normal subjects who received multiple infusions of 6% Hetastarch in 0.9% Sodium Chloride Injection. Total bilirubin was within normal limits at all times; indirect bilirubin returned to normal by 96 hours following the final infusion. The significance, if any, of these elevations is not known; however, caution should be observed before administering 6% Hetastarch in 0.9% Sodium Chloride Injection to patients with a history of liver disease.

Serum Amylase Levels

Elevated serum amylase levels may be observed temporarily following administration of 6% Hetastarch in 0.9% Sodium Chloride Injection although no association with pancreatitis has been demonstrated. Serum amylase levels cannot be used to assess or to evaluate for pancreatitis for 3-5 days after administration of 6% Hetastarch in 0.9% Sodium Chloride Injection. Elevated serum amylase levels persist for longer periods of time in patients with renal impairment. Hetastarch has not been shown to increase serum lipase.

Hemodialysis

6% Hetastarch in 0.9% Sodium Chloride Injection is not eliminated by hemodialysis. The utility of other extracorporeal elimination techniques has not been evaluated.

Granulocyte yield increase (Hespan only): Adjunct in leukapheresis to improve harvesting and increase the yield of granulocytes by centrifugation.

Plasma volume expansion: Blood volume expander used in treatment of hypovolemia.

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Severe impairment: Use is contraindicated.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), shortness of breath, excessive weight gain, swelling of arms or legs, bruising, bleeding, tachycardia, bradycardia, or arrhythmia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Dosage for Acute Use in Plasma Volume Expansion: 500 to 1000 mL by intravenous infusion
Maintenance dose: Total dosage and rate of infusion depends on the amount of blood or plasma lost and the resultant hemoconcentration
Maximum dose: Doses of more than 1500 mL per day (approximately 20 mL per kg of body weight) are usually not required although higher doses have been used in postoperative and trauma patients.

Dosage in Leukapheresis: 250 to 700 mL to which citrate anticoagulant has been added and administered to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood.

Comments:
-Hetastarch and citrate should be thoroughly mixed to assure effective anticoagulation.
-Hetastarch admixtures of 500 to 560 mL with citrate concentrations up to 2.5% are compatible for 24 hours at room temperature.

Data not available