FDA label d99027da-104a-4613-94c3-479dd5f3b463

WARNINGS Life-threatening anaphylactic/anaphylactoid reactions have been rarely reported with hetastarch injection; death has occurred, but a causal relationship has not been established. Patients who develop severe anaphylactic/anaphylactoid reactions may need continued supportive care until symptoms have resolved. Hypersensitivity reactions can occur even after hetastarch injection has been discontinued. Usage in Plasma Volume Expansion Hetastarch injection has not been adequately evaluated to establish its safety in situations other than treatment of hypovolemia in elective surgery. Large volumes of hetastarch injection may transiently alter the coagulation mechanism due to hemodilution and a mild direct inhibitory action on Factor VIII. Administration of volumes of hetastarch 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. Hetastarch injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. However, this risk of bleeding diminished within hours. 5-6 Hematocrit may be decreased and plasma proteins diluted excessively by administration of large volumes of hetastarch injection. Administration of packed red cells, platelets, and fresh frozen plasma should be considered if excessive dilution occurs. Use over extended periods: Hetastarch injection has not been adequately evaluated to establish its safety in situations other than leukapheresis that require frequent use of colloidal solutions over extended periods. In some cases, hetastarch 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 hetastarch injection on a chronic basis. For example, in patients with subarachnoid hemorrhage where hetastarch 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. 7 Usage in Leukapheresis Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using hetastarch 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 hetastarch injection may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels. None of these decreases are to a degree recognized to be clinically significant risks to healthy donors.

ADVERSE REACTIONS Reported adverse reactions associated with hetastarch include: General Hypersensitivity (see WARNINGS ). Death, life-threatening anaphylactic/anaphylactoid reactions, cardiac arrest, ventricular fibrillation, severe hypotension, non-cardiac pulmonary edema, laryngeal edema, bronchospasm, angioedema, wheezing, restlessness, tachypnea, stridor, fever, chest pain, bradycardia, tachycardia, shortness of breath, chills, urticaria, pruritus, facial and periorbital edema, coughing, sneezing, flushing, erythema multiforme, and rash. Cardiovascular Circulatory overload, congestive heart failure, and pulmonary edema (see PRECAUTIONS ). Hematologic Intracranial bleeding, bleeding and/or anemia due to hemodilution (see WARNINGS ) and/or Factor VIII deficiency, acquired von Willebrand's-like syndrome, and coagulopathy including rare cases of disseminated intravascular coagulopathy and hemolysis. Metabolic Metabolic acidosis. Other Vomiting, peripheral edema of the lower extremities, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, and muscle pains. Hydroxyethyl starch-associated pruritus has been reported in some patients with deposits of hydroxyethyl starch in peripheral nerves.