Hetastarch

HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma.

Dosage for Acute Use in Plasma Volume Expansion HEXTEND is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration as well as age, weight, and clinical condition of the patient. Adults: The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required although doses of isotonic solutions containing 6% hetastarch up to 1500 mL have been used during major surgery generally without a need for blood or blood products. Volumes in excess of 1500 mL per day have been used where severe blood loss has occurred although generally only in conjunction with the administration of blood and blood products.

Do not use HES products, including HEXTEND, unless adequate alternative treatment is unavailable.

Boxed warning (mortality, kidney injury, coagulopathy •): Use of hydroxyethyl starch (HES) products, including HEXTEND ®, increases risk of o Mortality o Kidney injury o Coagulopathy DO NOT use HES products, including HEXTEND ®, unless adequate alternative treatment is unavailable. • Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis, surgical patients, and blunt trauma patients • Avoid use in patients with pre-existing renal dysfunction • Discontinue use of HEXTEND at the first sign of renal injury • Continue to monitor renal function for at least 90 days as use of renal replacement therapy (RRT) has been reported up to 90 days after administration of HES products • Monitor the coagulation status of surgery patients, as excess bleeding has been reported with HES solutions in this population.

Serious adverse reactions reported in postmarketing clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects. In clinical trials comparing the plasma volume expanding properties of HEXTEND (n=60) with those of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=59), there were no significant differences in the number of adverse or serious adverse events between the two groups. Reported adverse reactions with isotonic solutions containing 6% hetastarch include: General Hypersensitivity.

Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F), however, brief exposure up to 40°C does not adversely affect the product.