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HETASTARCH Highlights (6% hetastarch in 0.9% sodium chloride injection)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. See full prescribing information for 6% Hetastarch in 0.9% Sodium Chloride Injection.
6% Hetastarch in 0.9% Sodium Chloride Injection, for intravenous use
Initial U.S. Approval: 1991

WARNING: MORTALITY;
KIDNEY INJURY; COAGULOPATHY

See full prescribing information for complete boxed warning.

  • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of
    • Mortality
    • Kidney injury (5.1)
    • Coagulopathy (5.2)
  • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. (1)

INDICATIONS AND USAGE

•
6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch indicated for treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. (1)
•
6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. (1)

DOSAGE AND ADMINISTRATION

For intravenous use only.

Recommended Dosage

 

Dose

Adults (2.1)

500 to 1000 mL

Leukapheresis
(2.2)

250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is added to the input line of the centrifugation apparatus.

DOSAGE FORMS AND STRENGTHS

•
30 g hetastarch in 500 mL 0.9% sodium chloride injection. (3)

CONTRAINDICATIONS

  • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

WARNINGS AND PRECAUTIONS

•
Avoid use in patients with pre-existing renal dysfunction (5.1)
•
Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis; surgical patients; and blunt trauma patients (5.1)
•
Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury (5.1)
•
Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection (5.1)
•
6% Hetastarch in 0.9% Sodium Chloride 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. Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy (5.2)
•
Monitor liver function in patients receiving HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection (5.2)

ADVERSE REACTIONS

•
Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or electronically at [email protected], or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Use with caution with drugs that negatively influence the coagulation system. (7)
•
The safety and compatibility of other additives have not been established. (7)

Revised: 7/2022

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