HESPAN

HESPAN- hetastarch and sodium chloride injection, solution
B. Braun Medical Inc.

WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY

  • Use of hydroxyethyl starch (HES) products, including HESPAN®, increases risk of
    • Mortality
    • Kidney injury (5.1)
    • Coagulopathy (5.2)
  • DO NOT use HES products, including HESPAN®, unless adequate alternative treatment is unavailable. (1)

1 INDICATIONS AND USAGE

HESPAN® 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.

The adjunctive use of HESPAN® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

2 DOSAGE AND ADMINISTRATION

Dosage for Acute Use in Plasma Volume Expansion

HESPAN® 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.

2.1 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. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].

2.2 Leukapheresis

250 to 700 mL of HESPAN® (6% hetastarch in 0.9% sodium chloride injection) with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The HESPAN® and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

2.3 Direction for use for HESPAN®

  • Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact.
  • Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
  • Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion.
  • For single use only. Discard unused portion.

CAUTION: Before administering to the patient, review these directions:

Visual Inspection

  • Do not remove the plastic infusion container from its overwrap until immediately before use.
  • Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
  • Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter.
  • Any container which is suspect should not be used.

To Open

  1. Tear overwrap down at notch and remove solution container.
  2. Check for minute leaks by squeezing solution container firmly.
  3. If any leaks are found, discard solution as sterility may be impaired.

Preparation for Administration

  1. Remove plastic protector from sterile set port at bottom of container.
  2. Attach administration set. Refer to complete directions accompanying set.

When stored at room temperature, HESPAN® admixtures of 500-560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.

3 DOSAGE FORMS AND STRENGTHS

Single-use container:

  • 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.

4 CONTRAINDICATIONS

  • Do not use HES products, including HESPAN®, unless adequate alternative treatment is unavailable.

5 WARNINGS AND PRECAUTIONS

5.1 Mortality and Renal Dysfunction

  • Critically ill patients, including patients with sepsis, are at increased risk of mortality and acute kidney injury (AKI), including need for renal replacement therapy (RRT).
  • Surgery patients are at increased risk of mortality and AKI
  • Blunt trauma patients are at increased risk of mortality and AKI.
  • Avoid use in patients with pre-existing renal dysfunction
  • Discontinue use of HESPAN® at the first sign of renal injury
  • 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 HESPAN®

5.2 Coagulopathy

  • HESPAN® 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. Monitor the coagulation status of surgery patients, as excess bleeding has been reported with HES solutions in this population. Discontinue use of HESPAN® at first sign of coagulopathy1-2

HESPAN® has not been adequately evaluated to establish its safety in uses over extended periods other than leukapheresis. HESPAN® has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand’s-like syndrome and/or Factor Vlll deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor Vlll deficiency is identified. If a coagulopathy develops, it may take several days to resolve. Certain conditions may affect the safe use of HESPAN® on a chronic basis. For example, in patients with subarachnoid hemorrhage where HESPAN® 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 HESPAN® 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 HESPAN® 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 HESPAN® 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).

5.3 Hypersensitivity Reactions

Life threatening anaphylactic/anaphylactoid reactions including death have been rarely reported with HESPAN®. 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.

5.4 Circulatory Overload

HESPAN® has not been adequately evaluated to establish its safety in situations other than treatment of hypovolemia in elective surgery.

Large volumes of HESPAN® may transiently alter the coagulation mechanism due to hemodilution and a direct inhibitory action on Factor Vlll. Administration of volumes of HESPAN® 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 HESPAN® 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. HESPAN® 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.

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