HESPAN- hetastarch and sodium chloride injection, solution
B. Braun Medical Inc.
RENAL REPLACEMENT THERAPY
- In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including HESPAN®, increases risk of
- Renal replacement therapy
- Do not use HES products, including HESPAN®, in critically ill adult patients including patients with sepsis
HESPAN® is indicated in the treatment of hypovolemia when plasma volume expansion is desired. 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.
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.
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)].
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.
- 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:
- 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.
- Tear overwrap down at notch and remove solution container.
- Check for minute leaks by squeezing solution container firmly.
- If any leaks are found, discard solution as sterility may be impaired.
- Remove plastic protector from sterile set port at bottom of container.
- 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.
- 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.
- Do not use hydroxyethyl starch (HES) products, including HESPAN®, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT).
- Do not use HES products, including HESPAN®, in patients with severe liver disease
- Do not use HES products, including HESPAN®, in patients with known hypersensitivity to hydroxyethyl starch
- Do not use HES products, including HESPAN®, in clinical conditions where volume overload is a potential problem (such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia).
- Do not use HES products, including HESPAN®, in patients with pre-existing coagulation or bleeding disorders
- 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 in hospitalized patients for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including HESPAN®
- 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. 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).
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.
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