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Hetastarch

FDA Drug Information • Also known as: Hetastarch In Sodium Chloride, Hextend

Brand Names
Hetastarch In Sodium Chloride, Hextend
Drug Class
Plasma Volume Expander [EPC]
Route
INTRAVENOUS
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY

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

    • Description

    11 DESCRIPTION 6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains: Hetastarch............................................................................ 6 g Sodium Chloride, USP........................................................ 0.9 g Water for Injection, USP..................................................... qs pH adjusted with Sodium Hydroxide, NF if necessary Concentration of Electrolytes (mEq/L): Sodium (Na + ) 154, Chloride (Cl - ) 154 (not including ions for pH adjustment). pH: 5.5 (3.5 to 7.0) Total osmolar concentration is 308 mOsmol/liter (calc). Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 670,000 with a range of 550,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,500,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is one 1–6 branch for every 20 glucose monomer units. The chemical name for hetastarch is hydroxyethyl starch. The structural formula is as follows: Amylopectin derivative in which R 2 , R 3 , and R 6 are H or CH 2 CH 2 OH, or R 6 is a branching point in the starch polymer connected through a 1-6 linkage to additional...

    What Is Hetastarch Used For?

    1 INDICATIONS AND USAGE 6% Hetastarch in 0.9% Sodium Chloride 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. The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

  • 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

    2 DOSAGE AND ADMINISTRATION Dosage for Acute Use in Plasma Volume Expansion 6% Hetastarch in 0.9% Sodium Chloride Injection 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. 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. 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 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 6% Hetastarch in 0.9% Sodium Chloride Injection 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 6% Hetastarch in 0.9% Sodium Chloride Injection

  • 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. The solution contains no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and is intended only for single-dose injection. When smaller doses are required the unused portion should be discarded. 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...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS Serious adverse reactions reported in postmarket 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. Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis.

  • 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. (Note: All of the studies listed below used licensed HES products except for reference 4.) A randomized controlled trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17; 95% CI, 1.01 to 1.36; p=0.03) and RRT (relative risk, 1.35; 95% CI, 1.01 to 1.80; p=0.04) in the HES treatment arm. 4 Another randomized controlled trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk, 1.20; 95% CI, 0.83 to 1.74; p=0.33) and a trend for RRT (relative risk, 1.83; 95% CI, 0.93 to 3.59; p=0.06) in HES patients. 5 A randomized controlled trial (N=7000) using different HES in a heterogeneous patient population consisting of critically ill adult patients admitted to the ICU reported no difference in mortality (relative risk, 1.06; 95% CI, 0.96 to 1.18; p=0.26) but increased use of RRT (relative risk, 1.21; 95% CI, 1.00 to 1.45; p=0.04) in HES patients. 6 In a retrospective study of adult patients (N=1442) undergoing pulmonary or esophageal surgery who were prophylactically fluid restricted during the procedure, 74 developed AKI (5.1%) within the first 72 hours postoperatively. Fluid restriction neither increased nor was a risk factor for AKI. AKI occurred more often when HES products were administered to patients with decreased renal function or having >2 risk factors with normal renal function, whereas restriction of crystalloid was unrelated to AKI, regardless of preoperative renal function. 12 In a retrospective case series of high-risk adult vascular surgery patients (N=796) receiving fluid therapy during a vascular surgery procedure, logistic regression analysis using prespecified confounding variables or suspected risk factors for AKI showed that intraoperative administration of an HES product was associated with increased likelihood of 30-day mortality and need for RRT, compared with use of crystalloids alone. 13 In a retrospective study of adult subjects undergoing elective noncardiac surgery, patients (N=14,680) receiving an HES product and crystalloid were propensity-matched with patients (N=14,680) receiving only crystalloid. After controlling for potential confounding variables, odds of experiencing AKI of severe intensity with HES was 21% greater than with crystalloid alone. In addition, AKI risk increased as a function of HES volume. 14 In a prospective observational study assessing the impact of HES products on recipient renal graft outcomes in brain-dead organ donors, data were obtained on 986 kidneys transplanted from 529 donors. Kidneys from donors who received HES had a higher rate of delayed graft function in recipient subjects (41% versus 31%). After accounting for the propensity of donors to receive HES products, HES product administration was independently associated with an increased risk of delayed graft function in recipients. A dose response...

    • Drug Interactions

    7 DRUG INTERACTIONS 6% Hetastarch in 0.9% Sodium Chloride Injection should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system.

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

    • Contraindications

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

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

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    8.3 Nursing Mothers It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic containers. Unit of Sale Concentration NDC 0409-7248-03 Case containing 12 Flexible Plastic Containers 30 g Hetastarch/500 mL (6 g Hetastarch/100 mL) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1287-6.0 Hospira logo

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.