HEXTEND How Supplied/Storage and Handling

HOW SUPPLIED

HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic infusion containers.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. 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.

References:

1.

Diehl J, et al., Clinical Comparison of Hetastarch and Albumin in Postoperative Cardiac Patients. The Annals of Thoracic Surgery, 1982;34(6):674-679.

2.

Gold M, et al., Comparison of Hetastarch to Albumin for Perioperative Bleeding in Patients Undergoing Abdominal Aortic Aneurysm Surgery, Annals of Surgery, 1990;211(4):482-485.

3.

Kirklin J, et al., Hydroxyethyl Starch versus Albumin for Colloid Infusion Following Cardiopulmonary Bypass in Patients Undergoing Myocardial Revascularization, The Annals of Thoracic Surgery, 1984;37(1):40-46.

4.

Moggio RA, et al., Hemodynamic Comparison of Albumin and Hydroxyethyl Starch in Postoperative Cardiac Surgery Patients, Critical Care Medicine, 1983;11(12):943-945.

5.

Knutson, JE, et al., Does Intraoperative Hetastarch Administration Increase Blood Loss and Transfusion Requirements After Cardiac Surgery? Anesthesia Analg., 2000;90: 801-7.

6.

Cope, JT, et al., Intraoperative Hetastarch Infusion Impairs Hemostasis After Cardiac Operations, The Annals of Thoracic Surgery, 1997;63: 78-83.

7.

Damon L, Intracranial Bleeding During Treatment with Hydroxyethyl Starch, New England Journal of Medicine, 1987; 317(15):964-965.

8.

Brutocao D, et al., Comparison of Hetastarch with Albumin for Postoperative Volume Expansion in Children After Cardiopulmonary Bypass, Journal of Cardiothoracic and Vascular Anesthesia, 1996;10(3):348-351.

9.

Perner A, Haase N, Guttormsen AB, et al. Hydroxyethyl Starch 130/0.42 versus Ringer's Acetate in Severe Sepsis. N Eng J Med 2012; 367(2): 124-34

10.

CRYSTMAS: Guidet B, Martinet O, Boulain T, et al. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 versus 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 2012; 16(3): R94

11.

Myburgh JA, Finfer S, Bellomo R, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012; 367(20): 1901-11

12.

Ahn HJ, Kim JA, Lee AR, et al. The risk of acute kidney injury from fluid restriction and hydroxyethyl starch in thoracic surgery. Anesth Analg 2016; 122(1):186–193.

13.

Green RS, Butler MB, Hicks SD, et al. Effect of hydroxyethyl starch on outcomes in high-risk vascular surgery patients: A retrospective analysis. J Cardiothorac Vasc Anesth 2016; 30(4):967–72.

14.

Kashy BK, Podolyak A, Makarova N, et al. Effect of hydroxyethyl starch on postoperative kidney function in patients having noncardiac surgery. Anesthesiology 2014; 121 (4):730–9.

15.

Patel MS, Niemann CU, Sally MB, et al. The impact of hydroxyethyl starch use in deceased organ donors on the development of delayed graft function in kidney transplant recipients: A Propensity-Adjusted Analysis. Am J of Transplant 2015; 15 (8):2152–8.

16.

Rasmussen KC, Johansson PI, Højskov M, et al. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg 2014; 259 (2):249–54.

17.

Bayer O, Schwarzkopf D, Doenst T, et al. Perioperative fluid therapy with tetrastarch and gelatin in cardiac surgery – a prospective sequential analysis. Crit Care Med 2013; 41(11):2532–42.

18.

Lagny MG, Roediger L, Koch JN, et al. Hydroxyethyl starch 130/0.4 and the risk of acute kidney injury after cardiopulmonary bypass: A single-center retrospective study. J of Cardiothorac and Vasc Anesth 2016: 30(4):869–75.

19.

Wilkes MM, Navickis RJ. Postoperative renal replacement therapy after hydroxyethyl starch infusion: a meta-analysis of randomized trials. Neth J Crit Care 2014; 18:4–9.

20.

Allen CJ, Valle EJ, Jouria JM, et al. Differences between blunt and penetrating trauma after resuscitation with HES. J Trauma Acute Care Surg 2014; 77(6):859–64.

21.

Eriksson M, Brattström O, Mårtensson J, et al. Acute kidney injury following severe trauma: Risk factors and long-term outcome. J Trauma Acute Care Surg 2015; 79(3):407–12.

To Open

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

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container that is suspect should not be used.

Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1288-2.0

Revised: 10/2021