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Hetastarch

Pronunciation

(HET a starch)

Index Terms

  • HES
  • HES 450/0.7
  • Hydroxyethyl Starch

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Hespan: 6% (500 mL)

Hextend: 6% (500 mL)

Generic: 6% (500 mL)

Brand Names: U.S.

  • Hespan
  • Hextend

Pharmacologic Category

  • Plasma Volume Expander, Colloid

Pharmacology

Produces plasma volume expansion by virtue of its highly colloidal starch structure

Excretion

Urine (33% to 40% within 24 hours); smaller molecular weight molecules (<50,000 daltons) rapidly excreted

Duration of Action

24-36 hours

Use: Labeled Indications

Granulocyte yield increase (Hespan): Used as an adjunct in leukapheresis to improve harvesting and increase the yield of granulocytes by centrifugation

Hypovolemia: Blood volume expander used in treatment of hypovolemia

Contraindications

Hypersensitivity to hydroxyethyl starch or any component of the formulation; renal failure with oliguria or anuria (not related to hypovolemia); any fluid overload condition (eg, pulmonary edema, congestive heart failure); pre-existing coagulation or bleeding disorders; critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy; severe liver disease

Hextend is also contraindicated in the treatment of lactic acidosis and in leukapheresis

Dosing: Adult

Plasma volume expansion: IV: 500-1000 mL (up to 1500 mL daily) or 20 mL/kg/day (up to 1500 mL daily). Note: With severe dehydration, administer crystalloid first. Daily dose and rate of infusion dependent on amount of blood lost, on maintenance or restoration of hemodynamics, and on amount of hemodilution. Titrate to individual colloid needs, hemodynamics, and hydration status. Do not use in the critically ill, those undergoing open heart surgery and cardiopulmonary bypass, or those with preexisting renal dysfunction.

Leukapheresis (Hespan): 250-700 mL; Note: Citrate anticoagulant is added before use and then the mixture is administered to the input line of the centrifuge apparatus.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Avoid use in patients with pre-existing renal dysfunction. Use is contraindicated in renal failure with oliguria or anuria (not related to hypovolemia). Discontinue use at the first sign of renal injury.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling; use with caution.

Administration

Do not use if crystalline precipitate forms or is turbid deep brown.

Volume expansion: Administer IV only; may be administered via infusion pump or pressure infusion. Administration rates vary depending upon the extent of blood loss, age, and clinical condition of patient but, in general, should not exceed 1.2 g/kg/hour (20 mL/kg/hour); however, rates up to 1000 mL over 7-8 minutes via pressure infusion have been studied in otherwise healthy subjects (McIlroy, 2003). Anaphylactoid reactions can occur, have epinephrine and resuscitative equipment available. If administered by pressure infusion, air should be withdrawn or expelled from bag prior to infusion to prevent air embolus. Do not administer Hextend with blood through the same administration set. Change IV tubing or flush copiously with normal saline before administering blood through the same line. Change IV tubing at least every 24 hours.

Leukapheresis: Mix Hespan and citrate well. Administer to the input line of the centrifuge apparatus at a ratio of 1:8 to 1:13 to venous whole blood.

Compatibility

Stable in NS.

Hespan:

Y-site administration: Incompatible with amikacin, cefotaxime, cefoxitin, gentamicin, theophylline, tobramycin.

Hextend:

Y-site administration: Incompatible: with amphotericin B, diazepam, sodium bicarbonate.

Storage

Store at 25°C (77°F); avoid excessive heat; do not freeze. Brief exposure up to 40°C (104°F) does not adversely affect the product. Do not use if crystalline precipitate forms or is turbid deep brown. In leukapheresis, admixtures of 500-560 mL of Hespan with citrate concentrations up to 2.5% are compatible for 24 hours.

Drug Interactions

Arbekacin: Hetastarch may enhance the nephrotoxic effect of Arbekacin. Avoid combination

Test Interactions

Serum amylase levels may be temporarily elevated following administration; could interfere with the diagnosis of pancreatitis.

Large hetastarch volumes may result in decreased coagulation factors, plasma proteins, and /or hematocrit due to dilutional effect.

Adverse Reactions

Frequency not defined.

Cardiovascular: Bradycardia, cardiac failure, circulatory overload, increased plasma volume, peripheral edema, tachycardia

Central nervous system: Chills, headache, intracranial hemorrhage

Dermatologic: Pruritus (dose dependent; may be delayed), skin rash

Endocrine & metabolic: Increased amylase (transient), metabolic acidosis

Gastrointestinal: Parotid gland enlargement, vomiting

Hematologic & oncologic: Anemia, blood coagulation disorder (Factor VIII deficiency, acquired von Willebrand's like syndrome, dilutional coagulopathy), disseminated intravascular coagulopathy (rare), hemolysis (rare), hemorrhage, prolonged bleeding time, prolonged partial thromboplastin time, prolonged prothrombin time, thrombocytopenia, wound hemorrhage

Hepatic: Increased serum bilirubin (indirect)

Hypersensitivity: Anaphylactoid reaction, hypersensitivity

Neuromuscular & skeletal: Myalgia

Respiratory: Bronchospasm, flu-like symptoms (mild), non-cardiogenic pulmonary edema

Miscellaneous: Fever

Postmarketing and/or case reports (Limited to important or life-threatening): Angioedema, cough, erythema multiforme, facial edema, hypotension, laryngeal edema, periorbital edema, renal insufficiency, severe hypotension, stridor, submaxillary gland enlargement, tachypnea, urticaria, ventricular fibrillation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Anaphylactic/anaphylactoid reactions have been reported; discontinue use immediately with signs of hypersensitivity and administer appropriate therapy. Patients allergic to corn may be allergic to hetastarch.

• Bleeding: Not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the period immediately afterward. HES solutions have been associated with excess bleeding in these patients. Monitor the coagulation status in patients undergoing open heart surgery in association with cardiopulmonary bypass. Discontinue use of HES at the first sign of coagulopathy. May cause coagulation abnormalities in conjunction with a reversible, acquired von Willebrands-like syndrome and/or factor VIII deficiency when used over a period of days. Consider replacement therapy if a severe factor VIII deficiency is detected. Coagulopathies may take several days to resolve. When used to prevent cerebral vasospasm in patients with subarachnoid hemorrhage (off-label use), significant clinical bleeding, intracranial bleeding and death have been reported.

• Fluid overload: Administration may cause fluid overload; use with caution in patients at risk from overexpansion of blood volume (eg, very young, elderly patients); use is contraindicated in heart failure or any pre-existing condition where volume overload is a potential concern.

• Hematologic: Large volumes of hetastarch may cause a reduction in hemoglobin concentration, coagulation factors, and other plasma proteins due to hemodilution; when used for leukapheresis, frequent clinical evaluation and complete blood counts (CBC) are recommended. If leukapheresis frequency is greater than whole blood donation guidelines, consider monitoring total leukocyte and platelet counts, leukocyte differential, PT, and PTT as well. Coagulation may be impaired (eg, prolonged PT, PTT, and clotting times) and a transient prolongation of bleeding time may be observed.

• Hepatic effects: Monitor liver function at baseline and periodically during treatment.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment. Monitor liver function at baseline and periodically during treatment. Use is contraindicated in patients with severe liver disease; may result in further reduction of coagulation factors, increasing the risk of bleeding.

• Renal impairment: Avoid use in patients with preexisting renal impairment; monitor fluid status, urine output, and infusion rate; discontinue use at the first sign of renal injury. Larger hetastarch molecules may leak into urine in patients with glomerular damage; may elevate urine specific gravity. Use is contraindicated with oliguria or anuria not related to hypovolemia.

• Thrombocytopenia: Use with caution in patients with thrombocytopenia; large volumes may interfere with platelet function and transiently prolong bleeding time. Observe for bleeding.

Special populations:

• Critically-ill patients: [U.S. Boxed Warning]: HES solutions have been associated with mortality and renal injury requiring renal replacement therapy in critically-ill patients, including patients with sepsis; avoid use in critically-ill adult patients, including those with sepsis. Use should also be avoided in patients admitted to the ICU (Brunkhorst, 2008; Perel, 2011; Perner, 2012; Zarychanski, 2009). The Society of Critical Care Medicine (SCCM) also recommends against the use of HES solutions for fluid resuscitation of severe sepsis and septic shock; crystalloids (eg, sodium chloride) are recommended instead (Dellinger, 2013). If used in patients who are not critically ill, avoid use in patients with pre-existing renal dysfunction and discontinue use at the first sign of renal injury. Since the need for renal replacement therapy has been reported up to 90 days after HES administration, continue to monitor renal function in all patients for at least 90 days.

Dosage form specific issues:

• Hextend: Contains calcium, lactate and potassium; use with caution in situations where electrolyte and/or acid-base disturbances may be exacerbated (renal impairment, respiratory alkalosis, metabolic alkalosis). Do not use in leukapheresis.

Other warnings/precautions:

• Appropriate use: Not a substitute for red blood cells or coagulation factors.

• Laboratory test interference: May cause temporarily elevated serum amylase levels and interfere with pancreatitis diagnosis. Dilutional effects (particularly with high doses) can cause decreased plasma proteins (including coagulation factors) and a decreased hematocrit.

Monitoring Parameters

Volume expansion: Blood pressure, heart rate, capillary refill time, CVP, RAP, MAP, urine output; if pulmonary artery catheter in place, monitor cardiac index, PCWP, SVR, and PVR; hemoglobin, hematocrit, serum electrolytes, renal function (continue to monitor for at least 90 days after administration), acid-base balance, coagulation parameters, liver function tests

Leukapheresis: CBC, total leukocyte and platelet counts, leukocyte differential count, hemoglobin, hematocrit, PT, PTT

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, or weight gain), shortness of breath, excessive weight gain, swelling of arms or legs, bruising, bleeding, tachycardia, bradycardia, or arrhythmia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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