Version May 2024
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Angina pectoris, edema, tachycardia
Central nervous system: Anxiety, chills, dizziness, fatigue, headache, insomnia, malaise, paresthesia, shakiness
Dermatologic: Acne vulgaris
Endocrine & metabolic: Weight gain (temporary)
Gastrointestinal: Diarrhea, increased serum amylase, nausea
Hematologic & oncologic: Blood coagulation disorder, hemorrhage
Hepatic: Increased serum bilirubin
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, hypersensitivity reaction (includes hypotension, urticaria, wheezing)
Neuromuscular & skeletal: Weakness
Respiratory: Nasal congestion
Miscellaneous: Fever
<1%, postmarketing, and/or case reports: Renal disease
Hypersensitivity to hydroxyethyl starch or any component of the formulation; bleeding disorders; congestive heart failure where volume overload is a concern; oliguria or anuria not related to hypovolemia
Concerns related to adverse effects:
• Bleeding: Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass. HES solutions have been associated with excess bleeding in these patients. If used in other patient populations, discontinue use of HES at the first sign of coagulopathy.
• Fluid overload: Administration can cause fluid overload; use with caution in patients at risk from overexpansion of blood volume (eg, very young patients, aged patients, or those with heart failure).
• Hematologic: Large volumes of pentastarch may cause reduction in hemoglobin concentration, coagulation factors, and other plasma proteins due to hemodilution; coagulation may be impaired (eg, prolonged PT, PTT, and clotting times) and a transient prolongation of bleeding time may be observed.
• Hypersensitivity: 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 pentastarch.
• Kidney failure: HES solutions have been associated with kidney injury requiring renal replacement therapy in critically ill patients (Reinhart 2012); avoid use in critically ill adult patients, including those with sepsis and those admitted to the ICU. If used in patients who are not critically ill, avoid use in patients with preexisting kidney dysfunction and discontinue use at the first sign of kidney 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.
• Treatment-related mortality: Avoid use in critically ill adult patients, including those with sepsis and those admitted to the ICU. HES solutions have been associated with an increased risk of mortality in the critically ill (Brunkhorst 2008; Perel 2012; Perner 2012; SSC [Evans 2021]). Crystalloids (eg, sodium chloride and balanced solutions) are recommended as the fluid of choice for initial resuscitation and ongoing resuscitation (SSC [Evans 2021]).
Disease-related concerns:
• Bleeding disorders (eg, von Willebrand’s disease): Use caution in severe bleeding disorders; may increase the risk of more bleeding.
• Heart failure: Use with caution in patients with heart failure; monitor closely for fluid overload.
• Hepatic impairment: Use with caution in patients with mild-to-moderate hepatic impairment. Avoid use in patients with severe hepatic impairment. May result in further reduction of coagulation factors in patients with ongoing hepatic impairment, increasing the risk of bleeding. Use with caution in patients with a history of liver disease due to elevations of indirect bilirubin (significance unknown).
• Renal impairment: Use with caution in patients with renal impairment; fluid status including urine output should be monitored closely. Use is contraindicated with oliguria or anuria not related to hypovolemia.
Other warnings/precautions:
• Appropriate use: Not a substitute for red blood cells or coagulation factors.
Not available in the US; All Canadian dosage forms have been discontinued for more than 1 year.
No
Note: Not approved in the US
Adjunctive treatment in the management of shock
Note: The Surviving Sepsis Campaign International Guidelines for the Management of Sepsis and Septic Shock recommends against the use of hydroxyethyl starch (eg, pentastarch) for fluid resuscitation of sepsis and septic shock (SSC [Evans 2021]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Arbekacin: Pentastarch may enhance the nephrotoxic effect of Arbekacin. Risk X: Avoid combination
Adverse events were observed in animal reproduction studies.
Excretion in human breast milk is unknown; use caution.
BP, heart rate, central venous pressure, capillary refill time, cardiac index; if pulmonary artery catheter in place, monitor pulmonary capillary wedge pressure, systemic vascular resistance, and pulmonary vascular resistance; urine output, hemoglobin, hematocrit, serum electrolytes, kidney function (continue to monitor for at least 90 days after administration), coagulation parameters.
Produces plasma volume expansion by virtue of its highly colloidal starch structure
Onset of action: Volume expansion: Within 1 hour
Duration: 18-24 hours (improves hemodynamic status for 12-18 hours)
Half-life elimination: ~2 days
Excretion: Urine (~70% within 24 hours; ~80% within 1 week)
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