pharmacopeia
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/api/v1/drug/hetastarch

Boxed 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 )

Mechanism of action

Sourced from openFDA

The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

• Avoid use in patients with pre-existing renal dysfunction ( 5.1 ) • Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis; surgical patients; and blunt trauma patients ( 5.1 ) • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury ( 5.1 ) • Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection ( 5.1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection 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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

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. 8.4 Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established.

Pharmacokinetics

Sourced from openFDA
Metabolism
Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
162 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Exposure During Pregnancy4226%
  2. 2Hypotension3522%
  3. 3Bradycardia3421%
  4. 4Live Birth3220%
  5. 5Stevens-johnson Syndrome148.6%
  6. 6Toxic Epidermal Necrolysis138.0%
  7. 7Drug Interaction106.2%
  8. 8Rash106.2%
  9. 9Drug Ineffective84.9%
  10. 10Off Label Use84.9%
  11. 11Ovarian Hyperstimulation Syndrome74.3%
  12. 12Haematocrit Decreased63.7%
  13. 13Multi-organ Failure63.7%
  14. 14Pneumonia63.7%
  15. 15Renal Failure63.7%

Literature

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Recent PubMed references pinned to Hetastarch as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 204 ClinicalTrials.gov registrations naming Hetastarch as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Hetastarch work?
The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.
What is Hetastarch used for?
According to FDA labeling, Hetastarch carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hetastarch?
Hetastarch is classified as Blood substitutes and plasma protein fractions, Plasma Volume Expander, Osmotic Activity, Structural Macromolecules, Decreased Blood Viscosity, Increased Intravascular Volume.
What are the brand names for Hetastarch?
Hetastarch is marketed under brand names including Hespan, Hextend.
What are the contraindications for Hetastarch?
Hetastarch labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for hetastarch is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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