HETASTARCH Boxed Warning (6% hetastarch in 0.9% sodium chloride injection) | Pfizer Medical Information - US

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WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY

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

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY

Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of
- Mortality...

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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...

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2 DOSAGE AND ADMINISTRATION

Dosage for Acute Use in Plasma Volume Expansion

6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous...

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3 DOSAGE FORMS AND STRENGTHS

Single-dose container:

•: 30 g hetastarch in 500 mL of 0.9% sodium chloride injection.

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4 CONTRAINDICATIONS

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

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5 WARNINGS AND PRECAUTIONS

5.1 Mortality and Renal Dysfunction

Critically ill patients, including patients with sepsis, are at increased risk of mortality and...

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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...

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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.

•

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire...

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11 DESCRIPTION

6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration.

Each 100 mL contains:
Hetastarch...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5%...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies of animals have not been performed to evaluate the carcinogenic...

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14 CLINICAL STUDIES

Surgical Patients Comparative Studies

In randomized, controlled, comparative studies of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=92...

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15 REFERENCES

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

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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.

...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.