Antithrombin III

Antithrombin III
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

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Overview

Antithrombin III is a anti-coagulant that is FDA approved for the {{{indicationType}}} of hereditary antithrombin III deficiency. Common adverse reactions include dizziness, chest discomfort, nausea, dysgeusia, chills.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hereditary Antithrombin III Deficiency

• Dosage should be determined on an individual basis based on the pre-therapy plasma ATIII level, in order to increase plasma ATIII levels to the level found in normal human plasma (80-120%).
• Dosage of antithrombin III can be calculated from the following formula:

• The recommendations for dosing are provided as a general guideline for therapy only. The exact loading and maintenance dosages and dosing intervals should be individualized for each subject, based on the individual clinical conditions, response to therapy, and actual plasma ATIII levels achieved.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Antithrombin III in adult patients.

Non–Guideline-Supported Use

Acquired Antithrombin III Deficiency

• Dosing Information

• (Dosage)

Heparin Resistance

• Dosing Information

• (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Antithrombin III FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Antithrombin III in pediatric patients.

Non–Guideline-Supported Use

Disseminated Intravascular Coagulation

• Dosing Information

• Children (1 month to 5 years): 250 units IV q8h, with or without heparin.
• Newborn infants: 40 units/kg/day + heparin 200 units/kg/day

Contraindications

None known.

Warnings

• Because antithrombin III is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
• No cases of transmission of viral diseases or CJD have ever been identified for antithrombin III.
• Inform patients that antithrombin III is made from human plasma and may contain infectious agents that can cause disease.
• While the risk that antithrombin III can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them.
• All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider.
• The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with antithrombin III.

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

Central Nervous System

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Postmarketing Experience

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Drug Interactions

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Drug 1

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Drug 2

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Drug 3

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Drug 5

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

Intravenous

Monitoring

• It is recommended that following an initial dose of Antithrombin III, plasma levels of ATIII be initially monitored at least every 12 hours and before the next infusion of Antithrombin IIII to maintain plasma ATIII levels greater than 80%.
• Measure preinfusion and 20 minutes postinfusion (peak) plasma ATIII levels following the initial loading dose, plasma ATIII level after 12 hours, then preceding the next infusion (trough level).
• Subsequently measure ATIII levels preceding and 20 minutes after each infusion until predictable peak and trough levels have been achieved, generally between 80%–120%.
• Plasma levels between 80%–120% may be maintained by administration of maintenance doses of 60% of the initial loading dose, administered every 24 hours.
• Adjustments in the maintenance dose and/or interval between doses should be made based on actual plasma ATIII levels achieved.
• In some situations, e.g., following surgery, hemorrhage or acute thrombosis, and during intravenous heparin administration, the half-life of antithrombin III (Human) has been reported to be shortened. In such conditions, plasma ATIII levels should be monitored more frequently, and antithrombin III administered as necessary.

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

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Chronic Overdose

Signs and Symptoms

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Management

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Pharmacology

Antithrombin III
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Mechanism of Action

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Structure

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Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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Condition 2

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Condition 3

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How Supplied

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Storage

There is limited information regarding Antithrombin III Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Antithrombin III interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Antithrombin III Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.