Antithrombin III: Difference between revisions

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

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Revision as of 15:50, 8 July 2014

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. ^[1]
Newborn infants: 40 units/kg/day + heparin 200 units/kg/day^[2]

Contraindications

Hypersensitivity to antithrombin III.

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

In clinical studies involving antithrombin III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were:

If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate.

Postmarketing Experience

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

Drug Interactions

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to antithrombin III. It is not known whether antithrombin III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Antithrombin III in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Antithrombin III during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Antithrombin III in women who are nursing.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.)

Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with antithrombin III of neonates be discussed with an expert on coagulation.

Geriatic Use

There is no FDA guidance on the use of Antithrombin III in geriatric settings.

Gender

There is no FDA guidance on the use of Antithrombin III with respect to specific gender populations.

Race

There is no FDA guidance on the use of Antithrombin III with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Antithrombin III in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Antithrombin III in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Antithrombin III in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Antithrombin III in patients who are immunocompromised.

Administration and Monitoring

Administration

Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
Administer only by the intravenous route.
Antithrombin III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions.
Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.

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

Solution 1
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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

Solution 1
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Solution 3

Not Tested

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Solution 3

Variable

Solution 1
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Incompatible

Solution 1
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Solution 3

Admixture

Compatible

Solution 1
Solution 2
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Not Tested

Solution 1
Solution 2
Solution 3

Variable

Solution 1
Solution 2
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Incompatible

Solution 1
Solution 2
Solution 3

Syringe

Compatible

Solution 1
Solution 2
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Not Tested

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Variable

Solution 1
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Incompatible

Solution 1
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TPN/TNA

Compatible

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Not Tested

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Variable

Solution 1
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Incompatible

Solution 1
Solution 2
Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Antithrombin III
Systematic (IUPAC) name
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Chemical data
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Therapeutic considerations
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Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

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

Images

Drug Images

{{#ask: Page Name::Antithrombin III |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Antithrombin III |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.

↑ T. Hanada, T. Abe & H. Takita (1985). "Antithrombin III concentrates for treatment of disseminated intravascular coagulation in children". The American journal of pediatric hematology/oncology. 7 (1): 3–8. PMID 4037242. Unknown parameter |month= ignored (help)
↑ R. von Kries, H. Stannigel & U. Gobel (1985). "Anticoagulant therapy by continuous heparin-antithrombin III infusion in newborns with disseminated intravascular coagulation". European journal of pediatrics. 144 (2): 191–194. PMID 4043133. Unknown parameter |month= ignored (help)

[1] T. Hanada, T. Abe & H. Takita (1985). "Antithrombin III concentrates for treatment of disseminated intravascular coagulation in children". The American journal of pediatric hematology/oncology. 7 (1): 3–8. PMID 4037242. Unknown parameter |month= ignored (help)

[2] R. von Kries, H. Stannigel & U. Gobel (1985). "Anticoagulant therapy by continuous heparin-antithrombin III infusion in newborns with disseminated intravascular coagulation". European journal of pediatrics. 144 (2): 191–194. PMID 4043133. Unknown parameter |month= ignored (help)

[1]

[2]

@@ Line 53: / Line 53: @@
   | pmid = 4043133
 }}</ref>
-|contraindications=None known.
+|contraindications=*Hypersensitivity to antithrombin III.
 |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.
@@ Line 60: / Line 60: @@
 *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.
-|clinicalTrials=======Central Nervous System======
+|clinicalTrials=In clinical studies involving antithrombin III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were:
+* [[Dizziness]]
+*[[Chest discomfort]]
+*[[Nausea]]
+*[[Dysgeusia]]
+*[[Chills]]
+*[[Abdominal pain]]
+*[[Dyspnea]]
+*[[Chest pain]]
+*[[Blurred vision]]
+*[[Iintestinal dilatation]]
+*[[Urticaria]]
+*[[Pyrexia]]
+*Wound secretion and [[hematoma]]
-: (list/description of adverse reactions)
+If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate.
+|drugInteractions=*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.
+|FDAPregCat=B
+|useInPregnancyFDA=Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to antithrombin III. It is not known whether antithrombin III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
+|useInPed=Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.)
-======Cardiovascular======
+Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower.  Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with antithrombin III of neonates be discussed with an expert on coagulation.
+|administration=*Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
-: (list/description of adverse reactions)
+*Administer only by the intravenous route.
+*Antithrombin III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions.
-======Respiratory======
+*Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.
-: (list/description of adverse reactions)
-======Gastrointestinal======
-: (list/description of adverse reactions)
-======Hypersensitive Reactions======
-: (list/description of adverse reactions)
-======Miscellaneous======
-: (list/description of adverse reactions)
-=====Condition 2=====
-======Central Nervous System======
-: (list/description of adverse reactions)
-======Cardiovascular======
-: (list/description of adverse reactions)
-======Respiratory======
-: (list/description of adverse reactions)
-======Gastrointestinal======
-: (list/description of adverse reactions)
-======Hypersensitive Reactions======
-: (list/description of adverse reactions)
-======Miscellaneous======
-: (list/description of adverse reactions)
-|postmarketing=(Description)
-|drugInteractions=* Drug 1
-* Drug 2
-* Drug 3
-* Drug 4
-* Drug 5
-=====Drug 1=====
-(Description)
-=====Drug 2=====
-(Description)
-=====Drug 3=====
-(Description)
-=====Drug 4=====
-(Description)
-=====Drug 5=====
-(Description)
-|useInPregnancyFDA=(Description)
-|useInPregnancyAUS=(Description)
-|useInLaborDelivery=(Description)
-|useInNursing=(Description)
-|useInPed=(Description)
-|useInGeri=(Description)
-|useInGender=(Description)
-|useInRace=(Description)
-|useInRenalImpair=(Description)
-|useInHepaticImpair=(Description)
-|useInReproPotential=(Description)
-|useInImmunocomp=(Description)
-|othersTitle=Others
-|useInOthers=(Description)
-|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).