Argatroban: Difference between revisions

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|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult======Heparin-Induced Thrombocytopenia=====
|fdaLIADAdult======Heparin-Induced Thrombocytopenia=====
* Before administering argatroban, discontinue heparin therapy and obtain a baseline aPTT.
* Before administering argatroban, discontinue [[heparin]] therapy and obtain a baseline [[aPTT]].
* Dosing Information
* Dosing Information
:* '''Initial dose: 2 mcg/kg/min''' (continuous infusion)  
:* '''Initial dose: 2 mcg/kg/min''' (continuous infusion)  
:*After the initiation of argatroban injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state aPTT in the target range  
:*After the initiation of argatroban injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state [[aPTT]] in the target range  
[[Image:Argatroban dosing.png|thumb|600px|left]]
[[Image:Argatroban dosing.png|thumb|700px|left]]
{{clr}}
{{clr}}


=====Prophylaxis in Percutaneous Coronary Intervention=====
=====Prophylaxis in Percutaneous Coronary Intervention=====
* '''Initial dose: 25 mcg/kg/min''' , administer a bolus of 350 mcg/kg via a large bore IV line over 3 to 5 minutes.   
* '''Initial dose: 25 mcg/kg/min''' , administer a bolus of 350 mcg/kg via a large bore IV line over 3 to 5 minutes.   
* Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed.   
* Check an [[activated clotting time]] ([[ACT]]) 5 to 10 minutes after the bolus dose is completed.   
* The PCI procedure may proceed if the ACT is greater than 300 seconds.
* The [[PCI]] procedure may proceed if the [[ACT]] is greater than 300 seconds.
* If the ACT is '''less than 300''' seconds, an additional intravenous bolus dose of '''150 mcg/kg''' should be administered, the infusion dose increased to '''30 mcg/kg/min''', and the ACT checked 5 to 10 minutes later  
* If the ACT is '''less than 300''' seconds, an additional intravenous bolus dose of '''150 mcg/kg''' should be administered, the infusion dose increased to '''30 mcg/kg/min''', and the [[ACT]] checked 5 to 10 minutes later  
[[Image:Argatroban Table 2.png|thumb|600px|left]]
[[Image:Argatroban Table 2.png|thumb|700px|left]]
{{clr}}
{{clr}}


*If the ACT is '''greater than 450''' seconds, decrease the infusion rate to '''15 mcg/kg/min''', and check the ACT 5 to 10 minutes later.
*If the ACT is '''greater than 450''' seconds, decrease the infusion rate to '''15 mcg/kg/min''', and check the ACT 5 to 10 minutes later.
[[Image:Argatroban Table 3.png|thumb|600px|left|<sup>†</sup>Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds. <br> * No bolus dose is given if ACT greater than 450 seconds]]
[[Image:Argatroban Table 3.png|thumb|700px|left|<sup>†</sup>Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds. <br> * No bolus dose is given if ACT greater than 450 seconds]]
{{clr}}
{{clr}}
*Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.
*Continue titrating the dose until a therapeutic [[ACT]] (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the [[PCI]] procedure.
|offLabelAdultGuideSupport======Condition 1=====
|offLabelAdultGuideSupport======Condition 1=====


Line 72: Line 72:
* Dosing Information
* Dosing Information
:* '''Initial dose: 0.75 mcg/kg/min'''
:* '''Initial dose: 0.75 mcg/kg/min'''
:*Check the aPTT two hours after the initiation of the argatroban infusion and adjust the dose to achieve the target aPTT.  
:*Check the [[aPTT]] two hours after the initiation of the argatroban infusion and adjust the dose to achieve the target [[aPTT]].  
:*Increments of '''0.1 to 0.25 mcg/kg/min''' for pediatric patients with '''normal hepatic''' function and increments of '''0.05 mcg/kg/min''' or lower for pediatric patients with '''impaired hepatic''' function may be considered  
:*Increments of '''0.1 to 0.25 mcg/kg/min''' for pediatric patients with '''normal hepatic''' function may be considered.
:*Increments of '''0.05 mcg/kg/min''' or lower for pediatric patients with '''impaired hepatic''' function may be considered.
* Initiate the infusion at a dose of '''0.2 mcg/kg/min''' among seriously ill pediatric patients with impaired hepatic function
* Initiate the infusion at a dose of '''0.2 mcg/kg/min''' among seriously ill pediatric patients with impaired hepatic function
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Argatroban in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Argatroban in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Argatroban in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Argatroban in pediatric patients.
|contraindications=* Patients with major bleeding.
|contraindications=* Patients with major bleeding.
* Patients with a history of [[[hypersensitivity]] to argatroban. (Airway, skin, and generalized hypersensitivity reactions have been reported)
* Patients with a history of [[hypersensitivity]] to argatroban. (Airway, skin, and generalized hypersensitivity reactions have been reported)
|warnings=====Risk of Hemorrhage====
|warnings=====Risk of Hemorrhage====
* Hemorrhage can occur at any site in the body in patients receiving argatroban.  
* [[Hemorrhage]] can occur at any site in the body in patients receiving argatroban.  
* Unexplained fall in hematocrit or blood pressure may indicate hemorrhage.   
* Unexplained fall in [[hematocrit]] or [[blood pressure]] may indicate hemorrhage.   
* Intracranial and retroperitoneal hemorrahage have been reported.  
* Intracranial and retroperitoneal [[hemorrahage]] have been reported.  
*The risk of hemorrahage with argatroban may be increased in severe hypertension; immediately following lumbar puncture, spinal anesthesia, major surgery (especially involving the brain, spinal cord, or eye), hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders, and gastrointestinal lesions such as ulcerations.
*The risk of [[hemorrahage]] with argatroban may be increased in severe [[hypertension]]; immediately following [[lumbar puncture]], spinal anesthesia, major [[surgery]] (especially involving the brain, spinal cord, or eye), hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders, and gastrointestinal lesions such as ulcerations.
*Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.
*Concomitant use of argatroban with antiplatelet agents, [[thrombolytics]], and other [[anticoagulants]] may increase the risk of bleeding.


====Use in Hepatic Impairment====
====Use in Hepatic Impairment====
*When administering argatroban to patients with hepatic impairment, start with a lower dose and carefully titrate until the desired level of anticoagulation is achieved.  
*When administering argatroban to patients with [[hepatic impairment]], start with a lower dose and carefully titrate until the desired level of anticoagulation is achieved.  
*Achievement of steady state aPTT levels may take longer and require more argatroban dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.
*Achievement of steady state [[aPTT]] levels may take longer and require more argatroban dose adjustments in patients with [[hepatic impairment]] compared to patients with normal [[hepatic function]].
* Also, upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban.   
* Also, upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban.   
*Avoid the use of high doses of argatroban in patients undergoing PCI who have clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal.
*Avoid the use of high doses of argatroban in patients undergoing [[PCI]] who have clinically significant hepatic disease or [[AST]]/[[ALT]] levels ≥3 times the upper limit of normal.


====Laboratory Tests====
====Laboratory Tests====
*Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT).   
*Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the [[activated partial thromboplastin time]] ([[aPTT]]).   
*Although other global clot-based tests including prothrombin time (PT), the International Normalized Ratio (INR), and thrombin time (TT) are affected by Argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy.  
*Although other global clot-based tests including [[prothrombin time]] ([[PT]]), the [[International Normalized Ratio]] ([[INR]]), and [[thrombin time]] (TT) are affected by argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy.  
*In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure.   
*In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure.   
*The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone.
*The concomitant use of argatroban and [[warfarin]] results in prolongation of the [[PT]] and [[INR]] beyond that produced by [[warfarin]] alone.


|clinicalTrials=======Central Nervous System======
|clinicalTrials=======Central Nervous System======

Revision as of 17:59, 8 July 2014

Argatroban
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]

Disclaimer

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Overview

Argatroban is a direct thrombin inhibitor that is FDA approved for the {{{indicationType}}} of thrombosis in heparin-induced thrombocytopenia and prophylaxis in PCI. Common adverse reactions include dyspnea, hypotension, fever, diarrhea, chest pain, back pain, nausea, vomiting, headache, sepsis, and cardiac arrest.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Heparin-Induced Thrombocytopenia
  • Before administering argatroban, discontinue heparin therapy and obtain a baseline aPTT.
  • Dosing Information
  • Initial dose: 2 mcg/kg/min (continuous infusion)
  • After the initiation of argatroban injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state aPTT in the target range
Prophylaxis in Percutaneous Coronary Intervention
  • Initial dose: 25 mcg/kg/min , administer a bolus of 350 mcg/kg via a large bore IV line over 3 to 5 minutes.
  • Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed.
  • The PCI procedure may proceed if the ACT is greater than 300 seconds.
  • If the ACT is less than 300 seconds, an additional intravenous bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later
  • If the ACT is greater than 450 seconds, decrease the infusion rate to 15 mcg/kg/min, and check the ACT 5 to 10 minutes later.
†Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds.
* No bolus dose is given if ACT greater than 450 seconds
  • Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Heparin-Induced Thrombocytopenia
  • Dosing Information
  • Initial dose: 0.75 mcg/kg/min
  • Check the aPTT two hours after the initiation of the argatroban infusion and adjust the dose to achieve the target aPTT.
  • Increments of 0.1 to 0.25 mcg/kg/min for pediatric patients with normal hepatic function may be considered.
  • Increments of 0.05 mcg/kg/min or lower for pediatric patients with impaired hepatic function may be considered.
  • Initiate the infusion at a dose of 0.2 mcg/kg/min among seriously ill pediatric patients with impaired hepatic function

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Argatroban in pediatric patients.

Contraindications

  • Patients with major bleeding.
  • Patients with a history of hypersensitivity to argatroban. (Airway, skin, and generalized hypersensitivity reactions have been reported)

Warnings

Risk of Hemorrhage

  • Hemorrhage can occur at any site in the body in patients receiving argatroban.
  • Unexplained fall in hematocrit or blood pressure may indicate hemorrhage.
  • Intracranial and retroperitoneal hemorrahage have been reported.
  • The risk of hemorrahage with argatroban may be increased in severe hypertension; immediately following lumbar puncture, spinal anesthesia, major surgery (especially involving the brain, spinal cord, or eye), hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders, and gastrointestinal lesions such as ulcerations.
  • Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.

Use in Hepatic Impairment

  • When administering argatroban to patients with hepatic impairment, start with a lower dose and carefully titrate until the desired level of anticoagulation is achieved.
  • Achievement of steady state aPTT levels may take longer and require more argatroban dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.
  • Also, upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban.
  • Avoid the use of high doses of argatroban in patients undergoing PCI who have clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal.

Laboratory Tests

  • Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT).
  • Although other global clot-based tests including prothrombin time (PT), the International Normalized Ratio (INR), and thrombin time (TT) are affected by argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy.
  • In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure.
  • The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone.

Adverse Reactions

Clinical Trials Experience

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)
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 Experience

(Description)

Drug Interactions

  • 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)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

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

Argatroban
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

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 Argatroban Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Argatroban 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 Argatroban 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.

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