Argatroban
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
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.
* 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
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- Strength of Evidence: (Category A/B/C) (Link)
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Condition 2
- Developed by: (Organisation)
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Non–Guideline-Supported Use
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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 and 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
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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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Condition 2
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Hypersensitive Reactions
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Postmarketing Experience
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Drug Interactions
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
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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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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
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Monitoring
Condition 1
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Condition 2
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Condition 3
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IV Compatibility
Solution
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Variable
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Incompatible
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Y-Site
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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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Variable
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Incompatible
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Overdosage
Acute Overdose
Signs and Symptoms
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Management
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Chronic Overdose
Signs and Symptoms
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Management
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Pharmacology
Argatroban
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Mechanism of Action
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Structure
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Nonclinical Toxicology
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Clinical Studies
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How Supplied
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Storage
There is limited information regarding Argatroban 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-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.