argatroban (Rx)

Brand and Other Names:Acova
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100mg/mL

ready-to-use injectable

  • 50mg/50mL 0.9% NaCl
  • 125mg/125mL 0.9% NaCl

Thrombocytopenia

Indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia

Initial: 2 mcg/kg/min IV continuous infusion over 1-3 hours until steady-state aPTT is 1.5-3 times initial baseline value  

Not to exceed infusion rate of 10 mcg/kg/min

Dosing considerations

  • Check aPTT and adjust dose until target aPTT is achieved

Percutaneous Coronary Intervention

Indicated as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI)

Initial: 25 mcg/kg/min IV infusion, AND  

A bolus of 350 mcg/kg IV over 3-5 minutes via large-bore IV line

Check activated clotting time (ACT) 5-10 minutes after bolus dose is completed; procedure may proceed if ACT is >300 seconds

If ACT is <300 seconds, administer additional IV bolus dose of 150 mcg/kg, increase infusion dose to 30 mcg/kg/min, and check ACT 5-10 minutes later

If ACT >450 seconds, decrease infusion rate to 15 mcg/kg/min, and check ACT 5-10 minutes later

After therapeutic ACT (300-450 sec) achieved, continue this infusion dose for duration of procedure

Dosing Modifications

Hepatic impairment

  • Approximately 4-fold decrease in clearance relative to those with normal hepatic function, so dosing modification warranted; monitor aPTT and adjust dosage as clinically indicated
  • Thrombocytopenia: Decrease initial dose to 0.5 mcg/kg/min IV  
  • PCI: For patients with hepatic impairment undergoing PCI and who have HIT or are at risk for HIT, carefully titrate argatroban until desired level of anticoagulation achieved; use of drug in PCI patients with clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal should be avoided

Safety and efficacy not established

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Interactions

Interaction Checker

and argatroban

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            Adverse Effects

            >10%

            GI bleeding (14%)

            Hematuria (12%)

            1-10%

            Chest pain (1-15%)

            Hemoglobin and hematocrit decrease (10%)

            Hypotension (7-10%)

            Dyspnea (8%)

            Fever (7%)

            Sepsis (6%)

            Cardiac arrest (6%)

            Diarrhea (6%)

            Nausea (5%)

            Groin hemorrhage (5%)

            Pain (5%)

            Urinary tract infection (5%)

            Ventricular tachycardia (5%)

            Bradyarrhythmia (4.5%)

            Infection (4%)

            Vomiting (2.6-4%)

            Intracranial hemorrhage (1-4%)

            Myocardial infarction (3.5%)

            Hemoptysis (3%)

            Nephrotoxicity (3%)

            Cough (3%)

            Atrial fibrillation (3%)

            Brachial hemorrhage (2%)

            Major GI hemorrhage (1-2%)

            Angina (1.8%)

            Coronary arterial hemorrhage (1.8%)

            Coronary artery thrombosis (1.8%)

            Frequency Not Defined

            Minor hematuria

            Pulmonary edema

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            Warnings

            Contraindications

            Hypersensitivity

            Active major bleeding

            Cautions

            Monitor therapy with aPTT

            Hemorrhagic diathesis, conditions that increase hemorrhage risk (eg, severe hypertension, major surgery, GI ulceration); unexplained fall in hematocrit or blood pressure may indicate hemorrhage

            Use caution in hepatic impairment; 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; avoid use of high doses in patients undergoing percutaneous coronary intervention (PCI) who have clinically significant hepatic disease

            Patients with illnesses that reduce clearance may require dose reduction

            Safety and efficacy of concomitant administration with thrombolytic agents not established

            Discontinue parenteral anticoagulant therapy prior to initiating treatment

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            Pregnancy & Lactation

            Pregnancy

            Limited data from published literature and postmarketing reports do not suggest an association between argatroban and adverse fetal developmental outcomes; there are risks to mother associated with untreated thrombosis in pregnancy and a risk of hemorrhage in mother and fetus associated with use of anticoagulants

            Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high risk pregnancy conditions; published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy

            Use of anticoagulants, including argatroban, may increase risk of bleeding in fetus and neonate; monitor neonates for bleeding

            Pregnant women should be carefully monitored for evidence of excessive bleeding or unexpected changes in coagulation parameters during labor or delivery

            Lactation

            There are no data on presence in human milk, or effects on milk production; it is present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition There are no data on presence in human milk, or effects on milk production; it is present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive, direct thrombin inhibitor that reversibly binds to thrombin active site; thrombin enables fibrinogen conversion to fibrin during the coagulation cascade

            Distribution

            Protein bound: 54%

            Vd: 174 mL/kg

            Metabolism

            Liver

            Elimination

            Half-life: 39-51 min

            Total body clearance: 5.1 mL/kg/min

            Excretion: Feces (65%); urine (22%)

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            Administration

            IV Compatibilities

            Y-site

            • Atropine
            • Diltiazem
            • Diphenhydramine
            • Dobutamine
            • Dopamine
            • Fentanyl
            • Hydrocortisone succinate
            • Metoprolol
            • Midazolam
            • Morphine sulfate
            • Norepinephrine
            • Phenylephrine
            • Verapamil

            IV Preparation

            100 mg/mL injectable, dilute to final concentration of 1 mg/mL in NS, D5W, or LR

            Ready-to-use preparations (1 mg/mL) require no further dilution; vial may be inverted for use with an infusion set

            IV Administration

            See adult dosing for infusion rate

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.