Classes
DEA Class; Rx
Common Brand Names; Acova
- Anticoagulants, Cardiovascular;
- Anticoagulants, Hematologic;
- Thrombin Inhibitor
Description
Intravenous, direct thrombin inhibitor
Used for thrombosis prophylaxis or treatment in patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI)
Hepatically eliminated, can use in end-stage renal disease without dosage adjustment
Indications
Indicated for use as an anticoagulant in the treatment of thrombosis (i.e., deep venous thrombosis (DVT), pulmonary embolism) or for venous thromboembolism (VTE) prophylaxis (i.e., deep venous thrombosis (DVT) prophylaxis, pulmonary embolism prophylaxis) in patients with heparin-induced thrombocytopenia (HIT).
Contraindications
Hypersensitivity
Active major bleeding
Adverse Effects
GI bleeding (14%)
Hematuria (12%)
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%)
Warnings
Monitor therapy with aPTT
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
Pregnancy and Lactation
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
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
Maximum Dosage
How supplied
Argatroban
injectable solution
- 100mg/mL
ready-to-use injectable
- 50mg/50mL 0.9% NaCl
- 125mg/125mL 0.9% NaCl
- 250mg/2.5mL 0.9% NaCl