Adult Dosing

Anticoagulation, heparin induced throbocytopenia (HIT)

• Start 2 mcg/kg/min IV as a continuous infusion
• Titrate: Adjust till steady state aPTT is 1.5-3 times of baseline
• Max:10 mcg/kg/min
• Note: Stop heparin before starting treatment and obtain baseline aPTT

Anticoagulation; PCI adjunct

• Start 350 mcg/kg bolus followed by infusion at 25 mcg/kg/min
• Measure activated clotting time (ACT) after 5-10 mins. If ACT <300 sec, give 150 mcg/kg bolus followed by infusion at 30 mcg/kg/min
• Measure ACT again after 5-10 mins. If ACT >450 sec, decrease to 15 mcg/kg/min

Co-administration of warfarin

Patients receiving argatroban up to 2 mcg/kg/min

• Measure INR daily during coadministration; argatroban can be discontinued when the INR is >4
• Repeat INR 4-6 hrs after stopping argatroban; if below the desired therapeutic range, resume argatroban infusion and repeat the procedure daily until desired therapeutic range on warfarin

Patients receiving argatroban at doses greater than 2 mcg/kg/min

• Temporarily reduce dose of argatroban to 2 mcg/kg/min and repeat the INR 4-6 hrs after reducing the argatroban dose
• Follow the process outlined above for administering argatroban at doses up to 2 mcg/kg/min
• Note: Argatroban should be diluted in 0.9% NaCl, 5% dextrose or lactated ringer's injection to a final concentration of 1 mg/mL

Pediatric Dosing

• Safety and effectiveness in pediatric patients <18 yrs of age have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prevention and treatment of thrombosis in patients with heparin induced thrombocytopenia (HIT)
• Anticoagulation in patients with or at risk for heparin induced thrombocytopenia, undergoing percutaneous coronary intervention (PCI)

• Hypersensitivity to any of the ingredients of the product
• Overt major bleeding

• N/A

Renal Dose Adjustment

• Renal impairment: Dose Adjustments not indicated
• Hemodialysis: Dose adjustments not defined

Hepatic Dose Adjustment

• Anticoagulation
• Moderate impairment: Start 0.5 mcg/kg/min; titrate as per clinical state
• Severe impairment: Not defined

• Anticoagulation, PCI adjunct
• Hepatic impairment: Dose adjustments not defined; avoid use if AST/ALT 3 x UNL

• Ensure all parenteral anticoagulants have been discontinued before administering argatroban
• Hemorrhage can occur at any site in patients receiving argatroban, use with extreme caution in disease states or circumstances in which there is an increased danger of hemorrhage
• Perform aPTT at baseline, 2 hrs after starting therapy tx, then periodically
• In patients undergoing PCI, perform ACT at baseline, 5-10min after bolus dosing and infusion rate changes. Monitor ACT q20-30 mins during prolonged procedure and at end of PCI
• Monitor AST/ALT at baseline

Cautions: Use cautiously in

• Hepatic impairment (use lower initial dose)
• Concurrent anticoagulant use
• Severe hypertension (increased risk of hemorrhage)
• Major surgery (increased risk of hemorrhage)
• Spinal anesthesia (increased risk of hemorrhage)
• Gastrointestinal leasions(increased risk of hemorrhage)
• Hypertension (increased risk of hemorrhage)
• Hx of hematologic disorders
• Lactation (use only if clearly needed)

Pregnancy Category:B

Breastfeeding: Safety unknown; due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• HEMA: Hemorrhage, arterial hemorrhage, arterial thrombosis, coronary occlusion, bleeding, decrease in hemoglobin and hematocrit, sepsis
• CNS: Headache, intracranial hemorrhage
• GI: GI bleeding, diarrhea, nausea, vomiting, abdominal pain
• CV: Cardiac arrest, hypotension, ventricular tachycardia, bradycardia, MI, myocardial ischemia, unstable angina, CABG
• NEURO: Intracranial hemorrhage
• RESP: Dyspnea, cough, pneumonia, hemoptysis
• GU: Minor GU hemorrhage and hematuria, UTI
• DERM: Rash, bleeding at puncture site
• MISC: Fever, allergic reaction, pain

• Anticoagulant; direct thrombin inhibitor that reversibly binds to the thrombin active site, exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors and platelet aggregation
• Metabolized by the liver by CYP3A4/5
• Excreted primarily in feces (14% unchanged); urine (16% unchanged)
• Half-life: 39-51 mins (increased in hepatic impairment)

US Trade Name(s)

• Acova

US Availability

argatroban (generic)

• INJ: 100 mg/mL (2.5 mL vial)
• INJ (in 0.9% NaCl): 50 mg/50 mL
• INJ: (in 0.9% NaCl): 125 mg/125 mL

Acova

• INJ: 100 mg/mL (2.5 mL vial)

Canadian Trade Name(s)

• Only generic available

Canadian Availability

argatroban (generic)

• INJ: 100 mg/mL (2.5 mL vial)

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Anticoagulants

Thrombin Inhibitors

Cardiovascular

Anticoagulants

Thrombin Inhibitors