ARGATROBAN — argatroban solution
Gland Pharma Limited
Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
Each 125 mL glass vial contains 125 mg of argatroban (1mg/mL); and, as supplied, is ready for intravenous infusion. Dilution is not required.
Argatroban Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the solution is cloudy, contains precipitates, or if the flip-off seal is not intact.
Initial Dosage:Before administering argatroban, discontinue heparin therapy and obtain a baseline aPTT. The recommended initial dose of argatroban for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion (see Table 1).
|Table 1. Recommended Doses and Infusion Rates for 2 mcg/kg/min Dose of Argatroban for Patients With HIT1 and Without Hepatic Impairment (1 mg/mL Concentration)|
|Body Weight (kg)||Dose (mcg/min)||Infusion Rate (mL/hr)|
1 with or without thrombosis
For use in HIT, therapy with Argatroban Injection is monitored using the aPTT with a target range of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds). Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within 1 to 3 hours following initiation of Argatroban Injection. Check the aPTT 2 hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.
Dosage Adjustment: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 [see Clinical Studies ( 14.1)].
Initiate an infusion of Argatroban Injection at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes (see Table 2). 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 (see Table 2).
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 (Table 3).
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.In case of dissection, impending abrupt closure, thrombus formation during the procedure, or inability to achieve or maintain an ACT over 300 seconds, additional bolus doses of 150 mcg/kg may be administered and the infusion dose increased to 40 mcg/kg/min. Check the ACT after each additional bolus or change in the rate of infusion.
|Table 2. Recommended Starting and Maintenance Doses (Within the Target ACT Range) of Argatroban Injection in Patients Undergoing PCI Without Hepatic Impairment (1 mg/mL Concentration)|
|Body Weight (kg)||Starting Bolus Dose (350 mcg/kg)||Starting and Maintenance Continuous Infusion Dosing For ACT 300-450 seconds 25 mcg/kg/min|
|Bolus Dose (mcg)||Bolus Volume (mL)||Continuous Infusion Dose (mcg/min)||Continuous Infusion Rate (mL/hr)|
NOTE: 1 mg = 1000 mcg; 1 kg = 2.2 lbs
|Table 3. Recommended Dose Adjustments of Argatroban Injection for Patients Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment (1 mg/mL Concentration)|
|Body Weight (kg)||If ACT Less than 300 seconds Dosage Adjustment2 30 mcg/kg/min||If ACT Greater than 450 seconds Dosage Adjustment1 15 mcg/kg/min|
|Additional Bolus Dose (mcg)||Bolus Volume (mL)||Continuous Infusion Dose (mcg/min)||Continuous Infusion Rate (mL/hr)||Continuous Infusion Dose (mcg/min)||Continuous Infusion Rate (mL/hr)|
NOTE: 1 mg = 1000 mcg; 1 kg = 2.2 lbs
1 No bolus dose is given if ACT greater than 450 seconds
2Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds.
For use in PCI, therapy with Argatroban Injection is monitored using ACT. Obtain ACTs before dosing, 5 to 10 minutes after bolus dosing, following adjustments in the infusion rate, and at the end of the PCI procedure. Obtain additional ACTs every 20 to 30 minutes during a prolonged procedure.
Continued Anticoagulation after PCI: If a patient requires anticoagulation after the procedure, Argatroban Injection may be continued, but at a rate of 2 mcg/kg/min and adjusted as needed to maintain the aPTT in the desired range. [see Dosage and Administration ( 2.1)].
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