Argatroban

ARGATROBAN — argatroban solution
Gland Pharma Limited

1 INDICATIONS & USAGE

1.1 Heparin-Induced Thrombocytopenia

Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).

1.2 Percutaneous Coronary Intervention

Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

2 DOSAGE & ADMINISTRATION

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.

2.1 Dosing in Patients With Heparin-Induced Thrombocytopenia

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)
50 100 6
60 120 7
70 140 8
80 160 10
90 180 11
100 200 12
110 220 13
120 240 14
130 260 16
140 280 17

1 with or without thrombosis
Monitoring Therapy:
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)].

2.2 Dosing in Patients Undergoing Percutaneous Coronary Interventions

Initial Dosage:
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.
Dosage Adjustment:
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)
50 17500 18 1250 75
60 21000 21 1500 90
70 24500 25 1750 105
80 28000 28 2000 120
90 31500 32 2250 135
100 35000 35 2500 150
110 38500 39 2750 165
120 42000 42 3000 180
130 45500 46 3250 195
140 49000 49 3500 210

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)
50 7500 8 1500 90 750 45
60 9000 9 1800 108 900 54
70 10500 11 2100 126 1050 63
80 12000 12 2400 144 1200 72
90 13500 14 2700 162 1350 81
100 15000 15 3000 180 1500 90
110 16500 17 3300 198 1650 99
120 18000 18 3600 216 1800 108
130 19500 20 3900 234 1950 117
140 21000 21 4200 252 2100 126

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.
Monitoring Therapy:
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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