Bivalirudin
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FDA Labeling Changes
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Uses
Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
Bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see Clinical Studies (14.1)] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
Bivalirudin is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.
Bivalirudin in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see Dosage and Administration (2.1) and Clinical Studies (14.1)].
The safety and effectiveness of bivalirudin have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
1.2 Percutaneous Coronary Intervention (PCI)Bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see Clinical Studies (14.1)] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
Bivalirudin is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.
1.3 Use with AspirinBivalirudin in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see Dosage and Administration (2.1) and Clinical Studies (14.1)].
1.4 Limitation of UseThe safety and effectiveness of bivalirudin have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
History
There is currently no drug history available for this drug.
Other Information
Bivalirudin is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20 amino acid peptide. The chemical name is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine trifluoroacetate (salt) hydrate (Figure 1). The molecular weight of bivalirudin is 2180 daltons (anhydrous free base peptide).
Bivalirudin is supplied in single-use vials as a white lyophilized cake, which is sterile. Each vial contains 250 mg bivalirudin, 125 mg mannitol, and sodium hydroxide to adjust the pH to 5-6 (equivalent of approximately 12.5 mg sodium). When reconstituted with Sterile Water for Injection, the product yields a clear to opalescent, colorless to slightly yellow solution, pH 5-6.
Sources
Bivalirudin Manufacturers
-
Hospira, Inc.
![Bivalirudin Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bivalirudin | Hospira, Inc.
2.1 Recommended DoseBivalirudin is for intravenous administration only.
Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.
For patients who do not have HIT/HITTS
The recommended dose of bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.
For patients who have HIT/HITTS
The recommended dose of bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
For ongoing treatment post procedure
Continuation of the bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.
2.2 Dosing in Renal ImpairmentNo reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].
2.3 Instructions for AdministrationBivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1. Dosing TableUsing 5 mg/mL
ConcentrationUsing 0.5 mg/mL
ConcentrationWeight
(kg)Bolus
0.75 mg/kg
(mL)Infusion
1.75 mg/kg/h
(mL/h)Subsequent
Low-rate Infusion
0.2 mg/kg/h
(mL/h)43-47
7
16
18
48-52
7.5
17.5
20
53-57
8
19
22
58-62
9
21
24
63-67
10
23
26
68-72
10.5
24.5
28
73-77
11
26
30
78-82
12
28
32
83-87
13
30
34
88-92
13.5
31.5
36
93-97
14
33
38
98-102
15
35
40
103-107
16
37
42
108-112
16.5
38.5
44
113-117
17
40
46
118-122
18
42
48
123-127
19
44
50
128-132
19.5
45.5
52
133-137
20
47
54
138-142
21
49
56
143-147
22
51
58
148-152
22.5
52.5
60
Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
2.4 Storage after ReconstitutionDo not freeze reconstituted or diluted bivalirudin. Reconstituted material may be stored at 2-8ºC for up to 24 hours. Diluted bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
2.1 Recommended DoseBivalirudin is for intravenous administration only.
Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.
For patients who do not have HIT/HITTS
The recommended dose of bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.
For patients who have HIT/HITTS
The recommended dose of bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
For ongoing treatment post procedure
Continuation of the bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.
2.2 Dosing in Renal ImpairmentNo reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].
2.3 Instructions for AdministrationBivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1. Dosing TableUsing 5 mg/mL
ConcentrationUsing 0.5 mg/mL
ConcentrationWeight
(kg)Bolus
0.75 mg/kg
(mL)Infusion
1.75 mg/kg/h
(mL/h)Subsequent
Low-rate Infusion
0.2 mg/kg/h
(mL/h)43-47
7
16
18
48-52
7.5
17.5
20
53-57
8
19
22
58-62
9
21
24
63-67
10
23
26
68-72
10.5
24.5
28
73-77
11
26
30
78-82
12
28
32
83-87
13
30
34
88-92
13.5
31.5
36
93-97
14
33
38
98-102
15
35
40
103-107
16
37
42
108-112
16.5
38.5
44
113-117
17
40
46
118-122
18
42
48
123-127
19
44
50
128-132
19.5
45.5
52
133-137
20
47
54
138-142
21
49
56
143-147
22
51
58
148-152
22.5
52.5
60
Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
2.4 Storage after ReconstitutionDo not freeze reconstituted or diluted bivalirudin. Reconstituted material may be stored at 2-8ºC for up to 24 hours. Diluted bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
-
Sandoz
Bivalirudin | Sandoz
2.1 Recommended DoseBivalirudin is for intravenous administration only.
Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.
For patients who do not have HIT/HITTS
The recommended dose of Bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.
For patients who have HIT/HITTS
The recommended dose of Bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
For ongoing treatment post procedure
Continuation of the Bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of Bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.
2.2 Dosing in Renal ImpairmentNo reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].
2.3 Instructions for AdministrationBivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1: Dosing Table Weight
(kg) Using 5 mg/mL
Concentration Using 5 mg/mL
Concentration Bolus
0.75 mg/k
(mL) Infusion
1.75 mg/kg/h
(mL/h) Subsequent
Low-rate Infusion
0.2 mg/kg/h
(mL/h) 43-47 7 16 18 48-52 7.5 17.5 20 53-57 8 19 22 58-62 9 21 24 63-67 10 23 26 68-72 10.5 24.5 28 73-77 11 26 30 78-82 12 28 32 83-87 13 30 34 88-92 13.5 31.5 36 93-97 14 33 38 98-102 15 35 40 103-107 16 37 42 108-112 16.5 38.5 44 113-117 17 40 46 118-122 18 42 48 123-127 19 44 50 128-132 19.5 45.5 52 133-137 20 47 54 138-142 21 49 56 143-147 22 51 58 148-152 22.5 52.5 60Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with Bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with Bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
2.4 Storage after ReconstitutionDo not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
-
Sandoz
Bivalirudin | Sandoz
2.1 Recommended DoseBivalirudin is for intravenous administration only.
Bivalirudin is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin.
For patients who do not have HIT/HITTS
The recommended dose of Bivalirudin is an intravenous (IV) bolus dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.
For patients who have HIT/HITTS
The recommended dose of Bivalirudin in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.
For ongoing treatment post procedure
Continuation of the Bivalirudin infusion following PCI/PTCA for up to 4 hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IV infusion of Bivalirudin may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.
2.2 Dosing in Renal ImpairmentNo reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of Bivalirudin may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h [see Use In Specific Population (8.6)].
2.3 Instructions for AdministrationBivalirudin is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.
Table 1: Dosing Table Weight
(kg) Using 5 mg/mL
Concentration Using 5 mg/mL
Concentration Bolus
0.75 mg/kg
(mL) Infusion
1.75 mg/kg/h
(mL/h) Subsequent
Low-rate Infusion
0.2 mg/kg/h
(mL/h) 43-47 7 16 18 48-52 7.5 17.5 20 53-57 8 19 22 58-62 9 21 24 63-67 10 23 26 68-72 10.5 24.5 28 73-77 11 26 30 78-82 12 28 32 83-87 13 30 34 88-92 13.5 31.5 36 93-97 14 33 38 98-102 15 35 40 103-107 16 37 42 108-112 16.5 38.5 44 113-117 17 40 46 118-122 18 42 48 123-127 19 44 50 128-132 19.5 45.5 52 133-137 20 47 54 138-142 21 49 56 143-147 22 51 58 148-152 22.5 52.5 60Bivalirudin should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following drugs should not be administered in the same intravenous line with Bivalirudin, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with Bivalirudin: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl. Dobutamine was compatible at concentrations up to 4 mg/mL but incompatible at a concentration of 12.5 mg/mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
2.4 Storage after ReconstitutionDo not freeze reconstituted or diluted Bivalirudin. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted Bivalirudin with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
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