DOSAGE AND ADMINISTRATION
The recommended dosage of Angiomax is an intravenous (IV) bolus dose of 1.0 mg/kg followed by a 4-hour IV infusion at a rate of 2.5 mg/kg/h. After completion of the initial 4-hour infusion, an additional IV infusion of Angiomax may be initiated at a rate of 0.2 mg/kg/h for up to 20 hours, if needed. Angiomax is intended for use with aspirin (300-325 mg daily) and has been studied only in patients receiving concomitant aspirin. Treatment with Angiomax should be initiated just prior to PTCA. The dose of Angiomax may need to be reduced, and anticoagulation status monitored, in patients with renal impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
INSTRUCTIONS FOR ADMINISTRATION:
Angiomax® (bivalirudin) is intended for intravenous injection and infusion. 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 5.
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 5.
Table 5. Dosing Table
|
|
Using 5 mg/mL Concentration |
Using 0.5 mg/mL Concentration |
| Weight |
Bolus (1 mg/kg) |
Initial 4-hour
Infusion (2.5 mg/kg/h) |
Subsequent
Low-rate Infusion (0.2mg/kg/h) |
| (kg) |
(mL) |
(mL/h) |
(mL/h) |
|
43-47
|
9
|
22.5
|
18
|
|
48-52
|
10
|
25
|
20
|
|
53-57
|
11
|
27.5
|
22
|
|
58-62
|
12
|
30
|
24
|
|
63-67
|
13
|
32.5
|
26
|
|
68-72
|
14
|
35
|
28
|
|
73-77
|
15
|
37.5
|
30
|
|
78-82
|
16
|
40
|
32
|
|
83-87
|
17
|
42.5
|
34
|
|
88-92
|
18
|
45
|
36
|
|
93-97
|
19
|
47.5
|
38
|
|
98-102
|
20
|
50
|
40
|
|
103-107
|
21
|
52.5
|
42
|
|
108-112
|
22
|
55
|
44
|
|
113-117
|
23
|
57.5
|
46
|
|
118-122
|
24
|
60
|
48
|
|
123-127
|
25
|
62.5
|
50
|
|
128-132
|
26
|
65
|
52
|
|
133-137
|
27
|
67.5
|
54
|
|
138-142
|
28
|
70
|
56
|
|
143-147
|
29
|
72.5
|
58
|
|
148-152
|
30
|
75
|
60
|
|
Angiomax should be administered via an intravenous line. No incompatibilities have been observed with glass bottles or polyvinyl chloride bags and administration sets. The following nine drugs should
not
be administered in the same intravenous line with Angiomax, since they resulted in haze formation, microparticulate formation, or gross precipitation when mixed with Angiomax: alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine edisylate, reteplase, streptokinase, and vancomycin HCl.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Angiomax containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
STORAGE AFTER RECONSTITUTION:
Do not freeze reconstituted or diluted Angiomax. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted Angiomax 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.
|
