Dosing and Administration
Angiomax® (bivalirudin) should be administered as follows:
- ANGIOMAX is intended for intravaneous (IV) injection and infusion after 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
(eg, 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 as a bolus
dose of 0.75 mg/kg. This should be followed by an infusion of 1.75 mg/kg/hour for
the duration of the PCI procedure
- Continuation of the infusion for up to 4 hours post-procedure is optional, at the
discretion of the treating physician
- Five minutes 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
Dosing and administration considerations
- Optional low-rate post-PCI infusion
-
After 4 hours of the initial infusion, an additional infusion may be initiated at
a rate of 0.2 mg/kg/hour for up to 20 hours, if needed
- If the low-rate infusion is used after the initial infusion, a lower concentration
bag of 0.5 mg/mL should be prepared. See Prescribing Information for diluting instructions
- Provisional use of GP IIb/IIIa inhibitor
- Use of GP IIb/IIIa inhibitor should be considered in the following circumstances:
decreased Thrombolysis in Myocardial Infarction trial (TIMI) flow (0 to 2) or slow
reflow, dissection with decreased flow, new or suspected thrombus, persistent residual
stenosis, distal embolization, unplanned stent, suboptimal stenting, side branch
closure, abrupt closure, clinical instability, and prolonged ischemia
- No reduction in the bolus dose is needed
- Patients with a creatinine clearance (CrCl) ≥30 mL/minute should receive the standard
infusion of 1.75 mg/kg/hour
- In patients with a CrCl <30 mL/minute, a reduction of the infusion rate to 1.0 mg/kg/hour
should be considered
- If a patient is on hemodialysis, the infusion should be reduced to 0.25 mg/kg/hour
- ACT should be monitored in renally impaired patients
- Please refer to Prescribing Information for pharmacokinetic information
SPECIAL PRECAUTION: It is important to note that the pre-PCI ANGIOMAX dose for patients
with acute coronary syndrome in the Acute Catheterization and Urgent Intervention
Triage StrategY (ACUITY) trial is not an approved dose and is much lower
than the approved PCI dose discussed in these instructions.
ANGIOMAX: Predictable Pharmacology1-3
* Modeled data.
ANGIOMAX achieves dose-related plasma concentrations, rapid onset, and predictable,
rapid decrease of effect after discontinuation of the infusion.
The figure indicates the plasma levels after discontinuation of the infusion. With
a half-life of 25 minutes, plasma levels of ANGIOMAX fall from therapeutic levels
to below 2 µg/mL within approximately 1 hour, thus providing a rationale for sheath
removal in most patients.
IV Line Incompatibilities4,5
Alteplase, Amiodarone HCl, Amphotericin B, Chlorpromazine HCl, Diazepam, Dobutamine
HCl (at 12.5 mg/mL)*, Prochlorperazine edisylate, Reteplase, Streptokinase, Vancomycin
HCl
* Dobutamine HCl at a concentration of up to 4 mg/mL was reported to be physically
compatible with ANGIOMAX; however; at a concentration of 12.5 mg/mL it was observed
to be physically incompatible.
View the ANGIOMAX IV Line Compatibility Chart
Print the Dosing Table
LMWH=low-molecular-weight heparin.
For additional switching information, visit
Switching to ANGIOMAX.
Store ANGIOMAX dosage units at 20°C-25°C (68°F-77°F). Excursions to 15°C-30°C permitted.
(See USP Controlled Room Temperature.) Do not freeze reconstituted or diluted ANGIOMAX.
Reconstituted material may be stored at 2°C-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.
Safety Considerations
ANGIOMAX with provisional use of glycoprotein IIb/IIIa inhibitor is indicated for
use as an anticoagulant in patients undergoing percutaneous coronary intervention
(PCI), and in patients with or at risk for heparin-induced thrombocytopenia and
thrombosis syndrome (HIT/HITTS) undergoing PCI. ANGIOMAX is intended for use with
aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX
is contraindicated in patients with active major bleeding or hypersensitivity to
ANGIOMAX or its components. The most common (≥10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache,
and hypotension. An unexplained fall in blood pressure or hematocrit, or any unexplained
symptom, should lead to serious consideration of a hemorrhagic event and cessation
of ANGIOMAX administration. Please see complete prescribing information.
1ANGIOMAX Prescribing Information. The Medicines Company; Parsippany,
NJ, December 6, 2005.
2Robson R. The use of bivalirudin in patients with renal impairment.
J Invas Cardiol. 2000;12(suppl F):33F-36F.
3Data on file. The Medicines Company; Parsippany, NJ.
4Trissel LA, Saenz CA. Compatibility screening of bivalirudin during
simulated Y-site administration with other drugs. Int J Pharm Compd. 2002;6:311-315.
5Hartman CA, Faria CE, Mago K. Visual compatibility of bivalirudin with
selected drugs. Am J Health Syst Pharm. 2004;61:1774, 1776.
6Reed MD, Bell D. Clinical pharmacology of bivalirudin. Pharmacotherapy.
2002;22:105S-111S.