About ANGIOMAX
Product Overview1
Angiomax® (bivalirudin) is a thrombin-specific antithrombotic with improved clinical outcomes when compared with heparin as a foundation anticoagulant in the contemporary catheterization lab setting
ANGIOMAX has been evaluated in 6 randomized trials of over 25,000 patients undergoing percutaneous coronary intervention(PCI).1,2
More than 1 million patients have been treated with ANGIOMAX since 2001.3,4,5
In randomized, double-blind clinical trials, ANGIOMAX with or without provisional glycoprotein (GP) IIb/IIIa:
- Demonstrated proven efficacy plus fewer bleeding complications for improved outcomes
- Significantly reduced major hemorrhagic events by 41% to 61%
- Demonstrated proven antithrombotic effect in low- to high-risk patients
- Avoided risks and limitations of heparin to reduce need for GP IIb/IIIa
- Resulted in cost savings which provide better economic outcomes
Description
- The active substance of ANGIOMAX is a short, synthetic, 20-amino acid peptide comprised of an active-site–directed peptide, D-Phe-Pro-Arg-Pro, linked via a tetraglycine spacer to a dodecapeptide analogue of the carboxy-terminal of hirudin
- ANGIOMAX is supplied in single-use vials as a white lyophilized cake, which is sterile
- ANGIOMAX is a potent, highly specific, reversible, bivalent inhibitor of thrombin
ANGIOMAX Is Naturally Cleaved by Thrombin
ANGIOMAX Is Unique Compared to Heparin
| Antithrombotic feature |
ANGIOMAX |
Heparin |
Effect |
| 100% bioavailable1 |
√ |
|
Provides a predictable dose response;
no continuous ACT monitoring required1 |
| IV, 25-minute half-life1 |
√ |
|
Enables fast-on, fast-off activity1 |
| Direct thrombin inhibition1 |
√ |
|
Does not require a binding cofactor to inactivate both circulating and clot-bound thrombin1 |
Requires antithrombin
as a binding cofactor6 |
|
√ |
Inhibits thrombin indirectly and does not effectively inactivate clot-bound thrombin6 |
| Binds reversibly to thrombin1 |
√ |
|
Thrombin is able to resume normal hemostatic functions1 |
Sheath removal 2 hours
after discontinuation in
most patients*7,8 |
√ |
|
Reduces access-site bleeding complications and improves throughput7,8,9 |
No heparin/platelet factor 4
cross-reactivity1 |
√ |
|
No risk of heparin-induced thrombocytopenia
or thrombosis syndrome (HIT/HITTS)1 |
| Activates platelets10 |
|
√ |
Promotes more platelet activation and platelet aggregation10 |
ACT = activated clotting time
IV = intravenous
*Sheath removal has not been studied in dialysis-dependent patients treated with ANGIOMAX. Follow standard hospital protocol for this population.
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.
2Stone GW, McLaurin BT, Cox DA, et al, for the ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-2216.
3Data on file. The Medicines Company, Parsippany, NJ.
4Source® Non-retail Database, 2002-2006. Conshohocken, Pa: Wolters Kluwer Health.
5ACTracker® Database, 2005. Evanston, Ill: Solucient, LLC.
6Bates SM, Weitz JI. The mechanism of action of thrombin inhibitors. J Invasive Cardiol. 2000;12(suppl F):27F-32F.
7Mehta S, Yebara S, Ibrahim M, et al. Cedars Medical Center's Experience: Early Ambulation post PCI with Use of Direct Thrombin Inhibitor, Bivalirudin Cath Lab Digest 2004;12:1-4.
8Minutello RM, Wong SC, Chou ET, et al. ANGIOMAX Facilitates Early Sheath Removal After Coronary Angioplasty: The AFRICA Study. Am J Cardiol 2003; 6 Suppl 1;146L.
9Schussler JM, Cameron CS, Anwar A, et al. Effect of bivalirudin on length of stay in the recovery area after percutaneous coronary intervention compared with heparin alone, heparin + abciximab, or heparin + eptifibatide. Am J Cardiol. 2004;94:1417-9.
10Xiao Z, Theroux P. Platelet activation with unfractionated heparin at the therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation. 1998;97:251-256.