Bivalirudin indications and usage: Difference between revisions
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== | ==Indications and Usage== | ||
===1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)=== | |||
Angiomax® (bivalirudin) is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). | |||
<ref>{{Cite web | last = | first = | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher = | date = | accessdate = 10 March 2014 }}</ref> | ===1.2 Percutaneous Coronary Intervention (PCI)=== | ||
Angiomax 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). | |||
Angiomax 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 Aspirin=== | |||
Angiomax 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 Use=== | |||
The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.<ref>{{Cite web | last = | first = | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher = | date = | accessdate = 10 March 2014 }}</ref> | |||
==References== | ==References== | ||
Revision as of 12:18, 10 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Indications and Usage
1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)
Angiomax® (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)
Angiomax 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).
Angiomax 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 Aspirin
Angiomax 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 Use
The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.[1]
References
- ↑ "ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]". Retrieved 10 March 2014.
Adapted from the FDA Package Insert.