ANGIOMAX

Bivalirudin exhibits linear pharmacokinetics following IV administration to patients undergoing PTCA. In these patients, a mean steady state bivalirudin concentration of 12.3 ± 1.7 mcg/mL is achieved following an IV bolus of 1 mg/kg and a 4-hour 2.5 mg/kg/h IV infusion.

DistributionBivalirudin does not bind to plasma proteins (other than thrombin) or to red blood cells.

EliminationBivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function. The total body clearance of...

Bivalirudin Angioplasty Trial (BAT) In the BAT studies, patients with unstable angina undergoing PCI were randomized 1:1 to a 1 mg/kg bolus of bivalirudin and then 2.5 mg/kg/h for four hours and then 0.2 mg/kg/h for 14 to 20 hours or to 175 IU/kg bolus of heparin followed by an 18 to 24 hour infusion of 15 IU/kg/h infusion. Additional heparin but not bivalirudin could be administered for ACT less than 350 seconds. The studies were designed to demonstrate the superiority of bivalirudin to heparin on the occurrence of any of the following during hospitalization up to seven days of death, MI, abr...

Most common adverse reaction (>2%) was bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the BAT trials, 79...

Bivalirudin is contraindicated in patients with:

• Active major bleeding;
• Hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see Adverse Reactions (6.1) ] .
• Active major bleeding ( 4 )
• Hypersensitivity to bivalirudin or its components ( 4 )

• Bleeding Events: Bivalirudin increases the risk of bleeding. ( 5.1 , 6.1 , 12.2 )
• Acute Stent Thrombosis: Increased incidence of acute stent thrombosis in STEMI patients undergoing primary PCI. ( 2.1 , 5.2 )
• Thrombotic Risk with Coronary Artery Brachytherapy: An increased risk of thrombus formation, including fatal outcomes, in gamma brachytherapy. ( 5.3 ) 5.1 Bleeding Events Bivalirudin increases the risk of bleeding [see Adverse Reactions ( 6.1 )] . An unexplained fall in blood pressure ...

7 DRUG INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), coadministration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications. Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk...