INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), co-administration of bivalirudin for injection 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 with concomitant use. ( 7 )
Bivalirudin for injection is contraindicated in patients with:
- Active major bleeding;
- Hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see Adverse Reactions (6.3) ] .
- Active major bleeding ( 4 )
- Hypersensitivity to bivalirudin or its components ( 4 )
AND PRECAUTIONS Bleeding Events: Bivalirudin for injection 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 for injection increases the risk of bleeding <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of bivalirudin for injection administration. Monitor patients receiving Bivalirudin for injection for signs and symptoms of bleeding. Monitor patients with disease states associated with an increased risk of bleeding more frequently for bleeding.
5.2 Acute Stent Thrombosis in Patients with STEMI Undergoing PCI Acute stent thrombosis (AST) (<4 hours) has been observed at a greater frequency in bivalirudin for injection treated patients (1.2%, 36/2889) compared to heparin treated patients (0.2%, 6/2911) with STEMI undergoing primary PCI. Among patients who experienced an AST, one fatality (0.03%) occurred in a bivalirudin for injection treated patient and one fatality (0.03%) in a heparin treated patient. These patients have been managed by Target Vessel Revascularization (TVR). Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.
5.3 Thrombotic Risk with Coronary Artery Brachytherapy An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin for injection in gamma brachytherapy. If a decision is made to use bivalirudin for injection during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> .