What are the contraindications for Angiomax (bivalirudin)?

Angiomax (Bivalirudin) Contraindications

Angiomax is contraindicated in only two clinical situations: patients with significant active bleeding and patients with hypersensitivity to bivalirudin or its components. 1

Absolute Contraindications

Significant Active Bleeding

• Any patient with ongoing, clinically significant hemorrhage should not receive bivalirudin. 1
• This includes intracranial bleeding, retroperitoneal bleeding, or any bleeding requiring transfusion or causing hemodynamic compromise. 1

Hypersensitivity Reactions

• Patients with documented hypersensitivity to bivalirudin or any component of the formulation are contraindicated from receiving the drug. 1
• Although rare, anaphylactic reactions have been reported in postmarketing surveillance. 1
• In clinical trials, only 2 of 494 patients tested positive for bivalirudin antibodies, and neither demonstrated allergic or anaphylactic reactions. 1

Important Clinical Caveats

Not Absolute Contraindications (But Require Caution)

Renal impairment is NOT a contraindication, but requires dose adjustment:

• For creatinine clearance <30 mL/min, reduce the maintenance infusion to 1 mg/kg/h (from standard 1.75 mg/kg/h). 1, 2
• For patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h. 1
• No bolus dose reduction is needed regardless of renal function. 1

Heparin-induced thrombocytopenia (HIT) is actually an INDICATION, not a contraindication:

• Bivalirudin is specifically indicated for patients with HIT or HIT with thrombosis syndrome undergoing PCI. 1, 3, 4
• The American Society of Hematology recommends bivalirudin as an alternative anticoagulant when HIT is suspected. 4

Special Warnings (Not Contraindications)

Coronary artery brachytherapy carries increased thrombotic risk:

• An increased risk of thrombus formation, including fatal outcomes, has been associated with bivalirudin use during gamma brachytherapy. 1
• This is a warning, not an absolute contraindication, but requires careful risk-benefit assessment. 1

Acute stent thrombosis risk in STEMI:

• Bivalirudin increases the risk of acute stent thrombosis compared to heparin with glycoprotein IIb/IIIa inhibitors (1.3% vs 0.3%). 2
• This risk can be mitigated by extending the post-PCI infusion at full dose (1.75 mg/kg/h) for 2-4 hours. 3, 2

Common Pitfalls to Avoid

• Do not confuse warnings with contraindications: Bleeding risk and thrombotic concerns are warnings that require monitoring and dose adjustment, not absolute contraindications. 1
• Do not withhold in renal failure: Simply adjust the maintenance infusion dose; the drug can still be used safely. 1, 2
• Do not avoid in HIT patients: This is precisely when bivalirudin should be considered as a preferred alternative to heparin. 3, 4, 1
• Do not combine with certain IV medications: While not contraindications to bivalirudin itself, avoid co-administration in the same IV line with alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine, reteplase, streptokinase, and vancomycin due to incompatibility. 1