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Bivalirudin

Class
Anticoagulants
Subclass
Direct thrombin inhibitors
Generic name
Bivalirudin
Brand names
Angiomax®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Coronary artery thrombosis, undefined PCI
•
Loading: 0.75 mg/kg IV once
•
Maintenance: 1.75 mg/kg/h IV continuous infusion for the duration of the procedure, with extended duration following PCI for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI)
Administered in combination with aspirin. Obtain an activated clotting time 5 minutes after the bolus dose has been administered and administer an additional bolus dose of 0.3 mg/kg if needed.
Thromboembolic complications in patients without heparin-induced thrombocytopenia, undefined cardiopulmonary bypass • Off-label
•
Loading: 0.75 mg/kg IV once
•
Maintenance: 1.75 mg/kg/h IV continuous infusion
Other off-label uses
•
Treatment of heparin-induced thrombocytopenia
•
Treatment of heparin-induced thrombocytopenia (acute, with thrombosis), undefined cardiopulmonary bypass
•
Prevention of thromboembolism in patients with unstable angina
Indications for use
Labeled indications
Adults
•
Prevention of coronary artery thrombosis, undefined PCI
Off-label indications
Adults
•
Treatment of heparin-induced thrombocytopenia
•
Treatment of heparin-induced thrombocytopenia (acute, with thrombosis), undefined cardiopulmonary bypass
•
Prevention of thromboembolic complications in patients without heparin-induced thrombocytopenia, undefined cardiopulmonary bypass
•
Prevention of thromboembolism in patients with unstable angina
Safety risks
Contraindications
Hypersensitivity to bivalirudin or any of the product components
Active major bleeding
Warnings and precautions
Bleeding
•
Maintain a high level of suspicion if an unexpected fall in BP or hematocrit presents, as that could be a sign of active bleed.
Subacute stent thrombosis
•
Use caution in patients undergoing primary PCI, as acute stent thrombosis has been observed at a greater frequency in those treated with bivalirudin when compared to heparin.
Thromboembolism
•
Use caution in patients undergoing gamma brachytherapy.
Specific populations
Renal impairment
CrCl > 30 mL/min
•
Use acceptable. No dose adjustment required. Monitor activated clotting time. For percutaneous coronary intervention.
CrCl < 30 mL/min
•
Reduce dose. Maximal dose of 1 mg/kg/hour for maintenance infusion, no dose adjustment for bolus dose for PCI.
Renal replacement therapy
Continuous renal replacement
•
Reduce dose. Maximal dose of 1 mg/kg/hour.
Intermittent hemodialysis
•
Reduce dose. Maximal dose of 0.25 mg/kg/hour.
Peritoneal dialysis
•
Use with caution.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Little information available on breastfeeding safety.
•
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Hypotension, back pain, headache, nausea, pain
Common 1-10%
•
Acute hemorrhage, bradycardia, ↓ platelet count, hypertension, abdominal pain, angina pectoris, anxiety, chest pain, fever, indigestion, injection site pain, insomnia, nervousness, pelvic pain, vomiting, stent thrombosis, thrombosis, urine retention
Uncommon < 1%
•
↓ urine output, delayed cerebral ischemia, facial nerve palsy, infections, renal failure, confusion, retroperitoneal hemorrhage, sepsis, VF
Rare < 0.1%
•
Intracranial hemorrhage
Unknown frequency
•
Allergic reactions, cardiac tamponade, ↑ INR, injection site hematoma, pulmonary hemorrhage
Interactions
Drug(s)
Check Interactions
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