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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 bypassOff-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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