Bivalirudin (bivalirudin)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Bivalirudin trifluoroacetate, a synthetic analog of hirudin that acts as a direct thrombin inhibitor, is an anticoagulant.
Bivalirudin, a synthetic 20-amino acid peptide analog of naturally occurring hirudin, is an anticoagulant. Hirudin is the polypeptide that is responsible for the anticoagulant properties of the saliva of the medicinal leech (Hirudo medicinalis).
Bivalirudin is a specific and reversible direct thrombin inhibitor that binds to the catalytic site and the anion-binding exosite of circulating and clot-bound thrombin. Inhibition of thrombin prevents various steps in the coagulation process (e.g., activation of factors V, VIII, and XIII; conversion of fibrinogen to fibrin; platelet activation and aggregation). These effects of bivalirudin are reversed as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site function.
The onset of anticoagulant effect is immediate following direct IV injection of bivalirudin. Bivalirudin therapy prolongs several coagulation assays, including the activated clotting time (ACT), activated partial thromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT). Coagulation times return to the normal range approximately 1-2 hours after discontinuance of the drug.
Generic name: bivalirudin
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Bivalirudin
Indications
The following indications are listed for Bivalirudin:
- Percutaneous Coronary Intervention Adjunct For Thrombosis Prevention
- Thrombosis Prevention During Percutaneous Coronary Intervention In Heparin-Induced Thrombocytopenia
- Thrombosis With Heparin-Induced Thrombocytopenia During Percutaneous Coronary Intervention
Also known as: Heparin-Induced Thrombotic Thrombocytopenia During Percutaneous Coronary Intervention, Thrombosis In Heparin-Induced Thrombopenia During Percutaneous Coronary Intervention, Thrombosis Prophylaxis During Percutaneous Coronary Intervention In Heparin-Induced Thrombocytopenia, White Clot Syndrome During Percutaneous Coronary Intervention, White-Clot Syndrome During Percutaneous Coronary Intervention.
Dosing
Dosage of bivalirudin trifluoroacetate is expressed in terms of bivalirudin.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Active major bleeding.
*Known hypersensitivity to bivalirudin or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effect of bivalirudin is bleeding. Major bleeding occurred in 3.7% of patients in the BAT trials, and included intracranial bleeding, retroperitoneal bleeding, overt bleeding with a reduction in hemoglobin concentration of more than 3 g/dL, and blood transfusions of more than 2 units of blood.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of bivalirudin have not been established in pediatric patients.
There are no adequate and well-controlled studies of bivalirudin in pregnant women; bivalirudin has not been studied in the perinatal period due to risk of hemorrhage during delivery. Animal findings do not suggest fetal harm at exposure levels equivalent to 1.6 and 3.2 times the maximum human dose; however, at exposure levels equivalent to 5.4 times the maximum human dose, some skeletal abnormalities and a reduction in live births were observed, possibly due to maternal toxicity.
It is not known whether bivalirudin is distributed into milk; effects of the drug on milk production and the breast-fed infant have not been studied.
Administration of bivalirudin to lactating rats was not associated with developmental harm to the pups. The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
The manufacturers make no specific dosage recommendations for geriatric patients.
In clinical trials of bivalirudin, geriatric patients experienced more bleeding complications than younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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