Biva
Generic: Bivalirudin
Daily Dose:
Course Duration:
Cheaper & Alternative Brands (250 mg/5 ml)
Same active generic (Bivalirudin), same form (IV Injection), exact same strength (250 mg/5 ml)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Biva is indicated for:
Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS
Unstable Angina/Non-ST-Elevation MI (Off-label)
STEMI Undergoing Primary PCI (Off-label)
Heparin-induced Thrombocytopenia
Contraindications
Bivalirudin is contraindicated in patients with: Active major
bleeding & Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components
Side Effects & Adverse Reactions
Bleeding, Body as a Whole: fever,infection, sepsis;
Cardiovascular: hypotension, syncope, vascular anomaly,ventricular fibrillation;
Nervous: cerebral ischemia, confusion, facialparalysis;
Respiratory: lung edema;
Urogenital: kidney failure, oliguria.
Warnings & Precautions
Bleeding Events
: Although most bleeding associated with the use of Biva in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Biva administration. Biva should be used with caution in patients with disease states associated with an increased risk of bleeding.
Coronary Artery Brachy therapy
: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Biva in gamma brachytherapy. If a decision is made to use Biva 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.
Pharmacology & Mechanism of Action
Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.
In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.