Uses of Biva: - Heart attack - Unstable angina As an anticoagulant in percutaneous coronary intervention Active major bleeding. CrCl <30 mL/min and dialysis-dependent patients. Severe uncontrolled HTN; subacute bacterial endocarditis.

Anti-platelet drugs

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.

How to use Bivalirudin: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Preparation To each 250 mg vial add 5 mL SWI Gently swirl until all material is dissolved Dilute each vial in 50 mL of D5W or NS to yield a final concentration of 5 mg/mL If low-rate infusion is used after initial infusion, a lower concentration bag should be prepared Inspect for particulate matter and discoloration prior to administration Do not use preparations containing particulate matter Reconstituted drug will be a clear to slightly opalescent, colorless to slightly yellow solution IV Administration Initial bolus injection followed by continuous infusion Adult Dose: Intravenous As an anticoagulant in percutaneous coronary intervention Adult: Initially, 0.75 mg/kg inj followed by an infusion of 1.75 mg/kg/hr during procedure and up to 4 hours postprocedure. If needed, may continue infusion at 0.25 mg/kg/hr for 4-12 hours. Hepatic impairment: No dosage adjustment needed. Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation 30-59 Reduced infusion to 1.4 mg/kg/hr. <30 Contraindicated. Dialysis Contraindicated.

May increase risk of bleeding when used w/ thrombolytics, oral anticoagulants or drugs that affect platelet function.

Active major bleeding. CrCl <30 mL/min and dialysis-dependent patients. Severe uncontrolled HTN; subacute bacterial endocarditis.

Common - Bruise >10% Back pain (42%) General pain (15%) Nausea (15%) Hemorrhage, minor (13.6%) Headache (12%) Hypotension (12%) 1-10% Injection site pain (8%) Insomnia (7%) Pelvic pain (6%) Hypertension (6%) Anxiety (6%) Vomiting (6%) Bradycardia (5%) Dyspepsia (5%) Abdominal pain (5%) Fever (5%) Nervousness (5%) Urinary retention (4%) Hemorrhage, major (2.3%) >3g/dL fall in Hgb (1.9%) TIMI minor bleeding (1.3%) RBC transfusions (1.3%)

Pregnancy Category B. No adequate and well-controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Bivalirudin is intended for use with aspirin . Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.

Precaution: Increased risk of potentially fatal thrombosis during brachytherapy procedure. Patients at high risk of serious bleeding; recent major surgery or puncture of large vessels or organ biopsy. Renal impairment. Pregnancy, lactation, elderly.

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Bivalirudin immediately and monitor the patient closely for signs of bleeding. There is no known antidote to Bivalirudin. Bivalirudin is hemodialyzable

Store at temperature not exceeding 30º C in a dry place. Do not freeze. Keep out of reach of children

Anti-platelet drugs

Bivalirudin is a synthetic 20-amino acid analogue of the naturally occurring hirudin. It is a specific and reversible direct thrombin inhibitor thats works by binding to the catalytic and anionic exosite of circulating and clot-bound thrombin. It is used as an anticoagulant in percutaneous coronary intervention.

Pregnancy There are no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes Animal data Reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times maximum recommended human dose (MRHD) of 15 mg/kg/day based on body surface area (BSA) during organogenesis, respectively, revealed no evidence of fetal harm Lactation Not known whether drug is present in human milk; no data are available on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition