Bivalirudin does not exhibit binding of plasma proteins (other than thrombin ) or red blood cells Innlinical trials with patient\s undergoing PTCA/PCI

Coadmin. of bivalirudin with heparin , warfarin, hrombollytics or GPIIb/IIIa inhibitors was associated with increased risks of major bleeding events compared with patients not receiving these concomittant medication

There is no expereience of coadmin of bivalirudin and plasma expanders such as dextran

Indication-

Concomittant aspirin therapy Heparin induced thrombocytopenia ( HIT )/ heparin induced thrombocytopenia - thrombosis syndrome ( HITTS ) PCI - percutaneous coronary intervention PTCA - percutaneous transluminal coronary angioplasty

Cardiovascular- Bradycardia, hypertension, hypotension

CNS - headache, insomnia, nervousness,

GI - abdominal pain, dyspepsia, vomiting,

GU- urinary retention,

Miscellaneous- anxiety, back pain, fever, injection- site pain, pain, pelvic pain

Any major bleeding , hypersenstivity to the drug or its components Special precautions-

Hematolgic efects- bivalirudin is not intended for IM admin. Although most bleeding with use of bivalirudin in PCI occurs at any site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hemtocrit or any unexplained symptom should lead to serious consideration of a hemorrhage condition and cessation of bivlirudin admin.

Brachytherapy- an increased risk of trombus formation has been associated with the use of bivlirudin in gamma brachytherapy including fatal outcomes Use caution during brachthrapy procedures

Antidote- no known antidote to bivalirudin. Bivalirudin is hemodialysable

Renal function impairment- clearance was reduced approximately 20% in patients with moderate to severe renal impairment and was reduced approximately 80% in dialysis dependent patients

Special risk- use bivlirudin in patients with disease states associated with an increased risk of bleeding

Pregnancy- Bilvulirudin is intended to be used with aspirin. Because of the possible adverse reactions on the neonate and potential for increased bleeding particularly during the third trimester , use bilvalirudin and aspirin together during pregnancy only if clearly needed.

Lactation- Because the drug is excreted in human milk excercise caution when bilvlirudin is administred to breast feeding woman,

Children- safety and efficacy of bivlirudin in pediatric patients have not been established

Elderly- Elderrly patients experienced more bleeding events than youngrer patients. Patients treated biavlirudin experienced fewer bleeding events in age stratum compared with heparin.

Indication

Concomittant aspirin therapy Heparin induced thrombocytopenia ( HIT )/ heparin induced thrombocytopenia - thrombosis syndrome ( HITTS ) PCI - percutaneous coronary intervention PTCA - percutaneous transluminal coronary angioplasty

Dosage

- recommended dosage- of bilivalirudin is an intravenous IV blous dose of 0.75mg/kg . This should be followed by an infusion of 1.75mg/kh/hr for the duration of the PCI procedure Five minutes after the bolus dose has been administered an activated clotting time ACT should be performed and an additional bolus dose of 0.3mg/kg/hr should be given if needed.

Pharmacology-

Bivallrudin directly inhibits thrombin by specifically binding to the catalytic site to the anion- binding exosite of circulating and clot-bound thrombin. The binding of bivaliirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin -Arg3- Pro4 bond, resulting in recovery of thrombin active functions

Pharmacokinetics-

Bivalirudin does not bind to plasma proteins( other than thrombin) or red blood cells. Bivalirudin is cleared from plasma by a combination of real mechanism and proteolytic clevage with a half-life in patients with healthy renal function in 25 minutes

Special precaution- Lactation