Angiomax package insert pdf

With, or at risk of, heparininduced thrombocytopenia hit or heparininduced thrombocytopenia and. Highlights of prescribing information coadministration of. There are no data available in pregnant women to inform a drugassociated risk of adverse. Highlights of prescribing information these highlights do not. The recommended dose of angiomax is an intravenous bolus dose of 0. The chemical name is dphenylalanyllprolyllarginyllprolylglycylglycylglycylglycyllasparagylglycyllaspartyllphenylalanyll. Target aptt 50 to 70seconds if weight greaterthan or equal to 70kg, 5000unitbolus followed by infusion of unitsh. Aggrastat tirofiban hydrochloride injection is an acutecare, hospitalbased cardiovascular pharmaceutical. Bivalirudin pre cath dosing and administration card accord. Bivalirudin 250 mg powder for concentrate for solution for injection or infusion bivalirudin.

Dosing and administration guide for kengreal cangrelor. Reconstituted material may be stored at 28c up to 24 hours. Mec approval csj 022714 csm 022714 chn2328 expires 022017 unless noted as pbo prescribed brand only, a formulary equivalent medication may be dispensed. Administer integrilinby volume according to patient weightsee table1.

Bivalirudin is a direct thrombin inhibitor dti used in patients experiencing heparininduced. Angiomax bivalirudin is a specific and reversible direct thrombin inhibitor. Angiomax is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. Jun 30, 2019 the recommended dose of angiomax is an intravenous bolus dose of 0. Integrilin should be given concomitantly with heparin dosed to achieve the following parameters. The recommended dose of angiomax in patients with hithitts undergoing pci is an iv bolus of 0. Angiomax bivalirudin dosing, indications, interactions. However, it is only about onethird the size of hirudin 20 vs. The recommended dose of bivalirudin injection is an intravenous bolus dose of 0. The binding of angiomax to thrombin is reversible as thrombin slowly cleaves the angiomaxarg3pro4 bond, resulting in recovery of thrombin active site functions. As noted in the current package insert for bivalirudin, this dose achieves a mean steady state bivalirudin concentration of 12. Evaluation of the use of argatroban or bivalirudin for the.

Bivalirudin is an anticoagulant thrombin inhibitor that helps prevent the formation of blood clots. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of dphenylalanyllprolyl larginyllprolylglycylglycylglycylglycyllasparagylglycyllaspartyllphenylalanyl lglutamyllglutamyllisoleucyl. When using an intravenous infusion pump, administer integrilin undiluted directly from the 100ml vial. Highlights of prescribing information for patients with renal.

Angiomax bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients. Bivalirudin angiomax or angiox, manufactured by the medicines company is a direct thrombin inhibitor dti chemically, it is a synthetic congener of the naturally occurring drug hirudin found in the saliva of the medicinal leech hirudo medicinalis bivalirudin is a dti that overcomes many limitations seen with indirect thrombin inhibitors, such as heparin. An improvement in survival or diseaserelated symptoms has not been established. For detailed prescription information, refer to the manufacturers package insert for each medication. Angiomax is supplied as a sterile, lyophilized powder in singledose, glass vials. Information for the user bivalirudin 250 mg powder for concentrate for solution for injection or infusion bivalirudin read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Angiomax bivalirudin dose, indications, adverse effects. Evaluation of appropriateness of bivalirudin prescribing at an. Angiomax is intended for use with aspirin 300325 mg daily and has been studied only in patients receiving concomitant aspirin. This guideline outlines the use of bivalirudin as an anticoagulant during extracorporeal membrane oxygenation. Bivalirudin is a direct thrombin inhibitor and can be used as an alternate to heparin as it does not cause hit heparininduced thrombocytopenia. This indication is approved under accelerated approval based on tumor response rate and duration of response. Left ventricular dysfunction and embryofetal toxicity see full prescribing information for complete boxed warning.

For use as an anticoagulant in patients undergoing percutaneous coronary intervention pci including patients with heparininduced thrombocytopenia hit and heparininduced thrombocytopenia and thrombosis. Bivalirudin 250mg powder for concentrate for solution for injection or infusion. However, angiomax must educate the buyers and doctors on the enormous value that will be derived from using angiomax over its competitor. Bivalirudin is indicated as an anticoagulant in adult.

Find patient medical information for angiomax intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Jun 01, 2019 angiomax has been studied only in patients receiving concomitant aspirin. Do not freeze reconstituted or diluted bivalirudin. If weight less than 70kg, 60unitskg bolus followed by infusion of 12unitskgh. Anticoagulant pregnancy risk category b action selectively inhibits thrombin by binding to its receptor sites, causing inactivation of coagulation factors v, viii, and xii and thus preventing conversion of fibrinogen to fibrin availability powder for injection. As noted in the current package insert for bivalirudin, this dose achieves. The dosage and administration of coumadin must be individualized for each patient according to the patients international normalized ratio inr response to the drug.

The recommended dose of angiomax is an intravenous iv bolus dose of 0. Package of 10 5367297 total content order size cardinal singledose glass vial 36 packages per case 5667233 container type case size hd smith 3666500 cap color mckesson 971671 xxxxx generic name bivalirudin for injection rld angiomax description sterile, lyophillized powder rating ap storage 2025 c 6877f shelf life morris. Bivalirudin injection is an anticoagulant for use in patients undergoing percutaneous coronary. Bivalirudin angiomax, the medicines company, parsippany, nj, usa is an oligopeptide analogue of hirudin, i. Angiomax contains bivalirudin which is a specific and reversible direct thrombin inhibitor. No reduction in the bolus dose is needed for any degree of renal impairment.

Diluted bivalirudin with a concentration between 0. Dosing and administration instructions for pci and primary pci bivalirudin accord prescribing information bivalirudin 250mg powder for concentrate for solution for injection or infusion please refer to the summary of product characteristics spc before prescribing. However, aspirin is sometimes given with bivalirudin, and taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. The entity bearing the cost of the supply will use code j0583. Switching to and from various anticoagulants disclaimer guidelines are not meant to replace clinical judgment or professional standards of care. An unwanted blood clot can occur with certain heart or blood vessel conditions bivalirudin is used to prevent blood clots in people with severe chest pain or other conditions who are undergoing a procedure called angioplasty to open blocked arteries. Guidelines for using bivalirudin during cardiopulmonary. This should be followed by an infusion at a rate of 1. Effects are dose and concentrationdependent and reversible. Angiomax rtu bivalirudin injection, for intravenous use. Five minutes after the bolus dose has been administered, an activated clotting time act should be performed and an additional bolus of 0. Clinical judgment must take into consideration all. Each vial contains 250 mg bivalirudin, 125 mg mannitol, and sodium hydroxide to adjust the ph to 5 to 6 equivalent of approximately 12. Patients with a history of a clinically significant low white blood cell count wbc or a druginduced leukopenianeutropenia should have their complete blood count cbc monitored frequently during the first few months of therapy and discontinuation of abilify should be considered at the first sign of a.

The recommended dose of angiomax is an intravenous iv bolus dose of. Angiomax information, side effects, warnings and recalls. This dose is currently under investigation in ongoing clinical trials. Bivalirudin has a short plasma halflife of 2536 min. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate. Angiomax for injection the medicines company, drug. Preparation instructions for bolus injection and continuous infusion to each 250 mg vial, add 5 ml of sterile water for injection, usp. The active substance is a synthetic, 20 amino acid peptide. Bivalirudin injection is an anticoagulant for use in patients undergoing percutaneous coronary intervention pci. Tell your doctor if you are pregnant before you are treated with bivalirudin and aspirin. Please refer to the summary of product characteristics. The medicines company application no 20873 approval date.

Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of dphenylalanyllprolyl larginyllprolylglycylglycylglycylglycyllasparagylglycyllaspartyllphenylalanyl lglutamyllglutamyllisoleucyll. To each 250 mg angiomax vial, add 5 ml of sterile water for injection, usp. Center the spike within the circle on the stopper top. This is different than package insert instructions. In in vitro studies, bivalirudin inhibited both soluble free and clotbound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partial. Clinical trials angiomax has been evaluated in five randomized, controlled interventional cardiology trials reporting 11,422 patients. Angiomax bivalirudin is a reversible direct thrombin inhibitor used to prevent blood clots in people with severe chest pain or other conditions undergoing a procedure called angioplasty to open blocked arteries.

Continued approval for this indication may be contingent. Left ventricular dysfunction and embryofetal toxicity left ventricular dysfunction. Bivalirudin angiomax, formerly known as hirulog, a hirudin analog, is a small synthetic 20aminoacid peptide molecular mass 2180 daltons and is a specific, direct inhibitor of thrombin. Angiomax definition of angiomax by medical dictionary. Angiomax bivalirudin injection description angiomax bivalirudin is a specific and reversible direct thrombin inhibitor. Angiomax bivalirudin for injection, for intravenous use. Jul 29, 2019 angiomax bivalirudin is a reversible direct thrombin inhibitor used to prevent blood clots in people with severe chest pain or other conditions undergoing a procedure called angioplasty to open blocked arteries. Jun 28, 2019 angiomax bivalirudin for injection, for intravenous use initial u. Healthcare professionals should refer to the summary of product characteristics for full prescribing information. The infusion dose of angiomax may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Angiomax bivalirudin for injection, for intravenous use initial u. Heparin is the most common agent used, but in selective circumstances, alternate form of anticoagulation may be considered. Angiomax fda prescribing information, side effects and uses. Perjeta pertuzumab injection, for intravenous use initial u.

Angiomax bivalirudin dosing, indications, interactions, adverse. Adjust the dose based on the patients inr and the condition being treated. The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1. Medscape indicationspecific dosing for angiomax bivalirudin. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral tcell lymphoma ptcl. Coumadin has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Side effects of angiomax bivalirudin, warnings, uses. Download fulltext pdf use of bivalirudin as an anticoagulant during cardiopulmonary bypass article pdf available in the journal of extracorporeal technology 373. Use of bivalirudin as an anticoagulant during cardiopulmonary.

Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding. Guidelines for using bivalirudin during cardiopulmonary bypass surgery during cardiopulmonary bypass procedures, systemic anticoagulation to prevent thrombosis in the patient as well as the circuit is utilized. Bivalirudin angiomax orders cath lab physician signature. Each reconstituted vial should be further diluted in 100 ml of 0. Undergoing percutaneous coronary intervention pci with provisional use of glycoprotein iibiiia inhibitor gpi. Bivalirudin is not expected to be harmful to an unborn baby. Thanks for your reply, can you tell how the angiomax itself would be charged for. Highlights of prescribing information for patients. Jul 29, 2019 angiomax bivalirudin for injection, for intravenous use. From january 20 through december 2015, 74 patients were identified with suspicion of hit while on crrt.