bivalirudin

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bivalirudin

 [bi-val´ĭroo-din]
an inhibitor of the clot-promoting activity of thrombin, used in conjunction with aspirin as an anticoagulant in patients with unstable angina pectoris who are undergoing percutaneous transluminal coronary angioplasty; administered intravenously.

bivalirudin

Angiomax, Angiox (UK)

Pharmacologic class: Thrombin inhibitor

Therapeutic class: 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: 250 mg/vial

Indications and dosages

Patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA); patients with or at risk for heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention

Adults: 0.75 mg by I.V. bolus followed by 1.75 mg/kg/hour by I.V. infusion for duration of procedure. Five minutes after bolus is administered, an activated clotting time should be obtained and an additional bolus of 0.3 mg/kg should be given if needed. Continuation of infusion for up to 4 hours post-procedure is optional, and at discretion of treating physician. After 4 hours, an additional I.V. infusion may be initiated at rate of 0.2 mg/kg/hour for up to 20 hours if needed.

Dosage adjustment

• Renal impairment
• Dialysis patients

Off-label uses

• PCTA (regardless of history of unstable angina)
• Anticoagulation during orthopedic surgery

Contraindications

• Hypersensitivity to drug
• Active major bleeding

Precautions

Use cautiously in:
• renal impairment, severe hepatic dysfunction, bacterial endocarditis, cerebrovascular accident, severe hypertension, heparin-induced thrombocytopenia, thrombosis syndrome
• diseases associated with increased risk of bleeding
• concurrent use of other platelet aggregation inhibitors
• pregnant or breastfeeding patients
• children.

Administration

• For I.V. injection and infusion, add 5 ml of sterile water to each 250-mg vial; gently mix until dissolved. Further dilute in 50 ml of dextrose 5% in water or normal saline solution for injection to a final concentration of 5 mg/ml.
• Don't mix with other drugs.
• Don't give by I.M. route.
• Know that drug is intended for use with aspirin.

Adverse reactions

CNS: headache, anxiety, nervousness, insomnia

CV: hypotension, hypertension, bradycardia, ventricular fibrillation

GI: nausea, vomiting, abdominal pain, dyspepsia, severe spontaneous GI bleeding

GU: urinary retention, severe spontaneous GU bleeding

Hematologic: severe spontaneous bleeding

Musculoskeletal: pelvic or back pain

Other: fever, pain at injection site

Interactions

Drug-drug.Abciximab, anticoagulants (including heparin, low-molecular-weight heparins, and heparinoids),

thrombolytics, ticlopidine, warfarin: increased risk of bleeding

Drug-diagnostic tests.Activated partial thromboplastin time, prothrombin time: increased

Drug-herbs.Ginkgo biloba: increased risk of bleeding

Patient monitoring

Monitor blood pressure, hemoglobin, and hematocrit. Be aware that decrease in blood pressure or hematocrit may signal hemorrhagic event.
• Monitor venipuncture site closely for bleeding.

Patient teaching

Instruct patient to immediately report bleeding, bruising, or tarry stools.
• Tell patient to avoid activities that can cause injury. Advise him to use soft toothbrush and electric razor to avoid gum and skin injury.

hirulog

(her-yū-log),
A synthetic thrombin inhibitor.
Synonym(s): bivalirudin

bivalirudin

/bi·val·i·ru·din/ (bi-val´ĭroo-din) an anticoagulant used with aspirin in patients with unstable angina pectoris who are undergoing percutaneous transluminal coronary angioplasty.

bivalirudin

[bi-val′roo-din]
an inhibitor of the clot-promoting activity of thrombin, used in conjunction with aspirin as an anticoagulant in patients with unstable angina pectoris who are undergoing percutaneous transluminal coronary angioplasty; administered intravenously.

bivalirudin

A specific direct-thrombin inhibitor, a synthetic analogue of hirudin, which is found in the saliva of Hirudo medicinalis, the medicinal leech. It is better than heparin in that it has a rapid onset of action, shorter half-life, is potent, specifically binds to thrombin and is reversible.

Indications
Anticoagulant for unstable angina and percutaneous coronary interventions, especially patients with heparin induced thrombocytopenia/heparin induced thrombosis-thrombocytopenia syndrome (HIT/HITTS).
References in periodicals archive ?
Bivalirudin was subsequently approved for use in the EU in 2004 under the trade name Angiox.
The positive opinion is based on results from the ACUITY trial of 13,819 patients with ACS, which found that Angiox with or without a glycoprotein IIb/IIIa inhibitor (GPI) resulted in similar rates of ischemic clinical outcomes compared to standard therapy of heparin (unfractionated or enoxaparin) plus a GPI.
The Medicines Co Receives European Approval for Angiox (
The National Institute for Health and Clinical Excellence (NICE) in the UK recently announced that Angiox (ex-US trade name of Angiomax) is economically dominant (less costly and more effective than currently available therapies) for heart attack patients.
The Medicines Company (NASDAQ:MDCO) announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).
Moreover, Angiox (Angiomax trade name in Europe) has Class I recommendation from the European Society of Cardiology for heart attack patients undergoing percutaneous coronary intervention (PCI).
Nycomed had been an excellent partner since 2004, but its strategic focus had also changed with its subsequent acquisition of Altana, a sizeable transaction, and its divestiture of Angiox, the only acute care cardiology product in its portfolio, which had been a strategic fit with Imagify.
Medicines Company Reacquires European Rights for Angiox 70
We are also pleased to demonstrate our commitment to investments in medical science in Germany - one of the world's most innovative and important hospital critical care markets - where Angiox and our other compounds can establish our presence strongly.
The Medicines Company Obtains Approval for Angiox by
The Medicines Company Re-acquires European Rights for Angiox II-88