bivalirudin

(redirected from Angiox)

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 ?
Acquisition of Angiox 250 mg IV drug destined for the Area Health Badajoz.
M2 PHARMA-July 8, 2014-The Medicines Company renews marketing approval for Angiox in Europe for treating adult patients undergoing percutaneous coronary intervention (PCI)
Healthcare company The Medicines Company (NasdaqGS:MDCO) reported on Monday the receipt of renewal of marketing approval for Angiox (bivalirudin) in Europe, reconfirming its favorable risk-benefit profile, for treating adult patients undergoing percutaneous coronary intervention (PCI).
M2 EQUITYBITES-July 8, 2014-The Medicines Company renews marketing approval for Angiox in Europe for treating adult patients undergoing percutaneous coronary intervention (PCI)
1 December 2009 - US-based pharmaceutical company The Medicines Company (NASDAQ: MDCO) announced today that it has received European approval for the use of Angiox (bivalirudin) as an anticoagulant in patients with heart attacks (so-called ST-segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).
The Commission Decision extends the current EU licence for Angiox and is applicable to all Member States of the European Union/European Economic Area.
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).
The HORIZONS-AMI trial compared Angiox to heparin plus a GPI in 3,602 patients (57 percent of whom were recruited in Europe) presenting with the most severe form of heart attack, known as STEMI, undergoing a emergency (primary) 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.
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.
In Europe, Angiox is indicated as an anticoagulant for patients undergoing PCI and for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention when used with aspirin and clopidogrel.
35 loss per share, resulting primarily from non-recurring charges related to the termination of our distribution agreement with Nycomed and the reacquisition of all development, commercial and distribution rights held by Nycomed for Angiox [R] (bivalirudin) in Europe.