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Included as part of the PRECAUTIONS section.

Bleeding Events

Although most bleeding associated with the use of Angiomax (bivalirudin) in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration [see ADVERSE REACTIONS]. Angiomax (bivalirudin) should be used with caution in patients with disease states associated with an increased risk of bleeding.

Coronary Artery Brachytherapy

An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax (bivalirudin) in gamma brachytherapy.

If a decision is made to use Angiomax (bivalirudin) during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels [see ADVERSE REACTIONS].

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Angiomax (bivalirudin) . Angiomax (bivalirudin) displayed no genotoxic potential in the in vitro bacterial cell reverse mutation assay (Ames test), the in vitro Chinese hamster ovary cell forward gene mutation test (CHO/HGPRT), the in vitro human lymphocyte chromosomal aberration assay, the in vitro rat hepatocyte unscheduled DNA synthesis (UDS) assay, and the in vivo rat micronucleus assay. Fertility and general reproductive performance in rats were unaffected by subcutaneous doses of Angiomax (bivalirudin) up to 150 mg/kg/day, about 1.6 times the dose on a body surface area basis (mg/m²) of a 50 kg person given the maximum recommended dose of 15 mg/kg/day.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day, (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). These studies revealed no evidence of impaired fertility or harm to the fetus attributable to Angiomax (bivalirudin) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Angiomax (bivalirudin) is intended for use with aspirin [see INDICATIONS AND USAGE]. Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Angiomax (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. Because many drugs are excreted in human milk, caution should be exercised when Angiomax (bivalirudin) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Angiomax (bivalirudin) in pediatric patients have not been established.

Geriatric Use

In studies of patients undergoing PCI, 44% were ≥ 65 years of age and 12% of patients were ≥ 75 years old. Elderly patients experienced more bleeding events than younger patients. Patients treated with Angiomax (bivalirudin) experienced fewer bleeding events in each age stratum, compared to heparin.

Renal Impairment

The disposition of Angiomax (bivalirudin) was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of Angiomax (bivalirudin) was reduced approximately 20% in patients with moderate and severe renal impairment and was reduced approximately 80% in dialysis-dependent patients. [see CLINICAL PHARMACOLOGY].

The infusion dose of Angiomax (bivalirudin) may need to be reduced, and anticoagulant status monitored in patients with renal impairment [see DOSAGE AND ADMINISTRATION].

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.