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ANGIOMAX is a brand name for Bivalirudin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Angiomax (bivalirudin) is contraindicated in patients with: x Hypersensitivity to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. x Uncontrollable active bleeding x Major blood clotting disorders x Acute gastric or duodenal ulcer x Cerebral hemorrhage x Severe cerebro-spinal trauma x Bacterial endocarditis x Severe uncontrolled hypertension x Diabetic or hemorrhagic retinopathy x Proximal use of spinal/epidural anesthesia WARNINGS AND PRECAUTIONS General Angiomax (bivalirudin) should not be administered intramuscularly.
There is no known antidote to Angiomax. Angiomax is hemodialysable (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).
Acute Stent Thrombosis:
Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see ADVERSE REACTIONS, HORIZONS and CLINICAL TRIALS, HORIZONS). Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.
An increased incidence of acute stent thrombosis has been mainly observed in STEMI patients undergoing primary PCI. The majority of these cases were non-fatal. 25 mg/kg/hour.
Brachytherapy:
To date, no formal clinical trials have been conducted with Angiomax as the principal anticoagulant when performing catheter-based brachytherapy (beta or gamma) to reduce the risk of in-stent restenosis. Therefore, Angiomax is not recommended for use in brachytherapy procedures.
Page 5 of 45 An increased risk of thrombus formation has been associated with the use of Angiomax in gamma brachytherapy, including fatal outcomes.
Cardiac Surgery:
When Angiomax is used in cardiac surgery, techniques that allow blood or blood-based solutions to lie stagnant should be avoided. Local bivalirudin levels may decrease due to metabolism by proteases from blood exposed to wound or foreign surfaces, potentially leading to local clot formation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bivalirudin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
During surgery, blood should not be allowed to stand in grafts, and grafts should preferably be stored and tested for flow and leakage with saline, instead of blood. Care should be taken to avoid stasis in the internal mammary artery after harvest.
Circulation throughout the cardiopulmonary bypass (CPB) circuit must be ensured with particular attention paid to bypass lines that are blood-filled and then clamped off, or lines that are intermittently used for perfusion.
Hematologic Hemorrhage:
Bleeding may occur in conjunction with use of any anticoagulant drug. As with other anticoagulants, Angiomax should be used with extreme caution in patients at increased risk of hemorrhage. Bleeding can occur at any site during therapy with Angiomax.
An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site (see DRUG INTERACTIONS and ADVERSE REACTIONS, Bleeding).
Immune Immunogenicity/Re-exposure:
In in vitro studies, Angiomax exhibited no platelet aggregation response against sera from patients with a history of HIT/TS. Among 494 patients who received Angiomax in clinical trials and were tested for antibodies, two had treatment-emergent positive bivalirudin antibody tests.
Neither patient demonstrated clinical evidence of allergic or anaphylactic reactions, and repeat testing was not performed. Nine other patients who had initial positive tests were negative on repeat testing. Of fifteen healthy volunteers who were exposed to Angiomax twice, none developed antibodies.
Laboratory Test Interference Angiomax affects International Normalized Ratio (INR), therefore INR measurements made in patients who have been treated with Angiomax may not be useful for determining the appropriate dose of warfarin.
Special Populations Pregnant Women:
There are no studies available evaluating Angiomax in pregnant women. Studies in rats and rabbits have demonstrated no evidence of impaired fertility or harm to the fetus attributable to bivalirudin at clinically relevant doses. Because animal reproduction studies are not always predictive of human response, Angiomax should be used during pregnancy only if clearly indicated.
In PCI, Angiomax is intended for use with ASA (see INDICATIONS AND CLINICAL USE). Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Angiomax and ASA should be used together Page 6 of 45 during pregnancy only with caution and if benefit is thought to outweigh risk.
Nursing Women:
It is not known whether Angiomax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Angiomax is administered to a nursing woman.
Pediatrics (<18 years of age):
The safety and efficacy of Angiomax in children have not been established.
Geriatrics (>65 years of age):
Across studies approximately 45% of patients were 65 years of age and 18% of patients were 75 years old. Elderly patients experienced more bleeding events than younger patients. ADVERSE REACTIONS Adverse Drug Reaction Overview As with any antithrombotic treatment, hemorrhagic manifestations can occur.
Risk factors for bleeding identified with the use of Angiomax (bivalirudin) include elderly status, female gender, and the concomitant use of drugs known to cause bleeding, such as heparin, warfarin and thrombolytics. These risks are comparable to those seen in heparin-treated patients.
Petechiae or easy bruising may precede frank hemorrhage. The early signs of bleeding may include epistaxis, hematuria, or […]