INDICATIONS AND USAGE

Angiomax is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:

• With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). (1.1)
• Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study. (1.2)
• With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI. (1.2)

Angiomax is intended for use with aspirin. (1.3)

Limitation of use

Safety and effectiveness not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI. (1.4)

DOSAGE AND ADMINISTRATION

For patients who do not have HIT/HITTS

• PCI/PTCA: 0.75mg/kg intravenous (IV) bolus dose followed by a 1.75mg/kg/h IVinfusion for the duration of the procedure. (2.1)
• Perform activated clotting time (ACT) test 5minutes post-bolus dose. If needed, give an additional bolus of 0.3mg/kg. (2.1)
• After PCI/PTCA, IVinfusion may be continued for up to 4hours, after which a rate of 0.2mg/kg/h can be used for up to 20more hours, if needed. (2.1)
• Consider glycoprotein IIb/IIIa inhibitor (GPI) administration with procedural complications. (2.1, 14.1)

For patients who have HIT/HITTS

• The recommended dose of Angiomax in patients with HIT/HITTS undergoing PCI is an IVbolus of 0.75mg/kg. This should be followed by an infusion at a rate of 1.75mg/kg/h for the duration of the procedure. (2.1)
• After PCI/PTCA, IVinfusion may be continued for up to 4hours, after which a rate of 0.2mg/kg/h can be used for up to 20more hours, if needed. (2.1)

For patients with Renal Impairment

• No reduction in bolus dose required. Consider reduction of the rate of infusion to 1mg/kg/h for CrCL <30mL/min or 0.25mg/kg/h if on dialysis. (2.2)

DOSAGE FORMS AND STRENGTHS

Vials containing 250mg of bivalirudin as a sterile, lyophilized powder for reconstitution. (3)

CONTRAINDICATIONS

• Active major bleeding (4)
• Hypersensitivity to bivalirudin or any product components (4)

WARNINGS AND PRECAUTIONS

• Bleeding events: Hemorrhage can occur at any site. Discontinue Angiomax for an unexplained fall in blood pressure or hematocrit. (5.1)
• Coronary artery brachytherapy: Risk of thrombus formation, including fatal outcomes, in gamma brachytherapy. (5.2)

ADVERSE REACTIONS

Most common adverse reaction was bleeding (28%). Other adverse reactions (incidence >0.5%) were headache, thrombocytopenia and fever. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company at 1-800-264-4662 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use. (7)

USE IN SPECIFIC POPULATIONS

• Pediatric patients: Safety and efficacy not established. (8.4)
• Geriatric patients: Elderly patients may experience more bleeding than younger patients. (8.5)
• Renal impairment: Reduce infusion dose and monitor ACT. (2.2, 8.6)