Dosing and Administration

• Instructions for Administration
• ANGIOMAX Bolus and Infusion Rates Calculated by Weight
• Dosage in Special Population: Renal Impairment
• Optional Low-Rate Post-PCI Infusion
• Switching Patients Undergoing PCI from Heparins to ANGIOMAX
• Storage Recommendations
• Provisional GP IIb/IIIa Criteria

Instructions for Administration¹

Angiomax® (bivalirudin) should be administered as follows:

• ANGIOMAX is intended for IV injection and infusion after dilution
• Each vial contains 250 mg of bivalirudin, 125 mg of mannitol, and sodium hydroxide to adjust the pH to 5-6
• To each 250-mg vial, add 5 mL of Sterile Water for Injection, USP
• Gently swirl until all material is dissolved
• Each reconstituted vial should be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of
  5 mg/mL (eg, 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL)
• The dose to be administered is adjusted according to the patient's weight
• The recommended dose is an intravenous (IV) bolus dose of 0.75 mg/kg. This should be followed by an infusion of 1.75 mg/kg/h for the duration of the PCI procedure.¹ SPECIAL PRECAUTION: It is important to note that the pre-PCI ANGIOMAX dose for patients with acute coronary syndrome in the ACUITY trial is not an approved dose and is much lower than the approved PCI dose discussed in these instructions.

View the ANGIOMAX IV Line Compatibility Chart

ANGIOMAX Bolus and Infusion Rates Calculated by Weight1

Print the Dosing Table

Dosage in Special Population: Renal Impairment¹

ANGIOMAX considerations for patients with renal impairment include the following:

• No reduction in the bolus dose is needed.
• If the creatinine clearance is less than 30 mL/minute, reduction of the infusion rate to 1 mg/kg/h should be considered.
• If a patient is on hemodialysis, the infusion should be reduced to 0.25 mg/kg/h.
• Activated clotting time should be monitored in renally impaired patients.

Optional Low-Rate Post-PCI Infusion¹

• After 4 hours of the initial infusion, an additional infusion may be initiated at a rate of 0.2 mg/kg/h for up to 20 hours, if needed.
• If the low-rate infusion is used after the initial infusion, a lower concentration bag of 0.5 mg/mL should be prepared.

Switching Patients Undergoing PCI From Heparins to ANGIOMAX²

• From unfractionated heparin (UFH) to ANGIOMAX: For patients started on UFH before PCI, wait until 30 minutes after the last dose of UFH before starting ANGIOMAX for PCI.
• From low-molecular-weight heparin (LMWH) to ANGIOMAX: For patients started on LMWH before PCI, wait 8 hours after the last LMWH dose before starting ANGIOMAX for PCI.

  For additional switching information, visit Switching to ANGIOMAX.

Storage Recommendations¹

Store ANGIOMAX dosage units at 20°C-25°C (68°F-77°F). Excursions to 15°C-30°C permitted. (See USP Controlled Room Temperature.) Do not freeze reconstituted or diluted ANGIOMAX. Reconstituted material may be stored at 2°C-8°C for up to 24 hours. Diluted ANGIOMAX with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.

Provisional GP IIb/IIIa Criteria

Use of GP IIb/IIIa should be considered with ANGIOMAX in the following circumstances: decreased TIMI flow (0 to 2) or slow reflow; dissection with decreased flow; new or suspected thrombus; persistent residual stenosis; distal embolization; unplanned stent; suboptimal stenting; side branch closure; abrupt closure; clinical instability; and prolonged ischemia.

Safety Considerations

ANGIOMAX with provisional use of glycoprotein IIb/IIIa inhibitor is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. The most common (10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration. Please see complete prescribing information.