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)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 06/2010
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
Angiomax® (bivalirudin) is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
1.2 Percutaneous Coronary Intervention (PCI)
Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see Clinical Studies (14.1)] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
Angiomax is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.
1.3 Use with Aspirin
Angiomax in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see Dosage and Administration (2.1) and Clinical Studies (14.1)].
1.4 Limitation of Use
The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
Angiomax is for intravenous administration only.
Angiomax is intended for use with aspirin (300-325mg daily) and has been studied only in patients receiving concomitant aspirin.
For patients who do not have HIT/HITTS
The recommended dose of Angiomax is an intravenous (IV) bolus dose of 0.75mg/kg, followed by an infusion of 1.75mg/kg/h for the duration of the PCI/PTCA procedure. Five min after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3mg/kg should be given if needed.
GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description [see Clinical Studies (14.1)] is present.
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 a continuous infusion at a rate of 1.75mg/kg/h for the duration of the procedure.
For ongoing treatment post procedure
Continuation of the Angiomax infusion following PCI/PTCA for up to 4hours post-procedure is optional, at the discretion of the treating physician. After four hours, an additional IVinfusion of Angiomax may be initiated at a rate of 0.2mg/kg/h (low-rate infusion), for up to 20hours, if needed.
2.2 Dosing in Renal Impairment
No reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of Angiomax may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30-59mL/min) should receive an infusion of 1.75mg/kg/h. If the creatinine clearance is less than 30mL/min, reduction of the infusion rate to 1mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25mg/kg/h [see Use In Specific Population (8.6)].
2.3 Instructions for Administration
Angiomax is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250mg vial, add 5mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 50mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5mg/mL (e.g., 1vial in 50mL; 2vials in 100mL; 5vials in 250mL). The dose to be administered is adjusted according to the patient's weight (See Table1).
If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this bag, reconstitute the 250mg vial with 5mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Each reconstituted vial should be further diluted in 500mL of 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 0.5mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table1.
