bivalirudin

(C) Vancouver General Hospital.
This monograph may not be reproduced without permission.
For further information, please contact a Pharmacist.

NAME OF DRUG
bivalirudin

CLASSIFICATION

Direct thrombin inhibitor

ALTERNATE NAMES
ANGIOMAX

INDICATIONS

for patients with heparin-induced thrombocytopenia who are to undergo percutaneous coronary intervention (PCI)
to replace GP IIb/IIIa inhibitors for patients undergoing PCI in situations where continuation of a GP IIb/IIIa inhibitor for 18 to 24 hours post-PCI is not feasible

RECONSTITUTION AND STABILITY

powder stable at room temperature
reconstitute 250 mg vial with 5 mL sterile water for injection to yield a 50 mg/mL solution
reconstituted solution stable for 24 hours in the fridge
further dilute reconstituted solution in 50 mL D5W or NS (i.e. 250 mg/50 mL = 5 mg/mL solution)
diluted solutions (0.5-5 mg/mL) stable for 24 hours at room temperature

COMPATIBILITY

compatible with NS and D5W;
DO NOT dilute with other solutions
incompatible with alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, prochlroperazine, reteplase, streptokinase, and vancomycin

ROUTES OF ADMINISTRATION

IV bolus
- given rapidly over a few seconds
- administer dose from prepared infusion bag of 250 mg in 50 mL IV solution
IV infusion
- dilute 250 mg in 50 mL IV solution

VH & HSC ADMINISTRATION POLICY

Restricted to Interventional Cardiology (Cardiac Cath Lab), CCU, CIU, Cardiac Sciences(C10AB, CD)

H - the IV infusion rate must be controlled by an automated infusion control device.

DOSAGE

Dosage for PCI (from REPLACE-2 trial)

Weight (kg)	Bolus 0.75 mg/kg	Procedural Infusion (1.75 mg/kg/hour)
48 – 52	7.5 mL	18 mL/hour
53 – 57	8.3 mL	19 mL/hour
58 – 62	9 mL	21 mL/hour
63 – 67	9.8 mL	23 mL/hour
68 – 72	10.5 mL	25 mL/hour
73 – 77	11.3 mL	26 mL/hour
78 – 82	12 mL	28 mL/hour
83 – 87	12.8 mL	30 mL/hour
88 – 92	13.5 mL	32 mL/hour
93 – 97	14.3 mL	33 mL/hour
98 – 102	15 mL	35 mL/hour
103 – 107	15.8 mL	37 mL/hour
108 – 112	16.5 mL	39 mL/hour
113 – 117	17.3 mL	40 mL/hour
118 – 122	18 mL	42 mL/hour

Patients with renal impairment (creatinine clearance < 30 mL/minute)

give 0.75 mg/kg IV bolus followed by 1 mg/kg/hour for duration of procedure
it is recommended to monitor ACT (maintain ~ 350 seconds); if ACT ≤250 seconds, re-bolus and double the infusion rate. If ACT 250-300 seconds, just re-bolus.

Patients on hemodialysis: 0.75 mg/kg IV bolus followed by 0.25 mg/kg/hour

Switching from unfractionated heparin (UFH) to bivalirudin

Switching from low molecular weight heparin (LMWH) to bivalirudin

POTENTIAL HAZARDS OF PARENTERAL ADMINISTRATION

bleeding, ranging from minor to major
overdosage: hemorrhage (no specific antidote; FFP may be indicated)
elevated aPTT, INR, ACT – coagulation times should return to normal range ~1-2 hours following discontinuation

IMPORTANT IMPLICATIONS

contraindicated in patients with active bleeding, blood dyscrasias, active peptic ulcer disease, cerebral hemorrhage, recent neurological procedure or trauma, bacterial endocarditis
do not administer via intramuscular (IM) route
increased risk of major bleeding events has been reported when used in combination with heparin, warfarin or thrombolytics

Rev. Oct 2007