EPTIFIBATIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EPTIFIBATIDE

Available from:

STRIDES PHARMA CANADA INC

ATC code:

B01AC16

INN (International Name):

EPTIFIBATIDE

Dosage:

0.75MG

Pharmaceutical form:

SOLUTION

Composition:

EPTIFIBATIDE 0.75MG

Administration route:

INTRAVENOUS

Units in package:

100ML

Prescription type:

Prescription

Therapeutic area:

PLATELET AGGREGATION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0137621001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-08-26

Summary of Product characteristics

1
PRODUCT MONOGRAPH
Pr
EPTIFIBATIDE INJECTION
Eptifibatide Injection
Intravenous Solution
2
mg/mL bolus Injection
0.75 mg/mL Injection (as infused)
PLATELET AGGREGATION INHIBITOR
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet,
Varennes, Quebec
J3X 1P7
Date of Revision:
August 25, 2020
Submission Control No.: 241665
2
PRODUCT MONOGRAPH
PR
EPTIFIBATIDE INJECTION
PLATELET AGGREGATION INHIBITOR
ACTION AND CLINICAL PHARMACOLOGY
GENERAL: Eptifibatide reversibly inhibits platelet aggregation by
preventing the binding of
fibrinogen, von Willebrand factor and other adhesive ligands to
glycoprotein IIb/IIIa
(GP IIb/IIIa). When administered intravenously, eptifibatide inhibits
_ ex vivo_ platelet aggregation
in a dose- and concentration-dependent manner. Platelet aggregation
inhibition is reversible
following cessation of eptifibatide; this is thought to result from
dissociation of eptifibatide from
the platelet receptor.
PHARMACODYNAMICS:
Eptifibatide
inhibits
platelet
aggregation
induced
by
adenosine
diphosphate (ADP) and other agonists in a dose- and
concentration-dependent manner. The effect
of eptifibatide is observed immediately after administration of a 180
mcg/kg intravenous bolus.
When followed by a 2.0 mcg/kg/min continuous infusion, this regimen
produces a >80% inhibition
of
20 μM ADP-induced
_ex vivo_
platelet aggregation, (at physiologic calcium
concentrations)
in more than 80% of patients, after more than 8 hours of infusion.
Platelet inhibition was
reversed, with a >50% return of platelet function towards baseline 4
hours after discontinuation of an
infusion of 2.0 mcg/kg/min.
The eptifibatide dosing regimen used in the ESPRIT study was similar
to that used in the
PURSUIT study (a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min
infusion), but added a second
180 mcg/kg bolus ten minutes after the first bolus to avoid a
transient decrease in platelet
aggregation inhibition before reaching steady-state with the
continuous 2.0 mcg/kg/min infusion.
This dosing regimen is recommended in order to maintain plate