A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Integrilin Indications, Dosage, Storage, Stability - Eptifibatide
Integrilin Indications, Dosage, Storage, Stability - Eptifibatide
INDICATIONS
INTEGRILIN is indicated:
- For the treatment
of patients with acute
coronary syndrome
(UA/NQMI), including patients who are to be managed medically
and those undergoing percutaneous
coronary intervention
(PCI). In this setting,
INTEGRILIN has been shown to decrease the rate
of a combined endpoint
of death or new myocardial
infarction.
- For the treatment
of patients undergoing PCI. In
this setting, INTEGRILIN has been shown to decrease the rate
of a combined endpoint
of death, new myocardial
infarction, or need for
urgent intervention.
In the clinical studies
of eptifibatide, most patients received heparin
and aspirin, as described in CLINICAL
STUDIES.
DOSAGE AND ADMINISTRATION
The safety and efficacy
of eptifibatide has been established in clinical
studies that employed concomitant
use of heparin and aspirin.
Different dose regimens
of eptifibatide were used in the major clinical
studies. (See CLINICAL
STUDIES)
Acute Coronary Syndrome. The recommended adult
dosage of eptifibatide
in patients with acute
coronary syndrome
is an intravenous
bolus of 180 mcg/kg as
soon as possible following diagnosis,
followed by a continuous infusion
of 2 mcg/kg/min until hospital
discharge or initiation
of CABG surgery,
up to 72 hours. If a patient
is to undergo a percutaneous
coronary intervention
(PCI) while receiving eptifibatide, consideration can be given to
decreasing the infusion
rate to 0.5 mcg/kg/min (the
infusion rate
in IMPACT II) at the time
of the procedure. Infusion should be continued for an additional
20-24 hours after the procedure, allowing for up to 96 hours of
therapy. In the PURSUIT Study,
patients weighing more than 121 kg
received a maximum bolus
of 22.6 mg (11.3 mL of the
2 mg/mL injection) followed by a maximum
infusion rate
of 15 mg (20 mL of the 0.75
mg/mL injection) per hour.
Percutaneous Coronary Intervention (PCI) in patients not presenting
with an acute coronary
syndrome. The recommended adult
dosage of eptifibatide
in patients undergoing PCI and not presenting with an acute
coronary syndrome
is an intravenous
bolus of 135 mcg/kg administered
immediately before the initiation of PCI followed by a continuous
infusion of 0.5 mcg/kg/min
for 20-24 hours. In the IMPACT
II Study, there was little experience
in patients weighing more than 143 kg.
In patients who undergo coronary
artery bypass
graft surgery,
eptifibatide infusion
should be discontinued prior to surgery.
In the clinical trials
that showed eptifibatide to be effective, most patients received
concomitant aspirin
and heparin. The aspirin
doses used in the clinical
studies were as follows:
|
Acute Coronary Syndrome
|
Angioplasty
|
|
(PURSUIT Study)
|
(IMPACT II Study)
|
|
160 mg
initially,
|
75- 325 mg
|
|
then 75- 325 mg
daily
|
1- 24 hours prior to intervention
|
The initial
target aPTT in the PURSUIT
study was 50-70 seconds, and the recommended heparin
dosing w.s.
- if weight >70
kg, 5000 U bolus followed
by infusion of 1000
U/hr
- if weight <70
kg, 60 U/kg bolus followed
by infusion of 12
U/kg/hr
When these patients were to undergo PCI, the target
ACT was 300-350 seconds, and the recommended heparin
doses were:
|
Initial Heparin Bolus
|
|
ACT (seconds)
|
Heparin Bolus
|
|
<150
|
100 U/ kg
(10,000 U maximum)
|
|
151- 225
|
75 U/ kg
|
|
226- 299
|
50 U/ kg
|
| > 300 |
none
|
|
Repeat Heparin Bolus*
|
|
ACT (seconds)
|
Heparin Bolus
|
|
<275
|
50 U/ kg
|
|
275- 299
|
25 U/ kg
|
|
> 300
|
none
|
*based on hourly ACT determinations
In the IMPACT II study, the target
ACT was 300-350 seconds before the procedure
and ≤350 seconds thereafter. The recommended heparin
doses were:
- prior to intervention: 100 U/kg bolus
- during intervention: up to 2000 U bolus
q15min
- after intervention: infusion
at physician’s discretion
Patients requiring thrombolytic
therapy had eptifibatide
infusions stopped and were discontinued from the studies.
Instructions for Administration
- Like other parenteral
drug products, INTEGRILIN
solutions should be inspected visually for particulate
matter and discoloration
prior to administration, whenever solution
and container permit.
- INTEGRILIN may be administered in the same intravenous
line as alteplase, atropine,
dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam,
morphine, nitroglycerin, or verapamil. INTEGRILIN should not be
administered through the same intravenous
line as furosemide.
- INTEGRILIN may be administered in the same IV
line with 0.9% NaCl
or 0.9% NaCl/5% dextrose. With either vehicle, the infusion
may also contain up to 60 mEq/L of potassium
chloride. No incompatibilities
have been observed with intravenous
administration
sets. No compatibility
studies have been performed with PVC
bags.
- The bolus dose
of INTEGRILIN should be withdrawn from the 10-mL vial
into a syringe. The bolus
dose should be administered
by IV push over 1-2 minutes.
- Immediately following the bolus
dose administration,
a continuous infusion
of INTEGRILIN should be initiated. When using an intravenous
infusion pump, INTEGRILIN
should be administered undiluted directly from the 100-mL vial.
The 100-mL vial should
be spiked with a vented infusion
set. Care should be taken to center
the spike within the
circle on the stopper
top.
INTEGRILIN is to be administered by volume
according to patient
weight. Patients should receive study drug
according to the following table:
1. INTEGRILIN Dosing Chart by Weight for Patients With Acute
Coronary Syndrome (180 micrograms/kg Bolus and 2 micrograms/kg/min
Infusion)
|
Patient
Weight
(kg)
|
Bolus
Volume
(2 mg/ mL)
|
Infusion
Rate
(0.75 mg/ mL)
|
|
37- 41
|
3.4 mL
|
6 mL/ h
|
|
42- 46
|
4
|
7
|
|
47- 53
|
4.5
|
8
|
|
54- 59
|
5
|
9
|
|
60- 65
|
5.6
|
10
|
|
66- 71
|
6.2
|
11
|
|
72- 78
|
6.8
|
12
|
|
79- 84
|
7.3
|
13
|
|
85- 90
|
7.9
|
14
|
|
91- 96
|
8.5
|
15
|
|
97- 103
|
9
|
16
|
|
104- 109
|
9.5
|
17
|
|
110- 115
|
10.2
|
18
|
|
116- 121
|
10.7
|
19
|
|
>121
|
11.3
|
20
|
2. INTEGRILIN Dosing Chart by Weight for Patients
Without Acute Coronary Syndromes Undergoing PCI (135 micrograms/kg
Bolus and 0.5 micrograms/kg/min Infusion)
|
Patient
Weight
(kg)
|
Bolus
Volume
(2 mg/ mL)
|
Infusion
Rate
(0.75 mg/ mL)
|
|
40- 55
|
3.4 mL
|
2 mL/ h
|
|
56- 68
|
4.2
|
2.5
|
|
69- 80
|
5.1
|
3
|
|
81- 93
|
5.9
|
3.5
|
|
94- 105
|
6.8
|
4
|
|
106- 118
|
7.6
|
4.5
|
|
119- 131
|
8.4
|
5
|
|
132- 143
|
9.2
|
5.5
|
HOW SUPPLIED
INTEGRILIN (eptifibatide) Injection is supplied as a sterile
solution in 10-mL vials
containing 20 mg of eptifibatide
(NDC 0085-1177-01) and 100-mL vials containing 75 mg
of eptifibatide (NDC 0085-1136-01).
Vials should be stored refrigerated at 2-8 o C (36-46
o F). Protect from light
until administration. Do not use beyond the expiration
date. Discard any unused portion left
in the vial.
Rx only.
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