EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Aflibercept, Quantity: 40 mg/mL

Available from:

Bayer Australia Ltd

INN (International Name):

Aflibercept

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: monobasic sodium phosphate monohydrate; sodium chloride; dibasic sodium phosphate heptahydrate; sucrose; water for injections; polysorbate 20

Administration route:

Intravitreal-Within The Vitreous Cavity Of The Eye

Units in package:

1 pre-filled syringe (Physician's sample pack), 1 pre-filled syringe (commercial pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EYLEA (aflibercept) is indicated in adults for the treatment of: - neovascular (wet) age-related macular degeneration (wet AMD) - visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) - diabetic macular oedema (DME) - visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) - visual impairment due to myopic choroidal neovascularisation (myopic CNV)

Product summary:

Visual Identification: EYLEA is a sterile, clear, colourless to pale yellow, preservative-free, iso-osmotic aqueous 40 mg/mL solution for intravitreal injection.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-03-07

Patient Information leaflet

EYLEA CMI VX1.0
Page 1 of 5
EYLEA
®
(EYE
•
LEAH)
_AFLIBERCEPT (RCH) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about EYLEA. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
EYLEA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT EYLEA IS USED
FOR
EYLEA is used to treat eye
conditions in adults for:
•
Neovascular wet age-related
macular degeneration (also
known as wet AMD)
•
visual impairment due to
macular oedema after central
retinal vein occlusion (also
known as CRVO)
•
visual impairment due to
macular oedema after branch
retinal vein occlusion (also
known as BRVO)
•
diabetic macular oedema
(DME), which is a swelling of
the retina occurring in patients
with diabetes
•
visual impairment due to
myopic choroidal
neovascularisation (also known
as myopic CNV), which is
associated with a severe form
of short sightedness.
Wet AMD is a condition in which
abnormal blood vessels grow in the
back of the eye (retina). These
blood vessels can leak blood and
fluid into the retina and damage it
leading to vision loss.
CRVO is caused by a blockage in
the main blood vessel that
transports blood away from the
retina, in the back of your eye.
The blockage stops blood from
flowing in and out of the retina
which causes swelling (macular
oedema) and can damage your
eyesight.
DME is a swelling of the retina
occurring in patients with diabetes
due to leakage of fluid from blood
vessels within the retina. When the
macula swells with fluid, central
vision becomes blurry.
BRVO is caused by a blockage in
one or more branches of the main
blood vessel that transports blood
away from the retina, in the back of
your eye. The blockage stops blood
from flowing in and

Summary of Product characteristics

CCDS 14 VX4.0; 04 Nov 2021
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION
EYLEA
® AFLIBERCEPT (RCH) SOLUTION FOR INTRAVITREAL INJECTION
1.
NAME OF THE MEDICINE
Aflibercept (rch)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of EYLEA solution contains 40 mg aflibercept.
Each vial and pre-filled syringe provides a usable amount to deliver a
single dose of 50 µL
solution for intravitreal injection containing 2 mg aflibercept.
Aflibercept is a recombinant fusion protein consisting of portions of
human VEGF receptor 1
and 2 extracellular domains fused to the Fc portion of human IgG1.
Aflibercept is produced in
Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for intravitreal injection.
EYLEA is a sterile, clear, colourless to pale yellow,
preservative-free, iso-osmotic aqueous
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EYLEA (aflibercept) is indicated in adults for the treatment of:
•
neovascular (wet) age-related macular degeneration (wet AMD)
•
visual impairment due to macular oedema secondary to central retinal
vein occlusion
(CRVO)
•
visual impairment due to macular oedema secondary to branch retinal
vein occlusion
(BRVO)
•
diabetic macular oedema (DME)
•
visual impairment due to myopic choroidal neovascularisation (myopic
CNV).
4.2
DOSE AND METHOD OF ADMINISTRATION
EYLEA is for intravitreal injection only.
It must only be administered by a qualified ophthalmologist
experienced in administering
intravitreal injections.
DOSAGE
The recommended dose for EYLEA is 2 mg aflibercept, equivalent to an
injection volume of
50 µL. The interval between doses injected into the same eye should
not be shorter than
one month.
CCDS 14 VX4.0; 04 Nov 2021
Page 2 of 36
Advice on treatment initiation and maintenance of therapy specific to
each patient population
is described in the section below. Once optimal visual acuity is
achieved and/or there are no
signs of disease activity,