EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle

Main information

  • Trade name:
  • EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180859
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180859

EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

7/03/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Refrigerate

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial (commercial pack)

(S4) Prescription Only Medicine

1 vial (Physician's sample pack)

(S4) Prescription Only Medicine

Components

1. EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle

Dosage Form

Injection, solution

Route of Administration

Intravitreal-Within The Vitreous Cavity Of The Eye

Visual Identification

EYLEA is a sterile, clear, colourless to pale yellow, preservative-free,

iso-osmotic aqueous 40 mg/mL solution for intravitreal injection.

Active Ingredients

Aflibercept

40 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 08:01:38 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

171121-cmi-eylea

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 out of the

retina which causes swelling

(macular oedema) and can damage

your eyesight.

Myopic CNV is a severe form of

myopia (short sightedness) which

leads to extremely elongated eyes

with additional defects in some

layers in the back of the eye. This

triggers the abnormal formation of

new blood vessels which can cause

bleeding and eventually may lead to

loss of vision.

In these conditions, EYLEA can

help to prevent the eyesight from

becoming worse or may improve it.

Proteins called vascular endothelial

growth factor-A (VEGF-A) and

placental growth factor (PlGF) play

an important part in the

development of new blood vessels

in your eye which contributes to the

progression of wet AMD or myopic

CNV and the development of

swelling (macular oedema) due to

either CRVO, BRVO or DME.

EYLEA is a type of treatment

known as anti-vascular endothelial

growth factor (anti-VEGF).

EYLEA contains the active

ingredient aflibercept, which

specifically recognises and binds to

VEGF-A and PlGF proteins. By

blocking these proteins, EYLEA

can stop the growth and leakage of

abnormal blood vessels and

swelling of the retina in the eye,

which in turn can help improve

your eyesight or stop if from getting

worse.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribed it

for another reason.

BEFORE YOU ARE

GIVEN EYLEA

When you must not be

given it

You must not be given EYLEA if

you have:

an allergy to aflibercept (the

active ingredient in EYLEA) or

any of the ingredients listed at

the end of this leaflet. Some of

the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty

breathing

171121-cmi-eylea

Page 2 of 5

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

an infection in or around your

eye.

pain or redness in your eye.

Do not give this medicine to

children under the age of 18

years. There is not enough

information to recommend the

use of EYLEA for children or

adolescents.

You must not be given this

medicine after the expiry date

printed on the pack.

The expiry date is printed on the

carton after “EXP” (for example

11 18 refers to November 2018).

The expiry date refers to the last

day of that month. If it has expired

return it to your pharmacist for

disposal.

You must not be given this

medicine if the packaging is torn

or shows signs of tampering.

If the packaging is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should be given this medicine,

talk to your doctor.

Before you are given it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you:

think you may be allergic to

aflibercept or any of the

ingredients in EYLEA

had any prior issues or

problems with injections into

your eyes

have glaucoma (injection with

EYLEA may trigger an increase

in eye pressure in some patients

within 60 minutes of the

injection and your doctor may

monitor this after each

injection)

have ever had a stroke or

experienced transient signs of a

stroke (known as a “TIA” or

“mini-stroke”)

have previously had or are

planning to have an eye surgery

within the past or next four

weeks

If you are pregnant or plan to

become pregnant or have the

potential to become pregnant,

please talk to your doctor. Your

doctor will discuss the risks and

benefits involved. It is

recommended that you use

effective contraception during

EYLEA treatment and for at least

three months after the last

injection of EYLEA.

If you are breast-feeding or

planning to breast-feed, EYLEA

is not recommended during

breast-feeding as it is not known

whether EYLEA passes into

breast milk.

If you have not told your doctor

about any of the above, tell

him/her before you are given

EYLEA.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket,

naturopath or health food shop.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid when you

are given this medicine.

HOW EYLEA IS GIVEN

EYLEA is given by your doctor as

an injection into your eye usually

under a local anaesthetic.

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions given, ask your

doctor for help.

Make sure you do not wear any

make up on the day of your

EYLEA appointment.

On the day of your injection, your

doctor or nurse will get you ready

for your EYLEA treatment.

How much is given

The recommended dose of EYLEA

is 50 µL (microlitre).

The interval between two doses

should be no shorter than one

month.

If you are being treated for wet

AMD:

The injection is given once a month

for the first 3 months followed by

one injection every 2 months.

If considered appropriate based on

your vision and test results at each

visit, your doctor may decide to

gradually increase or adjust the

treatment interval for your next

injection.

If you are being treated for

impaired vision due to macular

oedema caused by CRVO or BRVO:

You will start your treatment with

monthly injections. After the first

three injections, your doctor will

determine the most appropriate

treatment schedule for you based on

your vision and test results at each

visit. If considered appropriate,

your doctor may decide to gradually

increase or adjust the treatment

interval for your next injection.

If you are being treated for DME:

The injection is given once a month

for the first 5 months followed by

one injection every 2 months.

171121-cmi-eylea

Page 3 of 5

After the first 12 months of

treatment with EYLEA, your doctor

may decide to gradually increase or

adjust the treatment interval for

your next injection if considered

appropriate based on your vision

and test results at each visit.

If you are being treated for myopic

CNV:

You will start your treatment with

one injection and you will receive

additional injections only if, during

subsequent examinations, your

doctor finds that your disease

persists.

How it is given

A doctor experienced in giving eye

injections will inject EYLEA into

your eye under sterile conditions.

Before the injection your doctor

will use a disinfectant eyewash to

clean your eye carefully to prevent

infection. Your doctor may also

give you a local anaesthetic to

reduce or prevent any pain you

might have with the injection.

After the EYLEA injection is given,

your doctor may perform some

additional tests to make sure there

are no complications. Eye

injections like those with EYLEA

can increase the pressure inside

your eye.

When it is given

Your doctor will decide when you

will be given EYLEA.

How long to continue

treatment

Continue treatment with this

medicine for as long as your

doctor tells you.

Your doctor will arrange your next

EYLEA appointment. Make sure

you keep all of your scheduled

appointments.

Your doctor may decide to stop

your treatment with EYLEA if your

vision is not showing benefits.

Consult your doctor before

stopping treatment.

If you forget a treatment

If you miss a treatment with

EYLEA, contact your doctor to

make a new appointment for an

examination and injection as soon

as possible.

If you stop treatment with EYLEA,

your vision may get worse.

If you are given too much

(overdose)

If you are given more EYLEA than

you need, your doctor will check

the pressure in your eye and may

need to treat it if it is increased.

WHILE YOU ARE GIVEN

EYLEA

Things you must do

Tell your doctor if you experience

any problems during the

treatment, especially if you are

being given EYLEA injections

into both of your eyes at the same

time.

You may be more likely to

experience side effects if you

receive an injection to both of your

eyes at the same time.

Tell your doctor immediately if

you develop any signs or

symptoms of an infection in the

eye or other complications; for

example, eye pain or increased

discomfort, worsening eye

redness, blurred or decreased

vision, increased sensitivity to

light.

It is important to have any

symptoms diagnosed and treated as

soon as possible. A serious eye

infection or eye disorder can

sometimes develop after an

injection into the eye.

Things you must not do

Do not drive or use machinery

after your EYLEA injection as

you may experience some

temporary problems with vision.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are being treated

with EYLEA.

This medicine helps most people,

but it may have unwanted side

effects in a few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

visual disturbance including

blurred vision or dark spots

eye pain including injection site

pain

perception of having something

floating in the eye (floaters) or

sensation that something is in

the eye

increased tear production

The above list includes the more

common side effects of your

medicine which are usually mild

and short-lived.

Tell your doctor as soon as

possible if you notice any of the

following:

severe eye pain

deterioration of eyesight

sudden decrease in sharpness of

vision in the injected eye which

may be caused by tearing or

detachment of the retina (the

inner layer of the back of the

eye)

171121-cmi-eylea

Page 4 of 5

flashes of light and a sudden

increase in floaters in the eye

bloodshot eye caused by

bleeding from small blood

vessels in the outer layers of the

eye or bleeding at the injection

site

hazy vision (clouding of the

lens)

damage to or swelling of the

cornea (the transparent front

part of the eye)

swelling of the eyelid of the

injected eye

signs or symptoms of infection

and/or inflammation of the eye

rash, itching, hives on the skin

The above list includes serious side

effects that may require medical

attention.

Go to your nearest emergency

room immediately if you

experience any of the following:

signs of a stroke, such as

weakness or numbness of limbs

or face, difficulty speaking or

swallowing.

signs of heart attack, such as

chest pain which may spread to

the neck and shoulders

severe allergic reaction, such as

sudden signs of rash, itching or

hives on the skin; swelling of

the face, lips, tongue or other

parts of the body; shortness of

breath, wheezing or difficulty

breathing

The above are serious side effects

that might need immediate

medical attention or

hospitalisation.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, an increase in the pressure

inside your eye) can only be found

when your doctor does tests to

check your progress.

AFTER YOU ARE

GIVEN EYLEA

Storage

It is unlikely you will have to store

EYLEA at home.

If you do have to store it:

Store at 2

C to 8

(Refrigerate. Do not freeze).

Protect from light. Prior to

usage, the unopened vial or

pre-filled syringe blister pack

may be stored at room

temperature (25

C) for up to

24 hours.

Keep the pre-filled syringe in

its blister pack and carton in

order to protect from light.

Keep the vial in its carton in

order to protect from light.

Do not store EYLEA or any other

medicine in the bathroom, near a

sink, or on a window-sill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep the medicine where children

cannot reach it.

Disposal

Each EYLEA pre-filled syringe is

to be used for one injection only

and then discarded.

Each EYLEA vial and associated

filter needle are to be used for one

injection only and then discarded.

Return any expired or unused

medicine to your pharmacist.

PRODUCT

DESCRIPTION

What it looks like

EYLEA is a clear, colourless to pale

yellow solution, supplied as a single

dose in a glass vial or pre-filled

syringe for the treatment of one eye.

Pre-filled syringe

Each carton includes a sealed blister

pack with a pre-filled syringe

containing an extractable volume of

90 µL (microlitre) of solution.

Vial

Each carton includes a vial

containing an extractable volume of

100 µL (microlitre) of solution and

a filter needle for withdrawal of the

vial contents.

Not all presentations may be

marketed in Australia and New

Zealand.

Ingredients

Active ingredient:

40 mg/mL aflibercept

Inactive ingredients:

polysorbate 20

sodium phosphate, monobasic

monohydrate

dibasic sodium phosphate

heptahydrate

sodium chloride

sucrose

water for injections

Sponsor

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Bayer New Zealand Ltd

3 Argus Place

Hillcrest

North Shore

Auckland 0627

Australian registration

number

EYLEA pre-filled syringe

– AUST R 180860

EYLEA vial

– AUST R 180859

Date of preparation

November 2017

171121-cmi-eylea

Page 5 of 5

See TGA website

(www.ebs.tga.gov.au

) in Australia

or Medsafe website

www.medsafe.govt.nz) in New

Zealand for latest Consumer

Medicine Information.

Bayer Australia Ltd

All rights reserved.