LIDAVEG aflibercept 100mg/4mL injection, concentrated
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
15-07-2013
Summary of Product characteristics
(SPC)
12-05-2016
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
Aflibercept
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
Aflibercept
Patient Information leaflet
LIDAVEG
®
1
LIDAVEG
®
_(LID-AR-VEG) _
_Aflibercept (rch) (a-flib-er-cept) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lidaveg.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lidaveg
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
Keep this leaflet as you may need to
read it again.
WHAT LIDAVEG IS USED
FOR
Lidaveg is used to treat advanced
large bowel cancer (that is, cancer in
the colon or rectum) in combination
with chemotherapy agents.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Lidaveg contains the active
ingredient aflibercept.
Lidaveg is an anti-cancer medicine
that blocks the growth of blood
vessels that provide nutrients and
oxygen to cancer cells. This prevents
the growth of the cancer cells.
Your doctor may have prescribed
Lidaveg for another purpose.
This medicine is only available with
a doctor's prescription.
Lidaveg is not addictive.
BEFORE YOU ARE GIVEN
LIDAVEG
DO NOT RECEIVE LIDAVEG IF YOU ARE
ALLERGIC TO LIDAVEG OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include: skin rash, hives,
itching or redness of the skin;
shortness of breath, wheezing or
difficulty breathing; or swelling of
the face, lips, tongue or other parts of
the body.
LIDAVEG SHOULD NOT BE USED IN YOUR
EYE, SINCE IT MAY SEVERELY DAMAGE
IT.
DO NOT RECEIVE LIDAVEG:
AFTER THE EXPIRY DATE (EXP)
PRINTED ON THE VIAL.
IF THE PACKAGING IS DAMAGED OR
SHOWS SIGNS OF TAMPERING.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR ARE PLANNING ON
HAVING A BABY.
Do not use Lidaveg if you are
pregnant unless otherwise advised by
your doctor. Lidaveg may harm your
unborn baby.
Your doctor will advise you about
using effective contraception during
treatment with Lidaveg
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION
Lidaveg 100mg/4mL and 200mg/8mL Injection, Concentrated
lidaveg-ccdsv4-piv4-9may16
Page 1 of 29
PRODUCT INFORMATION
LIDAVEG
®
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Aflibercept (rch)
CHEMICAL STRUCTURE
Aflibercept is a recombinant protein consisting of sequences derived
from human vascular
endothelial growth factor (VEGF) receptor extracellular domains fused
to the Fc portion of human
immunoglobulin G1 (IgG1).
The extracellular domain sequences come from two different VEGF
receptors, VEGFR1 (also
known as Flt-1) and VEGFR2 (also known as KDR or Flk-1). Each of the
VEGF receptors are
composed of seven immunoglobulin (Ig) domains in their extracellular
regions, with Ig domains 2
and 3 contributing the majority of the binding energy for VEGF.
Thus the amino acid sequence structure of aflibercept comprises Ig
domain 2 from VEGFR1,
fused to Ig domain 3 from VEGFR2, which is in turn fused to the Fc
domain of IgG1.
There are no extraneous linker sequences between any of the peptide
domains. The presumptive
Ig domain structure of aflibercept is provided in Figure 1. FIGURE 1 - STRUCTURE OF AFLIBERCEPT
AFLIBERCEPT
2
2
3
3
I g G 1
1
2
3
4
5
6
7
1
2
3
4
5
6
7
V E G F R 1
V E G F R
VEGF Trap
PRODUCT INFORMATION
Lidaveg 100mg/4mL and 200mg/8mL Injection, Concentrated
lidaveg-ccdsv4-piv4-9may16
Page 2 of 29
MOLECULAR FORMULA
Aflibercept molecular formula (without glycosylation) is C
4318
H
6788
N
1164
O
1304
S
32
.
MOLECULAR WEIGHT
115 kDa
CHEMICAL NAME
1. Vascular endothelial growth factor receptor type VEGFR-1 (synthetic
human immunoglobulin
domain 2 fragment) fusion protein with vascular endothelial growth
factor receptor type VEGFR-
2 (synthetic human immunoglobulin domain 3 fragment) fusion protein
with immunoglobulin G1
(synthetic Fc fragment), dimer.
2. des-432-lysine-[human vascular endothelial growth factor receptor
1-(103-204)-peptide
(containing Ig-like C2-type 2 domain) fusion protein with human
vascular endothelial growth
factor receptor 2- (206-308)-peptide (containing Ig-like C2-type 3
do
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