Inlyta

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Axitinib

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

INLYTA
®

_Axitinib_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INLYTA.
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 taking INLYTA
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INLYTA IS USED
FOR
_WHAT INLYTA DOES_
INLYTA is used to treat a certain
type of kidney cancer called renal
cell carcinoma (RCC).
It belongs to a group of medicines
called tyrosine kinase inhibitors.
_HOW INLYTA WORKS_
INLYTA contains the active
substance axitinib. It works by
reducing the blood supply to the
tumour and slowing down the growth
of cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INLYTA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
INLYTA is only available with a
doctor's prescription. It is not
addictive.
_USE IN CHILDREN_
The safety and efficacy of INLYTA
have not been established in children.
BEFORE YOU TAKE
INLYTA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE INLYTA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing axitinib
•
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
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PR

Summary of Product characteristics

Version: pfpinlyt10713 
Supersedes:  pfpinlyt10712 

Page 1 of 17 
PRODUCT INFORMATION 
INLYTA  (AXITINIB) 
NAME OF THE MEDICINE 
Axitinib  has  the  chemical  name  _N_-methyl-2-[3-((_E_)-2-pyridin-2-yl-vinyl)-1_H_-indazol-
6-ylsulfanyl]-benzamide.  The molecular formula is C
22
H
18
N
4
OS and the molecular weight is 
386.47 Daltons.  The CAS Registry Number is 319460-85-0.

The chemical structure is:  
O
H
N
CH
3
S
N
H
N
N

DESCRIPTION 
Axitinib  is  a  white  to  light-yellow  powder  with  a  pKa  of  4.8.

The  solubility  of  axitinib  in 
aqueous  media  over  the  range  pH  1.1  to  pH  7.8  is  in  excess  of  0.2 

g/mL.

The  partition 
coefficient (n-octanol/water) is 3.5.

INLYTA  is  supplied  as  red  film-coated  tablets  containing  either  1  mg  or  5  mg  of  axitinib 
together  with  cellulose  -  microcrystalline,  lactose,  croscarmellose  sodium,  magnesium 
stearate, and Opadry II red 32K15441 as inactive ingredients.  The Opadry II red 32K15441 
film  coating  contains  lactose,  HPMC  2910/Hypromellose  15cP,  titanium  dioxide,  glycerol 
triacetate, and iron oxide red.   
PHARMACOLOGY 
MECHANISM OF ACTION 
Axitinib is a selective tyrosine
kinase inhibitor of vascular endothelial growth
factor receptors 
(VEGFR)-1,  VEGFR-2,  and  VEGFR-3.    These  receptors  are  implicated  in  pathological 
angiogenesis, tumour growth, and metastatic progression of cancer.

Axitinib has been shown 
to  inhibit VEGF-mediated endothelial cell proliferation and survival.  Axitinib  inhibited the 
phosphorylation  of  VEGFR-2  in  xenograft  tumour  vasculature  that  expressed  the  target  _in _
_vivo_  and  produced  tumour  growth  delay,  regression,  and  inhibition  of