情報リーフレット
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
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製品の特徴
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
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