EXEMESTANE PFIZER
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
09-03-2016
Summary of Product characteristics
(SPC)
30-06-2017
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
Exemestane
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
Exemestane
Patient Information leaflet
EXEMESTANE PFIZER
®
_Exemestane_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EXEMESTANE
PFIZER.
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
EXEMESTANE PFIZER against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT EXEMESTANE
PFIZER IS USED FOR
EXEMESTANE PFIZER is used to
treat breast cancer in women who no
longer have their menstrual periods,
either naturally due to their age (after
menopause) or because they have
had their ovaries surgically removed.
EXEMESTANE PFIZER is used to
reduce the risk of recurrence or
spreading of the breast cancer. It is
also used when the cancer has not
responded or has returned after
treatment with another medicine or
medicines.
_HOW EXEMESTANE PFIZER_
_WORKS_
EXEMESTANE PFIZER is an
aromatase inactivator. It works by
significantly reducing the supply of
oestrogen to cancer cells.
This stops the growth of those cancer
cells which need oestrogen, a natural
female sex hormone, to grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
EXEMESTANE PFIZER HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
EXEMESTANE PFIZER is only
available with a doctor's prescription.
It is not addictive.
BEFORE YOU TAKE
EXEMESTANE PFIZER
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EXEMESTANE
PFIZER AND TALK TO YOUR DOCTOR IF
YOU THINK YOU MAY HAVE AN ALLERGY
TO:
•
exemestane, the active ingredient
in EXEMESTANE PFIZER
•
any of the other ingredients in
EXEMESTANE PFIZER listed at
the end of this leaflet.
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 EXEMESTANE
Read the complete document
Summary of Product characteristics
Version: pfpexemt10617
Supersedes: pfpexemt10417
Page 1 of 13
PRODUCT INFORMATION
EXEMESTANE PFIZER
® TABLETS 25 MG (EXEMESTANE)
NAME OF THE MEDICINE
Non-proprietary name:
Exemestane
Chemical name:
6-methylenandrosta-1,4-diene-3,17-dione
Chemical structure:
CAS Number:
CAS-107868-30-4
DESCRIPTION
Exemestane
is
a
white
or
yellowish-white
powder,
which
is
freely
soluble
in
N,N-dimethylformamide, soluble in methanol and practically insoluble
in water. Due to the
very low solubility in water, the drug is micronised.
EXEMESTANE PFIZER tablets are sugar-coated tablets for oral
administration. In addition
to exemestane, the tablets contain colloidal hydrated silica,
crospovidone, hypromellose,
magnesium
carbonate
hydrate,
magnesium
stearate,
mannitol,
microcrystalline
cellulose,
methyl hydroxybenzoate, macrogol 6000, polysorbate 80, polyvinyl
alcohol, simethicone,
sodium starch glycollate, sucrose, titanium dioxide, cetyl esters wax,
purified talc and
carnauba wax. The tablets are imprinted “7663” on one side with
black printing ink.
PHARMACOLOGY
PHARMACODYNAMICS
Exemestane is an irreversible, steroidal aromatase inactivator,
structurally related to the
natural
substrate
androstenedione.
In
postmenopausal
women,
estrogens
are
produced
primarily from the conversion of androgens into estrogens through the
aromatase enzyme in
peripheral tissues. Estrogen deprivation through aromatase inhibition
is an effective and
selective treatment for hormone dependent breast cancer in
postmenopausal women. In
postmenopausal
women,
EXEMESTANE
PFIZER
significantly
lowered
serum
estrogen
concentrations starting from a 5 mg dose, reaching maximal suppression
(80-90%) with a
Version: pfpexemt10617
Supersedes: pfpexemt10417
Page 2 of 13
dose of 10-25 mg. In postmenopausal breast cancer patients treated
with the 25 mg daily
dose, whole body aromatisation was reduced by 98%.
Exemestane does not possess any progestogenic or estrogenic activity.
A slight androgenic
activity, probably due to the 17-hydro derivative, has been observed
mainly
Read the complete document
