Pemetrexed APOTEX pemetrexed 100 mg (as disodium) powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
pemetrexed disodium hemipentahydrate
Available from:
Apotex Pty Ltd
INN (International Name):
pemetrexed disodium hemipentahydrate
Authorization status:
Registered
Patient Information leaflet
PEMETREXED APOTEX
POWDER FOR INJECTION
_Contains the active ingredient pemetrexed (as disodium)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about pemetrexed. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Pemetrexed APOTEX Powder for
Injection, which is given as an
intravenous infusion. It contains the
active ingredient pemetrexed, as the
disodium salt.
It is used to treat:
•
mesothelioma, a rare cancer of
the lungs often related to
exposure to asbestos
•
non-small cell lung cancer, a type
of lung cancer.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Pemetrexed belongs to a group of
medicines called cytotoxic or
antineoplastic agents. They may also
be called chemotherapy medicines.
It affects enzymes within cancer cells
to kill cancer cells or prevent them
growing and multiplying.
Pemetrexed may be used in
combination
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Summary of Product characteristics
Product Information – Australia
Pemetrexed APOTEX
Page 1
PEMETREXED APOTEX
NAME OF THE MEDICINE
Pemetrexed disodium hemipentahydrate.
Chemical Name:
L-glutamic acid,
_N_-[4-[2-(2-amino-4,7-dihydro-4-oxo-1_H_-pyrrolo[2,3-_d_]
pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, hemipentahydrate.
Structural Formula:
.2
½
H
2
O
Molecular Formula:
C
20
H
24
N
5
Na
2
O
8
½
Molecular Weight:
516.412
CAS Registry Number:
357166-30-4
DESCRIPTION
Pemetrexed disodium is a white to almost white solid.
This medicine is supplied as a sterile lyophilized powder for
intravenous infusion in single dose vials;
the product is a white to either light yellow or green-yellow
lyophilized solid in 100 mg and 500 mg
vials. Each 100 mg vial contains pemetrexed disodium, equivalent to
100 mg pemetrexed, and 106
mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been
added to adjust pH. Each
500 mg vial contains pemetrexed disodium, equivalent to 500 mg
pemetrexed, and 500 mg mannitol.
Hydrochloric acid and/or sodium hydroxide may have been added to
adjust pH.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Pemetrexed is an antifolate antineoplastic agent. _ In vitro_ studies
have shown that pemetrexed
behaves as a multi-targeted antifolate by inhibiting thymidylate
synthase (TS), dihydrofolate reductase
(DHFR) and glycinamide ribonucleotide formyltransferase (GARFT), which
are key folate-dependent
enzymes for the _de novo_ biosynthesis of thymidine and purine
nucleotides that are essential for cell
replication. Both the reduced folate carrier and membrane folate
binding protein transport systems
appear to be involved in transport of pemetrexed into cells. Once in
the cell, pemetrexed is converted
to polyglutamate forms by the enzyme folyl polyglutamate synthetase.
The polyglutamate forms are
even more potent inhibitors of TS and GARFT than pemetrexed.
Polyglutamation is a time- and
concentration-dependent process that occurs in tumour cells and, to a
lesser extent, in normal tissues.
Polyglutamated metabolites have a longer intracellular
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