Pemetrexed-DRLA Pemetrexed Disodium 500 mg injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pemetrexed disodium

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

pemetrexed disodium

Patient Information leaflet

PEMETREXED-DRLA v2
1
PEMETREXED-DRLA
_Contains the active ingredient pemetrexed disodium _
CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about
pemetrexed. It does not contain all
the information that is known about
pemetrexed.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking this
medicine against the benefits they
expect it will 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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Pemetrexed-DRLA. It contains the
active ingredient pemetrexed
disodium.
Pemetrexed 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.
It 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.
Your doctor may have prescribed it
for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Pemetrexed may be used in
combination with other
chemotherapy drugs.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT TAKE THIS MEDICINE IF YOU
ARE ALLERGIC TO ANY MEDICINE
CONTAINING PEMETREXED DISODIUM
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN

Summary of Product characteristics

Product Information
Pemetrexed-DRLA PI V3
1
PEMETREXED-DRLA POWDER FOR INJECTION
NAME OF THE MEDICINE
Pemetrexed disodium
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.
Structural Formula:
Molecular formula:
C
20
H
19
N
5
Na
2
O
6
Molecular weight:
471.4
CAS Number:
150399-23-8.
DESCRIPTION
Pemetrexed disodium is a white to cream color powder with or without
green/yellow tinge.
Pemetrexed-DRLA powder for injection is supplied as a sterile
lyophilised powder for intravenous infusion
available in single dose vials. The product is a white to either
light-yellow or green-yellow lyophilized
powder. Pemetrexed-DRLA is supplied in 500 mg and 100 mg vials. Each
500 mg vial contains
pemetrexed disodium equivalent to 500 mg pemetrexed and 500 mg of
mannitol. Each 100 mg vial
contains pemetrexed disodium equivalent to 100 mg pemetrexed and 106
mg of mannitol. Hydrochloric
acid and/or sodium hydroxide may have been added to adjust pH.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pemetrexed is an antifolate antineoplastic agent_. In vitro _studies
have shown that pemetrexed behaves
as a multitargeted 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 half-life than the parent drug, re