Methotrexate Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Methotrexate

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

METHOTREXATE
INJECTION BP

CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Methotrexate
Injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Methotrexate
Injection against the benefits this
medicine is expected to have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT METHOTREXATE
INJECTION IS USED FOR
Methotrexate belongs to a group of
anticancer drugs known as
antineoplastics. Methotrexate works
by preventing the growth of certain
cells. It is used for different types of
cancer and also severe psoriasis (a
skin condition).
Methotrexate Injection may be used
for the treatment of other conditions
that are not mentioned above. Your
doctor will be able to tell you about
the specific condition for which you
have been prescribed it.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
METHOTREXATE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE METHOTREXATE INJECTION
IF:
•
you have an allergy to
methotrexate or any of the
ingredients listed at the end of
this leaflet
•
you have kidney disease or poor
kidney function
•
you have liver disease or poor
liver function
•
you are pregnant or planning to
get pregnant
•
you are breastfeeding
•
you have a problem with your
immune system such as severe or
repeated infections
•
you have a problem with your
blood such as anaemia
•
you are receiving radiotherapy
e.g. X-rays, ultra violet
radiotherapy
•
you have a stomach ulcer or
ulcerative colitis (bleeding f

Summary of Product characteristics

PRODUCT INFORMATION 
METHOTREXATE INJECTION BP 

Version : pfpmetti10311 
Supersedes :  pfpmetho10910 

Page 1 of 14 

WARNING 

Methotrexate must be used only by physicians experienced in
antimetabolite chemotherapy, or in the 
case of non-oncological conditions, by a specialist physician. 

Because of the possibility of fatal or severe toxic
reactions the patient should be fully informed by the 
physician of the risks involved and should be under his constant
supervision. 

Deaths have been reported with the use of methotrexate. 

In the treatment of psoriasis, methotrexate should be restricted to
severe, recalcitrant, disabling 
disease which is not adequately responsive to other forms of
therapy, but only when the diagnosis has 
been established by biopsy and / or after appropriate
consultation. 

1. 
Methotrexate may produce marked depression of bone marrow,
anaemia, aplastic anaemia, 
leucopenia, neutropenia, thrombocytopenia and bleeding. 
2. 
Methotrexate may be hepatotoxic, particularly at high dosage
or with prolonged therapy.  Liver 
atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis
have been reported.  Since 
changes may occur without previous signs of gastrointestinal or
haematological toxicity, it is 
imperative that hepatic function be determined prior to initiation
of treatment and monitored 
regularly throughout therapy.  Special caution is indicated in the
presence of pre-existing liver 
damage or impaired hepatic function.  Concomitant use of other
drugs with hepatotoxic 
potential (including alcohol) should be avoided. 
3. 
Malignant lymphomas, which may regress following withdrawal of
methotrexate, may occur in 
patients receiving low-dose methotrexate and, thus, may not require
cytotoxic treatment. 
Discontinue methotrexate first and, if the lymphoma does not regress,
appropriate treatment 
should be instituted. 
4. 
Potentially fatal opportunistic infections, espec