2. What should I know before treatment with TOMUDEX?
You should not be given TOMUDEX if you have ever had an allergic reaction to raltitrexed
or any of the ingredients listed at the end of the CMI; are taking calcium folinate
(folic acid) or vitamin preparations with folate; have severe kidney problems; are
pregnant or may become pregnant or are breastfeeding.
Talk to your doctor if you have any other medical conditions, including problems with
your liver, kidneys, blood or bone marrow, stomach or bowel problems; or take any
other medicines. Pregnancy must be avoided (including your partner if you are male)
while being treated with TOMUDEX, and for 6 months after treatment.
3. What if I am taking other medicines?
4. How is TOMUDEX given?
Your doctor will decide how much you will be given and for how long. TOMUDEX is given
as a slow drip into a vein. More instructions can be found in Section
4. How is TOMUDEX given? in the full CMI.
5. What should I know while I am being treated with TOMUDEX?
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Things you should do
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Remind any doctor, dentist, pharmacist and nurse who are treating you that you are
being given this medicine.
Tell your doctor immediately if you or your partner become pregnant.
Effective contraception must be used while receiving this medicine and for at least
6 months after stopping treatment for both females and males.
Keep all of your doctor's appointments so your progress can be checked.
Tell your doctor straight away if you experience certain side effects (refer to Section
5 in the full CMI).
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Things you should not do
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Do not breastfeed while you are being treated with TOMUDEX.
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Driving or using machines
|
Be careful driving or operating machines until you know how TOMUDEX affects you.
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6. Are there any side effects?
Side effects of this medicine may include diarrhoea, loss of appetite, weight loss,
constipation; nausea and vomiting, abdominal pain or indigestion, flatulence; blistering
of the digestive tract with risk of bleeding; sore throat, dry mouth, mouth ulcers,
oral thrush or cold sores; inflammation or bleeding in mouth/throat; unusual bleeding
or bruising; yellowing of the skin/eyes, changes in urine colour, fatigue; dehydration;
muscle aches and cramps, sadness, insomnia; dizziness; tingling or numbness of the
hands/feet; hiccups, runny or itchy nose that may bleed; hair loss, dry rash and itchy/peeling
of skin, sweating, altered taste; generally feeling unwell with flu-like symptoms;
back/chest pain; fever, chills, infection, low blood pressure, fast heart rate or
mental confusion.
Active ingredient(s): raltitrexed
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TOMUDEX.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TOMUDEX.
Where to find information in this leaflet:
1. Why am I being treated with TOMUDEX?
TOMUDEX contains the active ingredient raltitrexed. TOMUDEX belongs to a group of medicines known as anti-neoplastic or cytotoxic agents,
and also referred to as a chemotherapy medicine. These medicines are used for the
treatment of cancer. TOMUDEX works by killing cancer cells and stopping cancer cells
from growing and multiplying.
TOMUDEX is used to treat cancer which affects the colon and rectum (parts of your
large intestine or bowel).
2. What should I know before treatment with TOMUDEX?
Warnings
You must not be given TOMUDEX if:
you are allergic to raltitrexed or to any ingredients listed at the end of this CMI
you are taking calcium folinate (folic acid) or vitamin preparations with folate as
these preparations may interfere with the medication
you have severe kidney problems
are pregnant, may become pregnant during treatment, or are breastfeeding
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes. If you are not sure if you are allergic to any of the above, ask your doctor.
Check with your doctor if you have any other medical conditions such as:
kidney disease
problems with your liver
blood and bone marrow disorder with reduced number of red blood cells, white blood
cells or platelets.
stomach or bowel (intestinal) problems such as diarrhoea.
Tell your doctor if you have previously had radiation therapy (treatment with high
dose X-rays).
Your doctor may need to cease, delay or reduce treatment depending on your white
blood cell count.
Tell your doctor if you have been given TOMUDEX before and
experienced any of the following:
soreness or ulceration of the inside of your mouth
unusual bruising or bleeding
diarrhoea
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
TOMUDEX may have serious effects on a developing baby.
Females: Talk to your doctor if you are pregnant, or plan to become pregnant. TOMUDEX
must not be used in women who are pregnant, may become pregnant or are breastfeeding.
Pregnancy should be excluded before treatment with TOMUDEX is commenced.
Males: Pregnancy must be avoided while you are being treated with TOMUDEX. Tell your
doctor if your partner becomes pregnant or plans to become pregnant while you are
being treated with this medicine.
Females and males: It is recommended that pregnancy should be avoided for at least
6 months after completion of treatment. This includes if your partner is receiving
TOMUDEX.
Talk to your doctor about the need for additional contraception while being given
TOMUDEX.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You must not breastfeed during treatment with TOMUDEX, and for a period of time after
treatment has finished.
TOMUDEX may pass into breast milk as there may be potential serious side effects to
your baby.
Talk to your doctor who will provide you with appropriate instruction.
Use in children
The safety and effectiveness of TOMUDEX in children have not been established.
Use in the elderly
If you are over 65 years of age there may be a greater chance of kidney issues when
using TOMUDEX. Your doctor may order extra tests and will monitor you closely for
this.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with TOMUDEX and affect how it works.
These include:
medicines containing calcium folinate, folic acid or vitamin preparations containing
folate.
medicines containing warfarin, used to treat or prevent blood clots
non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen, used
to treat pain, inflammation or reduce temperature.
other medicines used to treat cancer containing cisplatin, carboplatin or oxaliplatin.
other treatments such as radiation therapy or any other treatment which lowers your
immune system
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while being given TOMUDEX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TOMUDEX.
4. How is TOMUDEX given?
How much is given
Your doctor will decide how much TOMUDEX you should receive and the length of time
for which you should receive it. This depends on your condition and other factors,
such as your weight, kidney function and other chemotherapy medicines you are being
given.
How is it given
TOMUDEX is usually given as intravenous infusion (as a slow drip into a vein) over
a period of 15 minutes.
How long will it be given for
TOMUDEX is usually given once every 3 weeks. Each infusion is called one ‘cycle’ of
chemotherapy. Your doctor will decide how many of these cycles you will need.
Several courses of TOMUDEX therapy may be needed depending on your response to treatment.
If you have any concerns or questions about the time between TOMUDEX doses, please
ask your doctor.
Your doctor will decide if TOMUDEX is given alone or in combination with other drugs.
If you are given too much TOMUDEX
As TOMUDEX Is given under supervision of your doctor, it is very unlikely that you
will receive too much. However, if you experience any severe side effects, after being
given this medicine, tell your doctor or nurse immediately. You may need urgent medical
attention.
Symptoms of a TOMUDEX overdose may include the side effects listed in Section 6. ‘Side
effects’ section but are usually of a more severe nature. Alert your doctor immediately
if you experience severe diarrhoea; redness, swelling, pain, sores, ulcers or bleeding
in the mouth or throat; fever, chills; severe cough or shortness of breath; any abnormal
bruising or bleeding including nosebleeds, bleeding gums, heavy periods, or blood
in your stool (poo) or urine (wee).
Tell your doctor or nurse immediately if you are concerned that you may have been
given too much TOMUDEX.
5. What should I know while I am being treated with TOMUDEX?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being treated with TOMUDEX.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine.
Tell your doctor or nurse immediately if;
you are having radiation therapy
you or your partner become pregnant while taking this medicine
you are going to have surgery. It is important to let the surgeon or anaesthetist
know that you are being treated with this medicine. It may affect other medicines
used during surgery.
Keep follow-up appointments with your doctor and have any tests as directed by your
doctor.
It is important to have your follow-up treatments (cycles) of TOMUDEX at the appropriate
times to get the optimal result from your treatment.
Use additional contraception while being given TOMUDEX.
Tell your doctor straight away if you experience:
shortness of breath, feel dizzy or lightheaded, experience swelling of the face, tongue,
lips, mouth or throat, or itching
severe pain on eating, drinking or swallowing, or difficulty talking due to ulcers
or pain
severe or persistent diarrhoea during or after treatment
fever, chills; severe cough or shortness of breath
any abnormal bruising or bleeding including nosebleeds, bleeding gums, heavy periods,
or blood in your stool (poo) or urine (wee)
discomfort with your infusion site at the time of treatment
Things you should not do
Do not breastfeed if you are being treated with this medicine.
Things to be careful of
During therapy with TOMUDEX, liver function, kidney function and blood cell counts
should be monitored. You should attend all tests as requested by your doctor.
This medicine can lower the number of white blood cells and platelets in your blood.
This means that you have an increased chance of getting an infection or bleeding.
The following precautions should be taken to reduce your risk of infection or bleeding:
Avoid people who have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain or find it painful or difficult to urinate.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Your body fluids will contain TOMUDEX and its associated breakdown products for a
number of days once you are given TOMUDEX. Body fluids and waste, include blood, urine
(wee), stool (poo), vomit and semen.
In general, precautions to protect other people should be taken both while receiving
and after treatment as directed by your doctor. Precautions include:
Flushing the toilet twice to dispose of any body fluids and waste.
Wearing gloves to clean any spill of body fluid or waste. Use paper towels or old
rags, a strong solution of non-bleaching detergent and large amounts of water to mop
up the spill. Discard the towels or rags into a separate waste bag and dispose of
fluids in the toilet.
Wash linen or clothing that is heavily contaminated by body fluids or waste separately
from other items. Use a strong solution of non-bleaching detergent and large amounts
of water.
Place soiled disposable nappies and other pads in a plastic bag, seal and dispose
into the garbage.
For sexual intercourse, use a barrier method such as a condom.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TOMUDEX
affects you.
TOMUDEX may cause extreme tiredness, dizziness or light-headedness in some people.
If you have these symptoms, do not drive, or or operate machinery which could be dangerous.
Drinking alcohol
No information is available.
Looking after your medicine
TOMUDEX will be stored in the pharmacy or on the hospital ward under the correct conditions.
Disposal of TOMUDEX
The hospital staff will dispose of any leftover TOMUDEX.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are
having treatment with TOMUDEX.
Diarrhoea and vomiting may be severe and lead to dehydration and kidney issues. Urgent
medical attention should be sought as treatment may be changed.
TOMUDEX may cause abnormalities of your blood, due to effects on your bone marrow
or your liver. Your doctor will check your blood regularly to detect whether abnormalities
have occurred.
Some of these side effects (for example certain liver conditions, and blood abnormalities)
can only be found when your doctor does tests from time to time to check your progress.
Other side effects not listed here may occur in some people.
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TOMUDEX contains
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Active ingredient
(main ingredient)
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raltitrexed
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate dodecahydrate
mannitol
sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
TOMUDEX does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
What TOMUDEX looks like
TOMUDEX is a powder for injection in a vial, which is white to cream coloured solid
powder.
TOMUDEX raltitrexed 2mg AUST R 54638
Who distributes TOMUDEX
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in December 2025.