NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
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
bone marrow disease
you have a stomach ulcer or ulcerative colitis (bleeding from your bowel)
you are an alcoholic
you have an infection
If you are not sure whether any of these apply to you, check with your doctor.
Do not use this medicine if you are taking acitretin or etretinate, a medicine used to treat psoriasis and other skin conditions.
Do not use live vaccine while you are using Methotrexate Injection.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Do not take this medicine/it after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
Before you are given it
The medicine may cause birth defects if either you or your partner is taking it. Both you and your partner must use a reliable method of contraception (birth control or condom) during treatment with Methotrexate Injection and for at least 12 weeks after you stop treatment.Your doctor will discuss with you what forms of contraception are suitable and when it is safe to stop using contraception if you wish to do so.
Tell your doctor if:
1.you have any allergies to:
any other medicine
any other substances, such as foods, preservatives or dyes
2.if you are pregnant or intend to become pregnant.
Methotrexate Injection may affect your developing baby if you take use it during pregnancy. If it is necessary for you to be given it, your doctor or pharmacist will discuss the risks and benefits of taking/using it during pregnancy.
3.you are breastfeeding or plan to breastfeed
Methotrexate Injection passes into breast milk and should not be used when breastfeeding.
4.you have or have had any medical conditions, especially the following:
any sort of infection or immune system disorder e.g. sinusitis, tooth abscess etc
stomach ulcer or ulcerative colitis (bleeding from your bowel)
fluid or swelling in your abdomen or stomach
fever, chills, sore throat or mouth ulcers
bleeding or bruising more than usual
tiredness, headaches, shortness of breath, dizziness, looking pale
diabetes
cancer
folate deficiency
If you have not told your doctor or pharmacist about any of the above, tell them before you are given Methotrexate Injection.
Your carer will also need to take some precautions, such as wearing of gloves, when handling the injection.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
If your doctor tells you to take folic acid, do not take it on the same day as methotrexate.
Some medicines and methotrexate may interfere with each other.These include:
other anticancer drugs such as cisplatin, mercaptopurine or asparaginase
antibiotics or antimalarial drugs including tetracyclines, penicillins, sulphonamides, trimethoprim and chloramphenicol, pyrimethamine
aspirin and other pain killers
medicines to relieve swelling or inflammation including medicines for arthritis
non-steroidal anti-inflammatory drugs, used to help with pain relief, such as azapropazone, diclofenac, indomethacin and ketoprofen
medicines for epilepsy such as phenytoin
corticosteroids such as hydrocortisone and prednisolone
medicines for diabetes such as sulphonylureas
medicines that reduce cholesterol such as cholestyramine
medicines for gout such as probenecid and allopurinol
vitamin preparations that contain folic acid
medicines for psoriasis such as etretinate
medicines for heart problems such as amiodarone
medicines used to treat asthma and related compounds such as theophylline
azathioprine, a medicine used to prevent transplant organ rejection
retinoids (acitretin or e-tretinate), medicines used to treat skin conditions
proton pump inhibitors, such as omeprazole, esomeprazole or pantoprazole
Methotrexate Injection can also be affected by the following:
blood transfusions
nitrous oxide anaesthetics
vaccinations
alcohol
radiation e.g. X-rays, radiotherapy
Your doctor will advise you about continuing to take other medicines while you are receiving methotrexate.
You may need different amounts of your medicine, or you may need to take/use different medicines.Your doctor or pharmacist will advise you.
You should not receive certain vaccinations while being treated with methotrexate.
How Methotrexate Injection is given
Methotrexate is given by injection into a vein, muscle or directly into the fluid around your spinal cord.Methotrexate must only be given by a doctor or nurse.
Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys and liver are working, and whether or not other medicines are being given at the same time.
If you are given too much (overdose)
This rarely happens as Methotrexate Injection is administered under the care of a highly trained doctor.However, if you are given too much methotrexate, you may experience some of the effects listed under “Side effects” below.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have given you too much Methotrexate.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Your doctor has information on how to recognise and treat an overdose.Ask your doctor if you have any concerns.
While you are being treated with Methotrexate Injection
Tell your doctor or pharmacist if you are taking any other medicines.
Drink plenty of water on the day you take the medicine.
The recommended daily intake is 8 glasses per day. Inadequate fluid intake can increase the side effects of the medicine. Keep all of your doctor’s appointments so that your progress can be checked.
You will need to have regular blood and urine tests.Regular blood tests will show any abnormal effects of methotrexate on the blood cells and the liver.As you may not get symptoms of these problems you must have regular blood checks.Your doctor may also want you to have some other tests.
Both you and your partner must use a reliable method of contraception (birth control) during and for at least 3 months after treatment with Methotrexate Injection. Your doctor will discuss with you what forms of contraception are suitable and when it is safe to stop using contraception if you wish to do so.
This is because methotrexate can cause damage to the baby during pregnancy and can also cause genetic problems if the baby is conceived while you are taking methotrexate.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you are using this medicine.
It may affect other medicines used during surgery.
Try to stay out of the sun and do not use sunlamps.
Methotrexate can increase your sensitivity to sunlight and cause severe reactions and increase risk of skin cancer (non-melanoma and melanoma). Some signs are:
redness
itching
swelling
blistering
rash.
If you need to be in the sun, use a 30+ sunscreen and wear a hat and shirt to protect your skin from the sun.
Do not drink any alcohol while you are being treated with Methotrexate Injection, as this may cause permanent liver damage.
Do not drive or operate machinery until you know how methotrexate affects you.
Methotrexate may cause dizziness or tiredness in some people and therefore may affect alertness.
If you can, avoid people with infections.
Check with your doctor immediately if you think that you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
be careful when using a tooth brush, toothpick or dental floss.
be careful not to cut yourself.
avoid activities where you might be injured or bruised.
wear disposable gloves when cleaning, especially when cleaning up body fluid or waste.
dispose of gloves, rags or other items safely in a sealed plastic bag.
Carers and other people who handle the injection should wear disposable gloves to avoid direct contact with the injection fluid.
Pregnant women should not handle the medicine at all.
Be careful not to drip the solution on any surfaces.
If you do, wipe up the area with paper towels and throw them into the ‘Sharps Bin’. Clean the area with lots of soap and water.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Methotrexate Injection.
Like other medicines, methotrexate can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.
Ask your doctor or nurse to answer any questions that you may have.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If any of the following happen, tell your doctor or nurse immediately or go to Accident and Emergency at your nearest hospital:
severe abdominal pain, upset stomach, or diarrhoea
nausea or vomiting, especially vomiting blood, loss of appetite
mild dizziness
mild chills
mild headache
sore eyes
an increased tendency to bleed, unusual bruising or get infections swelling of the face, lips or tongue or other parts of the body e.g. hands ankles or feet
rash, redness, hives, itching, pinpoint red spots or painful blistering resulting in peeling of layers of the skin
lighter patches on the skin, yellowing of the skin/eyes (jaundice)
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
These are very serious side effects. You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
Tell your doctor or nurse immediately if you notice any of the following:
infection of hair roots or hair loss, especially of the scalp
frequent or painful urination (cystitis/dysuria), or blood in the urine, or bowel motions
changes in the menstrual cycle (periods)
bleeding gums, sore mouth, difficulty swallowing, cold sores, mouth ulcers, swollen glands (lymph nodes)
coughing, wheezing, difficulty breathing, chest pain
black tarry stools or blood in the stools
fits, seizures or convulsions
These may be serious side effects. You may need urgent medical attention.
Tell your doctor or nurse if you notice any of the following and they worry you:
blurred vision, short term blindness
ringing in the ears
conjunctivitis (itchy eyes and crusty eyelids)
fever and chills, sore throat, sweats or feel generally unwell
tiredness, headaches, shortness of breath, dizziness, looking pale
sensitivity to the sun
acne or boils or skin ulcers
lack of appetite or weight loss
difficulty speaking, writing etc
drowsiness
weakness, numbness or paralysis, muscle cramps, spasms
feeling thirsty
irritability, depression, confusion or mood changes
changes in the toenails or fingernails
impotence or loss of interest in sex
painful muscles and joints
back pain
stiff neck
These are the more common side effects of methotrexate.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Other side effects may be only seen by blood urine or other tests. Your doctor will carry out any necessary tests. Some side effects of methotrexate may occur after you stop taking it.
Storage
Methotrexate Injection will be stored in the pharmacy or on the ward.The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Product Description
What it looks like
Methotrexate Injection is a yellow to orange solution in a plastic vial.
Methotrexate Injection can be identified by an Australian Registration Number, which is found on the packaging:
Aust R 10777: Methotrexate Injection 50mg in 2mL
Aust R 47648: Methotrexate Injection 500mg in 20mL
Aust R 10778: Methotrexate Injection 1000mg in10mL
Ingredients
Methotrexate Injection BP contains Methotrexate BP and Sodium Hydroxide BP in Water for Injections BP.The 2ml and 20ml presentations contain Sodium Chloride BP.It does not contain a preservative.
Manufacturer
Pfizer (Perth) Pty Limited
ABN 32 051 824 956
15 Brodie Hall Drive,
Bentley WA 6102 Australia
Sponsor and Distributor in Australia
Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free number: 1800 675 229.
www.pfizer.com.au
This Consumer Medicine Information was revised in April 2020.
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