Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using DBL Methotrexate Injection?
DBL Methotrexate Injection contains the active ingredient methotrexate. DBL Methotrexate
Injection is used to treat certain types of cancers, severe psoriasis or rheumatoid
arthritis when the condition does not improve with other medicines.
For more information, see Section
1. Why am I using DBL Methotrexate Injection? in the full CMI.
2. What should I know before I use DBL Methotrexate Injection?
Do not use if you have ever had an allergic reaction to DBL Methotrexate Injection
or any of the ingredients listed at the end of the CMI. Talk to your doctor if you
have any other medical conditions, take any other medicines, or are pregnant or plan
to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use DBL Methotrexate Injection? in the full CMI.
3. What if I am taking other medicines?
4. How do I use DBL Methotrexate Injection?
The dose of medicine given to you will depend on the condition being treated, your
medical condition, your age, your size and how well your kidneys and liver are working.
More instructions can be found in Section
4. How do I use DBL Methotrexate Injection? in the full CMI.
5. What should I know while using DBL Methotrexate Injection?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using DBL Methotrexate.
You and your partner must use a reliable method of contraception (birth control pills
or condom) during treatment with DBL Methotrexate and for at least 3 months after
you stop treatment for men and 6 months after you stop treatment for women.
Discuss with your doctor how much water or fluids you should have as not enough fluid
intake can increase the side effects of this medicine.
Remind your doctor you are on DBL Methotrexate if you are about to receive any vaccination.
Tell your doctor if you think you may be getting an infection (fever, chills, achiness,
sore throat).
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Things you should not do
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Do not go out in the sun without sunscreen and protective clothing. Do not use sun
lamps.
Do not breastfeed while using DBL Methotrexate.
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Driving or using machines
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Do not drive or operate machinery until you know how DBL Methotrexate affects you.
DBL Methotrexate may cause dizziness, drowsiness, blurred vision or tiredness, affecting
alertness.
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Drinking alcohol
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You must not drink alcohol whilst you are being given this medicine. Alcohol may increase
the side effects of DBL Methotrexate and cause liver damage.
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6. Are there any side effects?
Side effects include nausea, stomach pain, sore mouth (mouth ulcers, blisters), fatigue,
generally feeling unwell, dizziness, drowsiness, blurred vision, sore eyes, ringing
in ears and low numbers of blood cell counts. DBL Methotrexate Injection can cause
serious side effects including severe allergic reaction; sore throat, fever, chills,
achiness; severe skin rash with blistering; injection site reactions, persistent cough,
pain or difficulty breathing, or becoming breathless; spitting or coughing blood;
skin rash and fever with swollen glands; swelling of the hands, ankles or feet; yellowing
of the skin and eyes; loss of coordination, ability to speak or understand speech,
weakness and inability to move one side of the body or the whole body, convulsions
or fits.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING:
DBL Methotrexate Injection should only be used for severe disease and when diagnosis
has been made. It is a toxic medicine which can cause severe reactions and death.
You should be treated under the constant care and follow up of your doctor or specialist.
Methotrexate can cause blood disorders such as low numbers of red blood cells, white
blood cells or platelets. At high or repeated doses, methotrexate may be toxic to
your liver. Your doctor will need to do tests to check your liver regularly, before
and during treatment. Avoid alcohol while be treated with methotrexate.
Tell your doctor if you have cancer of the lymphatic system as methotrexate can affect
the treatment of this condition.
Serious infections, leading to death may occur with methotrexate treatment.
Methotrexate can cause birth defects, harm the unborn child or cause miscarriage.
Methotrexate should not be used in pregnant women or women who plan to become pregnant.
Methotrexate should not be started until it is confirmed you are not pregnant. If
you become pregnant during treatment or think you might be pregnant, speak to your
doctor as soon as possible. Your doctor will provide advice regarding the risk of
harmful effects on the child through treatment.
You must avoid becoming pregnant or avoid fathering a child during treatment and for
at least 3 months after the end of treatment for men and 6 months after the end of
treatment for women .
Women should not breastfeed while being treated with methotrexate.
Methotrexate should not be used if you have severe kidney problems.
Tell your doctor if you take medicines to relieve pain, swelling of inflammation (nonsteroidal
anti-inflammatory drugs - NSAIDs) as this can result in serious side effects when
being treated with methotrexate. It can affect your blood, stomach or gut and may
lead to death.
Tell your doctor if you develop a dry, non-productive cough or shortness of breath.
Your doctor will stop treatment and monitor you closely as these may be signs of damage
to the lungs.
Use of methotrexate for psoriasis conditions in children has not been well established.
Methotrexate should only be used once a week to treat certain conditions. Using methotrexate
more frequently than once a week for these conditions may cause serious reactions
and death.
Tell your doctor if you are to have radiotherapy (also known as radiation therapy)
while on methotrexate as this can cause damage to tissue and bone.
Tell your doctor if you are to have any vaccinations while on methotrexate as this
may lead to serious infections or death.
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Active ingredient(s):
methotrexate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Methotrexate Injection.
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 DBL Methotrexate Injection.
Where to find information in this leaflet:
1. Why am I using DBL Methotrexate Injection?
DBL Methotrexate Injection contains the active ingredient methotrexate.
DBL Methotrexate Injection is an antineoplastic or cytotoxic medicine. It may also
be called a chemotherapy medicine.
DBL Methotrexate Injection is used to treat certain types of cancers. It may also
be used in severe psoriasis or rheumatoid arthritis when the condition does not improve
with other medicines.
The medicine works by blocking an enzyme needed by the body's cells to live. This
interferes with the growth of some cells that are growing rapidly in psoriasis and
cancer. In rheumatoid arthritis, this medicine reduces the overactivity of the immune
system leading to less pain, swelling and damage to the joints.
2. What should I know before I use DBL Methotrexate Injection?
Warnings
Do not use DBL Methotrexate Injection if:
1. you are allergic to methotrexate, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine
2. you have severe kidney problems
3. you have lowered immunity due to diseases or due to other treatments
5. you are taking vitamin A derivatives (such as acitretin), medicines used to treat
psoriasis and other skin conditions
6. you are receiving radiatiotherapy (radiation therapy) e.g. x-rays, ultra violet radiotherapy
7. you are receiving a live vaccine
Do not use DBL Methotrexate Injection to treat psoriasis or rheumatoid arthritis if
you:
10. have any blood disorders, or conditions which cause a low number of red blood cells,
white blood cells, or platelets
11. have bone marrow disease
12. have low iron in the blood (anaemia)
13. have liver or severe kidney problems
15. have infectious disease or severe infections
16. have stomach ulcers (peptic ulcer disease)
17. have a condition where your large bowel is inflamed and has ulcers (ulcerative colitis)
Check with your doctor if you:
have any other medical conditions
kidney problems
liver problems, including hepatitis B or hepatitis C
lung problems
diabetes
low folate levels
blood disorders including abnormal blood cell count
immune system disorder
infection or high temperature
stomach ulcer or ulcerative colitis (bleeding from your bowel)
Before treatment is started your doctor may carry out blood tests to check the levels
of cells in your blood, and also to check how well your kidneys and liver are working.
You may also have a chest x-ray. Further tests may also be done during and after treatment.
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 and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
The medicine may harm the unborn child, cause birth defects and miscarriage if either
you or your partner is using it. Both you and your partner must use a reliable method
of contraception (birth control pills or condom) during treatment with DBL Methotrexate
Injection and for at least 3 months after you stop treatment for men and at least
6 months after stopping treatment for women. 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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
DBL Methotrexate Injection passes into breast milk and should not be used when breastfeeding.
Children and elderly
Special care will also be taken in children, the elderly and in those who are in poor
physical condition.
3. What if I am taking other medicines?
Tell your doctor 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 DBL Methotrexate Injection and affect how it works.
These include:
some antibiotics
sulphonylureas, medicines used to treat diabetes
para-aminobenzoic acid, a medicine used to treat skin and autoimmune disorders
diuretics, medicines to remove fluid or water from the body
phenytoin, a medicine used to treat epilepsy
ciclosporin and azathioprine, medicines used to prevent transplant organ rejection
vitamin supplements that contain folic acid or folinic acid
non-steroidal anti-inflammatory medicines (NSAIDs) and salicylates (e.g. aspirin),
medicines used to relieve pain, swelling and inflammation
disease modifying antirheumatic drugs (DMARDs), medicines used to slow down progression
of rheumatoid arthritis disease
allopurinol and probenecid, medicines used to treat gout
theophylline, a medicine used to relieve asthma
cholestyramine, a medicine used to lower high cholesterol
amiodarone, a medicine used to treat heart disorders
certain other medicines used to treat cancer
sulfasalazine, a medicine used to treat Crohn's disease, ulcerative colitis and rheumatoid
arthritis
other medicines that may cause damage to your liver
retinoids, medicines used to treat skin conditions such as acitretin
pyrimethamine, a medicine used for malaria
proton pump inhibitors, medicines used to treat stomach ulcers and reflux
methoxsalen, a medicine used with ultraviolet light in PUVA therapy for conditions
such as severe psoriasis
DBL Methotrexate Injection can also be affected by, or interfere with the following:
nitrous oxide anaesthetics
vaccines
blood transfusions
alcohol
radiotherapy (radiation therapy) e.g. x-rays, ultra violet radiotherapy
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Methotrexate Injection.
4. How do I use DBL Methotrexate Injection?
How much and when is it given
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.
Methotrexate should only be used once a week to treat certain conditions. Using methotrexate
more frequently than once a week for these conditions may cause serious reactions
and death.
This medicine may be given alone or in combination with other drugs. It may be given
as a short course or on an ongoing basis.
Additional treatment may not be repeated until your blood cell numbers return to acceptable
levels and any unwanted effects have been controlled.
How DBL Methotrexate Injection is given
DBL Methotrexate Injection may be given as an injection into a muscle, a vein, an
artery or into the spine.
DBL Methotrexate Injection must only be given by a doctor or nurse.
If you use too much DBL Methotrexate Injection
As DBL Methotrexate Injection will most likely be given to you in hospital or under
the supervision of your doctor, it is very unlikely that you will receive an overdose.
If you think that you have been given too much DBL Methotrexate Injection or experience
severe side effects, you may need urgent medical attention.
Symptoms of a DBL Methotrexate Injection overdose may include the side effects listed
in section 6, but are usually of a more severe nature. They may include blood in your
bowel motions (black tarry stools), bleeding, nausea, vomiting, mouth ulcers and severe
infections.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using DBL Methotrexate Injection?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being given DBL Methotrexate Injection.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine.
If you are going to have surgery, tell the surgeon, anaesthetist or dentist that you
are taking this medicine. It may affect other medicines used during surgery.
If you are about to be given an immunisation, remind your doctor that you are using
this medicine.
Discuss with your doctor how much water or fluids you should have whilst you are being
given this medicine. Inadequate fluid intake can increase the side effects of this
medicine.
Ask your doctor if there are any precautions you need to take to prevent your urine
becoming too acidic. Acidic urine can increase the side effects of this medicine.
Tell your doctor immediately if you are spitting or coughing up blood when using DBL
Methotrexate Injection.
Some patients have reported acute bleeding in the lungs when using DBL Methotrexate
Injection to treat rheumatoid arthritis and other related diseases.
Keep all of your doctor’s appointments so your progress can be checked.
Methotrexate can cause problems with your blood, liver and kidneys. Your doctor may
do blood tests to check for these problems or may ask you to have an operation to
have a small sample of your liver removed. There may also be a chest x-ray and a physical
examination to check for swelling of your lymph nodes (glands in your neck, armpits
and groin).
Things you should not do
Do not go out in the sun without wearing protective clothing (hat and shirt) and using
a sunscreen with a high protection factor. Avoid exposure to sunlamps.
DBL Methotrexate Injection can increase your sensitivity to sunlight and cause severe
reactions, increasing the risk of skin cancer (non-melanoma and melanoma). Symptoms
may include a skin rash, itching, swelling, redness, blistering or a severe sunburn.
Things to be careful of
DBL Methotrexate Injection 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.
DBL Methotrexate Injection may be excreted in body fluids and waste, including blood,
urine, faeces, vomit and semen. In general, precautions to protect other people should
be taken while you are receiving DBL Methotrexate Injection and for one week after
the treatment period by:
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.
Washing 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.
Placing 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.
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.
Driving or using machines
Be careful before you drive, use any machines or tools or do anything else that could
be dangerous until you know how DBL Methotrexate Injection affects you.
DBL Methotrexate Injection may cause dizziness, drowsiness, blurred vision or tiredness
in some people and therefore may affect alertness.
Drinking alcohol
You must not drink alcohol whilst you are being given this medicine.
Alcohol may increase the side effects of DBL Methotrexate Injection and cause liver
damage.
Looking after your medicine
DBL Methotrexate Injection is usually stored in the pharmacy, doctor’s surgery or
on the ward. It is kept in a cool dry place, protected from light, where the temperature
stays below 25°C.
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
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Serious side effects
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What to do
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Allergic reaction related
signs of an allergic reaction, such as shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching,
or hives on the skin.
Heart and blood related
chest pain, shortness of breath, fast or irregular heart beats, weakness or fatigue
pain, swelling, redness and warmth in the leg (signs of a blood clot in the leg)
weakness or paralysis on one side of the body or face, difficulty speaking or swallowing,
headache, loss of balance or vision (signs of stroke)
Eye related
temporary blindness
Lung related
persistent dry, non-productive cough
shortness of breath, wheezing, difficulty breathing or chest pain (may be due to accumulation
of fluid in the lungs called pulmonary oedema)
spitting or coughing blood
Nervous system related
fits, seizures or convulsions
difficulty speaking, writing or understanding language
weakness in the legs that spreads to the upper limbs and the face, which may result
in paralysis
headache, dizziness, vomiting, loss of coordination or confusion (may be due to accumulation
of fluid in the brain called brain oedema).
Infection related
fever and chills, sore throat, sweats, body aches or feel generally unwell
sore mouth (mouth ulcers, blisters), difficulty swallowing, cold sores, swollen glands
Severe skin reaction related
skin redness/rash, pinpoint red spots, ulceration, blistering; hives or itchy skin
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson
syndrome)
dark red or black patches of skin around the injection site
Bleeding related
blood in urine, vomit or bowel motion (e.g. black tarry stools, black vomit)
bleeding or bruising more easily than usual (e.g. bleeding gums, broken blood vessels)
Kidney related
swelling of hands, ankles or feet
frequent or painful urination, difficulty urinating, blood in urine, lower back or
side pain
Liver related
yellowing of the skin and eyes, nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itchy or lighter patches on the skin, pale coloured stools, dark coloured
urine
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.
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 DBL Methotrexate Injection contains
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Active ingredient
(main ingredient)
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methotrexate
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Other ingredients
(inactive ingredients)
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water for injections
sodium chloride (except for 1 g/10 mL)
sodium hydroxide
hydrochloric acid (as pH-adjustment agent)
sodium hydroxide (as pH-adjustment agent)
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Do not take this medicine if you are allergic to any of these ingredients.
What DBL Methotrexate Injection looks like
DBL Methotrexate Injection is a clear yellow liquid in clear glass vials.
DBL Methotrexate Injection is available in the following strengths and pack sizes:
5 mg/2 mL vial x 5 AUST R 16313
50 mg/2 mL vial x 5 AUST R 16314
500 mg/20 mL vial x 1 AUST R 47252
1 g/10 mL vial x 1 AUST R 16312
Who distributes DBL Methotrexate Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in August 2023