Description

Product Overview

WHAT METHOTREXATE INJECTION IS AND WHAT IT IS USED FOR

Methotrexate Injection is an anti-metabolite medicine (medicine which affects how the body’s cells grow) and immunosuppressant (medicine which reduces the activity of the immune system). Methotrexate is used in large doses (on its own or in combination with other medicines) to treat certain types of cancer such as breast cancer. In smaller doses it can be used to treat severe psoriasis (a skin disease with thickened patches of inflamed red skin, often covered by silvery scales), when it has not responded to other treatments.

BEFORE YOU ARE GIVEN METHOTREXATE INJECTION

You will not be given Methotrexate Injection if you
• are allergic (hypersensitive) to Methotrexate or any of the other ingredients of Methotrexate Injection
• have significant kidney or liver problems
• have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anaemia) or platelets
• have any infection
• your immune system is not working as well as it should

Tell your doctor if any of the above applies to you before this medicine is used.

Take special care with Methotrexate Injection if you
• have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut)
• have an infection
• have mild kidney problems
• have a medical condition which causes a build up of fluid in the lining of your lungs or in your abdomen (the fluid will need to be drained before methotrexate treatment is started)
• are to have radiotherapy (risk of tissue and bone damage may be increased)
• are to have any vaccinations

Tell your doctor if any of the above applies to you before this medicine is used.

Special care will also be taken in children, the elderly and in those who are in poor physical condition.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with
methotrexate, for example:
• non-steroidal anti-inflammatory medicines e.g. ibuprofen (medicines taken for pain relief)
• aspirin or similar medicines (known as salicylates)
• omeprazole, esomeprazole and pantoprazole (medicines used to reduce the production of stomach acid)
• diuretics (water tablets)
• medicines taken for diabetes (including insulin and tablets)
• antibiotics such as penicillins, sulphonamides, co-trimoxazole, trimethoprim, tetracycline,
chloramphenicol and paraaminobenzoic acid
• phenytoin (medicine often used to treat epilepsy)

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Methotrexate Injection and drinking alcohol
Do not drink alcohol whilst being treated with Methotrexate as alcohol increases the risk of
liver damage.

Pregnancy and breast-feeding

• Tell your doctor if you are pregnant, trying to become pregnant or breastfeeding before this medicine is used.
• This medicine must not be used during pregnancy.
• Mothers should not breast-feed whilst treatment with methotrexate in ongoing.
• Due to the risk of birth defects, conception should be avoided during methotrexate treatment and for at least 6 months after treatment is stopped.
• Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
• Do not drive or use machines if you experience any side effect (e.g. dizziness, drowsiness or blurred vision) which may lessen your ability to do so.

HOW YOU ARE GIVEN METHOTREXATE INJECTION

This medicine may be given by injection into a vein (intravenous injection), into muscle (intramuscular injection), into an artery (intraarterial injection) or into the spine (intrathecal injection)*. It may also be given by infusion (drip) into a vein. It may be
diluted before it is given.

Dose
• Your doctor will work out the correct dose of Methotrexate Injection for you and how often it must be given.
• The dose of medicine given to you will depend on the disease being treated, your medical condition, your age, your size and how well your kidneys are working.
• 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.

If you are given too much or too little Methotrexate Injection
• This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however,tell your doctor or nurse if you have any concerns

POSSIBLE SIDE EFFECTS

Methotrexate is a very toxic medicine and patients have died, or become very ill, whilst
being treated with it. During treatment you should watch for any side effects and report
them to the doctor.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• inflammation of the lung with breathlessness – you may develop a persistent cough, experience pain or difficulty breathing, or become breathless. This may be associated with changes in a particular type of white cell in your blood.
• symptoms of an infection e.g. fever, chills, achiness, sore throat
• unexpected bleeding e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

• low blood pressure (you may feel faint)
• fits
• blurred vision
• dizziness
• difficulty/inability to talk
• muscle weakness

Some different side effects may occur following injection into the spine. These are
• headache
• back or shoulder pain
• difficulty with bending your head down
• fever
• temporary paralysis or weakness
• problems with a particular part of your brain, leading to shaking, abnormal balance or staggering.

Methotrexate may lead to problems with your blood, liver and kidneys. Your doctor will take
blood samples to check for these problems and may ask you to have an operation to have a small sample of you liver removed.

Effects on fertility

Treatment with methotrexate may reduce fertility in men and women. Fertility is thought to go back to normal after methotrexate treatment is stopped. Tell your doctor if you have concerns.

HOW TO STORE METHOTREXATE INJECTION

• Keep out of the reach and sight of children

Expiry
• This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage
• The vials should be kept in the outer carton, in order to protect from light, and stored at, or below, 25°C. The vials should not be frozen.
• Unused portions of opened vials must not be stored for later use.
• Prepared infusions should be used immediately, however, if this is not possible they can, in certain circumstances, be stored for up to 30 days in a refrigerator provided they have been prepared in a way to exclude microbial contamination.