Methotrexate Injection

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 apersistent 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)

Serious Side Effects

• black tarry stools
• a sore mouth, particularly if you have a number of ulcers or blisters inside of the mouth or on the tongue
• skin rashes or blistering to the surfaces of the eyes, nose, vagina or anus (back passage)
• diarrhea,stroke/ weakness on one side of the body
• weakness in the legs that spreads to the upper limbs and the face, which may result in paralysis
• abdominal pain, fatty stools, vomiting
• chest pain (which may be due to heart or lung problems)

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

• low blood pressure (you may feel faint)
• fits,blurred vision,dizziness,muscle weakness
• difficulty/inability to talk
• you may feel the need to drink more than usual (diabetes)
• abnormally easily broken bones (osteoporosis)
• pain or redness of the blood vessels (vasculitis)
• itching or the appearance of lightened patches on the skin, bruises, boils, acne
• increased sensitivity to sunlight
• yellowing of the skin and whites of the eyes (jaundice)
• pain in the stomach, loins or abdomen
• you may need to pass urine more often than normal, which may be painful (cystitis)
• headaches,drowsiness,generally feeling tired or unwell
• reduced appetite, feeling or being sick
• irregular periods in women (periods may stop completely)
• hair loss,effects on learning and memory,ringing in the ears
• joint and muscle pain
• blood clot which causes pain, swelling or redness (cerebral, deep vein, retinal vein or arterial vein)
• mood alterations
• inflammation of the lungs, which causes breathlessness, cough and raised temperature, pneumonia
• shingles (Herpes Zoster)

Some different side effects may occur following injection into the spine.

• 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.
• Irritability and confusion,Stiffness, Fits,Sleepiness
• Confusion and loss of memory,Coma, Death

* 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.
* If any of the side effects gets serious, or if you notice any side effects.

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.

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.

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 para-aminobenzoic acid
— phenytoin (medicine often used to treat epilepsy)
— vitamin supplements containing folic acid
— probenecid (medicine used to treat gout)
— nitrous oxide (used for general anaesthesia and pain relief)
— retinoids, such as acitretin (a medicine used to treat psoriasis) or isotretinoin (used to treat severe acne)
— other drugs that may cause damage to your kidneys
— other drugs that may case damage to your liver
— live virus vaccines
— mercaptopurine (medicine used in the treatment of blood cell cancer)
— theophylline (medicine used in the treatment of asthma)

• 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 breast-feeding 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.