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METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): METHOTREXATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Methotrexate 25 mg/ml solution for injection/infusion
methotrexate
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet..
What is in this leaflet
1.
What Methotrexate 25 mg/ml solution for injection/infusion is and what it is
used for
2.
What you need to know before you use Methotrexate 25 mg/ml solution for
injection/infusion
3.
How to use Methotrexate 25 mg/ml solution for injection/infusion
4.
Possible side effects
5.
How to store Methotrexate 25 mg/ml solution for injection/infusion
6.
Contents of the pack and other information
1.
What Methotrexate 25 mg/ml solution for injection/infusion is and what it
is used for
Methotrexate is a substance with the following properties:
it interferes with the growth of tumour cells in the body that reproduce quickly
(anti-tumour agent)
it reduces undesired reactions of the body’s own defence mechanism
(immunosuppressant), and
it has anti-inflammatory effects.
Methotrexate is used to treat cancer, such as:

lymphatic leukaemia (disease of the blood or bone marrow with increased
number of white blood cells)

breast cancer

bone cancer (osteosarcoma)

head and neck cancer

gynaecologic cancer (choriocarcinoma, trophoblastic disease - tumour
development directly associated with pregnancy)

cancer of the lymphatic system (Non-Hodgkin´s lymphoma).

2.

What you need to know before you use Methotrexate 25 mg/ml solution for
injection/infusion

Do not use Methotrexate 25 mg/ml solution for injection/infusion if:

you are allergic to methotrexate or any of the other ingredients of this medicine
(listed in section 6)

you have significant kidney disease

you have significant liver disease

you have increased alcohol consumption

you have disorders of the blood-forming system

you have severe or existing infections

you have gastrointestinal ulcers or ulcers of the oral cavity

you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding
and fertility”)
You should not be given live vaccines during treatment with Methotrexate 25 mg/ml
solution for injection/infusion.
Tell your doctor before you use Methotrexate 25 mg/ml solution for injection/infusion
if you think any of the above applies to you.
Warnings and precautions
Take special care with Methotrexate 25 mg/ml solution for injection/infusion if you:

have diabetes mellitus treated with insulin

have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles
(herpes zoster))

have problems with your lung function

have/had any liver or kidney disease

experience any sign or symptoms suggestive of infection, e.g. fever

have abnormal accumulation of liquid in the abdomen or in the cavity between
the lungs and chest wall (ascites, pleural effusions)

are dehydrated or suffer from conditions leading to dehydration (vomiting,
diarrhoea, stomatitis).
Inform your doctor in case any of the above applies to you.
You should avoid solarium and direct sun light during treatment, as the skin is more
sensitive.
Methotrexate may be genotoxic. This means that the medicine may cause genetic
mutation. Methotrexate can affect sperm and egg production with the potential to
cause birth defects. You and your partner must avoid conception (becoming pregnant
or fathering children) if currently receiving methotrexate and for at least six months
after your treatment with methotrexate has stopped. See also section “Pregnancy,
breast-feeding and fertility”.
Since treatment with methotrexate may lead to infertility, it might be advisable for
male patients to look into the possibility of sperm preservation before starting
treatment.

Even if Methotrexate 25 mg/ml solution for injection/infusion is administered at low
dosage, severe side effects can occur. In order to diagnose them early, regular
monitoring by the doctor at short-term intervals is necessary.
Before treatment is started your doctor may carry out blood tests, 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. Do not miss appointments
for blood tests.
If the results of any of these tests are abnormal, treatment will only be resumed when
all readings are back to normal.
Other medicines and Methotrexate 25 mg/ml solution for injection/infusion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines including medicines, obtained without a prescription and herbal
or natural medicinal products. Remember to tell your doctor about your treatment
with Methotrexate 25 mg/ml solution for injection/infusion, if you are prescribed
another medicine while the treatment is still ongoing.
It is especially important to tell your doctor if you are using:
other treatments for rheumatoid arthritis or psoriasis such as leflunomide,
sulphasalazine (also used for ulcerative colitis), salicylates such as
acetylsalicylic acid, phenylbutazone, or amidopyrine
alcohol (should be avoided)
live vaccinations
azathioprine (used to prevent rejection after an organ transplant)
retinoids (used to treat psoriasis and other skin disorders)
anticonvulsant drugs (prevent fits)
cancer treatments
barbiturates (sleeping injection)
tranquillisers
oral contraceptives
probenecid (for gout)
antibiotics
pyrimethamine (used to prevent and treat malaria)
vitamin preparations, which contain folic acid
proton-pump inhibitors (used to treat severe heartburn or ulcers)
theophylline (used to treat asthma).
Methotrexate 25 mg/ml solution for injection/infusion with food, drink and
alcohol
During Methotrexate 25 mg/ml solution for injection/infusion treatment, you should
avoid any alcohol consumption as well as excessive consumption of coffee, caffeinecontaining beverages or black tea. Also make sure you drink plenty of liquids during
treatment with Methotrexate 25 mg/ml solution for injection/infusion, because
dehydration (reduction in body water) can increase the toxicity of Methotrexate 25
mg/ml solution for injection/infusion.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
You must not use Methotrexate 25 mg/ml solution for injection/infusion during
pregnancy. Men and women should use an effective method of birth control during
treatment and during a further six months after treatment with Methotrexate 25 mg/ml
solution for injection/infusion has been discontinued.
In women of child-bearing age, any existing pregnancy must be excluded with
certainty by taking appropriate measures e.g. pregnancy test, prior to therapy.
As methotrexate can be genotoxic, all women who wish to become pregnant are
advised to consult a genetic counselling centre, if possible already prior to therapy,
and men should seek advice about the possibility of sperm preservation before starting
therapy, see also section “Take special care with Methotrexate 25 mg/ml solution for
injection/infusion”.
Breast-feeding
Methotrexate passes into breast milk. Breast-feeding should be stopped prior to and
during treatment with Methotrexate 25 mg/ml solution for injection/infusion.
Driving and using machines
Tiredness and dizzinesscan occur during treatment. If affected you should not drive or
operate machinery.
Methotrexate 25 mg/ml solution for injection/infusion contains sodium
This medicinal product contains 0.21 mmol (or 4.945 mg) sodium per ml. To be taken
into consideration by patients on a controlled sodium diet.
3.

How to use Methotrexate 25 mg/ml solution for injection/infusion solution
for injection/infusion

Treatment with methotrexate should be initiated by or in consultation with a doctor
with considerable experience in cancer treatment. The dose is usually calculated based
on various factors e.g. the patient general health and body surface area and the type of
disease. The overall duration of treatment and intervals between administrations is
decided by the physician.
Methotrexate can be given intramuscularly (in a muscle), intravenously (in a vein),
intra-arterially (in an artery and intra-thecally. Higher doses are usually given as an
infusion over 24 h, either alone or in combination with other medicinal products used
to treat cancer.
Your doctor may instruct you to take sodium bicarbonate or acetazolamide tablets
while receiving your medicine to help make sure that methotrexate is not concentrated
in the kidnes. If you receive methotrexate in high doses, you will receive calcium
folinate as well to lessen the side effects of methotrexate.
Use in children

This medicine should be used with caution in children and in line with standard
therapy.
Methotrexate should not come into contact with the surface of the skin or mucosa. In
the event of contamination, the affected area must be rinsed immediately with plenty
of water.
If you use more Methotrexate 25 mg/ml than you should
Your doctor decides on the dosage, which is given by healthcare staff. Overdose is
therefore unlikely.
An overdose of methotrexate can lead to severe toxic reactions.
Overdose symptoms may include easy bruising or bleeding, unusual weakness, mouth
sores, nausea, vomiting, black or bloody stools. The antidote in case of an overdose is
calcium folinate.
If you forget or stop using Methotrexate 25 mg/ml solution for injection/infusion
You should not interrupt or discontinue Methotrexate 25 mg/ml solution for
injection/infusion treatment, unless you have discussed this with your doctor. In case
you forget your appointment for next dose, contact your doctor as soon as possible to
schedule a new appointment. If you suspect severe side effects, contact your doctor
immediately for advice.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4.

Possible Side Effects

Like all medicines Methotrexate 25 mg/ml solution for injection/infusion can cause
side effects, although not everybody gets them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting
your whole body).
Serious side effects
If you develop any of the following side effects, contact your doctor immediately:
 lung complaints (symptoms may be general illness; dry, irritating cough; shortness
of breath, breathlessness at rest, chest pain, or fever)
 severe peeling or blistering of the skin
 unusual bleeding (including vomiting blood) or bruising
 severe diarrhoea
 ulcers in mouth
 black or tarry stools
 blood in the urine or stools
 tiny red spots on the skin
 fever
 yellowing of the skin (jaundice)
 pain or difficulty in passing urine
 thirst and/or frequent urination





fits (convulsions)
loss of consciousness
blurred or decreased vision.

The following side effects have also been reported.
Very common (more than 1 in 10):
Inflammation of the mouth, indigestion, loss of appetite, nausea (feeling sick),
vomiting, tummy pain, inflammation and ulcers in the mouth and throat. Increase in
liver enzymes (can be detected by a test carried out by a doctor).
Common (between 1 in 100 and 1 in 10):
Changes in the number of blood cells and platelets (can be detected by a test carried
out by a doctor).
Headache, tiredness, sleepiness. Diarrhoea. Measles-like rash (alone), redness, and
itching.
Uncommon (between 1 in 1000 and 1 in 100):
Spinning sensation, confusion, depression, fits. Brain disorder
(leukoencephalopathy/enchepalopathy). Lung damage. Ulcers and bleeding in the
digestive tract. Liver disorders (can be detected by a test carried out by a doctor),
diabetes, decreased blood protein (can be detected by a test carried out by a doctor).
Nettle rash (alone), light sensitivity, brown skin, hair loss, increase of rheumatic
nodules (lumps of tissues), shingles, painful psoriasis, Joint or muscle pain, brittle
bones, inflammation. Ulcers in the bladder (possibly with blood in the urine), painful
urination. Severe allergic reactions. Inflammation and ulcers of the vagina.
Rare (between 1 in 1000 and 1 in 10000):
Inflammation of the lining of the heart, fluid around the heart. Severely visual
disturbance, mood alterations.
Low blood pressure, blood clots. Sore throat, interruption of breathing, asthma.
Inflammation of the digestive tract, bloody stools, inflamed gums, abnormal
digestion. Changed colour of nails, acne, red or purple spots.
Bone fracture. Kidney failure, little or no urine produced, waste products in the blood.
Very rare (less than 1 in 10000 and unknown):
Infections. Severe failure of the bone marrow (can be detected by a test carried out by
a doctor). Swollen glands. Sleeplessness. Pain, muscle weakness, pins and needles,
changes in sense of taste (metallic taste), inflammation of the lining of the brain
causing paralysis or vomiting. Red eyes, damage to the retina of the eye. Fluid on the
lungs. Vomiting blood. Cold sores. Protein in the urine (can be detected by a test
carried out by a doctor). Loss of sex drive, problems having an erection, low sperm
production, abnormal periods, vaginal discharge, infertility. Infection around a
fingernail, severe complication of the digestive tract, fungal infections, boils, dilated
small blood vessels in the skin, damage to the blood vessels of the skin. Lumps in the
armpit or groin. Slow wound healing.
Other: After injection into a muscle, there may be a burning sensation or damage at
the injection site.

If you get any side effects, talk to your doctor. This includes any side effects not listed
in this leaflet.
5.

How to store Methotrexate 25 mg/ml for injection/infusion






Keep the medicine out of sight and reach of children.
Keep the vial in the outer carton in order to protect from light.
Do not store above 25°C.
For single dose use only. Discard any unused solution immediately and safely
after initial use.
This medicine should only be administered by a medically qualified person, e.g.
a doctor.
Do not use Methotrexate 25 mg/ml solution for injection/infusion if there are
any visible signs of deterioration.
Do not use Methotrexate 25 mg/ml solution for injection/infusion after the
expiry date which is printed on the carton and vial after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.






6.

Contents of the pack and other information

What Methotrexate 25 mg/ml solution for injection/infusion contains
The active substance is: methotrexate.
Each 1 ml of this sterile solution for injection/infusion contains 25 milligrams
methotrexate.
The other ingredients are: sodium chloride, hydrochloric acid, sodium hydroxide,
water for injections.
What Methotrexate 25 mg/ml solution for injection/infusion looks like and
contents of the pack
Methotrexate 25 mg/ml solution for injection/infusion is a yellow and sterile solution
in clear glass vials.
Each pack contains 5 vials of 2 ml, 4 ml or 10 ml solution.
Each pack contains 1 vial of 40 ml solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer:
Agila Specialties Polska Sp.z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
This leaflet was last revised in 09/2014

The following information is intended for medical or healthcare professionals
only
Methotrexate 25 mg/ml solution for injection/infusion solution for injection/infusion
may be further diluted with an appropriate preservative-free medium such as glucose
solution (5 %) or sodium chloride solution (0.9 %) to an in-use concentration of 2
mg/ml.
With respect to the handling the following general recommendations should be
considered: The product should be used and administered only by trained personnel;
the mixing of the solutions should take place in designated areas, designed to protect
personnel and the environment (e.g. safety cabins); protective clothing should be worn
(including gloves, eye protection, and masks if necessary).
The product is for single use only. Discard any unused solution immediately after
initial use. Waste should be disposed of carefully in suitable separate containers,
clearly labelled as to their contents (as the patient’s body fluids and excreta may also
contain appreciable amounts of antineoplastic agents and it has been suggested that
they, and material such as bed linen contaminated with them, should also be treated as
hazardous waste). Any unused product or waste should be disposed of in accordance
with local requirements by incineration. For example, chemical destruction methods
(oxidation with e.g., potassium permanganate and sulphuric acid or aqueous alkaline
potassium permanganate or sodium hypochlorite) have also been used.
Adequate procedures should be in place for accidental contamination due to spillage;
staff exposure to antineoplastic agents should be recorded and monitored.
If a cytotoxic drug should contaminate the skin it should be washed off immediately
using copious amounts of running water for at least ten minutes. For example, if eyes
are sprayed with cytotoxic material they should be rinsed immediately with copious
amounts of water and bathed with sterile sodium chloride solution for at least ten
minutes.
Pregnant staff should avoid handling antineoplastic agents.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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