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METHOTREXATE ADOH 22.5 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): METHOTREXATE

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Methotrexate 22.5 mg Solution for injection in pre-filled syringe
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 or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Methotrexate is and what it is used for
2.
What you need to know before you use Methotrexate
3.
How to use Methotrexate
4.
Possible side effects
5.
How to store Methotrexate
6.
Contents of the pack and other information

1.

What Methotrexate is and what it is used for

Methotrexate is a drug with the following properties:
- it interferes with the growth of certain 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 indicated for the treatment of:
-

2.

Active rheumatoid arthritis in adult patients,
Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal antiinflammatory drugs (NSAIDs) has been inadequate,
Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as
phototherapy, PUVA, and retinoids, and severe psoriatic affecting the joints (psoriac arthritis) in adult
patients.

What you need to know before you use Methotrexate

Important warning with reference to the dosing of methotrexate:
Methotrexate for the therapy of rheumatic diseases or diseases of the skin must only be used once weekly.
Faulty dosing of methotrexate may lead to serious adverse effects including fatal course. Please read section 3
of this PL very carefully.
Please ask your doctor or pharmacist before using Methotrexate if you have any question.

Do not use Methotrexate:
- if you are allergic (hypersensitive) to methotrexate or any of the other ingredients of this medicine..
- If you have significant kidney disease (your doctor decides the severity of the disease)
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-

If you have significant liver disease (your doctor decides the severity of your disease)
If you have disorders of the blood-forming system
If your alcohol consumption is high
If you have an impaired immune system
If you have a severe or existing infection, e.g. tuberculosis and HIV
If you have gastrointestinal ulcers
If you are pregnant or breast-feeding (see section “Pregnancy and lactation”)
If you receive vaccinations with live vaccines at the same time.

Take special care with Methotrexate:
- If you have diabetes mellitus treated with insulin
- If you have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles (herpes zoster)
- If you have/had any liver or kidney disease
- If you have problems with your lung function
- If you are severely overweight
- If you have abnormal accumulation of liquid in the abdomen or in the cavity between the lungs and
chest wall (ascites, pleural effusions)
- If you are dehydrated or suffer from conditions leading to dehydration (vomiting, diarrhoea, stomatitis)
The therapy is to be administered once a week.
Incorrect intake of methotrexate can lead to severe, including potentially lethal, side effects.
Read section 3 of this package leaflet carefully.
If you have experienced problems with your skin after radiation therapy (radiation induced dermatitis) and
sun-burn these conditions can reappear under methotrexate therapy (recall-reaction).
Use in children, adolescents and elderly
Dose instructions depend on patient’s body weight. Use in children < 3 years of age is not recommended due
to the insufficient experience in this age group.
Children and the elderly under Methotrexate treatment should be kept under particularly close, medical
surveillance, in order to identify possible side effects as early as possible.
Dose for elderly patients should be relatively low due to age-related reduced liver and kidney function and
low folate reserves.
Special precautionary measures during treatment of Methotrexate
Methotrexate should only be prescribed by doctors with sufficient experience in the Methotrexate
treatment of the disease concerned.
Methotrexate temporarily affects sperm and egg production. 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 and lactation”.
Skin changes caused by psoriasis can worsen during treatment with Methotrexate if exposure to UV
irradiation occurs at the same time.
Recommended follow-up examinations and precautions:

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Even when Methotrexate is used at low doses, serious side effects can occur. In order to recognise these in
good time, your doctor must carry out check-ups and laboratory tests.
Before the start of treatment:
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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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, 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), aspirin, 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 (against 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)
Using Methotrexate with food and drink
During treatment with Methotrexate, you should not drink any alcohol and you should avoid
excessive consumption of coffee, soft drinks containing caffeine and black tea.
Also make sure you drink plenty of liquids during treatment with Methotrexate because dehydration
(reduction in body water) can increase the toxicity of Methotrexate.

Pregnancy, breast-feeding and fertility
Pregnancy
Do not use Methotrexate during pregnancy or if you are trying to become pregnant. Methotrexate can cause
birth defects, harm unborn babies or cause miscarriages and so it is very important that it is not given
to pregnant patients or patients planning to become pregnant. Therefore, in women of child-bearing age any
possibility of pregnancy must be excluded with appropriate measures, e.g. a pregnancy test, before starting
treatment. You must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after
treatment is stopped. Therefore you must ensure reliable contraception during this whole period (see also
section “Take special care with Methotrexate”).
If you do become pregnant during treatment, you should be offered advice regarding the risk of harmful
effects on the child through treatment.

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If you wish to become pregnant you should consult your doctor, who may refer you for specialist advice,
before the planned start of treatment, because methotrexate may be genotoxic, which means that the
medicine may cause genetic mutation.
Breast-feeding
Do not breast-feed during treatment, because methotrexate passes into breast milk. If your attending doctor
considers treatment with methotrexate absolutely necessary during the lactation period, you must stop breastfeeding.
Male fertility
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. Therefore, you must avoid
fathering a child whilst taking methotrexate and for at least 6 months after treatment is stopped. 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 (see also section “Take special care with
Methotrexate”).
Driving and using machines
Side effects affecting the central nervous system, such as tiredness and dizziness, may occur during treatment
with Methotrexate. In some cases, the ability to drive vehicles and/or use machines may therefore be impaired.
If you feel tired or dizzy, you should not drive or use machines.
Important information about some of the ingredients of methotrexate
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3.

How to use methotrexate

Methotrexate should only be prescribed by physicians who are familiar with the various
characteristics of the medicinal products and its mode of action.
Always use Methotrexate exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are unsure.
Methotrexate is administered once a week only. Together with your doctor you decide on a suitable weekday
each week on which you receive your injection.
Incorrect intake of Methotrexate can lead to severe, including potentially lethal, side effects. The
usual dose is:
Dose in patients with rheumatoid arthritis
The recommended starting dose for methotrexate is 7.5 mg once a week. Methotrexate is given in a single
application as injection under the skin or into a muscle (see section “Method and duration of
administration”).
In case of inadequate action and if tolerated well, Methotrexate doses may be increased. The mean weekly
dose is 15-20 mg. Generally, a weekly dose of 25 mg Methotrexate should not be exceeded. Upon achieving
desired therapeutic results, the dose should – if possible – be gradually reduced to the lowest possible effective
maintenance dose.
Dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
The recommended dose is 10-15 mg/m² body surface area per week. In cases with inadequate response, the
weekly dose may be increased up to 20 mg/m2 body surface area/week. However, regular check-ups should
be done more often. It should only be given by subcutaneous (under the skin) or intramuscular (into the
muscle) injection.
Use in children < 3 years of age is not recommended due to the insufficient experience in this age group.

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Adults with severe forms of psoriasis vulgaris or psoriatic arthritis
It is recommended to administer a single test dose of 5-10 mg, in order to assess possibly damaging effects.
This dose can be administered subcutaneously (under the skin) or intramuscularly (into a muscle).
If, one week later, no blood count changes are observed, therapy is continued with a dose of approximately
7.5 mg. The dose may be gradually increased (in steps of 5-7.5 mg per week and under blood count
surveillance) until ideal therapeutic results are obtained. Generally, a weekly dose of 20 mg can be
associated with significant increase in toxicity. A dose of 30 mg per week should not be exceeded..
Upon achieving desired therapeutic results, the dose should be weekly reduced to the lowest possible
effective maintenance dose for the individual patient.
Patients with a kidney disorder
Patients with a kidney disorder may need a reduced dose.
Method and duration of administration
The duration of the treatment is determined by the treating physician. Methotrexate is injected once weekly!
It is recommended to specify a certain day of the week as “day for injection”.
Methotrexate is given as injection under the skin or into a muscle. Treatment of rheumatoid arthritis, juvenile
idiopathic arthritis, psoriasis vulgaris and psoriatic arthritis with Methotrexate is a long-term treatment.
Rheumatoid arthritis
Generally, improvement of the symptoms can be expected after 4-8 weeks of treatment.
Symptoms may return after Methotrexate discontinuation.
Severe types of psoriasis vulgaris and psoriatic arthritis (psoriasis arthropatica)
Response to treatment can generally be expected after 2-6 weeks. Depending on the clinical picture and the
changes of laboratory parameters, the therapy is then continued or discontinued.

At the start of your therapy, Methotrexate may be injected by medical staff. However, your doctor may
decide that it is right for you to learn how to inject Methotrexate under the skin yourself. You will receive
appropriate training for you to do this. Under no circumstances should you attempt to inject yourself unless
you have been trained to do so.
How to give yourself an injection of methotrexate
If you have trouble handling the syringe, ask your doctor or pharmacist. Do not try to inject yourself if you
have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately.
Before injecting yourself with methotrexate
- Check the expiry date on the medicine. Do not use if the date has passed.
- Check the syringe is not damaged and the medicine in it is a clear solution. If not, use another syringe.
- Check your last injection site to see if the last injection caused any redness, change in skin colour, swelling,
oozing or is still painful, if so talk to your doctor or nurse.
- Decide where you are going to inject the medicine. Change the place where you inject each time.
Instructions on injecting yourself with methotrexate
1) Wash your hands and the area that you will inject with soap and water. Dry them.
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place you are going to
inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
3) Remember to change the place where you inject everytime.
4) Carefully pull off the needle cap from the methotrexate syringe. Throw away the cap. The syringe is prefilled and ready to use.

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Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead to a loss of the
medicine. Once you have removed the cap, do not allow the needle to touch anything. This is to make sure
the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and with your other hand, gently pinch the
cleaned area between your forefinger and thumb to make a fold in the skin.
Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle). Insert the full length
of the needle into the skin fold.
7) Press down on the plunger with your finger until the syringe is empty. This will send the medication under
the skin. Make sure you hold the skin fold throughout the injection.

8) Remove the needle by pulling it straight out. A protective sleeve will automatically cover the needle. You
can now let go of the skin fold.

Note: the safety system allowing release of the protective sleeve, can only be activated when the syringe has
been emptied by pressing the plunger all the way down. To avoid bruising, do not rub the injection site
after you have injected yourself.
9) Drop the used syringe with its protective sleeve into the sharps bin provided. Close the container lid tightly
and place the container out of reach of children. If you accidently get methotrexate on the surface of the skin
or mucosa you must rinse with plenty of water . When the container is full, give it to your doctor or home
care nurse for disposal. Do not put it in the household rubbish.

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If you use more Methotrexate than you should
Follow the dose recommendations of your treating doctor. Do not change the dose of your own accord.
If you suspect that you (or someone else) have used too much Methotrexate, please tell your doctor or
contact the nearest hospital casualty department immediately. He/she will decide on any necessary treatment
measures, depending on the severity of intoxication.
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, coughing up
blood or vomit that looks like coffee grounds, and decreased urinating. See also section 4.
Take your medicine package with you if you go to a doctor or hospital.
The antidote in case of an overdose is calcium folinate.
If you forget to use Methotrexate
Do not take a double dose to make up for forgotten individual doses, but continue taking the ordered dose.
Ask your doctor for advice.
If you stop taking Methotrexate
You should not interrupt or discontinue Methotrexate treatment, unless you have discussed this with your
doctor. 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 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:
common:
uncommon:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
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rare:
very rare:
not known:

affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

Very common:
loss of appetite, nausea (feeling sick), vomiting, tummy pain, inflammation and ulcers in the mouth
and throat, and increase in liver enzymes
Common:
Reduced blood cell formation with decrease in white and/or red blood cells and/or platelets
(leukopenia, anaemia, thrombocytopenia), headache, tiredness, drowsiness, inflammation of the lungs
(pneumonia) with dry, non-productive cough, shortness of breath and fever, diarrhoea, rash, reddening
of the skin, itching.
Uncommon:
Decrease in the number of blood cells and platelets , dizziness, confusion, depression, fits,
inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver disorders,
diabetes, decreased blood protein, nettle rash (alone), light sensitivity, brown skin, hair loss, increase
of rheumatic nodules, shingles, painful psoriasis, joint or muscle pain, osteoporosis (reduction of bone
mass), inflammation and ulcers of the bladder (possibly with blood in the urine), painful urination,
severe allergic reactions, inflammation and ulcers of the vagina, slow wound healing.
Rare:
Inflammation of the sac around the heart, fluid in the sac around the heart, severe visual disturbance,
mood fluctuationslow blood pressure, blood clots, sore throat, interruption of breathing, asthma,
inflammation of the digestive tract, bloody stools, inflamed gums, abnormal digestion, acute hepatitis
(inflammation of the liver), changed colour of nails, acne, red or purple spots due to vessel bleeding,
bone fracture, kidney failure, decrease or absence of urine, electrolyte disturbances, defective sperm
formation, menstruation disorders.
Very rare:
Infections, severe failure of the bone marrow, liver failure, 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 in the lungs,
vomiting blood, cold sores, protein in the urine, fever, loss of sex drive, problems having an erection,
infection around a fingernail, severe complication of the digestive tract, boils, small blood vessels in the
skin, fungal infections, damage to the blood vessels of the skin, vaginal discharge, infertility, male
breast enlargement (gynaecomastia).
When methotrexate is given by the intramuscular route, local undesirable effects (burning sensation) or
damage (formation of sterile abscess, destruction of fatty tissue) at the site of injection can occur
commonly. Subcutaneous application of methotrexate is locally well tolerated. Only mild local skin
reactions were observed, decreasing during therapy.
Methotrexate may cause a reduction in the number of white blood cells and your resistance to infection
may be decreased. If you experience an infection with symptoms such as fever and serious deterioration
of your general condition, or fever with local infection symptoms such as sore throat/sore pharynx/sore
mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check
for possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about
your medicine.
Methotrexate may cause serious (sometimes life-threatening) side effects. Therefore, your doctor will do
tests to check for abnormalities developing in the blood (e.g. low white blood cells, low platelets,
lymphoma) and changes in the kidney and the liver.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
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effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store methotrexate
Keep out of the sight and reach of children.
Store below 30°C.
Keep the syringe in the outer carton in order to protect from light.
Do not use this medicinal product after the expiry date which is stated on the label of the pre-filled
syringe and the carton after EXP. The expiry date refers to the last day of that month.
The product has to be used immediately after opening.
You must not use Methotrexate, if the solution is not clear and contains particles.
For single use only. Any used solution should be discarded! This medicine and its packaging must not
be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines
or packaging no longer required. These measures will help protect the environment.

6.

Contents of the pack and other information

What methotrexate contains
-

The active substance is methotrexate. 1 ml of solution contains methotrexate corresponding to 25
mg methotrexate.
The other ingredients are sodium chloride, sodium hydroxide, water for injections.

What methotrexate looks like and contents of the pack
Methotrexate pre-filled syringes contain a clear, yellow solution. The pre-filled syringes are attached with
an injection needle and with a safety device to prevent needlestick injury and reuse.
The following pack sizes are available:
Pre-filled syringes of 0.9 ml contain 22.5 mg methotrexate
Solution for injection in packs of 1, 4, 6 and 24 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
ADOH B.V.
Godfried Bomansstraat 31
6543 JA Nijmegen
The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark
Methotrexate ADOH 22,5 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Finland

Methotrexate ADOH 22,5 injektioneste, liuos, esitäytetty ruisku

The Netherlands

Methotrexaat ADOH 22,5 oplossing voor injectie in een voorgevulde spuit

Sweden

Methotrexate ADOH 22,5 onjektionsvätska, lösning i förfylld spruta

This leaflet was last revised in 05/2015.
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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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