Methotrexate treatment www.bspar.org.uk
These guidelines have been written tohelp you understand more about lowdose methotrexate. Sometimes yourtreatment may differ from theinformation provided in this leaflet. The doctor or nurse will be able toexplain the reasons for this when theyadvise you about your treatment. Please keep this pre-treatment leaflet as there is important information that can act as a reminder to you while you are treated with methotrexate. Please take this leaflet with you when you go to see your doctor, nurse or pharmacist. Contact details for the healthcare staff looking after you Low dose methotrexate (25mg or less once a week) What it is Methotrexate was first used, in high doses, to treat cancer but experience over thirty years has shown that methotrexate at much lower doses is helpful in the treatment of a number of joint, skin and bowel conditions. Methotrexate is a well established effective treatment for several different types of rheumatic diseases (for example, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis), severe psoriasis and for bowel diseases (such as Crohn's disease). It is also used in some other conditions where the body's natural defence system is overactive.
Most people receiving methotrexate are greatly helped by itand suffer few, if any, problems. It is however a powerfulmedicine and must be treated with respect. This leaflet tellsyou more about methotrexate and how the risks orproblems can be kept to a minimum.
The doctor or nurse treating your condition may give youmore information that explains about your particularcondition and your treatment. You should read all theinformation you receive.
This leaflet only provides information for people being treated with low dose methotrexate (25mg or less once a week) for inflammatory conditions. It does not cover treatment for cancer as the dose of methotrexate is much higher and the treatment may vary considerably to the information provided in this leaflet. What methotrexate can do Methotrexate acts by slowing the production of new cells by the body's immune system. This helps to reduce the inflammation that causes swelling and stiffness of joints, thickened skin or damage to the bowel responsible for the problems you experience with your condition. Methotrexate reduces the permanent damage to joints caused by continuing inflammation. It is not a painkiller. Seeing the benefits It may take up to 12 weeks after reaching the best dose for your condition before you notice any benefits. It is important that you continue to take your treatment. Although you may not feel any benefit during this time, it is likely that the methotrexate is working.
Methotrexate cannot cure your condition and you may needto take it for several years to keep your symptoms controlled. What happens before I start treatment?
Before you start treatment you will need some blood tests tocheck your blood count, liver and kidneys. You may be askedto have a chest x-ray and may also be asked to havebreathing tests to check your lungs. This information willprovide a record of how you are before you start treatmentand to check whether methotrexate is a suitable treatmentfor you. A very small number of people will be unable to takemethotrexate because of lung or liver problems.
You will be asked about any other medicines, herbal,complementary or alternative therapies you are taking asthese can interact with the methotrexate.
Effective contraception must be used by both men and women receiving methotrexate. You must not take methotrexate if you might be pregnant or are wishing to start a family. Your dose
A typical dose will range from 7.5mg to 25mg once a week. Methotrexate is never taken every day. The dose will vary for each person depending upon many factors such as how active your disease is and how you respond to the treatment.
Methotrexate is usually given as tablets but in somecircumstances can be given as a liquid or by injection. If youare prescribed a liquid or injection, you should check how totake these with your doctor, nurse or pharmacist.
Once a week Your methotrexate should only be taken as a single once a week dose on the same day each week. What happens if I forget to take my tablets? If you miss your methotrexate on your normal day, don’t worry: you can take it the following day or two. For example, if your normal day for taking your dose is Tuesday, you can take it on Wednesday or Thursday. Do not take the dose if you are three or more days late. A flare-up of the disease during this time is unlikely. In both cases, take your next dose on your usual day the following week. Folic acid A vitamin supplement called folic acid has been shown to help your body cope with the methotrexate and also reduces some of the side effects you may experience. Your doctor or nurse will advise you when you should take these tablets. See the section on possible side effects later in this leaflet.
It is important that you do not forget to take the folic acidthat you are prescribed.
How to take methotrexate You should take the tablets by mouth, after food. Swallow the tablets whole with a glass of water and do not crush or chew them. Safety in the home You must keep methotrexate out of reach of children and pets and handle the methotrexate as little as possible.
Tablets should be stored at room temperature.
If you have been prescribed a liquid or injection you should check how to store these with your pharmacist or nurse.
Check your prescription and tablets very carefully every time you collect your medicines Methotrexate tablets are made in two different strengths, 2.5mg and 10mg. The two strengths are different shapes but the tablets are a very similar colour.
It is important that you take the correct strength and doseof tablets. Always double-check your prescription carefullyin case you have been given a different strength of tabletto usual.
Some hospitals and doctors have agreed to only use the2.5mg strength to prevent any confusion; ask your doctor,nurse or pharmacist whether this has been agreed in your area.
It is important that you do not use your medicine if you think you have the wrong strength. Check with your doctor, nurse or pharmacist as soon as possible.
The doctor may wish to change the dose of methotrexate you take. If your dose changes, the number of tablets you need to take may change. It is important to show the pharmacist your record book each time you collect your medicines. You will still need to take the medicine only once a week. Why you need regular blood tests
When you first start treatment, blood tests will usually betaken every week or at least once a fortnight. Once the doseis stable, and the blood tests are satisfactory, the frequencyof your monitoring will be reduced. Regular blood tests willhelp your doctor, nurse or pharmacist check how well yourbody is coping with the methotrexate and will help to decidewhether you can continue on the treatment. The doctor mayincrease or decrease the number of tablets you takedepending upon how well your treatment is controlling your condition.
It will be your responsibility to ensure that you attend regularly for your blood tests. It is important that you do not miss your blood tests.
It is important that you do not take methotrexate unless you are having regular blood tests. You should attend for your review appointments to ensure that you are being carefully monitored whilst you are receiving treatment.
In most cases your blood tests will tell the doctor how yourliver and bone marrow is coping with the methotrexate. Occasionally further tests (for example, liver biopsy) may beneeded to decide if you can stay on your medicine. Who will be checking my blood test? When you start treatment your doctor or nurse will explain to you how the monitoring of your medication will be managed. This may be managed by your hospital team or shared between the hospital and your own general practitioner team. Details of your blood test results will be recorded in the monitoring booklet section of this leaflet. Monitoring booklets The monitoring booklet is a valuable document which should be kept carefully and taken with you every time you see your general practitioner or attend hospital appointments. Although in some parts of the country computer systems allow some sharing of blood test results
between your general practitioner and hospital, there aremany parts of the country where your specialist or thedoctor treating you in an emergency will not have access tothe results of blood tests organised by your generalpractitioner. It is therefore important that the results of yourblood tests are recorded and are kept up-to-date.
What problems must I look out for?
Most people on low dose methotrexate cope well with few,if any, side effects. However, you should be aware of some ofthe problems which can occur. It is always important to takenote of any new symptoms you experience after startingtreatment and discuss them with your doctor, nurse orpharmacist.
There are also some side effects that must be dealt with immediately (see ‘Side effects/problems that mean I need to stop treatment immediately and get urgent medical advice’). General information about some side effects
If you experience one of the side effects mentioned below do not take your next dose of methotrexate until you have sought advice. You will be advised by your doctor or nurse whether you will be able to restart methotrexate once your problem has been investigated. Do not take your next dose until you have spoken to your doctor, nurse or pharmacist. Feeling sick, upset stomach or diarrhoea When you first start treatment you may feel unwell. This normally settles but may persist. Speak to your doctor or nurse as something can be done to help. These symptoms can be helped in one of three ways:
• you may be advised to increase the amount of the
• you may be advised to take another tablet that reduces the
feeling of sickness. These tablets are called anti-emetics;
• the doctor may wish to change your treatment to
methotrexate by injection once a week.
If you vomit within a few hours of taking methotrexate do not take another dose. Make a note that you have been unable to take your tablet and tell your doctor or nurse if this happens again the following week. Effects on your bone marrow or liver Your blood tests will help to monitor these. Symptoms that may show problems with the bone marrow or liver include regularly catching infections, bruising or bleeding easily. Your doctor or nurse monitoring your treatment will contact you if there are any problems with your blood test results. Occasionally changes in your blood may mean you have to stop your methotrexate. Mouth ulcers, sore throat or sore mouth
If you experience mouth ulcers, or a sore throat or mouth,speak to your doctor, nurse or pharmacist. It may benecessary for you to have a blood test to check how yourbody is coping. In many cases, if your blood tests are normal,you may be given some medication to treat these problems.
Infections Methotrexate may reduce your ability to fight infections and this can be a problem in some individuals who may be more vulnerable to infections.
It is important to get prompt advice if you think you have aninfection (for example, a wound that fails to heal promptly,pain or burning when passing water, or a chest infection). Rashes – new rash or severe itching anywhere on the body If you get a new rash or severe itching seek advice from your doctor, nurse or pharmacist. Thinning of the hair This can happen, although it is uncommon and, if it does happen it is usually slight. Hair growth usually returns to normal on stopping treatment. If you feel this becomes more than a very slight hair loss you should discuss it with your doctor. Other problems may be experienced. Report these to your doctor or nurse if the problems continue or if they occur after every dose. Side effects/problems that mean I need to stop treatment immediately and get urgent medical advice Shortness of breath (breathlessness) Methotrexate can very occasionally cause inflammation of the lungs. The breathlessness caused by methotrexate can come on gradually or over a few days. You may also have a dry cough. If you feel breathless when resting and you don’t have a heavy cold (runny nose and temperature) you should stop your methotrexate and contact your doctor or nurse. It is important that the doctor examines you as very occasionally methotrexate can cause severe inflammation of the lungs. If the whites of your eyes become yellow or you develop severe itching of the skin
Stop treatment and seek advice from your doctor or nurse,
as these are sometimes signs of liver problems. Infections, including fever, chills or severe sore throats It is important that you are careful about the risks of infections and take sensible precautions to avoid them. If you have any infection stop your methotrexate and get prompt advice from your doctor or nurse. New unexplained bleeding or bruising This can sometimes mean that your blood cells are affected by the methotrexate. Stop your methotrexate and seek advice from your doctor or nurse. Severe and continuing diarrhoea or vomiting If you have severe diarrhoea and vomiting or are unable to take fluids you may become dehydrated. Your kidneys may then be unable to flush methotrexate from your blood. Stop your methotrexate and seek advice from your doctor or nurse. If you think you are pregnant Methotrexate may harm the unborn child and cause a miscarriage. Men who are taking methotrexate should note that your treatment may affect your sperm and therefore you should ensure your partner should not become pregnant whilst you are on the treatment. Women who become pregnant whilst on the treatment should stop their treatment immediately and speak to their doctor. For women who have a partner taking methotrexate, please see your doctor for advice if you become pregnant. Chickenpox and shingles If you are taking methotrexate and have never had chickenpox you may be at risk of severe infection from the virus which causes chickenpox and shingles. If you come into close contact with someone who has either of these conditions, you should contact your doctor or nurse promptly as you may need special treatment. What happens if I need an operation (surgery) - do I have to stop treatment?
Let your doctor or nurse know so they can advise you on
what to do about your methotrexate. Make sure you takeyour monitoring booklet with you to all appointments orpre-assessment clinics. If you are having an operation, inmost cases you will be advised to continue with yourtreatment but it will help the doctors plan your care.
You should also make sure that your dentist knows you areon methotrexate so they take this into account when theyare carrying out any dental treatment. What happens if I am severely unwell - do I have to stop treatment? Sometimes if you become severely unwell or immediately after an operation it may be necessary for you to stop your methotrexate for a short while. Your hospital will make sure that the medicines you are given are safe to be taken together. This is because certain medications, for example
some antibiotics, interact with methotrexate and it isimportant you don’t take them together especially if you are dehydrated.
The team looking after you will also make sure that youdon’t get dehydrated and your kidneys are able to pass usualamounts of urine so that your body can cope normally withyour medicines. Speak to your doctor or nurse for advice.
Other advice Taking other medicines It is important that your doctor knows about all the tablets and remedies you take, including herbal and alternative remedies.
You must not take co-trimoxazole (Septrin) or trimethoprim whilst taking methotrexate. These can react with methotrexate and can be dangerous.
Always check with your doctor or pharmacist before takingany other medicine. This includes checking medicines youcan buy over the counter such as aspirin, paracetamol oribruprofen, and medicines for coughs, colds and flu. Someof these can interact with methotrexate. It is helpful to bringa list of current medications with you when you see thedoctor, nurse or pharmacist.
If you have any additional problems that you are trying totreat yourself, speak to your doctor, nurse or pharmacistbefore purchasing any supplements or treatments to makesure they can be taken with your methotrexate. It is possiblethat the symptoms you are experiencing might be related toyour methotrexate. What should I do if I accidentally take too much methotrexate? If you make a mistake and take too much methotrexate you may need urgent hospital treatment. Keep the bottles/cartons, make a note of how many tablets you think you have taken and contact your doctor or local accident and emergency department immediately. If the error is not considered serious, you may just need to have your blood checked and miss your next dose. If it is serious, however, you may need urgent treatment with a drug (calcium leukovorin) which can reduce the effects of methotrexate. Alcohol Methotrexate and alcohol may both cause liver damage. The risk of liver damage from methotrexate appears to be greater in psoriasis than with individuals who have rheumatoid arthritis. The risk is increased by alcohol. If you are taking methotrexate you should ensure that your alcohol intake is well within the maximum limits (2-3 units per day for women and 3-4 units per day for men).
If you have psoriasis, it may be recommended that you avoidalcohol altogether. You may also have an additional bloodtest (PIIINP) to monitor your liver although sometimes afurther test is needed (a needle biopsy of the liver). Yourdoctor or nurse can provide further individual advice on this.
Food Methotrexate may reduce your ability to fight infection. There are some reports of bacteria (germs) found in food that may cause a problem to those with a reduced ability to fight infections. These risks have not been directly linked to taking low dose methotrexate. However, the few cases reported are usually linked to those taking a number of medicines that dampen down immunity. It would be sensible to be cautious about unpasteurised milk or soft cheese and be aware of food preparation and normal hygiene conditions in the handling of food, particularly if you are also taking steroids or one of the newer biologic therapies (adalimumab, anakinra, etanercept and infliximab). Having a baby Methotrexate can reduce fertility in men and women. It may also damage the unborn child.
Women should not take methotrexate if they arebreastfeeding, pregnant or wish to become pregnant. If you think you might be pregnant do not takemethotrexate. Men should not attempt to father a babywhile taking methotrexate.
It is recommended that women wait at least three monthsafter stopping treatment, before trying for a baby. It is alsorecommended that men wait at least three months afterstopping treatment before trying to father a child, as spermcan be affected. You should talk to your doctor or nurseabout effective contraception.
Vaccinations It is important that any doctor or nurse you see is aware that you are on methotrexate and that you should not receive any live vaccines.
This is because live vaccines may not work well while you areon methotrexate.
Live vaccines include yellow fever, MMR and rubella(German Measles). There are often alternatives to livevaccines that can be given. You should speak to your doctoror nurse for advice.
Close relatives and family members may have live vaccines asnormal. This will not be a risk to you.
Flu vaccination and Pneumovax are safe as they are not live vaccines.
Speak to your doctor or nurse for advice. Other information
If your treatment ends and you have some methotrexate leftover, return any remaining medicine to your pharmacist. Donot flush them down the toilet or throw them away.
Use the monitoring booklet section of this leaflet to recordyour blood test results. Contact information www.nhsdirect.nhs.uk www.nhsdirect.wales.nhs.uk
You must tell NHS Direct if you are taking oral methotrexateif seeking their help. Specific patient information leaflets areproduced that can give you information about yourcondition and treatment with methotrexate. Patient and professionals organisations www.arthritiscare.org.uk www.arc.org.uk www.rheumatoid.org.uk
National Association for Colitis and Crohn's disease
www.nacc.org.uk www.psoriasis-association.org.uk www.thepaa.org www.rheumatology.org.uk
British Association of Dermatologists www.bad.org.uk/public
National Library for Health on skin conditions www.library.nhs.uk/skin
British Society for Paediatric and Adolescent Rheumatology www.bspar.org.uk Patient-held blood monitoring and dosage record Choose a day of the week to take your oral methotrexate
Please remember that your methotrexate is only evertaken as a once a week dose. Choose a day of the weekto take your oral methotrexate and stick to it.
If you miss your methotrexate on your normal day, don’tworry. You can take it the following day or two. Forexample, if your normal day for taking your dose isTuesday, you can take it on Wednesday or Thursday. Donot take the dose if you are three or more days late. Aflare-up of the disease during this time is unlikely. Inboth cases, take your next dose on your usual day thefollowing week.
You will also be prescribed folic acid (a vitaminsupplement). Your doctor, nurse or pharmacist willadvise you when you should take the tablets.
Write down your chosen day of the week on thefollowing page and this will help you remember whichday to take your dose. Things you must tell healthcare professionals caring for you If you need emergency treatment, the staff caring for you will need to know that you are taking oral methotrexate. You must tell the doctor, nurse or pharmacist if you are taking other medicines including over-the-counter drugs. This includes medicines, mineral or herbal supplements and Chinese medicines you can buy over the counter such as pain relief (for example, ibruprofen) or medicines for coughs, colds and flu. You should not use these without first checking that they are safe to use with methotrexate.
If you have any other problems that you wish to treatyourself, speak to your doctor, nurse or pharmacistbefore purchasing any supplements or treatments. This is to make sure it is safe to take these with yourmethotrexate and that the staff know about your symptoms.
Please show this booklet to any doctors, nurses,pharmacists, dentist or other healthcare professionalstreating you so they are aware of your treatment andyour blood results. Record of your dose Keep a record of your dose by filling in details of your dose and the number of tablets you should take. If your dose changes, for example after a blood test, ask the doctor or nurse to record the new dose here.
Take this new dose, and not the dose shown on thebottle or carton label.
Show this record to your pharmacist each time youreceive some more methotrexate tablets. Record of your dose Date of dose Weekly dose Strength of instruction 15 May 2006 Signature of Number of doctor or doctor or changing dose Blood tests: Methotrexate blood test monitoring record Test Date Next test date
Blank rows may be used for special tests. The person responsible for prescribing/ monitoring your methotrexate can help you complete this record.
Tests in Bold (CRP, ESR or PV ) may be required 3 monthly. Test marked with * are required 3/6 monthly. PIIINP tests may be required for some patients. Blood tests: Methotrexate blood test monitoring record Test Date Next test date
Blank rows may be used for special tests. The person responsible for prescribing/ monitoring your methotrexate can help you complete this record.
Tests in Bold (CRP, ESR or PV ) may be required 3 monthly. Test marked with * are required 3/6 monthly. PIIINP tests may be required for some patients. What the terms mean
It is common for people with long term conditions tohave blood results that may be slightly different frompeople who don’t have a chronic condition. Forinstance, people with rheumatoid arthritis are oftenslightly anaemic. So, although your treatment can causeanaemia (low haemoglobin), there may be otherreasons related to your condition that should bechecked with regular monitoring. Keeping results ofyour blood tests will help you to know what is 'normal'for you and you will get to know more about this as youcontinue your treatment.
When checking blood results the doctors and nurses arenot only looking at 'what is normal for you' but alsolooking for any trends in the blood results that mightchange gradually over time. These gradual 'trends' canbe as important as the 'normal values' set out on thefollowing page.
Different laboratories may have slightly different normalvalues from the ones set out on the following page. Askthe doctor or nurse to check that these normal valuesare right for your local area. Explanation normal values
Haemoglobin is the oxygen-carrying protein
inside red blood cells: low levels may show that
The average volume of a red blood cell: two
potential causes of large red blood cells are
methotrexate toxicity and a deficiency of folic acid.
White blood cells are important in fightinginfections. The count can rise as a result of
infection or from taking steroids: a low count
may indicate that methotrexate is harming thebone marrow.
Platelets are essential for normal blood clotting:
a low count may indicate that methotrexate is
A type of white blood cell that has an important
role in protecting your body from infections. Explanation normal values Neutrophils
A type of white blood cell that usually increases
ALT/AST are tests to see how your liver is
These are tests that help to show how your
kidneys are working. You will normally have
these checked before you start treatment and
from time to time (usually 3 - 6 monthly) when
Indicators of inflammation which may be raised
CRP, ESR & PV
Your doctor or nurse will explain the need for
other monitoring tests which may be needed.
Other tests that may be requested
There are some tests that may be required in addition tothose outlined in your monitoring booklet. Some ofthese tests are to give the doctors and nurses caring foryou additional information about your treatment,especially when the routine blood tests fall outside whatis 'normal for you'. Some of these additional tests include:
Alkaline Phosphatase: This is a test that measures some liver, bone and stomach conditions. In many cases Alkaline Phosphatase will not be routinely recorded as slightly raised levels are common. PIIINP This is a more specific test to monitor the effect of methotrexate on your liver. It is used in patients receiving methotrexate for the treatment of psoriasis, as the risk of liver inflammation appears to be greater than in people with rheumatoid arthritis. Important notice This patient information leaflet has been compiled, after consideration of the information available, by the National Patient Safety Agency as at June 2006. It is not intended to be exhaustive and should not be used as a substitute for consulting your clinician on any particular issue. The National Patient Safety Agency makes no representations, warranties or guarantees as to the accuracy, completeness or adequacy of any of the content of this patient information leaflet and cannot be held responsible for any liability, loss or damage whatsoever which may arise from the use of, or reliance upon, this patient information leaflet, except as may otherwise be required by law. The National Patient Safety Agency 4 - 8 Maple Street London W1T 5HD T 020 7927 9500 F 020 7927 9501 0267SEP05
National Patient Safety Agency 2006. Copyright and other intellectual
property rights in this material belong to the NPSA and all rights are
reserved. The NPSA authorises healthcare organisations to reproduce this
material for educational and non-commercial use.
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