METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`Medicines for Children: information for parents and carers.
`Drug: Methotrexate for Rheumatological Conditions
`This leaflet is about the use of Methotrexate for Rheumatological Conditions in children and young people for
`example: Juvenile Idiopathic Arthritis, Juvenile Dermatomyositis (JDM), Systemic Lupus Erythematosus (SLE),
`Scleroderma, Uveitis (inflammatory eye disease).
`
`This leaflet has been written specifically for parents and carers about the use of this medicine in children. The
`information may differ from that provided by the manufacturer. Please read this leaflet carefully. Keep it
`somewhere safe so that you can read it again. It is designed to give a broad overview of methotrexate. You
`should direct any questions you have about this medication to your child’s rheumatology nurse specialist or
`doctor.
`The aim of this drug is to suppress, “dampen down” your child’s overactive immune system. The immune
`system helps the body to fight infections such as colds and stomach bugs as well as helping to keep you
`healthy. Sometimes the immune system starts to attack parts of the body, for example the lining of the joints
`or blood vessels, for no apparent reason, and this causes inflammation. This attack on the body is described
`as autoimmune disease.
`Methotrexate is also used in the treatment of cancer but in much higher doses. In rheumatological conditions
`lower doses are used. Methotrexate has been used in children, young people and adults for many years with
`good effect.
`Methotrexate is not a cure but it should help your child’s condition by reducing the symptoms and the need for
`other medicines.
`The usual practice is to remain on methotrexate until your child is in remission (no active inflammation) this
`may be for several years.
`If it is decided your child is to have methotrexate a more detailed teaching session will be given before your
`child starts this medication. Your child’s Rheumatology Nurse Specialist or Doctor will tell you what to do and
`who to contact if your child becomes ill whilst taking Methotrexate.
`
`Name of drug
`Methotrexate. Brand Names: (Metoject prefilled syringes)
`Why is it important for my child to take this medicine?
`Methotrexate has been shown to be an effective treatment for a number of inflammatory conditions, but it
`needs to be taken as prescribed over a long period of time often years.
`What is Methotrexate available as?
`Tablets: 2.5 mgs and 10 mg tablets
`(cid:120)
`Methotrexate tablets are available in 2.5mg and 10 mg tablets. In many hospitals and community
`pharmacy’s only 2.5 mg tablets are available. The reason for this is that the tablets look very similar and it
`would be very easy to mix them up and give too much. It is important that every time you pick up a new
`prescription you check what strength the tablets are to prevent overdose. The National Patient Safety
`Agency recommends the use of 2.5 mg tablets only.
`(cid:120) Liquid medicine: this is by special order and will either be prepared for your child by your local
`hospital or a homecare delivery company.
`(cid:120) Subcutaneous Injections (injections given into the fatty tissue under the skin)
`Your doctor or rheumatology nurse specialist will discuss with you the best way for your child to have
`their methotrexate.
`
`Page 1 of 6
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`MEDAC Exhibit 2001
`ANTARES v. MEDAC
`IPR2014-01091
`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`Page 00001
`
`

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`METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`When should I give Methotrexate?
`(cid:120) Methotrexate is given once weekly. Try to give it at about the same time and on the same day each
`week
`How much should I give?
`Your doctor will work out the amount of methotrexate (the dose) that is right for your child. The dose will
`be shown on the medicine label.
`It is important that you follow your doctor’s instructions about how much to give.
`How should I give it?
`Tablets: should be swallowed whole with a glass of water or juice and preferably on an empty stomach.
`Liquid medicine: Ideally the liquid should be supplied by your pharmacist or home care delivery
`company, with the correct dose already in a syringe. If you get the methotrexate liquid in a bottle,
`measure out the right amount using an oral syringe. You can get these from your pharmacist. You will
`need to wear gloves when handling the methotrexate. You will be given a container to get rid of your used
`gloves, bottles and medicine syringes. When this is full you should return this to the hospital, GP practice
`or your homecare delivery company waste collection service, who will then give you a new one.
`Injections: These are usually given at home, by the parent / carer or if possible by the child or young
`person themselves. This is only after training has been given by your child’s rheumatology nurse
`specialist, children’s community nurse or homecare delivery company nurse.
`In some circumstances it may be possible for methotrexate to be given by:
`(cid:120) A children’s community nurse coming to your home once weekly
`(cid:120) The practice nurse at your child’s GP practice
`This will all be discussed with you by your child’s Rheumatology Nurse Specialist
`When should the medicine start working?
`Methotrexate takes approximately 8 to 12 weeks to take its full effect
`What if my child is sick (vomits)?
`Medication by mouth
`If your child is sick less than 30 minutes after having a dose of Methotrexate, give them the same
`(cid:120)
`dose again.
`If your child is sick more than 30 minutes after having a dose of Methotrexate, you do not need to
`give them another dose. Wait until the next normal dose.
`Medication by injections
`If your child vomits after being given their injection of methotrexate inform your child’s rheumatology
`(cid:120)
`specialist nurse or doctor during normal working hours. Your child may need to have anti-sickness
`medications.
`What if I forget to give it?
`You should give the dose as soon as you remember but never give doses less than 5 days apart
`If you are unsure, contact your rheumatology nurse specialist, rheumatology doctor or pharmacist for
`advice. Do not double the dose to catch up.
`What if I give too much?
`It can be dangerous to give too much Methotrexate.
`If you think you may have given your child too much methotrexate, contact your doctor of NHS Direct
`(0845 4647) or, take your child to hospital immediately.
`Take the medicine container or packet with you, even if it is empty. This will be useful to the doctor. If you
`telephone for advice have the packet with you.
`Where I should keep this medicine?
`Keep the tablets or liquid medicines in preferably a locked cupboard, away from heat and direct
`(cid:120)
`sunlight. It does not need to be kept in the fridge.
`Some injections of methotrexate need to be stored safely in a fridge between 2°-8°c. You may need
`to use a fridge lock or ideally a separate drug fridge. Check the label for storage instructions
`(cid:120) Make sure that children cannot see or reach the medicine.
`
`(cid:120)
`
`(cid:120)
`
`Page 2 of 6
`
`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:19)(cid:19)(cid:19)(cid:19)(cid:21)
`
`

`
`METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`General safety and hygiene
`It is recommended that you wear disposable gloves when handling methotrexate these will be provided
`by your child’s rheumatology team, pharmacy department or be delivered to your home with your child’s
`methotrexate supplies.
`Good hand washing is very important when handling methotrexate.
`If you are a parent or carer giving methotrexate to your child and you are planning to be or are pregnant it
`is recommended that you do not handle methotrexate.
`Are there any possible side-effects?
`We use medicines to make our children better, but sometimes they have other effects that we don’t want
`(side-effects).
`Common Side Effects Treatment
`Nausea (feeling of sickness), Folic acid (vitamin tablet / liquid)
`vomiting, loss of appetite Anti-emetics (anti-sickness medication)
`& diarrhoea. May be helped by giving methotrexate by
` Injection
`Skin rash / sun sensitivity Use high factor sun cream
`Mouth ulcers Folic acid (vitamin tablet)
`Sore gums
`Sore throat
`Rare Side Effects Treatment
`May cause hair thinning
`Disturbance in the blood counts Usually return to normal if
`(change in blood tests results) methotrexate dose reduced or
`Upset liver function stopped
`Pneumonitis - serious problem with lungs causing Seek urgent medical advice
`breathing difficulties.
`Affects adults - never seen in children.
`Not everyone will have side effects when taking Methotrexate. Your child’s doctor and or rheumatology
`nurse will be checking your child’s medication and progress. If the blood tests become abnormal the
`Methotrexate may need to be stopped temporarily or the dose may need to be lowered. You may find that
`your child has some mild side effects from the medication before you notice any benefits from the
`treatment. It is important they keep taking the medication. You can speak to your child’s doctor or
`rheumatology nurse if you are worried.
`Can other medicines be given at the same time as Methotrexate?
`You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told
`(cid:120)
`you not to.
`Check with your doctor or pharmacist before giving any other medicines to your child. This includes
`herbal or complementary medicines.
`You should tell your child’s dentist about their medications.
`(cid:120)
`When not to give Methotrexate
`If your child has or you suspect they have chicken pox, shingles, measles, mumps, TB or other
`(cid:120)
`infectious diseases you must contact your rheumatology doctor, rheumatology nurse specialist or GP
`immediately.
`(cid:120) You may be advised, by the person that monitors your bloods, to stop your child’s methotrexate
`temporarily, if your child has an abnormal blood result. You will be given advice as to when to restart
`their methotrexate.
`
`(cid:120)
`
`Page 3 of 6
`
`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:19)(cid:19)(cid:19)(cid:19)(cid:22)
`
`

`
`METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`What tests are required when taking Methotrexate?
`Methotrexate can affect blood counts (white blood cells, red blood cells and platelets) and can sometimes
`cause problems with the liver. Your child’s blood count and liver function test will be checked before
`starting methotrexate and on a regular basis once your child has started methotrexate.
`
`It is very important that your child attends regularly for blood tests. Your doctor or rheumatology nurse
`specialist will arrange these with you. Failure to attend for regular blood tests could lead to your child’s
`medication being stopped.
`It may be possible to arrange for the blood tests to be taken by the Practice Nurse at your child’s GP
`(cid:120)
`surgery or your local hospital.
`(cid:120) You may be given a booklet where the results of your child’s blood test are recorded to take to clinic
`with you.
`Vaccinations
`Live vaccines or immunisations are not safe for your child while they are taking Methotrexate or for six
`months after finishing treatment.
`Always check with your rheumatology nurse or doctor before you or a family member have any
`vaccinations.
`It is recommended that your child has the annual seasonal flu vaccine.
`It is also recommended that your child has pneumococcal vaccine if not already given as part of the
`routine childhood immunisation schedule – please check with your GP, Health Visitor or Practice Nurse.
`What do I do if my child is in contact with someone who has chicken pox?
`Your child should have a blood test at diagnosis to see if they are immune to chicken pox. If your child is
`not immune your rheumatology doctor will decide if your child and/ their brothers or sisters need to be
`given the chicken pox vaccine before treatment with methotrexate starts. Sometimes it is not possible to
`vaccinate your child because their condition requires them to start treatment immediately.
`If your child is immune to chicken pox you will be told that being in contact with chicken pox should not be
`a problem. However if your child develops chicken pox you must contact your rheumatology team or GP
`immediately as they will need to see your child and start treatment for chicken pox. Your child will need to
`stop their methotrexate temporarily.
`
`What do I do if my child is in contact with someone who has measles?
`Measles tends to be a rare illness because children in the UK are generally given two doses of the MMR
`vaccine. If your child has not had their MMR they may be at risk if they come into contact with measles.
`If you think that you child has been in close contact with someone who develops a rash, which could be
`measles, please contact your doctor, rheumatology nurse or GP for advice. If your child develops proven
`measles, whilst taking methotrexate they may need to be given human immunoglobulin, treatment given
`in hospital, to help to reduce the severity of the measles. Your child will need to stop their methotrexate
`temporarily.
`What do I do if my child is in contact with someone who has TB?
`You must contact your child’s doctor, rheumatology nurse or GP immediately as they will need to decide
`whether your child needs further treatment.
`Alcohol
`Ideally your child should not drink Alcohol while taking methotrexate. This is because methotrexate and
`alcohol are both metabolised (broken down) in the liver the two combined puts extra strain on the liver.
`However, as long as your child is legally old enough to drink alcohol an occasional glass of wine or beer
`is unlikely to be harmful. Excessive regular alcohol and binge drinking should be avoided.
`REMEMBER – 1 unit of alcohol is equivalent to a half pint of 4 % lager, a small glass of wine 125mls =
`1.5 units. Most Alco pops are 1.4 units per 275 ml bottle. For more information please check out:
`http://www.need2know.co.uk/
`http://www.talktofrank.co.uk/
`(13+ years)
`
`Page 4 of 6
`
`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:19)(cid:19)(cid:19)(cid:19)(cid:23)
`
`

`
`METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`Sexual Health
`As for ALL young people, irrespective of medication and/or chronic condition, when they are considering
`becoming sexually active, it is important that they have information regarding contraception AND
`protection against sexually transmitted infections (e.g. condoms). Such information should also include
`signposting to young person friendly sexual health services which they can access easily. This has
`additional importance with methotrexate therapy since, should a pregnancy occur, methotrexate may be
`harmful to the unborn baby. It is therefore important for sexually active young people to use effective
`contraception (male and females) whilst taking methotrexate and for 6 months after it has been stopped
`to prevent harm to an unborn baby. In the event of pregnancy please seek advice from your child’s
`doctor, rheumatology nurse specialist or GP.
`For further information about sexual health and young people check out www.brook.org.uk who give
`information about young person-friendly sexual health clinics in your area (up to 25 year olds) and
`www.fpa.org.uk gives useful information for parents
`What do I need to know if I am going on holiday?
`Check whether any vaccines are needed for your holiday destination. If vaccinations are required, you
`must check, with your rheumatology team that they are safe to have with your child’s treatment.
`Inform your travel insurance company about your child’s illness and their treatment.
`All medications should be carried in your hand luggage. If you are supplied with methotrexate that needs
`to be refrigerated you will need to carry your methotrexate in a cool bag and keep it cool until you can put
`it in a fridge at your holiday destination. If required your rheumatology team will provide a letter for the
`airline.
`Take your most recent clinic letter with you to assist medical staff treating your child should they become
`unwell or be involved in an accident.
`Ensure you take enough supplies of your child’s drugs with you, for example always take some spare
`medication and check it will not expire whilst you are away.
`Unlicensed drugs
`Many of the drugs used to treat children and young people are unlicensed. However the Royal College of
`Paediatrics and Child Health (RCPCH) www.rcpch.org.uk have produced a leaflet which gives guidance
`to the use of unlicensed drugs for children and young people. Please ask your rheumatology team for a
`copy of this leaflet.
`Methotrexate is not licensed for use in children and young people.
`Who to contact for more information
`Your child’s doctor, pharmacist or rheumatology nurse specialist will be able to give you more information
`about methotrexate and about other medicines used to treat Rheumatological Conditions.
`You can also get more information from NHS Direct (0845 46 47, www.nhsdirect.nhs,uk)
`
`NHS 24 (Scotland) 08454 24 24 24,
`NHS Direct (Wales/Galw lechyd Cymru) 0845 46 47
`NHS NI (Northern Ireland) 0845 46 47
`
`More leaflets and information about rheumatological conditions are available at the British Society for
`Paediatric and Adolescent Rheumatology website www.bspar.org.uk
`
`Useful websites: -
`www.lupus.org.uk
`Useful numbers: -
`
` www.arthritisresearch.org.uk www.ccaa.org.uk
`www.lupusuk.com
`www.arthritiscare.org.uk
`www.kidwitharthritis.org www.printo.it
`Arthritis care 0808 800 4050
`Arthritis Research UK Tel: +44 (0) 1246 558033
`
`DREAM Team: Dedicated Rheumatology Expert Adolescent Multi-disciplinary Team (This site provides
`resources for young people with conditions like arthritis, their families and the health professionals who
`look after them): http://www.dreamteam-uk.org/index.php?main
`
`Page 5 of 6
`
`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:19)(cid:19)(cid:19)(cid:19)(cid:24)
`
`

`
`METHOTREXATE The British Society for
`Paediatric and Adolescent
`Rheumatology
`
`Registered Charity # 1132967
`
`Who to contact for more information / continued.......
`Questions and answers that young people have asked on drugs, weight, bullying, relationships,
`stress and sex: www.teenagehealthfreak.org
`Healthy diets – including calcium and vitamin D – www.milk.co.uk
`British Red Cross – cosmetic camouflage www.redcross.org.uk 020 72355454
`Medic alert jewellery – www.medicalert.org.uk
`Patient held record – www.sickkids.on.ca/myhealthpassport/
`Careers – www.connexions.gov.uk or www.skill.org.uk
`Arthritis: A guide for teenagers (available online or free from; www.arthritisresearch.org.uk or ask in clinic
`for a copy)
`http://www.arthritiscare.org.uk/LivingwithArthritis/Youngpeople
`
`Chat booklet for all parents, CHAT 2 parents booklet for parents of teenagers www.ccaa.org.uk
`
`Disclaimer
`
`We have written this leaflet to help you understand more about the medicine you are giving to your child. We take great care to make sure that the information
`is correct and up-to-date. However, medicines can be used in different ways for different patients. It is therefore important that you follow the advice of your
`doctor or pharmacist, as they understand your child’s illness. If you are not sure about something, ask your doctor or pharmacist. Note that this leaflet applies
`to the use of these medicines in the UK; it may not apply to other countries. BSPAR does not accept responsibility or legal liability for any errors contained
`within this leaflet. We recommend that readers check the up to date published product information and data sheets provided by the drug
`manufactures. Consideration should be given to current codes of conduct and safety regulations.
`
`Date produced: March 2011
`Review Date: March 2014
`
`Page 6 of 6
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`BSPAR is a Charitable Company registered in England and Wales. Company number 06978211
`Registered office: 105 St Peter’s Street St Albans Herts AL1 3EJ
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:19)(cid:19)(cid:19)(cid:19)(cid:25)