Leflunomide Treatment Rheumatology Patient Information Leaflet Originator: Dr K Douglas Date: September 2011 Version: 2 Date for Review: September 2014 DGOH Ref No: DGOH/PIL/00217
Contact numbers If your have any questions or are unsure about any of the information in thisor booklet, please contact If your haveprovided any questions are unsure about any your of thepharmacist or the Rheumatology Helpline on theplease number below:information provided in this booklet, contact your pharmacist or the Rheumatology Helpline on the number below:russells Hall Hospital Tel 01384 244789. Russells Hall Hospital Tel 01384 244789. 2 NHS Direct Tel: 0845 4647 http://www.nhsdirect.nhs.uk/ Dudley Group of Hospitals NHS Trust Tel: 01384 456111 (Switchboard) The Rheumatology Department Tel: 01384 244789 (Helpline) http://www.dgoh.nhs.uk/ http://www.dgoh.nhs.uk/_public/_servportals/rheumatology/_public/ _servportals/rheumatology/default.asp 15
Remember, whilst you are on this medication, it is your responsibility to ensure that you have regular blood tests and it is important that you do not miss any of these tests. If your hospital appointment is rescheduled, contact the Rheumatology Helpline if you need more blood forms. Contact information Leflunomide Treatment This leaflet has been prepared to support information given to you as part of your discussions with the doctor, nurse or pharmacist before you start treatment with leflunomide. This leaflet should be used to help you in these discussions. The specialists you are seeing may also provide you with some information about your condition and how to take your leflunomide. If you have any problems or questions, contact the Rheumatology helpline or your pharmacist department of Rheumatology Helpline Tel. 01384 244789. What is leflunomide? This is an answering machine. Calls are answered within 24 hours on week days and on Mondays after the weekend (Tuesdays following a bank holiday). Leflunomide is a drug used to treat rheumatoid arthritis and psoriatic arthritis. It works by dampening down inflammation. It is usually prescribed to people who have had side-effects or have not benefited from other treatments. Leflunomide helps to slow down the progression of the arthritis. It is not an emergency line. Patient and Professional Organisations with Useful Links Arthritis Care Tel: 0808 800 4050 Arthritis Care: Welcome to Arthritis Care http://www.arthritiscare.org.uk 14 Most people receiving Leflunomide are greatly helped by it and suffer few, if any, problems. It is however a powerful medicine and must be treated with respect. This leaflet tells you more about Leflunomide and how the risks or problems can be kept to a minimum. The doctor or nurse treating your condition may give you more information that explains about your particular condition and your treatment. You should read all the information you receive. 3
What Leflunomide can do? Leflunomide 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 you experience with your condition. Leflunomide reduces the permanent damage to joints caused by continuing inflammation. It is not a painkiller. We recommend you to have the annual flu vaccination. How long will it take for leflunomide to work? Alcohol should be avoided whilst taking leflunomide as this may increase the Likelihood of liver damage. Leflunomide usually takes about 4 to 6 weeks to work. During this time you should notice less swelling, pain and stiffness of your joints. There may be further improvement for a further 4 to 6 months after starting the treatment. Other treatments What happens before I start treatment? There are "alternative treatments" that some people find useful and leaflets provided by Arthritis Research Council are available in our clinics. Before you start your treatment you will need some blood tests to check your blood count, liver and kidneys. We will also check your blood pressure is normal and weigh you. This information will provide a record of how you are before you start treatment and to check whether leflunomide is a suitable treatment for you. A very small number of people will be unable to take leflunomide because of liver problems and we recommend that any high blood pressure is treated before starting leflunomide. 4 You should avoid vaccination with live vaccines; these include yellow fever, polio, MMR and rubella (German measles). Always let your doctor know that you are taking leflunomide before having a vaccination. You always have the choice when taking any medication prescribed in Rheumatology. Over the counter medications may be used alone or in combination with prescribed medication you are taking however, you are always advised to discuss with your doctor who has prescribed before taking. Medication bought over the counter may help to control your pain but not always the condition. 13
those who are breast-feeding, must not take leflunomide. Men who are trying to father a child must not have taken leflunomide for a period of three months. You will be asked about any other medicines, herbal, complementary or alternative therapies you are taking as these can interact with the leflunomide. Both male and female patients taking leflunomide must use reliable contraception. If a pregnancy is planned the leflunomide must be stopped 2 years before considering a pregnancy. This period may be shortened to 3 months if a special 'washout' treatment is used. If you are considering a pregnancy, please talk to your doctor first. Effective contraception must be used by both men and women receiving leflunomide. You must not take leflunomide if you might be pregnant or are wishing to start a family. If you think you are pregnant you must stop taking leflunomide at once and consult your doctor. Likewise women should not breast feed whilst taking leflunomide. Chickenpox and shingles If you are taking Leflunomide and are unsure whether you had chickenpox or shingles in the past, you may be at risk of severe infection from the virus, which causes chickenpox and shingles. If you inadvertently come into close contact with someone who has either of these conditions, you should contact your doctor promptly as you may need special treatment. Do I need to take any other precautions? If you have had tuberculosis in the past tell your doctor, as you will need to be monitored to make sure it does not become active again. 12 How should I take leflunomide? The dose of leflunomide prescribed is either 10mg or 20mg once a day (your doctor will advise you about the dose). You can take leflunomide at any time of day, but it is best to keep to the same time each day. Leflunomide can be taken with or without food. You will be given your first prescription from the hospital that will last for four weeks. See your own GP regarding repeat prescriptions. (If you have any problems obtaining repeat prescriptions, contact the Rheumatology department via the Helpline). Safety in the home You must keep leflunomide out of reach if children and pets and handle the leflunomide as little as possible. Tablets should be stored at room temperature. 5
Will I have any side effects? New unexplained bleeding or bruising Most patients have no side effects. However some people do experience side effects from leflunomide. The most common side effects are diarrhoea, nausea (feeling sick), abdominal pain, and loss of appetite and weight loss. Leflunomide sometimes causes rashes, mild thinning of the hair and mild increase in blood pressure, headache and mouth ulcers. This can sometimes mean that your blood cells are affected by the leflunomide. Stop your Leflunomide and seek advice from your doctor or nurse Less common, but more serious side effects include weakness, difficulty breathing and a drop in blood pressure. If you experience any of these reactions, stop taking the leflunomide and contact your doctor or the Rheumatology Helpline. Leflunomide is not a painkiller so you can continue with your usual painkillers if needed. Anti-inflammatory drugs (NSAIDs) can also be continued if needed. Do I need any special tests while taking leflunomide? Yes, because in a few patients leflunomide can lower certain blood cells, or affect the liver enzymes, so regular blood tests are needed to check for this. You will need a blood test before you start the leflunomide and then every month for the first six months of treatment. It will be done once every two months after that if there are no problems. Your blood pressure will be checked in clinic before you start the leflunomide and then once a month for the first six months. It will be checked once every two months from then on. This can usually be 6 Can I take other medicines with leflunomide? Some drugs interact with leflunomide, such as cholestyramine (sometimes used to treat high cholesterol). This can also occur with warfarin. Therefore if you take warfarin you will need to inform your anticoagulation clinic and that you have started (or stopped) leflunomide as you may have some more regular checks of your INR. If this applies to you please tell any doctor who is prescribing for you, or the pharmacist if you are buying over the counter medicines that you take leflunomide. Can I take leflunomide if I am planning to start a family? Women who are pregnant or are planning to become pregnant, and 11
Side effects/problems that mean I need to stop treatment immediately and get urgent medical advice Shortness of breath (breathlessness) Leflunomide can very occasionally cause inflammation of the lungs. The breathlessness caused by Leflunomide can come on gradually 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 the leflunomide and contact your doctor or nurse. It is important that the doctor examines you as very occasionally leflunomide 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 Leflunomide and get prompt advice from your doctor or nurse. 10 arranged at your GP's surgery. It is your responsibility to have your blood tests. In order for us to receive the results from your blood tests, you will have to have the blood test at any of the following centres: Russell Hall Hospital: Monday to Friday 08.30am to 7.30pm or Saturday 9.30am to 11.30am. No appointments required. Corbett Hospital: Monday to Friday 08.30am to 4.30 pm. No appointments required. Netherton Health Centre: Appointment required, ring 01384 366500 Cross Street Health Centre: Appointment required, ring 01384 459500 Lady's Walk Clinic: Appointment required, ring 01902 575103 What problems must I look out for? If you experience one of the side effects mentioned below do not take the next dose of leflunomide until you have sought advice. You will be advised by your doctor or nurse whether you will be able to restart leflunomide once your problem have been investigated. Do not take your next dose until you have spoken to your doctor, nurse or pharmacist. 7
Feeling sick, upset stomach or diarrhoea Infections 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. Leflunomide may reduce your ability to fight infections and this can be a problem in some individuals who may be more vulnerable to infections. If you vomit within a few hours of taking leflunomide 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 regularly. It is important to get prompt advice from your GP, if you think you have an infection (for example, a wound that fails to heal promptly, pain or burning when passing water, or a chest infection). Effects in your bone marrow or liver Rashes - new rashes or severe itching anywhere on the body 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 may have to stop your leflunomide. 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 be necessary for you to have a blood test to check how your body is coping. In many cases, if your blood tests are normal, you may be given some medication to treat these problems. 8 If you get a new rash or severe itching seek advice from your doctor, nurse or pharmacist. Thinning of the hair This can happen 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 they occur after every dose. 9