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1 Gilenya Exceptional healthcare, personally delivered

2 Your Consultant Neurologist has suggested that you may benefit from treatment with Gilenya. The decision to start this form of treatment can be difficult. Therefore, this leaflet gives you some information about Gilenya. Your Consultant Neurologist, Speciality Doctor or MS Specialist Nurse will be able to answer any further questions you may have. 2 Gilenya

3 What is Gilenya? Gilenya is an oral medication which is given to try and reduce the frequency of MS relapses. We hope that this may reduce the chance of accumulating disability over time (years). However we are uncertain as to whether or not it will make a significant impact on your level of disability over the long term. Normally our immune system defends our bodies against infection. In MS we believe that the immune system mistakes the body s nerve tissue in the brain and spinal cord for intruders and attacks it. This causes damage to the protective coating (called myelin), which surrounds the nerves and can lead to scarring (sclerosis) of the tissue. This causes disruption of the messages that are sent via the brain and spinal cord and can cause a variety of symptoms. Lymphocytes are a type of white blood cell which are part of the immune system and are involved in the attacking process. Gilenya works mainly by trapping these cells in the lymph glands, hence reducing the amount of lymphocytes circulating in the bloodstream. Lymph glands are found throughout the body and act as filters for trapping viruses, foreign particles and bacteria. Gilenya interrupts the signals which tell the lymphocytes to leave the lymph glands. This reduces the amount of lymphocytes in the bloodstream which prevents them entering the brain and spinal cord, therefore causing less damage and inflammation to the nerve cells. Most lymphocytes (98%) are already stored within your lymph nodes. Only 2% of your lymphocytes are normally in your blood stream. Therefore the trapping of the majority of this 2% of lymphocytes does not cause lymph gland swelling. Gilenya 3

4 Things your Consultant needs to know Medications (VERY IMPORTANT) Before starting any new medication it is vitally important that you inform your consultant of ALL the medication you are taking, both prescribed and bought over the counter. This includes any recreational medications. This is so he/she can ensure that your medication does not clash with Gilenya. You should also check any new medication with your GP, MS team or Pharmacist before taking it. In particular it is essential to know if you are taking any medications for a heart condition or high blood pressure. Such medications can potentially interact and be dangerous when taken with Gilenya. If in doubt, please ask. Common medications used in MS that can interact potentially dangerously with Gilenya include Amitrypyline and other so called tricyclic antidepressants, Propranolol, Prochlorperazine, Citalopram, Solifenacin and Tolterodine. Ideally these should NOT be used with Gilenya. Several antibiotics can also interact. Any drug that can prolong what is known as the QT interval (cardiac conduction) are best avoided. In addition other immunosuppressant or immunomodulating medications should be avoided. IF IN DOUBT PLEASE ASK. Chickenpox If you have never had chickenpox or the chickenpox vaccination you will need to inform your Consultant. You may require a vaccination against this before starting Gilenya. 4 Gilenya

5 Pregnancy or breast feeding Gilenya should not be taken during pregnancy so it is very import to inform your Consultant if you think you might be pregnant or are planning to have a baby in the near future. You should have a reliable source of contraception whilst taking Gilenya and for 3 months after stopping. Gilenya has been shown to cause harm to animal foetuses (unborn babies) in animal studies. Gilenya is passed into breast milk. For this reason you should not breast feed whilst taking Gilenya. Infection It is important to inform your Consultant of any serious infection which is still active such as hepatitis or tuberculosis. You should also inform them of any diseases or medications you are taking which can lower your immune system. Other health problems You will need to inform your Consultant of any other health conditions you may have or have had in the past, especially: n Abnormal heartbeat (arrhythmia) n Any other heart condition n Any respiratory condition, such as Asthma n Any previous history of TB n Any history of inflammation of the eye (Uveitis) n Cancer (except cutaneous basal cell carcinoma) n High blood pressure n Liver problems n If you are allergic to any of the ingredients in Gilenya n Episodes of loss of consciousness such as fainting episodes. Gilenya 5

6 What tests will I need before I can start Gilenya? Prior to starting Gilenya we will need to perform some tests. This will include: n ECG (tracing of the heart) and continuous 6 hourly ECG monitoring after the first dose of Gilenya. n Ophthalmology review (review of eyes) n Blood and urine tests to include a pregnancy test n Peak flow test (breathing test) n Three blood pressure recordings n Pulse rate n Testing and possible vaccination against chickenpox (if no previous history of chickenpox) How is Gilenya given? Gilenya is an oral medication which is taken once a day. For your first dose of Gilenya you will be asked to come into hospital for the day. This is so that the hospital staff can monitor your blood pressure, temperature and heart rate. Providing you are well during this time you will be discharged home and will continue to take Gilenya on a daily basis. If there are any concerns during this day case you may be asked to stay in hospital for further monitoring. 6 Gilenya

7 It is important that you take Gilenya everyday at the same time. This can be with or without food. If you miss Gilenya for 14 days you will be asked to attend hospital again for monitoring. Possible side effects n Temporary fall in heart rate (common) n Small rise in blood pressure (common) n Cardiac arrythmias that can cause palpitations, light headedness and loss of consciousness (rare) n Changes in liver function, including jaundice (rare) n Infection risk, usually mild (rare) n Chest infection (rare) n Headache (rare) n Flu (rare) n Diarrhoea (rare) n Cough (rare) n Back pain (rare) n Shortness of Breath (rare) n Visual Disturbance - Macula Oedema- swelling in the eye (rare) Gilenya 7

8 What happens next? If you and your Consultant decide this is the right treatment for you, you will need to sign a consent form. After this the MS nurse will arrange with you a date to have the baseline tests before the first dose and then a date to come into hospital to take your first dose of Gilenya. Whilst you are taking Gilenya it is very important you attend hospital appointments for regular assessments and blood tests. It is very important to attend these appointments, failing to do so will result in your prescriptions being stopped. Alternative medications Currently there are other therapies recommended for the treatment of relapses however these will be offered to you if appropriate by your Consultant. Frequently asked Questions When can I start? After all of the pre tests have been completed your MS Nurse will arrange a date for you to come into hospital to start Gilenya. You will be asked to stay in hospital for at least 7 hours. Can I go abroad? Yes. You can continue your medication as normal. Check with your airline first to ensure a letter to travel with medication is not needed. 8 Gilenya

9 What if I need vaccinations? Always check with your Consultant or MS Specialist nurse before you have any vaccinations. Vaccinations may be less effective during the time you are taking Gilenya and for 2 months after. Live vaccinations may carry the risk of infection and should therefore be avoided. Can I drink alcohol? There is no firm evidence to suggest that alcohol should be avoided however please drink responsibly in accordance with government guidelines. What if I miss a dose? If you forget a dose one day, do not take two doses at the same time. Continue to take the next dose as you normally would. If you stop taking Gilenya for more than 14 days you will need to inform your MS Nurse as you will need to attend hospital for monitoring again. Can I still have Steroids whilst taking Gilenya? Steroids modify your immune system as like Gilenya. Your Consultant will advise on the use of steroids if they are required. You will need to inform your Consultant if you are already taking steroids or have recently had a course of steroids before starting Gilenya. Gilenya 9

10 Can I drive? We would strongly advise you arrange for someone to drive you to and from the hospital on the day of your first dose. Following this, there are no guidelines to state you cannot drive. Do I need to inform other health care professionals that I am taking this drug? Yes. Other health care professionals such as your GP or Dentist may want to prescribe you new medication. Please always inform your GP / Dentist or other prescribing doctor that you are taking Gilenya when new medications are suggested. A list of contra-indicated medications can be given to you if requested. More information You can find further information and support from the following organisations: nmultiple Sclerosis Trust n Multiple Sclerosis Society n NICE 10 Gilenya

11 References National Institute for Health and Excellence (Nice)Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis,2012, Nice: London. Novartis Summary of product characteristics, 2011, Novartis: West Sussex. Novartis Gilenya patient information, 2011, Novartis; West Sussex. NHS Constitution. Information on your rights and responsibilities. Available at Gilenya 11

12 If you or the individual you are caring for need support reading this leaflet please ask a member of staff for advice. North Bristol NHS Trust. This edition published May Review due May NBT002671

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