Teriflunomide (Aubagio) 14mg once daily tablet

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1 Teriflunomide (Aubagio) 14mg once daily tablet Exceptional healthcare, personally delivered

2 Your Consultant Neurologist has suggested that you may benefit from treatment with Teriflunomide. The decision to start this form of treatment can be difficult. Therefore, this leaflet gives you some information about Teriflunomide. Your Consultant Neurologist, Speciality Doctor or MS Specialist Nurse may be able to answer any further questions you may have. What is Teriflunomide? Teriflunomide is a tablet 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, although clinical trials have shown Teriflunomide reduces relapse rates, it is still unknown 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 is it believed that the immune system mistakenly identifies the body s nerve tissue in the brain and spinal cord as a foreign intruder 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. Teriflunomide helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (Lymphocytes). This limits the inflammation that leads to nerve damage in MS. How is Teriflunomide taken? Teriflunomide is a once daily, oral tablet which can be taken at any time of the day, though we would recommend that it is taken at roughly the same time each day. It can be taken with or without food. 2 Teriflunomide (Aubagio) 14mg once daily tablet

3 Things your Consultant needs to know Medications Before starting any new medication it is important that you inform your consultant of all the medication you are taking, both prescribed and bought over the counter. This will include any recreational medications. This is so your consultant can ensure that your medication does not interact with Teriflunomide. If you do begin taking Teriflunomide you should also check with your GP, MS team or pharmacist for interactions with any new medication you are prescribed before taking it. In addition other immunosuppressant or immunomodulating medications should be avoided. Infection It is important to inform your Consultant if you have any infections. We will be required to check your blood prior to initiating treatment this is to ensure you have enough white blood cells and platelets prior to starting Teriflunomide. This is because Teriflunomide decreases the number of white cells in the blood which may lead to difficulty fighting infection. It may be necessary to delay/stop treatment until the infection has resolved. Other Health ProblemsPrior to starting treatment your consultant will wish to ensure the drug is suitable for you. You will need to inform your consultant of any other health conditions you may have or have had previously. In particular it is important to inform your specialist if you have or are suffering from liver disease. Teriflunomide (Aubagio) 14mg once daily tablet 3

4 Pregnancy or breast feeding It is very important that you do not take Teriflunomide if you are trying to conceive, pregnant, or think you may be pregnant. If you are pregnant or become pregnant whilst taking Teriflunomide, the risk of having a baby with birth defects is believed to be increased. Therefore if you suspect you are pregnant whilst taking Teriflunomide or in the two years after you have stopped treatment, you must contact your doctor immediately. It is also important to tell your doctor if you plan to become pregnant after stopping treatment. It can take a long time for the effects of Teriflunomide to be naturally removed from your body. It is therefore advised that woman should not try to conceive for TWO years after stopping Teriflunomide. However there are medications that can be given once Teriflunomide is stopped that accelerate the removal of this medication allowing safe pregnancy earlier. Blood tests will need to be performed after such accelerated elimination. Do not take Teriflunomide if you are breast feeding, as Teriflunomide passes on through the breast milk. Contraception Woman of childbearing potential must use an effective method of contraception during two years after stopping treatment with Teriflunomide. Talk to your GP about the best methods of contraception for you. The effects of teriflunomide on male fertility continue to be evaluated but, to date, there is no evidence to restrict its use in men who wish to father a child. Lactose Teriflunomide contains lactose. If you think you maybe intolerant to some sugars please discuss this with your GP prior to taking this medication. 4 Teriflunomide (Aubagio) 14mg once daily tablet

5 What tests will I need before I can start Teriflunomide? Prior to starting Teriflunomide we will need to perform some tests. These will include: n Blood and urine test including a pregnancy test (if applicable) n A recording of your blood pressure What test will need to be done once I commence Teriflunomide? You will be required to attend a health facility for monitoring of your blood every 2 weeks for the first 6 months and every 8 weeks thereafter. It is very important to attend these appointments, failing to do so could cause you harm and may result in our being able to continue your prescriptions. You blood pressure will be monitored at regular intervals whilst you are on treatment. Possible side effects Like all medicines, this medicine can cause side effects, although according to large trials with MS patients these appear to be largely infrequent. The following side effects may happen with this medicine. Serious side effects Tell your GP or MS Nurse straight away, if you notice any of the following serious side effects: n Jaundice, yellowing of your skin or the whites of your eyes, darker urine than normal or unexplained nausea and vomiting - these may be signs of a liver problem and you will need to have a blood test. Teriflunomide (Aubagio) 14mg once daily tablet 5

6 n Infection this may include flu (fever or flu like symptoms); sinus or throat infection; urinary tract infection or cystitis; bronchitis; diarrhoea or being sick; cold sores; tooth infection; laryngitis or fungal foot infection. Other side effects include: Very common side effects (may effect more than 1 in 10 people): n Upper respiratory tract infection, urinary tract infection n Pins and needles n Diarrhoea, feeling sick n Increase in ALT ( increase in blood levels of certain liver enzymes) shown in your regular blood tests. This typically reverses when the drug is stopped. n Hair thinning, this is reported as being transient and usually occurs within the first six months. Common side effects (may effect up to 1 in 10 people): n Bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, fungal infection of the foot n Low levels of white blood cells shown in your regular blood tests n Mild allergic reaction n Feeling anxious n Feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers, increased feeling of sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves. 6 Teriflunomide (Aubagio) 14mg once daily tablet

7 n Increase in blood pressure, this is usually mild. n Vomiting n Toothache n Rash, acne n Pain of the tendons, joints, bones, muscle pain n Needing to urinate more often than usual n Heavy periods n Pain n Changes in liver and white cell test n Weight loss Uncommon side effects (may effect up to 1 in 100): n Decrease in the number of red cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia) n Peripheral Neuropathy. In placebo controlled trials peripheral nerve damage including carpal tunnel syndrome was seen more commonly in patients taking Teriflunomide than those taking placebo. The symptoms of peripheral nerve damage can sometimes be difficult to determine from MS symptoms. Very rare side effects (may effect up to 1 in 10,000 people) n Inflammation of the lung (interstitial lung disease) n Inflammation of the pancreas (pancreatitis) Teriflunomide (Aubagio) 14mg once daily tablet 7

8 Can this medication cause Cancer? There does not appear to be an increased risk of malignancy with Teriflunomide within the clinical trials. The risk of cancer, particularly cancer of the white blood cells, is increased with use of some other agents that affect the immune system (class effect). What happens next? If you and your consultant decide this is the right treatment for you, an appointment may be arranged for you to attend your MS Outpatient Clinic for baseline assessments and bloods. Providing all your assessments are within normal limits we will proceed with requesting your prescription. The medication will be delivered to your nominated delivery address after a prescription is issued by your MS doctor. It is very important that you read the product information provided with the medication. It is also very important that you remember to take this medication on a regular basis and do not accidently take more than one dose within 24 hours. It will be your or your carer s responsibility to ensure that you have the recommended blood tests after starting Teriflunomide. These should ideally be carried out at your GP surgery. However if this is not possible the MS team can try to help. 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. 8 Teriflunomide (Aubagio) 14mg once daily tablet

9 Frequently asked Questions 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. What if I need vaccinations? Always check with your GP, Consultant or MS Specialist nurse before you have any vaccinations. 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. Do not stop Teriflunomide without talking to your consultant first. Can I still have Steroids whilst taking Teriflunomide? Yes if necessary. Your Consultant or GP will advise on the use of steroids if they are required. Can I drive? Teriflunomide may cause you to feel dizzy, which will possibly impair your ability to concentrate and react. If you are affected by this you should not drive or use any machinery. Teriflunomide (Aubagio) 14mg once daily tablet 9

10 Do I need to inform other health care professionals that I am taking this drug? Yes. We will let your GP know, but other health care professionals such as other GPs or your Dentist may want to prescribe you new medication. Please always inform your GP / dentist or other prescribing doctor that you are taking Teriflunomide when new medications are suggested. What shall I do if I wish to become pregnant? If you are considering starting a family in the near future you MUST discuss your plans with a health care professional prior to stopping medication and contraception. 10 Teriflunomide (Aubagio) 14mg once daily tablet

11 More information You can find further information and support from the following organisations: Multiple Sclerosis Trust Multiple Sclerosis Society NICE References: Summary of product characteristics, 2013, Sanofi-aventis groupe: Paris Information for the patient, 2013, Sanofi-aventis groupe: Paris National Institute for Health and Excellence (Nice) Teriflunomide for treating relapsing-remitting multiple sclerosis, 2014, Nice: London NHS Constitution. Information on your rights and responsibilities. Available at Teriflunomide (Aubagio) 14mg once daily tablet 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 NBT002842

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