Understanding your Tecfidera. treatment. Information for patients who have been prescribed treatment with Tecfidera.

Transcription

1 Understanding your Tecfidera treatment Information for patients who have been prescribed treatment with Tecfidera.

2 Contents Treatment with Tecfidera About Multiple Sclerosis (MS) Multiple sclerosis A brief description Diagnosis and treatment About Tecfidera How does Tecfidera work? What effect does Tecfidera have? About your treatment with Tecfidera Talk to your doctor or nurse How to take Tecfidera Side effects of Tecfidera Useful tips when taking Tecfidera Following up your treatment If you want more information Notes Treatment with Tecfidera Your doctor has prescribed Tecfidera (dimethyl fumarate) for treatment of your relapsing-remitting multiple sclerosis (MS). Tecfidera is taken as a capsule in the morning and evening. This brochure has been produced to help you to get started with and to continue your treatment. It contains important information about multiple sclerosis (MS) and your treatment. Please keep the brochure. You may need to read it again in the future. Talk to your doctor or nurse if you have any questions about the contents of this brochure. Remember that this brochure does not replace any advice they give you. Please read the patient information leaflet that is enclosed with Tecfidera before you start your treatment. 2 3

3 Multiple sclerosis A brief description In multiple sclerosis (MS), inflammation occurs that hinders the passage of the electric signals between nerve cells in the central nervous system. The inflammation can occur in different parts of the central nervous system and the symptoms can vary from relapse to relapse. In Sweden about 20,000 people have multiple sclerosis (MS) and about 1,000 people become ill every year. MS is an autoimmune, neurological disease that affects the central nervous system (brain and spinal cord). Autoimmune means that the body s immune system, which normally fights foreign bodies such as viruses or bacteria, is activated to fight the body s own tissues. The progression of the disease can vary greatly from person to person. In some people, the disease can progress slowly, while in others it can be more aggressive. MS is a chronic disease; fortunately, a number of different types of disease-modifying drugs are available. They have in common that they affect the body's immune system. This means they can reduce the risk of new relapses and delay progression of the disease. Individual factors can be important for the choice of medication; what is the best solution for one patient may not be the best for another. The treatment goal is to minimise the inflammatory activity in order to limit the development of permanent damage. Most people with MS have relapses. This means that they have periods with symptoms of relapse followed by better periods, with milder symptoms or no symptoms at all. Because the inflammation can occur in different parts of the central nervous system, the symptoms can vary widely. These can include: Numbness and loss of sensation Poor balance or dizziness Problems with vision Tiredness (fatigue) Difficulties thinking and concentrating Problems walking Pain Stiffness and muscle spasms Sexual problems Problems with the bladder and intestines Depression 4 5

4 Healthy nerve fibre Nerve cells send information through nerve fibres as electrical signals to other cells. The nerve fibres are surrounded by myelin, a fatty layer that acts as insulation and makes it easier for the electrical signals to travel. Damaged nerve fibre The myelin has broken down, making it difficult for the signals to travel between the nerve cells. Inflammation can be present even if there are no symptoms Inflammation in the central nervous system does not always show itself as a relapse. Sometimes an MRI investigation at the time of the first signs of the disease can detect scars from previous inflammation in the brain or spinal cord. That person can have had the disease for a while without any symptoms. The brain has a very large reserve capacity and these small inflammations which may be only a few millimetres often do not give any symptoms. So although you may be receiving treatment and do not have physical symptoms, the disease can still be active. This type of "silent" inflammation is nevertheless important to detect because it can indicate that the treatment is not as effective as it should be. Today, a number of different disease-modifying drugs are available for MS, and there is now a higher probability of finding a drug optimally suited to the individual. The name multiple sclerosis means many scars, and refers to the scars left in the central nervous system when an inflammation has ceased. 6 7

5 Diagnosis and treatment The diagnosis of MS is generally made by a neurologist. Using magnetic resonance imaging, the neurologist can see if there are MS lesions in the brain and spinal cord. The diagnosis of MS is based on the results of clinical examinations (type and severity of symptoms) and magnetic resonance imaging (MRI) of the brain and spinal cord. Frequently, the spinal fluid is also analysed (using a lumbar puncture). The MS treatments available today have shown that they can reduce the number of relapses and slow development of the disease. The treatments work in various ways and the expected effect can differ for the individual treatments. The profiles of the side effects are also different. Currently, there are no cures for MS. How does Tecfidera work? Tecfidera is quite different to all other treatment for MS. The active substance in Tecfidera, dimethyl fumarate, is a compound that acts in several different ways in the body; however, the exact mechanism of action is not known. If you wish, you can discuss the theories on Tecfidera's mechanism of action with your doctor. Tecfidera as treatment of relapsing-remitting MS has been investigated in two major global clinical trials. Tecfidera was shown to be able to reduce the number of relapses and to slow the progression of the disease in MS. The treatment was also shown to be able to reduce the number of new MS lesions in the brain and spinal cord. The side effects experienced by patients treated with Tecfidera were generally mild to moderate. Knowledge of the importance of an early and correct diagnosis has increased in recent years. This makes it possible to start effective disease-slowing treatment at an earlier stage, which is proven to improve the prognosis and the possibility of a good life with MS. 8 9

6 What effect does Tecfidera have? Patients who received Tecfidera in the clinical trials experienced on average 50% fewer relapses compared to patients who did not receive any form of treatment for MS. In one study, Tecfidera also clearly reduced the risk of functional impairment. It is important to continue your treatment. MS is a chronic disease. It is important to try to limit the number of relapses to slow the disease progression. Tecfidera is eliminated quickly from the body and it is therefore important that you take the capsule every day in the morning and evening. To get the most benefit from your treatment, you must continue to take your Tecfidera as you have been instructed, even when you do not experience any symptoms. To get the most benefit from your treatment, you must continue to take your Tecfidera as you have been instructed, even when you do not experience any symptoms

7 Talk to your doctor and nurse It is important that you tell your doctor and nurse how you feel in general and whether you have taken, are taking, or plan to take other medicines. Talk to your doctor if you have a serious infection (e.g. pneumonia) or kidney, liver or gastrointestinal disease. If you are pregnant or breastfeeding, believe you could be pregnant, or are planning to become pregnant, ask your doctor or MS nurse for advice before you start taking Tecfidera. You must not use Tecfidera if you are pregnant unless you have first discussed this with your doctor. How to take Tecfidera First you take the starting dose (one 120 mg capsule twice a day) for 7 days. Then you switch and continue with the recommended dose (one 240 mg capsule twice a day). Remember to take Tecfidera in accordance with your doctor s instructions. STARTING DOSE 7 DAYS 120 mg MORNING 120 mg EVENING CONTINUE WITH 240 mg MORNING 240 mg EVENING 120 MG = GREEN-WHITE CAPSULE 240 MG = GREEN CAPSULE Twice a day! Morning Evening 12 13

8 Side effects of Tecfidera As with all medicines, Tecfidera can cause side effects, but not everybody gets them. The following side effects are very common (can occur in more than one in 10 people) but are generally mild to moderate (for a complete list see fass.se): Redness on the face or body, feeling hot or flushing, sweating or itching Loose stools (diarrhoea) Take Tecfidera with a meal it can help to reduce the side effects. Take Tecfidera with food. Nausea Stomach pains or cramps If you experience redness of the skin, acetylsalicylic acid can help. (e.g. Aspirin or Magnecyl). Ask your doctor about the dose and when you should take acetylsalicylic acid. Long-term use of acetylsalicylic acid is not recommended for managing skin redness. You doctor may reduce the dose. Do not reduce the dose unless your doctor has told you to do so. Talk to your doctor or nurse if you experience any side effects. This also applies to any side effects not listed here. You can read more about side effects in the patient information leaflet and on Useful tips when taking Tecfidera When you take Tecfidera Swallow the capsule whole with water. You must not divide, crush, dissolve, chew or suck the capsule. Take Tecfidera with a meal it can help to reduce some of the side effects. If you have forgotten to take a dose of Tecfidera: Do not take a double dose to make up for a forgotten or missed dose. You can take a missed dose if there are at least 4 hours before the next dose. You must immediately inform your doctor if you take too many capsules. If you are unsure about how to take Tecfidera, ask your doctor or nurse for advice. How to store Tecfidera Tecfidera must be kept out of the sight and reach of children. The capsules are sensitive to light and must be kept in the original packaging a maximum of 30 C

9 Following up your treatment Before starting treatment, you will have some laboratory tests. If you continue the treatment, follow-up samples will occasionally be taken at your regular check-ups with your doctor and nurse. How do you know if the treatment is effective? Tecfidera does not cure the disease but can slow its progression. The medicine cannot make the disease go into remission or repair previous damage. This means that you may not feel better or notice any differences at all. This does not mean that the treatment is not working. If you want more information We hope that this brochure has given you sufficient information about Tecfidera. If you have any more questions about MS or your treatment, please talk to your doctor or nurse. Make a regular note of how you feel during your treatment. Your notes will be a good help at your scheduled check-ups and on occasions when you need to talk to other healthcare personnel. Important telephone numbers My doctor: My nurse: 16 17

10 Notes 18 19

11 The information in this brochure is intended to form part of the patient information on Tecfidera provided by the treating doctor. The text is based on the patient information leaflet and the Summary of Product Characteristics for Tecfidera. See also TF-SWE-0038(7) / March 2018 Issued Please read the patient information leaflet before you start your treatment with Tecfidera. TECFIDERA, Rx F, (dimethyl fumarate), NO7XX09, SPC 11/2017. Indication: Tecfidera is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis. Dosage: Starting dose is 120 mg twice daily. After 7 days the dose is increased to the recommended dose of one 240 mg capsule twice daily. Side effects: Common side effects during the start phase of treatment are gastrointestinal problems and skin redness. Special warnings and precautions for use: In rare cases, treatment with Tecfidera has led to PML, progressive multifocal leukoencephalopathy. Tecfidera is not recommended during pregnancy or for women of child-bearing age who do not use a suitable contraceptive. For further information on pack sizes, contraindications, warnings and precautions, side effects and price please go to For further information go to Biogen Sweden AB, Kanalvägen 10a, SE Upplands Väsby. Tel