Understanding your Tecfidera treatment

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1 Understanding your Tecfidera treatment Information for patients who have been prescribed treatment with Tecfidera. (dimethyl fumarate)

2 Contents About Multiple Sclerosis (MS) What is MS? Symptoms of MS Diagnosis and treatment About Tecfidera How does Tecfidera work? What effect does Tecfidera have? About your treatment with Tecfidera Talk with your doctor and nurse How to take Tecfidera Side effects of Tecfidera Useful tips when taking Tecfidera Following up your treatment If you want to know more

3 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 with 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.

4 What is MS? MS is a disease with many faces MS, which often proceeds with attacks, or so-called relapses, is an autoimmune disease. This 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. In MS, the immune system reacts against nerve cells in the central nervous system - the CNS (the brain and spinal cord). This reaction results in inflammation that damages the nerve cells causing scars known as lesions. This disrupts the communication between the brain and other parts of the body and can cause the symptoms of MS. MS also results in the formation of large amounts of harmful substances called free radicals. In MS, more free radicals are produced than the body s immune system can deal with. This condition is called oxidative stress. Oxidative stress can damage nerve cells in the same way as inflammation. Relapsing means a random worsening of the disease that is caused by flare up of inflammation in the CNS and results in various symptoms. These could be a new MS symptom or an earlier symptom that increases for a time then frequently disappears again. The degree and type of symptom depends in part on the extent of the inflammation and which area of the CNS is affected.

5 Symptoms of MS Each MS patient s symptoms are individual. These can include: Numbness and loss of sensations Poor balance or dizziness Problems with vision Tiredness Difficulties thinking and concentrating Acute or chronic pain Stiffness and muscle spasms Sexual problems Problems with the bladder and intestines Depression Problems walking

6 Diagnosis and treatment A 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. Knowledge on the importance of an early and correct diagnosis has been strengthened in recent years. This makes it possible to start effective diseaseslowing treatment at an earlier stage which is proven to improve the prognosis and the possibility of a good life with MS.

7 How does Tecfidera work? Tecfidera is quite different to all other treatments against MS. The active substance in Tecfidera, dimethyl fumarate, is a compound that acts in a number of different ways in the body. In MS, Tecfidera is thought to protect against inflammation caused by the immune system as well as against damage by the free radicals. 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. 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. Tecfidera can increase the body s production of antioxidants and can thus strengthen the body s own defence against free radicals.

8 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 against MS. In one study, Tecfidera also clearly lowered the risk of reduced functionality. 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.

9 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 of the disease.

10 Talk with 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.

11 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 CONTINUE WITH 120 mg MORNING 120 mg EVENING 240 mg MORNING 240 mg EVENING 120 MG = GREEN-WHITE CAPSULE 240 MG = GREEN CAPSULE

12 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: Redness of the face or body, feeling hot or flushing, sweating or itching Loose stools (diarrhoea) Nausea Stomach pains or cramps The following can help to reduce the side effects: Take Tecfidera with food. 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 acetyl salicylic 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

13 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 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 at less than 30 C.

14 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.

15 If you want to know more 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 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 (1) / November 2014 / McBride Please read the patient information leaflet before you start your treatment with Tecfidera. Tecfidera, Rx (F), (dimethyl fumarate), NO7XX09, SPC October Indication: Tecfidera is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS). 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. Pack sizes: 1) 120 mg capsules x 14 capsules. 2) 240 mg capsules x 56 capsules. Warnings and precautions: Tecfidera is not recommended during pregnancy or for women of child-bearing age who do not use a suitable contraceptive. For further information on contraindications, warnings and precautions, side effects and price please go to For further information go to (dimethyl fumarate) BiogenIdec Sweden AB, Kanalvägen 10a, Upplands Väsby.Tel

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