IF YOU ARE RECEIVING (NATALIZUMAB) TREATMENT WITH TYSABRI FOR RELAPSING-REMITTING MS Read the patient information leaflet that accompanies the medicine carefully. 1
This brochure is a supplement to the healthcare provider s patient information on TYSABRI. IF YOU ARE RECEIVING TYSABRI This brochure is for people who have MS and whose doctor has prescribed the drug TYSABRI (natalizumab). You will find more information about TYSABRI, how the drug works, what effects you can expect, and any side effects. It also contains a brief background about the disease, what happens in your body and how it can affect you. Do not hesitate to contact your doctor or MS nurse if there is anything you wonder about, or need an answer to. Please read the package leaflet that is enclosed with TYSABRI before you start your treatment. This medicinal product is subject to additional monitoring. The black triangle is intended to be used in all EU member states to identify those medicines that are under additional monitoring, which means that the medicine is monitored more closely than other medicines. The black triangle makes it possible to quickly identify which medicines are under additional monitoring. Patients and healthcare personnel in particular are encouraged to report all suspected side effects of a medicine that is marked with the black triangle so that new information can be quickly evaluated. More information is available on www.multipelskleros.nu www.tysabripatientinfo.se 2
CONTENTS Facts about MS... 4 How TYSABRI acts... 7 Facts about the treatment... 9 Questions and answers... 12 Other information... 13 Terminology... 15 3
FACTS ABOUT MS In Sweden about 18,000 people have multiple sclerosis, MS, and about 1,000 people become ill every year. MS is a neurological disease that affects the central nervous system (brain and spinal cord). The central nervous system can be described as the body's "computer". Nerve cells in the central nervous system receive and send out large amounts of information through the nerve fibres or "axons". The nerve fibres join the nerve cells together in an enormous network. The information is passed between the nerve cells as weak electrical impulses along the nerve fibres. The nerve fibres are surrounded by a fatty layer called myelin. This has an insulating effect so that the electrical signals travel quickly and efficiently. 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. 4
In MS, small inflammations occur in the brain or spinal cord. These damage the myelin causing it to break down. This makes it more difficult for the electrical signals to move through the affected area. The brain's ability to communicate effectively with the various parts of the body is affected. This makes it more difficult for the brain to control the nerves for motor function (movement) or to process sensory input. Most people with MS have relapses. This means that they have periods with symptoms due to new damage followed by better periods with weaker or no symptoms at all. The inflammation in MS can occur in different parts of the central nervous system. This means many bodily functions can be affected and the symptoms can vary from relapse to relapse and from person to person. Cerebrum Cerebellum Brain stem Spinal cord When the inflammation in the central nervous system has subsided, the nervous system can repair itself and rebuild the myelin around the nerve fibres. Occasionally the damage persists. In the long term, this persistent damage in the central nervous system increases and can cause increasing impairment of function. It is therefore important when choosing the treatment for MS to weigh up the advantages and risks of the treatment against the risks associated with the disease itself. 5
In time treatment At the beginning in relapsing-remitting MS there is often complete recovery after a relapse. The brain's repair cells build up new myelin around the nerve fibres. But new inflammations can lower the possibility for recovery. Once the myelin has broken down, the nerve fibre itself can be attacked and destroyed. Damage that occurs as a result of broken down nerve fibres or dead nerve cells can become permanent. This is why it is important to check as early as possible how active your disease is before damage occurs that the body cannot repair. If you are an adult with highly active relapsing-remitting MS you can be treated with TYSABRI. This means: Continued disease activity in spite of treatment with other disease-modifying drugs or High disease activity when the disease first appeared. 6
FACTS ABOUT TYSABRI How TYSABRI acts In MS, immune cells pass from the blood stream into the central nervous system. For some unknown reason, the immune cells have become programmed to attack the myelin, the insulating layer around the nerve fibres. TYSABRI is an antibody that affects the immune system and thus MS. TYSABRI prevents the cells that cause the inflammation in MS from entering the central nervous system by attaching to the immune cells' "keys". This means that the "keys" do not fit the "keyhole" in the central nervous system. This reduces the risk of new nerve damage. Nerve fibre with myelin Blood stream The immune cells 7
WHAT YOU CAN EXPECT FROM THE TREATMENT The best way to study and demonstrate the effects of a drug is to conduct so-called clinical studies. Researchers study how the disease develops in patients who receive the drug compared with a control group who receive a placebo (a drug with no effect). In clinical studies, TYSABRI almost halved the rate at which function impairment developed in MS, and it also reduced the number of MS relapses by about two-thirds. How will I know whether TYSABRI has an effect? When you are treated with TYSABRI you are regularly monitored for any effect. All relapses are noted, and any changes in physical and cognitive functions (capacity to move and think) are monitored. If you experience that your disease does not stabilise when treated with TYSABRI, you should discuss with your doctor whether this is the right treatment for you. If you are treated with TYSABRI you are followed up regularly for treatment effects 8
FACTS ABOUT THE TREATMENT One infusion every four weeks TYSABRI is administered as an intravenous infusion, this is a drip into a blood vessel in the arm. The drip is administered in the hospital Reception or on a Day Ward every fourth week by healthcare personnel and takes about an hour. In connection with the infusion you are checked for any allergic reactions; but these are uncommon. Attending the hospital every four weeks can offer additional security. These regular visits mean it will also be easy for healthcare personnel and your doctor to monitor the effects of your treatment. Patient information card You will be given a patient card which contains important information on TYSABRI. Show the card to all doctors and other healthcare personnel involved in your treatment. Show the patient card to your partner and family too, so that they are familiar with the treatment with TYSABRI and what they should be aware of. PATI INFOENT RMA TION CARD FOURTH EVERY WEEK 9
Side effects Most medicines give some side effects and that applies to TYSABRI as well. Most of the side effects with TYSABRI are mild and soon disappear. A small number of patients react with hypersensitivity associated with the infusion. The reaction normally occurs within a few hours and may mean that you need to stay behind for observation after the infusion. Other common side effects include urinary tract infections, sore throats and runny or blocked nose, shaking, itchy rashes (urticaria), headache, dizziness, nausea, vomiting, joint pain, fever and tiredness. Talk to your doctor if you experience any side effects. The patient information leaflet enclosed with TYSABRI contains more information on the side effects. PML an uncommon but serious infection In rare cases, treatment with TYSABRI has resulted in PML, progressive multifocal leukoencephalopathy. PML is an infection in the brain that can give serious consequences, including damage to the central nervous system in people who are affected. The infection is caused by a virus called the JC virus. About half the population carry this virus without it causing them any problems or disease. If you are treated with TYSABRI and carry the JC virus, there is a certain risk that you could develop PML. Carrying the virus does not mean that you will get PML; this is just one of three known risk factors The known risk factors are: Being a carrier of the JC virus, which is necessary for development of PML. If you are a carrier of the JC virus your risk is also affected by: How long the treatment is continued. Previous treatment with an immunosuppressive drug, which means a drug that inhibits the body s defence systems. 10
TYSABRI was approved in 2006. In June 2015 about 142,000 MS patients around the world had been treated with TYSABRI. Individual assessment of the treatment and follow-up A simple blood test is used to determine whether there are antibodies to the JC virus in the blood. If antibodies are present, the test result will be positive ; this means the virus is present in the body. If you do not have antibodies to the JC virus the test result is negative. This test helps you and your doctor assess the risk of PML and helps to ensure that you get the best treatment and follow-up. Important to be alert The symptoms with PML are similar to the symptoms with MS. It is therefore important that if you are receiving TYSABRI you are alert, and immediately contact your doctor if you feel your MS is getting worse or if you experience new symptoms. This will enable us to exclude early that it is PML. Tell your close family about the treatment so that they can help you notice any changes or worsening of your condition. 11
QUESTIONS AND ANSWERS What happens if I am hypersensitive to TYSABRI? If you are found to be hypersensitive to TYSABRI you will most probably not be allowed to continue the treatment with TYSABRI What happens if I become pregnant? Tell your doctor if you are pregnant, believe you are pregnant or are planning to become pregnant. You must not use TYSABRI if you are pregnant unless you have first discussed this with your doctor. Many people experience a significant improvement in their MS while they are pregnant. However, a few months after giving birth there is an increased risk of a relapse. Can I breastfeed? You must not breastfeed if you are being treated with TYSABRI. Discuss with your doctor when deciding whether to breastfeed or receive TYSABRI. Can I drive a car? TYSABRI is not expected to affect your ability to drive a car or use machinery. Talk to your doctor if you are uncertain. Can I take other medicines? Tell your doctor if you take or have recently taken other medicines. This also applies to herbal products and over-the-counter medicines. Can I stop my treatment temporarily? After each infusion TYSABRI disappears slowly from the body. TYSABRI is therefore given every fourth week to ensure that there is sufficient medicine in the blood. If the time between infusions is longer than four weeks, the effect of the treatment may be reduced and the activity of your MS could increase. Any temporary pause in your treatment, for example in connection with pregnancy, must be discussed with your doctor. 12
OTHER INFORMATION Talk to your doctor or nurse if you have any questions about your disease or treatment. They have the best overview of your treatment and situation. www.multipelskleros.nu provides more information and reports on MS. More information on TYSABRI: read the patient information leaflet on FASS.se. See also www.tysabripatientinfo.se 13
QUESTIONS I MUST REMEMBER TO ASK THE DOCTOR 14
TERMINOLOGY Antibody Proteins that are used by the body s immune system to detect and identify foreign substances such as viruses or bacteria. If the body forms antibodies against a given substance this is a sign that the substance is present in the body. Autoimmune disease A disease in which the immune system attacks the body s own tissues. Examples include MS and rheumatoid arthritis. Axon Nerve fibre that links nerve cells together with other cells Central nervous system (CNS) Comprises the brain and spinal cord and acts as the body s control and communication centre. Cognition The capacity to think, plan and remember. Disease-modifying drug A medicine that slows the progression of a chronic disease. TYSABRI is an example of a disease-modifying drug. Function impairment Reduced ability to function physically or mentally. Immune system The collective name for the body s complex defence mechanisms against infections. Immunosuppressive drug Medicine that is used to inhibit and slow the body s immune system so that it does not reject foreign substances in the body, for example after a transplant. Inflammation Reaction to damage to a tissue. Infusion Supply of a medicine, for example through a drip into a blood vessel in the arm. JC virus, JCV A virus that is carried by about half the population without it causing disease. When treated with TYSABRI, the JC virus has been shown to give an increased risk of developing PML. Multiple sclerosis Means many scars, and denotes the scars in the nervous tissue after the inflammatory reaction has ceased. Myelin The fatty sheath that protects the nerve fibres and makes it possible for the electrical signals to travel through the nerve fibres. Damage to the myelin makes it difficult for the signals to travel through the fibres. Natalizumab The active substance in TYSABRI. Natalizumab is an antibody that is similar to the antibodies produced by the body. Nerve Expressed simply, it is a type of cell that sends signals from various parts of the body to the brain and from the brain out to the body. Nerve fibre Another name for an axon, a projection on a nerve cell through which signals are sent to other cells. Patient information leaflet The printed information that is enclosed with a medicine. This information is also available on FASS.se. Placebo A medicine that does not contain any active ingredients. Is used for comparison in medical trials when studying the effect of a given medicine. PML Progressive multifocal leukoencephalopathy is a rare and serious virus infection in the brain. Quality of life The term quality of life is used to measure the subjective feeling of having a good life. This can be studied over time using various methods. Relapse A disease episode with a period of worsening due to new damage to the myelin. Side effect An unexpected or unintended effect of a medicine. 15
The information in this brochure is intended to form part of the information on TYSABRI provided for the patient by the treating doctor. The text is based on the patient information leaflet and the Summary of Product Characteristics for TYSABRI. See also www.fass.se TY-SWE-0191 / November 2015 TYSABRI (natalizumab), 300 mg concentrate for solution for infusion. Read the patient information leaflet before you start treatment with TYSABRIL. This drug is under additional monitoring. t Indications: Tysabri is intended for patients with highly active relapsing-remitting multiple sclerosis in spite of treatment with beta-interferon or glatiramer acetate; or patients with rapidly developing severe relapsing-remitting multiple sclerosis. Posology and method of administration: Tysabri is administered as a 300 mg infusion every four weeks under monitoring by healthcare personnel. Special warnings and precautions for use: Treatment with TYSABRI has been associated with an increased risk for PML, progressive multifocal leukoencephalopathy. Before start of treatment with Tysabri results of magnetic resonance imaging (MRI) performed within the last three months must be available for reference. The patients must be regularly checked for new or worsened neurological symptoms or status findings that could indicate PML Contraindications: Hypersensitivity to natalizumab or any of the excipients listed in the contents. Progressive multifocal leukoencephalopathy (PML). Patients with an increased risk for opportunistic infections, including patients with a compromised immune system. Combination with beta-interferons or glatiramer acetate. Known active cancers with the exception of patients with dermal basal cell cancer. Children and adolescents less than 18 years of age. Based on the Summary of Product Characteristics: 09/2015 2015 Biogen Sweden AB Kanalvägen 12, Floor 7, 194 61 Upplands Väsby Tel. +46 08 594 113 60. Fax + 46 08 594 113 69 www.multipelskleros.nu www.biogen.se www.tysabripatientinfo.se 16