Medication Update Multiple Sclerosis Limited Acknowledgement We acknowledge and pay respect to the traditional custodians past and present on whose lands we meet today. We acknowledge the deep feelings of attachment and the relationship of Aboriginal people to country and respect the cultural authority of the elders in each community Multiple Sclerosis Limited 1
Treatment & Management of MS Medical Management Network of professional support Management of Symptoms Health Promotion to Improve Quality of Life Continual Assessment & Reassessment Multiple Sclerosis Limited Wellness Approaches ESSENTIALS for living well with MS; Exercise or physical activity Social and family connections; supportive environment Stress management, rest, recreation Employment, occupation, volunteering Nutrition and complementary health Timely medication and symptom management Intimacy and sexuality Accessing emotional and physical support Learning about MS, knowledge and personal growth Spirituality or finding meaning Multiple Sclerosis Limited 2
Treatments for MS Treating the Disease Treating Relapses Treating Symptoms Multiple Sclerosis Limited Treating the Disease Medications to change the immune processes believed to be responsible for MS The principles behind treatment are: Reducing relapse rate Increasing time between relapses Slowing the progression of disability Multiple Sclerosis Limited 3
Disease Modifying Treatments Self injected Avonex: Weekly intra-muscular Plegridy: Fortnightly sub-cutaneous Copaxone: Daily sub-cutaneous or 3 times/week Rebif: 3 times/week sub-cutaneous Betaferon: 2nd Daily sub-cutaneous Multiple Sclerosis Limited Disease Modifying Treatments Infusion Tysabri : monthly Lemtrada : complex regime Oral medication Gilenya: daily Aubagio : daily Tecfidera : twice daily Multiple Sclerosis Limited 4
Relative efficacy Changing Medication When do I need to change my MS medication? Medication side effects Control of Relapses Multiple Sclerosis Limited Efficacy versus Toxicity Tysabri Lemtrada Tecfidera Gilenya Copaxone Betaferon / Avonex / Rebif Aubagio Relative toxicity Multiple Sclerosis Limited 5
Other Disease Modifying Treatments Immunosuppressants Mitoxantrone (Novantrone) Methotrexate Multiple Sclerosis Limited Maintaining Treatment Learning the process Managing side effects Available Support MS Consultants (Registered Nurses) MS Clinics Pharmaceutical Company Specific programs Neurologist Multiple Sclerosis Limited 6
Managing Side Effects Don t be afraid to ask - any changes - anything new Seek regular reviews - injection site reactions - flu like symptoms - regular blood tests depending on medications - other possible side effects Multiple Sclerosis Limited What is a Relapse? Relapses last at least 24 hours Must rule out pseudo-relapses (sepsis, temperature rise) At least 30 days should separate onset of separate relapses Resource available: Managing a Relapse Multiple Sclerosis Limited 7
Treatment of Acute Relapses Exclude pseudo exacerbation Individual Assessment Treatment IV Steroids Oral Steroids Multiple Sclerosis Limited Treating Symptoms Bladder and Bowel Neurological pain Spasticity Mobility Sexual dysfunction Fatigue Altered sensation Multiple Sclerosis Limited 8
Summary Medications for disease process Medications for symptom management complementary therapies Medication for other conditions Side effects Interplay between medications Impact on symptoms Multiple Sclerosis Limited Future Directions Myelin repair and regeneration Stem cell therapy to reset the immune system Clinical Trials Multiple Sclerosis Limited 9
The symptoms of MS vary from person to person. A person s symptoms of MS vary over time. Every person is an individual and requires a personalised management plan. Multiple Sclerosis Limited Contacts MS Connect 1800 042 138 MSConnect@ms.org.au www.ms.org.au Multiple Sclerosis Limited 10
Treatments for MS: Immunotherapy There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. Gilenya (fingolimod) Gilenya belongs to a class of medications call sphingosine 1-phosphate (s1p) receptor modulator. The active ingredient in Gilenya is fingolimod. Gilenya acts on certain types of white blood cells called lymphocytes. In multiple sclerosis, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds the nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Gilenya helps prevent lymphocytes leaving the lymph nodes. This lowers the number of Lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. Gilenya has been shown in clinical trials to: Reduce the frequency of relapses 1,2 Delay progression of physical disability 1,2 There is also evidence it may have a direct effect in enhancing re-myelination of damaged nerve cells. Glatiramer acetate (Copaxone ) Copaxone is a synthetic protein made up of a combination of four amino acids, which are the natural building blocks of protein in the body. It is thought to work by connecting cells to stop them attacking the myelin. It is administered by a daily injection given under the skin. In Australia, glatiramer acetate is sold under the brand name Copaxone. My Support Team is a telephone helpline (call 1800 502 802) run by CSL Biotherapies for people using this treatment. In clinical trials Copaxone has been shown to: delay the onset of definite MS after a first time experience of symptoms that suggests MS 4 Glatiramer acetate is not an interferon so it does not have any flu-like side effects. Some discomfort at the injection site may be experienced and this can usually be managed by the use of heat or cold packs prior to injecting and carefully rotating injection sites. On rare occasions, a post-injection reaction has been experienced by some people, where they experience a sense of panic shortly after injecting. This passes quickly reduce the frequency of relapses 3. delay progression of physical disability 3. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia
Treatments for MS: Immunotherapy continued Interferon beta (Avonex, Betaferon, Rebif ) Interferons are proteins that occur naturally in the body. They help fight viral infections and regulate the immune system. It is thought interferon beta may reduce immune responses directed at myelin. These medications are given as an injection either just under the skin or into the muscle. In Australia, there are three different types of interferon beta available. Each type is sold under a different brand name: Avonex (interferon beta-1a): An injection into the muscle once per week. The Avonex Alliance is a telephone helpline (call 1800 286 639) run by Biogen Idec Australia. Betaferon (interferon beta-1b): An injection given under the skin every second day. Betaplus is a telephone helpline (call 1800 557 960) run by Bayer Australia. Rebif (interferon beta-1a): Injected under the skin three times per week. Rebif Extracare is a telephone helpline (call 1800 073 243) run by Merck Serono Australia. In clinical trials interferon beta has been shown to: reduce the frequency and severity of relapses 5,6,7. slow the rate of disease progression and physical disability 6,7. delay the onset of definite MS after a first time experience of symptoms that suggests MS 8,9. All the interferons may give you mild flu-like symptoms (e.g. chills, fever, head/muscle aches and sweating) when you don t actually have the flu. These side effects are usually easily managed by taking paracetamol or ibuprofen pain relief prior to injecting and they generally settle after a period of time. On rare occasions, some people may develop liver, blood or thyroid problems, allergic reactions or depression. Some irritation and discomfort may be experienced at the injection site. This can be managed by using a heat or cold pack prior to injecting and by applying a soothing cream or lotion after the injection if required. Tecfidera (dimethyl fumarate) Tecfidera (dimethyl fumarate) - previously known as BG-12 - is an oral treatment for Australian patients with relapsing-remitting multiple sclerosis (MS). The recommended starting dose of Tecfidera is 120mg, twice daily. After 7 days the dose may be increased to the recommended dose of 240mg twice daily. Tecfidera has been shown to have antiinflammatory and neuro-protective properties. It is thought that Tecfidera works in MS by inhibiting immune cells and molecules, and may have antioxidant properties that protect the brain and spinal cord from damage. Clinical trials have shown it can reduce relapse rates and delay the progression of disability in people with relapsing remitting MS. In clinical trials of Tecfidera, the most common side-effects experienced were flushing, diarrhea, nausea and abdominal pain. Less common but more serious side-effects include more severe gastrointestinal side-effects, effects on the kidneys and liver, and reduced white blood cell counts. While increased frequencies of infection were not seen in clinical trials, it is recommended that patients on Tecfidera have their white blood cell counts monitored at least annually. Tecfidera has not been tested in people under the age of 18 or in women who are pregnant or breastfeeding. Women who are pregnant, planning pregnancy or breastfeeding should seek advice from their doctor. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 2
Treatments for MS: Immunotherapy continued Natalizumab (Tysabri ) Natalizumab belongs to a class of medications called monoclonal antibodies (MABs) which are a type of protein. Natalizumab works by attaching to the surface of specific immune cells. It then indicates to the body that these cells should not cross from the blood stream into the central nervous system (the brain and spinal cord), where they could attack the myelin sheath. This treatment is administered through the veins (intravenous infusion) once a month. In Australia, natalizumab is sold under the brand name Tysabri. Tysabri Linked Care is a patient support program (call 1800 897 227) run by Biogen Idec Australia. In clinical trials, natalizumab has been shown to: The most common possible side effects are joint pain, fever, blocked or runny nose, tiredness, nausea, headache and dizziness. A rare but serious brain infection, progressive multifocal leucoencephalopathy (PML), has occurred in a very small percentage of people taking natalizumab. There are tests to help determine your individual risk of developing PML. Your neurologist can provide you with more information about these tests. To reduce the risk of people developing PML, and to make sure that PML is picked up as quickly as possible in people who develop the condition, there are strict safety protocols in place which include an observation period after your infusion.neurologist. reduce the frequency of relapses 10. slow the rate of disease progression and physical disability 10. Teriflunomide (Aubagio ) Teriflunomide belongs to a class of medications called pyrimidine synthesis inhibitors. It is a film coated tablet taken daily by mouth. Teriflunomide acts by interrupting the lifecycle of certain types of white blood cells, called lymphocytes. In MS, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Teriflunomide works by reducing the production of an enzyme (a type of protein) which lymphocytes, need to divide and mature. This lowers the number of lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. In Australia, teriflunomide is sold under the brand name Aubagio. In clinical trials teriflunomide has been shown to: reduce the frequency of relapses11,12. delay progression of physical disability11,12. Side effects include Nausea, abnormal liver tests, diarrhoea and hair thinning or loss. On rare occasions, some people may develop liver skin or blood problems, increased blood pressure or pain. Teriflunomide interacts with ingredients in some oral contraceptive pills so it is important to discuss with your doctor the type of contraceptive pill you are taking if you are. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 3
Treatments for MS: Immunotherapy continued Lemtrada (alemtuzumab) Lemtrada is in a class of medications called monoclonal antibodies, which means it can bind specifically to molecules present on the surface of cells. Lemtrada works by binding to CD52 molecules which are present on the surface of B and T cells of the immune system and once it is bound, the body s own immune system destroys those cells. Since B and T cells are known to play a role in the disease process of MS, depleting B and T cells in the circulation may slow the disease process in some individuals. Lemtrada is used to treat relapsing forms of MS in adults with active disease. Lemtrada is not recommended for patients with inactive disease or those who are stable on their current therapy. Lemtrada is a liquid preparation which is given by intravenous infusion in two treatment courses one year apart. The first course consists of infusions given over five consecutive days, the second course consists of infusions given over three days. Due to potential side effects, once you have received Lemtrada you will need to undergo regular monitoring so that any side effects can be detected and treated promptly. Monitoring must continue for four years after the last infusion. In clinical trials, Lemtrada has been shown to: Reduce the frequency of relapses when compared with interferon beta treatment Delay the progression of disability in some people when compared to interferon beta treatment. 13,14 The treatment does have side effects including infusion-associated reactions (such as headache, rash and nausea), lowered blood cell counts and infections. Serious autoimmune side effects include: An overactive or underactive thyroid gland, leading to thyroid-related side effects. These side effects are treatable but can require careful monitoring and lifelong thyroid medication. A blood clotting disorder known as immune thrombocytopenic purpura (ITP), which is caused by low numbers of platelets in the blood. This can lead to internal bleeding. ITP can be fatal, but monitoring strategies enable ITP to be detected early and treated appropriately.13, 14 There is an increase in the risk of infection with Lemtrada treatment, though the incidence of serious infections in clinical trials was low. Lemtrada has not been tested in women who are pregnant. Women of childbearing age should use effective birth control measures when receiving a course of treatment with Lemtrada and for 4 months following that course of treatment. For more information on these treatments or other treatments in MS Speak to your neurologist about what treatment best suits your individual circumstances. MS Nurses also provide information, training and ongoing support in managing your immunotherapy. Contact your state office on 1800 042 138 or visit www.msaustralia.org.au for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials in MS. Visit www.msra.org.au for more information. Making Sense of MS Research provides plain language summaries of independent, high-quality research about MS treatments. Visit www.makingsenseofmsresearch.org.au INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 4
Treatments for MS: Immunotherapy continued For information about MS and MS Australia services: Freecall: 1800 042 138 Web: www.msaustralia.org.au Disclaimer: Information contained in this fact sheet is intended to provide useful and accurate information of a general nature for the reader but is not intended to be a substitute for legal or medical advice. MS Australia is not recommending medical or legal advice and readers must seek their own medical or legal advice as may be appropriate. Printing and photocopying this publication in its original form is permitted for educational purposes only. Reproduction in any other form without written permission is prohibited. References 1) Kappos L, Raude EW, O Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. NEJM 2010;362:387-401. 2) Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. NEJM 2010;362:402-15. 3) Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis. Neurol 1995;45:1268-76. 4) Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome. Lancet 2009;374:1503-11. 5) Jacobs LD, Cookfair DL, Rudick R A et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-94. 6) INFB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurol 1993;43:655-61. 7) PRISMS Study Group. Randomised double-blind placebo controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-504. 8) Jacobs LD, Beck RW, Simon JH et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. NEJM 2000;343:898-904. 9) Kappos L, Polman CH, Freedman MS et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurol 2006;67:1242-9. 10) Polman CH, O Connor PW, Havrdova E et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. NEJM 2006;354:899-910. 11) O Connor PW, Li D, Freedman MS et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurol 2006:66:894-900 12) 12. O Connor P, Wolinsky JS, Confavreux C et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis NEJM 2011; 365: 1293-303 13) Cohen JA, Coles AJ, Arnold DL et al., Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1819-28. 14) Coles AJ, Twyman CL, Arnold DL et al., Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1829-39. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 5
Treatments for MS: Aubagio (Teriflunomide) There are currently nine disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Aubagio (Teriflunomide) and how does it work? Aubagio belongs to a class of medications called pyrimidine synthesis inhibitors. It is a film coated oral tablet taken once daily. It acts by interrupting the lifecycle of certain types of white blood cells, called lymphocytes. In MS, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Aubagio works by reducing the production of an enzyme (a type of protein) which lymphocytes, need to divide and mature. This lowers the number of lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. In Australia, teriflunomide is sold under the brand name Aubagio. In clinical trials Aubagio has been shown to: reduce the frequency of relapses 11. delay progression of physical disability 11. The treatment does have side effects. More common side effects include nausea, elevated liver enzymes, diarrhoea and hair thinning or loss. Less frequent effects include increased blood pressure and skin disorders. On rare occasions some people may develop liver or blood problems. Based on animal studies Aubagio may cause birth defects if used during pregnancy. It should not be taken by pregnant women, or women of childbearing age who are not using effective birth control. How is Aubagio (Teriflunomide) supplied? Aubagio has been approved by the Therapeutic Goods Administration (TGA) and entered in the Australia Register of Therapeutic Goods (ARTG). It has also been approved for listing on the Pharmaceutical Benefits Scheme and will be available for purchase from December 1, 2013. Please discuss with your neurologist whether Aubagio (teriflunomide) is the right treatment for you. INFORMATION FOR PEOPLE LIVING WITH MS November 2013 Multiple Sclerosis Australia
Treatments for MS: teriflunomide continued For more information on this treatment or other MS treatments Speak to your neurologist about what treatment best suits your individual circumstances. For more information about teriflunomide visit: www.msra.org.au/tga-registers-teriflunomide Our MS Nurses also provide information, training and ongoing support in managing your immunotherapy. Contact your state office on 1800 042 138 or visit www.msaustralia.org.au for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials in MS. Visit www.msra.org.au for more information. Making Sense of MS Research provides plain language summaries of independent, high-quality research about MS treatments. Visit www.makingsenseofmsresearch.org.au MS One to One is a patient support program run by Genzyme, a Sanofi company, for people using Aubagio (call 1800 222 121 or speak to your neurologist or MS nurse for further information). In Australia, Aubagio is supplied by: genzyme, a sanofi company Building D 12-24 Talavera Rd Macquarie Park NSW - 2113 For information about MS and MS Australia services: Call MS Connect: 1800 042 138 Web: www.msaustralia.org.au References 1. O Connor PW, Li D, Freedman MS et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurol 2006:66:894-900 2. O Connor P, Wolinsky JS, Confavreux C et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis NEJM 2011; 365: 1293-303 Disclaimer: Information contained in this fact sheet, prepared by Multiple Sclerosis Limited, is intended to provide useful and accurate information of a general nature for the reader but is not intended to be a substitute for legal or medical advice. Multiple Sclerosis Limited is not recommending medical or legal advice and readers must seek their own medical or legal advice as may be appropriate. Printing and photocopying this publication in its original form is permitted for educational purposes only. Reproduction in any other form without written permission is prohibited. 2 INFORMATION FOR PEOPLE LIVING WITH MS November 2013 Multiple Sclerosis Australia
Treatments for MS: Avonex There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Avonex and how does it work with MS? Avonex is interferon beta-1a. Interferons are proteins produced naturally in the human body to help fight infections and regulate the immune system. Beta interferons have been shown to slow down activity and disease progression in MS. They do this by helping regulate the immune system, reducing attacks on myelin or nerves. Researchers are still investigating exactly how this process works. Clinical trials found that Avonex (interferon beta -1a) has a significant beneficial effect in people with relapsing-remitting multiple sclerosis by reducing the accumulation of permanent physical disability, exacerbation frequency and disease activity measured by gadolinium-enhanced lesions on brain magnetic resonance images (MRI). If you would like information about the results of the trials please contact your local MS organisation. How is Avonex administered? Avonex is taken weekly. You will receive a month s supply in a box, which will consist of four injections. Avonex is available through the Pharmaceutical Benefits Scheme (PBS). As it is a very expensive medication, your doctor will need to obtain an authority to prescribe the medication for you, and only a neurologist can write your first prescription. There are a number of criteria you must meet before your doctor receives authority to write this prescription. For details of the criteria you need to meet to receive Avonex through the PBS, please visit the official PBS website at: www.pbs.gov.au How much does Avonex cost? If you are eligible for medications through the PBS, you will need to pay a contribution fee for each month s supply. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card and the number of prescriptions you have had dispensed in a year. The amount of this fee is set each year by the Federal Government. In 2009 the fee for people with a Medicare card is $32.90. The fee is $5.30 for people with a Medicare card and a pension or concession card. INFORMATION FOR PEOPLE LIVING WITH MS August 2013 Multiple Sclerosis Australia 2013 1
Avonex continued Further information about the PBS and your entitlements is available through the Medicare Australia website at: www.medicare.gov.au If you are not eligible for Avonex through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. This means you will have to pay the full cost at the pharmacy that dispenses your medication. The cost is likely to be over $1000 per month. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS. General Information Most pharmacies will not keep Avonex in stock. Instead they will place an order with the manufacturer to have stock delivered especially for you. It is therefore important to let your pharmacist know a few days before you need the medication. Avonex Bioset vials needs to be stored below 25 C. Avonex prefilled syringes need to be kept between 2-8 C. If the outside temperature is warm it is a good idea to take your medication home in an ice cooler. Your pharmacist may be able to assist with this. Biogen Idec runs a toll free helpline called The Avonex Alliance 1800 286 639 Avonex is manufactured by: Biogen Idec Australia Pty Ltd Suite 2, Level 4 123 Epping Road North Ryde NSW - 2113 For more information on MS and other MS treatments: Speak to your neurologist about what treatment best suits your individual circumstances. For information about MS, MS treatments and to find contact details for your state MS organisation visit www.msaustralia.org.au. MS Nurses at you state MS organisation can also provide information, training and ongoing support in managing your immunotherapy. Contact your state office for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials at www.msra.org.au Please note: MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects, should be made in careful consultation with the person s neurologist. 2 INFORMATION FOR PEOPLE LIVING WITH MS Updated January 2014 Multiple Sclerosis Australia
Treatments for MS: Betaferon There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Betaferon and how does it work with MS? The active ingredient of Betaferon is interferon beta-1b. Interferons are proteins produced naturally in the human body to help fight infections and regulate the immune system. Beta interferons have been shown to slow down activity and disease progression in MS. They do this by helping regulate the immune system, reducing attacks on myelin or nerves. Researchers are still investigating exactly how this process works. Clinical trials found that Betaferon (interferon beta -1b) has a significant beneficial effect in people with relapsing-remitting multiple sclerosis by reducing the accumulation of permanent physical disability, exacerbation frequency and disease activity measured by gadolinium-enhanced lesions on brain magnetic resonance images (MRI). If you would like information about the results of the trials, please contact your local MS organisation. How is Betaferon administered? Betaferon is taken every second day. A month s supply consists of fifteen injections. Betaferon is available through the Pharmaceutical Benefits Scheme (PBS). As it is a very expensive medication, your doctor will need to gain an authority to prescribe the medication for you, and only a neurologist can write your first prescription. There are a number of criteria you must meet before your doctor can obtain authority to write this prescription. Further details of the criteria you need to meet to receive Betaferon through the PBS are available from the official PBS website at: www.pbs.gov.au How much does Betaferon cost? If you are eligible for medications through the PBS, you will need to pay a contribution fee for each month s supply. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card and the number of prescriptions you have had dispensed in a year. The amount of this fee is set each year by the Federal Government. The fee in 2009 for people with a Medicare card is $32.90. The fee is $5.30 for people with a Medicare card and a pension or concession card. Information about the PBS and your entitlements is available on the Medicare Australia website at: www.medicare.gov.au INFORMATION FOR PEOPLE LIVING WITH MS January 2014 Multiple Sclerosis Australia 2013 1
Betaferon If you are not eligible for Betaferon through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. This means you will have to pay the full cost to the pharmacy that dispenses your medication. The cost is likely to be over $1000 per month. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS. General Information Most pharmacies will not keep Betaferon in stock. Instead they will place an order with the manufacturer to have stock delivered especially for you. This means it is important to let your pharmacist know a few days before you need the medication. Betaferon needs to be stored below 25 C. If the outside temperature is warm it is a good idea to take your medication home in an ice cooler. Your pharmacist may be able to assist with this. Bayer Australia runs a toll free helpline called Betaplus 1800 557 960 Betaferon is manufactured by: Bayer Australia Ltd. 875 Pacific Hwy Pymble 2073 For more information on MS and other MS treatments: Speak to your neurologist about what treatment best suits your individual circumstances. For information about MS, MS treatments and to find contact details for your state MS organisation visit www.msaustralia.org.au. MS Nurses at you state MS organisation can also provide information, training and ongoing support in managing your immunotherapy. Contact your state office for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials at www.msra.org.au Please note: MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects, should be made in careful consultation with the person s neurologist. 2 INFORMATION FOR PEOPLE LIVING WITH MS Updated January 2014 Multiple Sclerosis Australia
Treatments for specific MS symptoms: Botox (botulinum toxin type A) There are therapies available for treating specific symptoms of MS that work without altering the course of the disease. This includes treatments for muscle problems such as stiffness and tremors, fatigue, neurological symptoms such as visual disturbances, incontinence and neuropsychological problems such as depression, anxiety or memory difficulties. What is Botox (botulinum toxin type A) and how does it work? Botox is a pharmaceutical preparation of the botulinum toxin type A produced by the bacterium Clostridium botulinum, which has muscle relaxant properties. It can be used in people with MS for the relief of focal muscle spasticity (spasticity that is localised to a particular region of the body such as the hand, arm or leg) and for the treatment of urinary incontinence due to neurogenic overactivity of the detrusor muscle. This fact sheet refers only to the use of Botox for urinary incontinence. For the treatment of urinary incontinence, Botox is generally offered only to patients for whom other treatments, such as anticholinergics, have failed. Botox works by temporarily relaxing overactive muscles. It is administered through an injection directly into the muscle, in the case of urinary incontinence, injections are made directly into the bladder wall (the detrusor muscle). The treatment is administered by a doctor in the form of multiple injections into the muscle using a specific instrument called a cytoscope. The total Botox dose is 200 units. Botox usually begins to work within two weeks of the injection and lasts between 8-10 months for urinary incontinence due to neurogenic detrusor overactivity. Once the effects begin to wear off, the treatment can be repeated, but not more often than every three months. In Australia, botulinum toxin type A is sold under the brand name Botox. In clinical trials Botox has been shown to: reduce the number of urinary incontinence episodes1 improve urodynamic measures such as maximum capacity to contract and expel urine, maximum detrusor muscle pressure and improve Incontinence Quality of Life total scores1 The treatment does have side effects. Common side effects include urinary tract infection and urinary retention. Intermittent self-catheterisation may be necessary. Other side effects include difficulty sleeping, constipation, muscle weakness and spasm, bulge in the bladder wall, tiredness and problems with walking and falls. There may also be side effects directly related to the injection procedure such as blood in the urine after the injection. Botox is not recommended during pregnancy. It should not be taken by pregnant women or women of childbearing age who are not using effective birth control. How is Botox supplied? Botox was approved by the Therapeutic Goods Administration for the treatment of urinary incontinence due to neurogenic detrusor overactivity in MS in 2012. Botox became available on the Pharmaceutical Benefit Scheme (PBS) on 1 October 2013. For details of the criteria required to receive a prescription for Botox treatment through the PBS, please visit the official PBS website at: www.pbs.gov.au INFORMATION FOR PEOPLE LIVING WITH MS September 2013 Multiple Sclerosis Australia 2013 1
Botox continued How much does Botox cost? For people eligible for medications through the PBS, patients will need to pay a contribution fee for each supply. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not individuals have a pension or concession card and the number of prescriptions dispensed in a year. The amount of this fee is set each year by the Federal Government. In 2013 the fee for people with a Medicare card is $36.10. The fee is $5.90 for people with a Medicare card and a pension or concession card. Further information about the PBS and your entitlements is available through the Medicare Australia website at: www.medicare.gov.au For people who are not eligible for Botox through the PBS, for example visitors from overseas, a neurologist, urologist or urogynaecologist may write a private prescription and the patient will have to pay the full cost at the pharmacy that dispenses your medication. Pharmacists can provide a quote for the price of any medication which is not subsidised by the PBS. For more information on this treatment or other treatments Speak to your neurologist about what treatment best suits your individual circumstances. For more information on Botox visit http://www.msra.org.au/botox-treatment-urinary-incontinence-pbs MS Nurses at the state MS societies can also provide information about symptomatic treatment options. Visit www.msaustralia.org.au for more information and contact details for state MS Societies. MS Research Australia provides information on the latest research and clinical trials in MS. Visit www.msra.org.au for more information. Making Sense of MS Research provides plain language summaries of independent, high quality research about MS treatments. Visit www.makingsenseofmsresearch.org.au In Australia Botox is supplied by: Allergan Australia Pty Ltd Level 4, 810 Pacific Highway Gordon NSW 2072 Reference: 1. Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag- Molkenteller C. Efficacy and safety of onabotulinumtoxina in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011; 60(4):742-50. 2 INFORMATION FOR PEOPLE LIVING WITH MS Multiple Sclerosis Australia 2013
Treatments for MS: Copaxone There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Copaxone and how does it work with MS? The active ingredient in Copaxone is glatiramer acetate. Glatiramer acetate is a mix of four amino acids which form a protein very similar to the basic protein which makes up myelin. Glatiramer acetate appears to block myelin-specific autoimmune responses. Researchers are still investigating exactly how this process works. Glatiramer acetate is a different class of medication to the interferons. Clinical trials found that Copaxone (glatiramer acetate) has a significant beneficial effect in people with relapsing-remitting multiple sclerosis by reducing the accumulation of permanent physical disability, exacerbation frequency and disease activity measured by gadolinium-enhanced lesions on brain magnetic resonance images (MRI). If you would like information about the results of the trials please contact your local MS organisation.. How is Copaxone administered? Copaxone is taken every day. You will receive a month s supply which will consist of twenty-eight injections. Copaxone is available through the Pharmaceutical Benefits Scheme (PBS). As it is a very expensive medication, your doctor will need to obtain an authority to prescribe the medication for you, and only a neurologist can write your first prescription. There are a number of criteria you must meet before your doctor can receive authority to write this prescription. Details of the criteria you need to meet to get Copaxone through the PBS can be accessed from the official PBS website at: www.pbs.gov.au How much does Copaxone cost? If you are eligible for medications through the PBS, you will need to pay a contribution fee for each month s supply. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card and the number of prescriptions you have had dispensed in a year. The amount of this fee is set each year by the government. In 2009 the fee for people with a Medicare card is $32.90. The fee is $5.30 for people with a Medicare card and a pension or concession card. INFORMATION FOR PEOPLE LIVING WITH MS Updated January 2014 Multiple Sclerosis Australia
Copaxone Further information about the PBS and your entitlements can be viewed on the Medicare Australia website at: www.medicare.gov.au If you are not eligible for Copaxone through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. You will have to pay the full cost to the pharmacy that dispenses your medication. The cost is likely to be over $1000 per month. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS. General Information Most pharmacies do not keep Copaxone? in stock. Instead they will place an order with the manufacturer to have stock delivered especially for you. It is therefore important to let your pharmacist know a few days before you need the medication. Copaxone prefilled syringes need to be kept between 2-8 C. If the outside temperature is warm it is a good idea to take your medication home in an ice cooler. Your pharmacist may be able to assist with this. Copaxone is manufactured by: CSL Limited 45 Poplar Road Parkville Vic 3052 For more information on MS and other MS treatments: Speak to your neurologist about what treatment best suits your individual circumstances. For information about MS, MS treatments and to find contact details for your state MS organisation visit www.msaustralia.org.au. MS Nurses at you state MS organisation can also provide information, training and ongoing support in managing your immunotherapy. Contact your state office for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials at www.msra.org.au Please note: MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects, should be made in careful consultation with the person s neurologist. 2 INFORMATION FOR PEOPLE LIVING WITH MS Updated January 2014 Multiple Sclerosis Australia
Treatments for MS: Gilenya (fingolimod) There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Gilenya and how does it work? Gilenya belongs to a class of medications call sphingosine 1-phosphate (s1p) receptor modulator. The active ingredient in Gilenya is fingolimod. Gilenya acts on certain types of white blood cells called lymphocytes. In multiple sclerosis, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds the nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Gilenya helps prevent lymphocytes leaving the lymph nodes. This lowers the number of Lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. Gilenya has been shown in clinical trials to: Reduce the frequency of relapses Delay progression of physical disability There is also evidence it may have a direct effect in enhancing remyelination of damaged nerve cells. How is Gilenya administered? Gilenya is taken in capsule form (0.5mg), once a day. The first does of Gilenya is given in a doctors office or clinic, where the person is observed for six hours to monitor heart rate and any adverse side effects. Following the initial dose, the person takes one capsule each day. If Gilenya therapy is discontinued for more than two weeks and reintroduced, the same process used for initial dosing is applied. How is Gilenya supplied? Gilenya is available through an Authority Prescription from your neurologist. Gilenya comes in a box which contains 28 gel capsules. Each capsule contains 0.5mg of the active ingredient, fingolimod. Gilenya needs to be stored at room temperature (below 30C) and away from moisture. Not all pharmacies keep Gilenya in stock, however, most ar able to order it for you if you notify them a few days before you need it. In Australia, Gilenya is supplied by Novartis Australia. INFORMATION FOR PEOPLE LIVING WITH MS November 2013 Multiple Sclerosis Australia
How much does Gilenya cost? Gilenya is approved under the Pharmaceutical Benefits Scheme (PBS) which means the cost of this medication is subsidised by Medicare Australia. If you are eligible for medications through the PBS, you still need to pay a patient contribution each time your prescription is dispensed. For more information about the PBS speak to your pharmacist or visit www.medicareaustralia.gov.au. What are the potential side effects of Gilenya? Gilenya was generally well tolerated by participants in clinical trials. The most common side effects included headache, influenza, infection, diarrhea, back pain, abnormal liver, enzyme levels and coughing. Less common but potentially serious side effects included slow heart rate (when starting treatment), breathing difficulties, increased risk of infection, and macular oedema (swelling in the back of the eye). To reduce the risk of people developing any one of these serious side effects and to ensure that they are identified as quickly as possible in people who develop them, there are strict safety protocols in place. These include a number of screening tests before you are prescribed Gilenya and an observation period after your initial capsule. Your neurologist or clinic staff can provide you with more information about this process. Your doctor or pharmacist can provide comprehensive information on the safe use of Gilenya, precautions and a complete list of common and more serious side effects. Gilenya has not been tested in people under the age of 18 or in women who are pregnant or breastfeeding; therefore the side effects are unknown in these groups. Despite the clinical trials, the safety, tolerability and efficacy of Gilenya beyond two years and any long-term side effects are still unknown. The prescription of Gilenya is based on strict criteria and the medical opinion and close supervision of a treating neurologist. For more information: Speak to your neurologist about what treatment best suits your individual circumstances. MS Research Australia (MSRA) provides information on the latest research and clinical trials in MS. Visit www.msra.org.au for more information. For information about MS and MS Australia services: Call MS Connect: 1800 042 138 Web: www.msaustralia.org.au Disclaimer: Information contained in this fact sheet is intended to provide useful and accurate information of a general nature for the reader but is not intended to be a substitute for legal or medical advice. Multiple Sclerosis Australia is not recommending medical or legal advice and readers must seek their own medical or legal advice as may be appropriate. Printing and photocopying this publication in its original form is permitted for educational purposes only. Reproduction in any other form without written permission is prohibited. INFORMATION FOR PEOPLE LIVING WITH MS November 2013 Multiples Sclerosis Australia 2
Treatments for MS: Lemtrada (alemtuzumab) There is a range of disease modifying therapies approved for people with MS in Australia. These therapies, also called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. What is Lemtrada (alemtuzumab) and how does it work? Lemtrada is in a class of medications called monoclonal antibodies, which means it can bind specifically to molecules present on the surface of cells. Lemtrada works by binding to CD52 molecules which are present on the surface of B and T cells of the immune system and once it is bound, the body s own immune system destroys those cells. Since B and T cells are known to play a role in the disease process of MS, depleting B and T cells in the circulation may slow the disease process in some individuals. Lemtrada is used to treat relapsing forms of MS in adults with active disease. Lemtrada is not recommended for patients with inactive disease or those who are stable on their current therapy. Lemtrada is a liquid preparation which is given by intravenous infusion in two treatment courses one year apart. The first course consists of infusions given over five consecutive days, the second course consists of infusions given over three days. Due to potential side effects, once you have received Lemtrada you will need to undergo regular monitoring so that any side effects can be detected and treated promptly. Monitoring must continue for four years after the last infusion. In clinical trials, Lemtrada has been shown to: Reduce the frequency of relapses when compared with interferon beta treatment1,2 The treatment does have side effects. Common side effects include infusion-associated reactions (such as headache, rash and nausea), lowered blood cell counts and infections. Serious autoimmune side effects include: An overactive or underactive thyroid gland, leading to thyroid-related side effects. These side effects are treatable but can require careful monitoring and lifelong thyroid medication. A blood clotting disorder known as immune thrombocytopenic purpura (ITP), which is caused by low numbers of platelets in the blood. This can lead to internal bleeding. ITP can be fatal, but monitoring strategies enable ITP to be detected early and treated appropriately. There is an increase in the risk of infection with Lemtrada treatment, though the incidence of serious infections in clinical trials was low. Lemtrada has not been tested in women who are pregnant. Women of childbearing age should use effective birth control measures when receiving a course of treatment with Lemtrada and for 4 months following that course of treatment. Women who are pregnant, planning pregnancy or breastfeeding should seek advice from their doctor. Delay the progression of disability in some people when compared to interferon beta treatment2 INFORMATION FOR PEOPLE LIVING WITH MS January 2014 Multiple Sclerosis Australia