How are unresolved Myasthenia Gravis symptoms disrupting your day? Talk to your doctor about your symptoms
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- Beatrix Mosley
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1 How are unresolved Myasthenia Gravis symptoms disrupting your day? Talk to your doctor about your symptoms
2 Recognize the symptoms of your generalized Myasthenia Gravis (gmg) Anti-acetylcholine receptor (AchR) antibody positive gmg is the most common form of gmg, a rare autoimmune disease that can cause muscle weakness and fatigue. Unresolved symptoms of gmg are often unpredictable. Because patients may experience gmg and its complications in many different ways, the more your doctor knows about your gmg, the better your healthcare provider can support you. Talk to your doctor: About how gmg is affecting your activities of daily living To determine your antibody status To find the appropriate treatment plan for you SYMPTOMS Double vision or drooping eyelid Difficulty speaking and chewing Choking and difficulty swallowing Difficulty supporting neck Difficulty breathing at rest or with physical activity Weakness in arms and/or legs Tiredness Difficulty walking Difficulty standing IMPACTED ACTIVITIES Driving Reading Watching TV Working Talking Eating and drinking Eating and drinking Driving Exercising Sleeping Exercising Completing daily tasks Working Exercising Getting around public places Doing household chores Personal grooming Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. 2
3 Living with this disease is not easy. It takes a lot out of you. I used to wake up in the morning and take a medication to be able to chew my food and swallow without choking, or to walk a block without having to stop because I felt so tired and weak. Female patient with anti-achr+ gmg SELECT IMPORTANT SAFETY INFORMATION What is the most important information I should know about SOLIRIS? SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. 1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine. 2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible. 3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. 4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination. 5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms, eyes sensitive to light. Take on your day Soliris (eculizumab) is the first treatment approved in more than 60 years to treat anti-achr+ gmg. Soliris has been approved to treat other rare diseases for 10 years. Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections.
4 Complement plays a key role in gmg In anti-achr+ gmg, antibodies disrupt nerve-to-muscle signaling by activating a part of your immune system called complement. Under normal circumstances, complement helps the body fight off infection. 1 This is where your anti-achr autoantibodies bind to the receptors normally reserved for acetylcholine, blocking the nerve-muscle signal. NERVE Acetylcholine 2 This is where the anti-achr autoantibodies bind to multiple acetylcholine receptors at once. These receptors are taken in and degraded by the muscle cell. NEUROMUSCULAR JUNCTION AchR 3 This is where the anti-achr autoantibodies bind and activate complement. This uncontrolled 1 activation leads to postsynaptic membrane damage, resulting in a loss of AchRs, further decreasing MUSCLE SURFACE nerve-to-muscle communication, which contributes to symptoms of muscle weakness and fatigue. 2 3 MUSCLE SURFACE Anti-AchR antibody Complement When you have anti-achr+ gmg, complement activation causes damage to the muscle surface, weakening communication between muscles and nerves. Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. 4
5 Soliris (eculizumab) is the only complement inhibitor approved for anti-achr+ gmg Soliris is a complement inhibitor, which is thought to reduce complement-mediated damage at the neuromuscular junction (NMJ). NERVE S NEUROMUSCULAR JUNCTION S S S Acetylcholine AchR Anti-AchR antibody Complement MUSCLE SURFACE SELECT IMPORTANT SAFETY INFORMATION Who should not receive SOLIRIS? Do not receive SOLIRIS if you: have Talk to a meningococcal your doctor about whether infection. Soliris is an option for you. have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See What is the most important information I should know about SOLIRIS? S Soliris Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. Take on your day
6 Soliris (eculizumab) studies showed improvement in anti-achr+ gmg patients who responded by 12 weeks In clinical trials, Soliris was shown to improve activities of daily living (MG-ADL) and muscle weakness (QMG) in patients who had unresolved symptoms despite multiple treatments. Improvement in patients MG-ADL score through 52 weeks REGAIN Extension study Weeks IMPROVEMENT a Placebo to Soliris crossover Patients previously treated with placebo switched to Soliris and continued to see improvement through 52 weeks Soliris Placebo Placebo to Soliris Double-blind phase Double-blind induction Open-label Soliris 62 patients received Soliris 63 patients received placebo 56 Soliris-treated patients remained on Soliris 61 placebo-treated patients switched to Soliris a Change from baseline in MG-ADL total score (95% CI). Over 90% of the patients in the Soliris trial were MGFA Stage II or III. Muscle and joint pain were the most common side effects of Soliris. The most common side effects in people with gmg treated with Soliris reported in the clinical trial over 26 weeks included muscle and joint (musculoskeletal) pain ( 10%). Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. 6
7 Soliris is given through an intravenous infusion (IV) Dosing occurs in 2 phases. Initially, infusions are given weekly for 4 weeks, followed by a fifth dose 1 week later. Then, ongoing infusions are given every 2 weeks. Each infusion lasts about 35 minutes. Soliris treatment schedule Maintenance therapy Serious allergic reactions can happen during your Soliris infusion. Tell your doctor or nurse right away if you experience any of these symptoms during your Soliris infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; or if you feel faint or pass out. If you have an allergic reaction to Soliris, your doctor may need to slow or stop the infusion. After each infusion, you should be monitored for at least 1 hour for allergic reactions. If your doctor decides that Soliris is right for you, he or she may have you sign a form to get started on treatment. Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. Take on your day
8 Meningococcus is a serious infection that can be life-threatening* Because of the way Soliris (eculizumab) works to treat gmg, it can lower your body s ability to fight infections. It s very important to make sure you do not leave yourself open to certain infections while receiving treatment. If you have had a meningococcal vaccine in the past, talk to your doctor, as you may need an additional vaccination before starting Soliris. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. * Talk to your doctor about where you can get a meningococcal vaccine. In most cases, this vaccination can be given at a doctor s office, a retail pharmacy, or a travel center. You must have a meningococcal vaccine at least 2 weeks prior to starting treatment with Soliris. Signs and symptoms of a meningococcal infection include: Headache with nausea or vomiting Headache and fever Headache with a stiff neck or stiff back Fever Fever and a rash Confusion Muscle aches with flu-like symptoms Eyes sensitive to light Tell your doctor immediately if you experience any of these symptoms during your Soliris infusion. Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. 8
9 OneSource is here to help Your healthcare team is your best resource when it comes to support and information about your anti-achr+ gmg. If your doctor decides Soliris is an option for you, you may be assigned a Nurse Case Manager from OneSource, a complimentary, personalized patient support program from the makers of Soliris. Your OneSource team can help with: Disease information Health insurance navigation Treatment logistics Connecting you to others in your community living with gmg My Nurse Case Manager from OneSource reached out and wanted to know how I felt and if there was anything that she could do to help me. It was very reassuring for me to know that I could reach out to her with any questions or concerns. If she couldn t answer my question, she quickly directed me to the right resources. Female patient with anti-achr+ gmg Patient Safety Card Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly. Learn more about OneSource at AlexionOneSource.com, or call to connect with the OneSource Nurse Case Manager Team. Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. Take on your day
10 Indication & Important Safety Information for SOLIRIS (eculizumab) INDICATION What is SOLIRIS? SOLIRIS is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat: adults with a disease called generalized Myasthenia Gravis (gmg) who are anti-acetylcholine receptor (AchR) antibody positive It is not known if SOLIRIS is safe and effective in children with gmg. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SOLIRIS? SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. 1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine. 2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible. 3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. 4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination. 5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting headache and fever headache with a stiff neck or stiff back fever fever and a rash confusion muscle aches with flu-like symptoms eyes sensitive to light Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly. SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection give you information about the symptoms of meningococcal infection give you a Patient Safety Card about your risk of meningococcal infection, as discussed above make sure that you are vaccinated with a meningococcal vaccine Please see accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. 10
11 SOLIRIS may also increase the risk of other types of serious infections. If your child is treated with SOLIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count. Who should not receive SOLIRIS? Do not receive SOLIRIS if you: have a meningococcal infection. have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See What is the most important information I should know about SOLIRIS? Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever. are pregnant or plan to become pregnant. It is not known if SOLIRIS will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects. It is important that you: have all recommended vaccinations before you start SOLIRIS receive 2 weeks of antibiotics if you immediately start SOLIRIS stay up-to-date with all recommended vaccinations during treatment with SOLIRIS Know the medications you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine. What are the possible side effects of SOLIRIS? SOLIRIS can cause serious side effects including: See What is the most important information I should know about SOLIRIS? Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain trouble breathing or shortness of breath swelling of your face, tongue, or throat feel faint or pass out If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See How will I receive SOLIRIS? in the Medication Guide. The most common side effects in people with gmg treated with SOLIRIS include: muscle and joint (musculoskeletal) pain Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call FDA Please see the accompanying full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. Please see accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. Take on your day
12 Talk to your doctor and take on your day Discussing your generalized Myasthenia Gravis (gmg) symptoms and how they affect daily activities is never easy, but sharing as much as you can with your doctor is very important. The more your doctor knows how you are trying to cope with your gmg, the better your healthcare provider can support you. Use this simple guide to help foster discussion with your doctor in the exam room today. Tell your doctor In the last 12 months: Number of exacerbations you have had Number of times you have stayed overnight in the hospital due to your gmg Number of times you have visited the emergency room due to your gmg Symptoms you have experienced related to your gmg Trouble with your eyes Becoming tired easily Difficulty chewing, swallowing, or speaking Weakness in arms or legs Difficulty sleeping Difficulty breathing or shortness of breath Frustration and/or depression How your gmg has impacted your social, family, or work-related activities Ask your doctor What is the antibody status of my gmg? According to Myasthenia Gravis Foundation of America (MGFA) clinical classification, what stage is my gmg? What treatment options may be available for me? Ask your doctor if Soliris (eculizumab) is right for you. Learn more at Soliris.net Please see Important Safety Information on pages 10 to 11 and accompanying full Prescribing Information and Medication Guide for Soliris, including Boxed WARNING regarding serious meningococcal infections. Soliris and Alexion are registered trademarks and OneSource is a trademark of Alexion Pharmaceuticals, Inc. Copyright 2018, Alexion Pharmaceuticals, Inc. All rights reserved. US/SOL-g/ /18 Take on your day
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