Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
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An introduction to Clinically Isolated Syndrome (CIS) If you’re facing a diagnosis of clinically isolated syndrome (or early multiple sclerosis), you probably have questions and want to know as much as you can. Your doctor is your primary resource for information, but this brochure can help you get the conversation started. Models used for illustrative purposes only. INDICATIONS BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. IMPORTANT SAFETY INFORMATION Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. Please see Important Safety Information throughout and Important Facts About BETASERON® on pages 14 and 15. For BETACONNECT™ Instructions for Use, please visit www.betaconnectifu.com, and for myBETAapp™ Instructions for Use, please visit www.mybetaappifu.com.
Understanding Clinically Isolated Syndrome What is clinically isolated syndrome (CIS)? What happens during a CIS episode? CIS is a first episode of neurologic symptoms caused by inflammation in the central nervous The location where the damage to the myelin occurs in the central nervous system will determine system. The episode must last for at least 24 hours and is considered a relapsing form of multiple what symptoms you might experience during a CIS episode. Damage can be in the spinal cord, sclerosis (MS). In fact, CIS is often referred to as early MS. optic nerve, or brain. Inflammation in the central nervous system happens when your body’s immune system When damage to the myelin occurs in the spinal cord, the onset of symptoms may be sudden, mistakenly attacks and damages the protective coating around your nerves, which is called myelin. developing over 1 to 2 hours, or more gradual, happening over a week or more. Symptoms can This damage prevents your nerves from sending signals to your brain, spinal cord, and other parts include muscle weakness; abnormal sensations in the toes and feet; numbness or tingling in of your body the way they should. the arms, legs, or face; bladder and bowel problems; or Lhermitte’s sign (an electric shock-like sensation when the neck is moved that is felt down the spine, and often into the arms and legs). How is CIS diagnosed? When damage to the myelin occurs in the optic nerve, the onset of symptoms may be sudden or develop over a few hours. Symptoms can include blurred vision or loss of sight, pain behind the To make a diagnosis of CIS, your doctor—most likely a neurologist— will perform a magnetic eyeball, impaired color or blind spots surrounded by an area of normal vision, or other resonance imaging (MRI) scan to look for signs of inflammation and loss of myelin in the central eye problems. nervous system. When damage to the myelin occurs in the brain, the symptoms may include nausea, vomiting, Your doctor may also perform: double vision, dizziness, hearing loss, or problems with balance or walking. • A physical examination, including a neurologic examination • A complete medical history with specific questions about your symptoms and how long you have had them Abbreviations used in this brochure • Lab tests to rule out other possible causes of your symptoms CIS–clinically isolated syndrome Occasionally, your doctor may perform a spinal tap to look at the fluid that surrounds your brain DMT–disease-modifying therapy and spinal cord. IV–intravenous MRI–magnetic resonance imaging MS–multiple sclerosis RRMS–relapsing-remitting multiple sclerosis IMPORTANT SAFETY INFORMATION (continued) INDICATIONS BETASERON can cause serious side effects, including: BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms • Liver Problems Including Liver Failure: Symptoms of liver problems may include yellowing of of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily and active secondary progressive disease, in adults. or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON. • Serious Allergic Reactions: Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may Please see Important Safety Information throughout and Important include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or Facts About BETASERON® on pages 14 and 15. skin bumps. 2 3
Understanding Clinically Isolated Syndrome How is CIS treated? What is the difference between CIS and RRMS? In some cases, treatment with a high-dose oral or intravenous (IV) steroid is recommended to Patients who experience CIS may or may not progress to other forms of relapsing MS. Relapsing- reduce symptoms caused by inflammation. Disease-modifying therapy (DMT) is recommended remitting multiple sclerosis (RRMS) is the most common form of relapsing MS (85% of patients). when CIS is considered more likely to progress. The goal of using DMT is to delay a second episode. In both CIS and RRMS, damage to the myelin interferes with the way the nerves send signals, which causes similar neurologic symptoms. The main difference, however, is that a person with CIS Is DMT effective at delaying another episode? has only experienced a first episode, while someone with RRMS has had more than one. Many large clinical studies have been conducted to prove that early treatment with DMT With CIS, MRI results may show damage in the area of the brain that is responsible for the current can delay another episode. Based on the results of these studies, the FDA has approved several symptoms. In RRMS, the MRI scan may show multiple lesions (areas of damage) in different areas medicines to treat patients in the CIS stage. of the brain. When the MRI scan shows that another episode occurred in the past, the person may be diagnosed with RRMS. Early treatment with DMT may lessen the chance of the disease progressing because of additional damage to nerve cells. Does CIS always progress? Not all people who experience CIS will go on to develop RRMS. An MRI scan is one of the most important tools used to identify the risk of the disease progressing. Studies have shown there is a high risk of developing RRMS when CIS is accompanied by brain lesions that are similar to those seen in other relapsing forms of MS. When this is the case, patients have a 60% to 80% chance of a second episode and diagnosis of RRMS within several years. Beginning treatment with disease-modifying therapy Where can I find more information? as soon as possible is recommended for patients who have CIS and have MRI results consistent with more advanced types of relapsing MS. Multiple Sclerosis Association of America myMSAA.org National Multiple Sclerosis Society nationalMSsociety.org IMPORTANT SAFETY INFORMATION (continued) • Depression or Suicidal Thoughts: Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide INDICATIONS or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, behavior or mood. and active secondary progressive disease, in adults. Other possible serious side effects with BETASERON include: • Heart Problems: BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased Please see Important Safety Information throughout and Important ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not Facts About BETASERON® on pages 14 and 15. being able to lay flat in bed. 4 5
About BETASERON® (interferon beta-1b) What is BETASERON? How can BETASERON® help? (continued) BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary MRI data from the same 2-year study Proven to reduce the number progressive disease, in adults. showed that BETASERON patients with of newly active brain lesions the first symptoms of MS had fewer BETASERON is similar to certain interferon proteins that are produced in the body and is given by newly active lesions at 2 years. 56% injection under your skin (subcutaneous injection) every other day. The exact relationship between MRI findings and the clinical status of How can BETASERON help? patients is not known. BETASERON has proven to be effective for patients who have clinically isolated syndrome. FEWER NEWLY ACTIVE LESIONS§ § Newly active lesions=nonenhancing new or enlarging T2 lesions; new In a 2-year study, 292 patients with clinically Proven to delay time to Gd-enhancing lesions. isolated syndrome* who started treatment early with BETASERON significantly reduced a second flare-up Newly active brain lesions their likelihood of having a second flare-up With BETASERON With placebo 50% compared with 176 patients on placebo.† 3.7 (292 patients) 8.5 (176 patients) *Patients included in the BENEFIT Study experienced a first neurological event LESS RISK‡ suggestive of multiple sclerosis, which is also referred to as clinically isolated syndrome. Patients also had at least 2 lesions on a T2-weighted brain MRI scan that did not cause any symptoms. Key safety information from study † A placebo looks exactly like the medicine but does not have any of the actual medicine in it. Likelihood of a second flare-up within 2 years • Most common adverse events found in the study: injection-site reactions, flu-like syndrome, ‡ By proportional hazard ratio regression headache, asthenia, leukopenia, upper respiratory tract infection, paresthesia, fever, rash, adjusted for age/gender/steroids/ With BETASERON With placebo and depression 28% 45% T2 lesions/Gd lesions. • Five patients discontinued BETASERON treatment due to abnormal liver function test results, which did not last INDICATIONS BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms IMPORTANT SAFETY INFORMATION (continued) of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. • Injection Site Problems: Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will Please see Important Safety Information throughout and Important lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area Facts About BETASERON® on pages 14 and 15. of the skin that is sore, reddened, infected or has other problems. 6 7
Your BETASERON® (interferon beta-1b) Financial Support Journey A BETAPLUS® coverage specialist will help you understand your insurance benefits and navigate any issues. They can also help if you experience insurance changes. One-on-one support is always there When you become a BETASERON patient, you get all the benefits of the BETAPLUS® Patient when you need it. Support Program. BETAPLUS provides you with personalized one-on-one support throughout your treatment. Step 1 Your BETAPLUS coverage specialist will determine if you qualify for $0 copay assistance $0 copay Get up to $14,500 in copay assistance each calendar year, for as long as you’re on treatment.‡ Step 2 A BETA Nurse will schedule an appointment for your in-home injection training* Step 3 Your BETASERON and BETACONNECT™ autoinjector will be delivered to your home BETA Bridge Step 4 You will receive your comprehensive injection training kit and in-home training from an MS-trained BETA Nurse. Your BETA Nurse will show you how to prepare At the start of your treatment, while your insurance benefits are being determined, BETA Bridge gets your therapy your medication, inject BETASERON properly, and manage your injection site started right away. If you face an insurance gap, BETA Bridge rotations. He or she will also provide you with tools to help you manage your can also keep your treatment going for up to 12 months therapy and help pair your BETACONNECT™ with myBETAapp™ at no cost.§ After your one-on-one injection training, your BETA Nurse will stay in touch to: • Guide you to the resources you need • Answer questions about BETASERON ‡ Some limitations apply. Please visit betaseron.com/affordability or call 1-800-788-1467 for more information. Patients who are enrolled in any type of government insurance or reimbursement program are not eligible. • Support and help you stay motivated—on the phone, in person, via webcam, or by email As a condition precedent of the copayment support provided under this program, eg, copay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits And, when you share your injection data with myBETAapp, your BETA Nurse can follow your they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, progress and provide you with proactive support.† He or she can help to: taxed, or restricted. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Offers are subject to change at any time. • See if you have missed any injections § If you have commercial insurance, you’re eligible. • Remind you to rotate injection sites properly • Identify your typical injection patterns *Where state laws and insurance allow. † Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in myBETAapp for HCPs to obtain this information. You can talk with a BETA Nurse any time, day or night, about BETASERON. INDICATIONS IMPORTANT SAFETY INFORMATION (continued) BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms • Flu-like Symptoms: BETASERON can cause flu-like symptoms including fever, chills, tiredness, of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, sweating, muscle aches when you first start to use it. These symptoms may decrease over and active secondary progressive disease, in adults. time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms. • Seizures: Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, Please see Important Safety Information throughout and Important or to a combination of both. If you have a seizure after taking BETASERON call your healthcare Facts About BETASERON® on pages 14 and 15. provider right away. 8 9
Medication Meets Communication 1 Your doctor makes treatment decisions based on the best information available. Give them the 4 Track with myBETAapp™ most accurate information you can—automatically.* Share your injection data with your BETA 2 By keeping track of your injection information, you can go 1 4 Nurse and healthcare team every time you inject.* By providing an in-depth view of your injection information, you can have more meaningful discussions with your healthcare team. back and review important aspects of your treatment. With myBETAapp, you can see a snapshot of: • Your injection calendar (view past and 1 4 2 3 future injections) TREAT TRACK SHARE • Injection sites (to help plan your rotation schedule) Treat with Your real-time Give your And, when you use the Wellness Tracker in myBETAapp, 2 BETASERON® using injection healthcare team BETACONNECT™ and automatically capture your 3 information is sent to myBETAapp™ the most accurate information you can, you can track your everyday health by recording how you feel—whenever, wherever—by answering a few questions on your phone. injection so you can track automatically* 3 information* your progress Watch it in action. Share with your BETA Nurse and healthcare team§ betaconnectsystem.com Keep the communication going by sharing your injection * When using the BETACONNECT autoinjector, injection data is automatically transferred to information with myBETAapp. Your BETA Nurse can track myBETAapp whenever the autoinjector is powered on and within range of a patient’s mobile your progress and help you when needed by: device. myBETAapp must be open and running in order for data transfer to occur. Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing • Seeing if you’ve missed any injections in myBETAapp for HCPs to obtain this information. Please note: If a patient is not using • Reminding you to rotate your injection sites BETACONNECT to administer injections, he/she can also record injections manually. Patients are able to modify the details or delete injection data manually recorded in myBETAapp. • Identifying your typical injection patterns Models used for illustrative purposes only. If you share your information, your doctor also has the ability to follow your progress and provide you with Treat using the BETACONNECT™ autoinjector support if needed.§ Exclusively for BETASERON patients, the autoinjector provides: • Automatic needle insertion and retraction (once the injection is complete), § Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in so you never need to see a needle during the injection process myBETAapp for HCPs to obtain this information. • Built-in injection reminders, so you know when to take your next dose† • Customizable injection speed and depth‡ † Use the built-in reminder only as a backup. You still must take BETASERON on schedule and follow the instructions from your healthcare provider, even if you use the built-in reminder. ‡ Before you change your injection speed or depth settings, talk with your healthcare provider or BETA Nurse. INDICATIONS BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, IMPORTANT SAFETY INFORMATION (continued) and active secondary progressive disease, in adults. • Blood Problems: You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily. Please see Important Safety Information throughout and Important Facts About BETASERON® on pages 14 and 15. • Pregnancy: Tell your doctor if you are pregnant or plan to become pregnant. 10 11
Frequently Asked Questions What Questions Can I Ask My Doctor? How is CIS diagnosed? If you have been diagnosed with CIS, you probably want to learn as much as you can. Asking questions about which treatment is right for you and learning about all your options, are important Your doctor will take a complete medical history and perform a physical examination and tests, parts of managing your condition. Some questions you may want to ask include: including MRI. • How will you manage my condition? If I have CIS will it definitely progress? • How do DMT medicines work? Patients who experience CIS may or may not progress to other forms of relapsing MS. An MRI • How long will I need to be on treatment? scan is one of the most important tools used to identify the risk of disease progression. • Can I start a family if I am taking medicine? • Are there any side effects that can happen from my medicine? Why should I begin treatment for CIS if I don’t know that it • Is there any way to lessen side effects? will progress? • What other safety information should I know about? Studies have shown there is a high risk of developing RRMS when CIS is accompanied by brain Using the lines below, write down other questions that you want to ask your doctor and bring them lesions that are similar to those seen in other relapsing forms of MS. Disease-modifying therapy is with you to your next appointment. recommended in this situation, with the goal of delaying a second episode. Early treatment may lessen the chance of the disease progressing because of additional damage to nerve cells. Where can I find more information? To learn more, visit betaseron.com or ask your healthcare provider. You can also find information on the following websites: the Multiple Sclerosis Association of America (myMSAA.org) and the National Multiple Sclerosis Society (nationalMSsociety.org). What type of symptoms can I track in myBETAapp™? With the Wellness Tracker, the symptoms you can track include ability to walk, memory, coordination, bowel and bladder control, eating habits, and more. If I share my injection data in myBETAapp, who will see it? When you enable sharing, your BETA Nurse can see your information; however, you can also choose to share with your doctor.* If you do share your data with your BETA Nurse or doctor, your personal information will never be shared or sold. *Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in myBETAapp for HCPs to obtain this information. Does BETASERON® require refrigeration? No. BETASERON can be stored at room temperature. IMPORTANT SAFETY INFORMATION (continued) INDICATIONS Most Common Side Effects: BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms The most common side effects of BETASERON include low white blood cell count, increases in your of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach and active secondary progressive disease, in adults. pain, weakness. These are not all the possible side effects of BETASERON. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions. Please see Important Safety Information throughout and Important You are encouraged to report side effects or quality complaints of prescription drugs to the FDA by Facts About BETASERON® on pages 14 and 15. visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. 12 13
Important Facts About Symptoms of injection site problems may include: – swelling, redness, or pain at the injection site BETASERON® (interferon beta-1b) – fluid drainage from the injection site – breaks in your skin or blue-black skin discoloration It is important for you to change your injection site each time you inject BETASERON. This will What is BETASERON? lessen the chance of you having a serious skin reaction at the site where you inject BETASERON. BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to Avoid injecting BETASERON into an area of skin that is sore, reddened, infected or has include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive other problems. disease, in adults. • flu-like symptoms. BETASERON can cause flu-like symptoms including: – fever, chills, tiredness, sweating, muscle aches when you first start to use it. Who should not take BETASERON? These symptoms may decrease over time. Taking medicines for fever and pain relief on the days Do not take BETASERON if you are allergic to interferon beta-1b, to another interferon beta, you are using BETASERON may help decrease these symptoms. to human albumin, or mannitol. • seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to their MS, to BETASERON, What Warnings and Precautions should I know about BETASERON? or to a combination of both. If you have a seizure after taking BETASERON call your healthcare BETASERON can cause serious side effects, including: provider right away. • liver problems including liver failure. Symptoms of liver problems may include: What should I know before starting BETASERON? • yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, Before you take BETASERON, tell your healthcare provider if you: bruising easily or bleeding problems. • have or have had depression (sinking feeling or sadness), anxiety (feeling uneasy, nervous, or Your healthcare provider will do blood tests to check for these problems while you fearful for no reason) or trouble sleeping take BETASERON. • have or have had liver problems • serious allergic reactions. Serious allergic reactions can happen quickly and may happen after • have or have had blood problems such as bleeding or bruising easily, low red blood cells (anemia) your first dose of BETASERON or after you have taken BETASERON many times. Symptoms or low white blood cells may include: • have or have had seizures – difficulty breathing or swallowing • have or have had heart problems – swelling of the mouth or tongue • are pregnant or plan to become pregnant – rash, itching, or skin bumps • are breastfeeding or plan to breastfeed. It is not known if BETASERON passes into your • depression or suicidal thoughts. Call your healthcare provider right away if you have any of breast milk. the following symptoms, especially if they are new, worse, or worry you: Tell your healthcare provider about all the medicines you take, including prescription and – thoughts about suicide or dying nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep – new or worse depression a list of them to show your healthcare provider and pharmacist when you get a new medicine. – new or worse anxiety – trouble sleeping (insomnia) What are the possible side effects of BETASERON? – acting aggressive, being angry, or violent The most common side effects of BETASERON include: – acting on dangerous impulses • low white blood cell count, increases in your liver enzymes, headache, increases in your muscle – hallucinations tension, pain, rash, problems sleeping, stomach pain, and weakness. – other unusual changes in behavior or mood These are not all the possible side effects of BETASERON. For more information, ask your • heart problems. BETASERON may worsen heart problems including congestive heart failure. healthcare provider or pharmacist. Symptoms of heart problems may include: – swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness Tell your healthcare provider if you have any side effect that bothers you or does not go away. in chest, increased need to urinate at night, not being able to lay flat in bed. For important risk and use information about BETASERON, please see the enclosed Full • injection site problems. Serious skin reactions can happen in some people including areas of Prescribing Information. severe damage to skin and the tissue below the skin (necrosis). These reactions can happen The risk information provided here is not comprehensive. To learn more about BETASERON, talk anywhere you inject BETASERON. with your healthcare provider or pharmacist. Visit www.betaseron.com to obtain the FDA-approved product labeling or call 1-888-842-2937. You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Important Safety Information throughout. 14 15
icons Committed to Supporting Patients, Every Step of the Way BETASERON.com Now Available - orange icons BETASERON®, an effective therapy SERON.com Now Available - orange Innovative ge 24/7 BETA Nurse financial support support BETACONNECT™, ® myBETAapp™, a fully electronic for on-the-go autoinjector tracking Models used for illustrative purposes only. To learn more about CIS or RRMS and treatment with BETASERON, visit betaseron.com/efficacy and talk with your healthcare provider today. Last edits made: May 11, 2017 Please see Important Safety Information throughout and Important Facts About BETASERON® on pages 14 and 15. For BETACONNECT™ Instructions for Use, please visit www.betaconnectifu.com, and for myBETAapp™ Instructions for Use, please visit www.mybetaappifu.com. Last edits made: May 11, 2017 BAYER, the Bayer Cross, BETAPLUS and BETASERON are registered trademarks of Bayer. BETACONNECT and myBETAapp are trademarks of Bayer. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Bayer is under license. iPhone is a registered trademark of Apple Inc., registered in the U.S. and other countries. ©2019 Bayer. Whippany, NJ 07981. All rights reserved. PP-BETA-S-US-0564-1 September 2019
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