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How KEVZARA® (Sarilumab) Works

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How KEVZARA® (Sarilumab) Works How does my new treatment work? Get to know KEVZARA better. Click here for full Prescribing Information including1 risk of SERIOUS SIDE EFFECTS and Medication Guide. You're starting . so you may have some KEVZARA . questions about it. Your healthcare provider just prescribed you a new treatment. That means you're probably wondering what you should expect once you start KEVZARA. GOT A QUESTION? In addition to your healthcare provider, you can give us a call at Let’s take a closer look at your new 1-844-KEVZARA (1-844-538-9272) treatment together and help you answer: What Is KEVZARA? p. 2 What is KEVZARA? KEVZARA® (sarilumab) is an injectable prescription medicine called an Interleukin-6 (IL-6) receptor blocker. KEVZARA is p. 6 How do I take KEVZARA? used to treat adult patients with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called p. 8 What do I need to know before a disease modifying antirheumatic drug (DMARD) has been getting started? used and did not work well or could not be tolerated. IMPORTANT SAFETY INFORMATION p. 16 What important safety information KEVZARA can cause serious side effects including: should I know about KEVZARA? • SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have serious infections while using KEVZARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Please see additional IMPORTANT SAFETY INFORMATION on pages 16-18. 2 1 What is KEVZARA? It's a treatment for adults with moderately to severely active RA. What kind of treatment is it? KEVZARA is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. It's used to treat adults with moderately to severely active RA. Your healthcare provider prescribed KEVZARA after at least one other medicine called a disease-modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated. IMPORTANT SAFETY INFORMATION (cont’d) • Before starting KEVZARA, tell your healthcare provider if you: – think you have an infection or have symptoms of an infection, with or without a fever, such as sweats or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal or feel very tired; or are being treated for an infection, get a lot of infections, or have repeated infections Please see additional IMPORTANT SAFETY INFORMATION on pages 16-18. 2 3 What exactly is IL-6? IL-6 is believed to contribute to the symptoms IL-6 proteins tell cell receptors to send and the impact of RA. out signals that may lead to inflammation. You may be wondering, what is IL-6 and what does it IL-6 have to do with RA? IL-6 is a protein that’s produced by the white cells in your blood. Elevated IL-6 levels are believed to be associated with RA. Receptor Cell KEVZARA is an IL-6 receptor blocker. IL-6 IMPORTANT SAFETY INFORMATION (cont’d) KEVZARA • Before starting KEVZARA, tell your healthcare provider if you: Receptor – have diabetes, HIV, or a weakened immune system – have TB, or have been in close contact with someone with TB Cell Please see additional IMPORTANT SAFETY INFORMATION on pages 16-18. 4 5 How do I take KEVZARA? Sticking to your schedule is important. KEVZARA comes in a prefilled syringe that is recommended to be taken once every 2 weeks, either on its own, with It is recommended to be methotrexate (MTX), or with other conventional disease- taken once every 2 weeks modifying antirheumatic drugs (DMARDs). To help ensure your treatment works as it should, follow using a prefilled syringe. the dosing and treatment schedule set by your healthcare provider. Even if you don't feel a change right away, it's important to continue taking KEVZARA as prescribed by your healthcare provider. But, if you experience any side effects or have other concerns, tell your doctor immediately. Need support self-injecting? Even if you have past experience self-injecting medicine, ask your healthcare provider to show you how to use the syringe. You can also: • Check out “How do I take KEVZARA correctly?” • Watch the video on how to self-inject at KEVZARA.com IMPORTANT SAFETY INFORMATION (cont’d) • Before starting KEVZARA, tell your healthcare provider if you: • Call your KevzaraConnect® Nurse Educator at – live or have lived, or have traveled to certain parts of the 1-844-KEVZARA (1-844-538-9272). They’ll gladly country (such as the Ohio and Mississippi River valleys answer your questions or provide you with injection and the Southwest) where there is an increased chance training to meet your needs of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis) Please see additional IMPORTANT SAFETY INFORMATION on pages 16-18. 6 7 What do I need to know before getting started? Knowing the possible Take notice of any changes. side effects of any new When you start a new treatment like KEVZARA, it’s important to take notice of how you may be treatment is important. affected. Tracking these things will help you keep your healthcare provider better informed about how KEVZARA is working for you. Common side effects are: • Injection site redness • Upper respiratory tract infection • Urinary tract infection • Nasal congestion, sore throat, and runny nose These are the most common side effects, but there may be some others. Even if they're not listed in this guide, you should always tell your doctor about any changes or side effects. IMPORTANT SAFETY INFORMATION (cont’d) • Before starting KEVZARA, tell your healthcare provider if you: – have or have had hepatitis • After starting KEVZARA, call your healthcare provider right away if you have any symptoms of an infection. Please see additional IMPORTANT SAFETY INFORMATION on pages 16-18. 8 9 Infections can be a serious side effect. You shouldn’t take KEVZARA if you have Before starting KEVZARA, tell your healthcare an infection. provider if you think you have an infection Biologics are commonly used to treat RA and affect the or symptoms of an infection, with or without immune system. KEVZARA is a biologic. This means it can a fever. Don’t start treatment unless your lower the ability of your immune system to fight infections, healthcare provider says it’s okay. making it easier to get one or worsen one you already have. Some people get serious infections while taking KEVZARA, including tuberculosis (TB) and infections caused by bacteria, Watch out for any signs of infection, such as: fungi, or viruses that can spread throughout the body. Some people have died from these infections. • Fever • Warm, red, or painful skin or sores Your healthcare provider should test you for TB before starting • Sweating or chills • Diarrhea or stomach pain KEVZARA and continue to monitor you closely for signs and • Muscle aches • Burning when you urinate symptoms of TB during treatment. • Cough • Urinating more often • Shortness of breath than normal • Blood in phlegm • Feeling very tired • Weight loss After starting KEVZARA, call your healthcare provider right away if you have any symptoms of an infection. Please see additional IMPORTANT SAFETY INFORMATION on pages 16 -18. 10 11 Look for other side effects, some of which could be serious: Changes in certain laboratory test results Tears of the stomach or intestines You’ve probably been given quite a few blood tests to keep Some people taking KEVZARA get tears, or small holes track of your moderately to severely active RA, but do you known as perforations, in their stomach or intestine. know what your healthcare provider is tracking? This happens most often in people taking medicines like aspirin or ibuprofen, corticosteroids, or disease-modifying With KEVZARA, your healthcare provider should give you blood antirheumatic drugs (DMARDs) like methotrexate. tests before you start treatment, 4 to 8 weeks after starting, and then every 3 months during treatment to check for: • Low white blood cell counts • Low platelet counts • A change in certain liver function tests • An increase in blood cholesterol levels Call your doctor right away if you have a Once you start treatment, if there’s a change in any of your fever and stomach blood test results, your healthcare provider may interrupt (abdominal) pain that or modify your treatment for a period of time and/or decrease doesn't go away. your dose if necessary. Changes in test results are common with KEVZARA and can be severe. Cancer KEVZARA may increase your risk of certain cancers. Tell your healthcare provider if you’ve ever had any type of cancer. Please see additional IMPORTANT SAFETY INFORMATION on pages 16 -18. 12 13 What does my healthcare provider need to know? Before you start KEVZARA, make sure your healthcare provider knows about any other medical conditions you currently have or have had in the past, as some conditions can lead to a higher chance of getting an infection. ☐ An allergic reaction to sarilumab or any of the ingredients Tell your healthcare provider about in KEVZARA all your medicines. ☐ An infection That means prescription and nonprescription ☐ Liver problems medicines, vitamins, and herbal supplements. Any medications you’re using to treat your ☐ Stomach area pain, ulcers in your stomach or intestines, moderately to severely active RA are especially or inflammation in parts of your intestines known as diverticulitis important to tell your healthcare provider about.
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