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. ☐ Vaccines you’ve recently received or are scheduled to receive ☐ Surgery or planned medical procedures KEVZARA can be taken with or without ☐ Diabetes, HIV, or a weak immune system other disease-modifying antirheumatic ☐ TB, or if you’ve been in close contact with someone with TB drugs (DMARDs) like methotrexate. ☐ Hepatitis B or hepatitis C ☐ Plan to become pregnant or are pregnant ☐ Plan to breast-feed or are breast feeding ☐ If you’ve ever lived or traveled to areas in the US, like the Southwest or Ohio and Mississippi River valleys, where there’s an increased chance of getting certain fungal infections. These infections may happen more often or worsen if you use KEVZARA. Ask your healthcare provider if you’re unsure whether you’ve lived where these infections are common Please see additional IMPORTANT SAFETY 14 INFORMATION on pages 16-18. 15 What Is KEVZARA? • CHANGES IN CERTAIN LABORATORY TEST RESULTS: KEVZARA® (sarilumab) is an injectable prescription medicine Your healthcare provider should do blood tests before and called an Interleukin-6 (IL-6) receptor blocker. KEVZARA is after starting KEVZARA to check for low neutrophil (white used to treat adult patients with moderately to severely active blood cells that help the body fight off bacterial infections) rheumatoid arthritis (RA) after at least one other medicine called counts, low platelet (blood cells that help with blood clotting a disease modifying antirheumatic drug (DMARD) has been and stop bleeding) counts, and an increase in certain liver used and did not work well or could not be tolerated. function tests. Changes in test results are common with KEVZARA and can be severe. You may also have changes in IMPORTANT SAFETY INFORMATION other laboratory tests, such as your blood cholesterol levels. KEVZARA can cause serious side effects including: • TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: • SERIOUS INFECTIONS: KEVZARA is a medicine that affects your Some people using KEVZARA get tears in their stomach or immune system. KEVZARA can lower the ability of your immune intestine. Call your healthcare provider right away if you have system to fight infections. Some people have serious infections fever and stomach (abdominal) pain that does not go away. while using KEVZARA, including tuberculosis (TB), and infections • CANCER: KEVZARA may increase your risk of certain cancers caused by bacteria, fungi, or viruses that can spread throughout by changing the way your immune system works. Tell your the body. Some people have died from these infections. healthcare provider if you have ever had any type of cancer. • Before starting KEVZARA, tell your healthcare provider if you: • SERIOUS ALLERGIC REACTIONS: Serious allergic reactions – think you have an infection or have symptoms of an infection, can happen with KEVZARA. Get medical attention right away with or without a fever, such as sweats or chills, muscle aches, if you have any of the following signs: shortness of breath or cough, shortness of breath, blood in phlegm, weight loss, trouble breathing; feeling dizzy or faint; swelling of the lips, warm, red or painful skin or sores on your body, diarrhea or tongue, or face; moderate or severe stomach (abdominal) stomach pain, burning when you urinate or urinating more pain or vomiting; or chest pain. often than normal or feel very tired; or are being treated for • Do not use KEVZARA if you are allergic to sarilumab or any an infection, get a lot of infections, or have repeated infections of the ingredients of KEVZARA. – have diabetes, HIV, or a weakened immune system • Before using KEVZARA, tell your healthcare provider if you: – have TB, or have been in close contact with someone with TB – have an infection – live or have lived, or have traveled to certain parts of the – have liver problems country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance – have had stomach (abdominal) pain or a condition known of getting certain fungal infections (histoplasmosis, as diverticulitis (inflammation in parts of the large intestine) coccidioidomycosis, or blastomycosis) or ulcers in your stomach or intestines – have or have had hepatitis – recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines • After starting KEVZARA, call your healthcare provider right – plan to have surgery or a medical procedure away if you have any symptoms of an infection. Please see additional IMPORTANT SAFETY 16 INFORMATION on page 18. 17 IMPORTANT SAFETY INFORMATION (cont’d) – are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby – are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk – take any medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use any other medicines to treat your RA. Using KEVZARA with these medicines may increase your risk of infection • The most common side effects include: – injection site redness – upper respiratory tract infection – urinary tract infection – nasal congestion, sore throat, runny nose

These are not all the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not Support along the way, if and when you need it. go away. You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or To help you get started with treatment, we offer call 1-800-FDA-1088 or to Sanofi-Aventis at 1-800-633-1610. a variety of support with KevzaraConnect®. Find out more and sign up at KEVZARA.com or 1-844-KEVZARA To learn more, talk about KEVZARA with your healthcare (1-844-538-9272) today. provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com Click here for full Prescribing Information including risk or by calling 1-844-KEVZARA (1-844-538-9272). of SERIOUS SIDE EFFECTS and Medication Guide. Click here for full Prescribing Information including risk of SERIOUS SIDE EFFECTS and Medication Guide.

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