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1 Watch Now! Hear real patients and experts. Search for our Facing CIU Channel. Plus, get the CIU Tracker app XOL/012215/0008a(4) 1 1/17 If antihistamines aren t enough for your chronic hives where the cause is unknown, learn more. All pictures within this brochure do not depict real patients. For illustrative purposes only.

2 What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. Important Safety Information What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider s office or treatment center. This brochure has been specially developed to help you understand a type of hives called chronic idiopathic urticaria, or CIU, and a treatment option called XOLAIR. Learn important information about CIU symptoms and diagnosis, and discover you re not alone. page About CIU Diagnosing CIU XOLAIR Treatment Information Includes Before & After images What to Expect When Taking XOLAIR Important Safety Information Financial Resources Living With CIU xolair.com 01

3 About CIU About CIU Are you reading this brochure because you or a loved one has itchy red bumps or welts that have appeared on the skin? This may be hives. When hives last 6 weeks or more, and if doctors cannot identify a cause, there is a chance it s chronic idiopathic urticaria, or CIU. Learn more about CIU in the next few pages

4 About CIU What Is Chronic Idiopathic Urticaria? Before you start learning about CIU, you should know what urticaria is. Urticaria is another word for hives. Hives are red bumps or welts that can appear on your skin unexpectedly. They may cause mild to severe itching. There are 2 main types of urticaria, or hives: A Acute hives Acute hives last for up to 6 weeks, usually going away within a few days. In most cases, the cause can be found. Chronic hives Chronic hives last 6 weeks or more. In about 3 out of 10 cases, the cause can be found. C 04 05

5 CIU Is a Type of Chronic Hives For 7 out of 10 people with chronic hives, doctors cannot find the cause. When this happens, the diagnosis is CIU. CIU is the most common type of chronic hives. CIU stands for chronic idiopathic urticaria : CIU facts and figures Here is some more information about CIU you may want to know: Most CIU symptoms, or flares, occur between the ages of 20 and 40 Women are twice as likely to have CIU than men For most people with CIU, flares come and go for 1 to 5 years. Some patients have symptoms even longer than that 06 07

6 CIU Symptoms CIU symptoms, or flares, are similar to other types of hives. In general: Hives are red, white, or flesh-colored bumps with distinct edges that may change shape. Your doctor may call them wheals. Wheals can be as small as a pencil tip or larger. Hives usually itch. The itch can be mild to severe. Hives often occur on the chest, back, arms, and legs, but can appear anywhere on the body. Hives may also move around. For example, they may show up on your hand, go away within a day, then show up later on your shoulder. A red hive will turn pale when pressed in the center. This is called blanching. HIVES 08 09

7 Diagnosing CIU Diagnosing CIU Diagnosing CIU can take time. It may be very frustrating to keep searching for a cause, hoping for an answer that never comes. Once you are finally told you have CIU, it may be hard to accept that its cause is not known. But it may help to know you re not alone. Read on to learn more

8 Who Diagnoses CIU? Diagnosing CIU Primary care doctors, allergists, and dermatologists can diagnose and treat CIU. An allergist is a specialist trained to diagnose, treat, and manage allergic diseases that can affect different parts of the body. A dermatologist is a specialist skilled at diagnosing and treating diseases of the skin. Your doctor and these specialists can help you: Get diagnosed with CIU Find out about CIU treatment options that may be right for you Before you see the doctor, prepare to talk about your symptoms. How your CIU symptoms affect you is important. Make notes of where hives have shown up on your body and how much they itch. Remember, too, that hives can move around from hour to hour. They may even disappear. It s a good idea to take photos of your hives at different times during your flares so your doctor can get a complete view of your symptoms

9 How Is CIU Diagnosed? Your primary care doctor or specialist will diagnose your condition after examining you and reviewing your medical history. At your appointment, be ready to answer the following questions: When did your hives start? How often do you have flares? Where do your hives usually show up on your body? Do they itch? Is the itching mild or severe? Have you been sick or had an infection lately? Are you taking any medications? Does anyone in your family have hives or an autoimmune disease? After you share your answers and describe your symptoms, your doctor will take a look at your hives. Then he or she may order one or more tests. These may include a: Blood test A blood sample may be taken to count the different parts of your blood, like white blood cells and red blood cells. This may be done to rule out infection as the cause of your hives. Diagnosed with CIU? You re not alone. 7 out of 10 people with chronic hives are diagnosed with CIU. Skin test Your skin may be pricked to confirm whether you have allergies. These tests and more may be done to rule out any other health conditions that could be causing your symptoms. If a cause still isn t found and if your symptoms have lasted 6 weeks or more, your doctor may diagnose you with CIU

10 Face Your CIU With XOLAIR If H1 antihistamines aren t giving you enough relief, you may want to consider XOLAIR. Prescription XOLAIR is a once-monthly injectable medication approved by the FDA to treat appropriate patients with CIU. XOLAIR has been shown to significantly reduce the number of hives as well as how much hives itch. Treatment Info Learn more about XOLAIR in the pages that follow. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. Important Safety Information (continued) Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. 16 xolair.com 17

11 Treatment Info About XOLAIR XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. XOLAIR is the first monoclonal antibody approved to treat CIU. Monoclonal antibodies are made to be similar to natural antibodies found in the human body. Did you know that patients taking antihistamines at approved doses may still experience CIU symptoms? Even when the doctor increases the antihistamine dose, it may not be enough. If this is your story, ask your doctor about XOLAIR. In clinical studies,* XOLAIR was shown to help reduce the severity of itch and the number of hives in patients who continued to have symptoms that were not controlled by antihistamines. *Based on results from CIU Studies 1 and 2. Your results may vary. Important Safety Information (continued) Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have ever had a severe allergic reaction called anaphylaxis have or have had a parasitic infection have or have had cancer are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR. 18 xolair.com 19

12 XOLAIR May Help XOLAIR has been shown to help relieve CIU symptoms. In a 24-week clinical study called CIU Study 1, severity of itch* and number of hives were measured weekly in patients who continued to have hives while on antihistamine therapy. A total of 319 patients with CIU who were already taking an antihistamine participated in the study. They were given different doses of XOLAIR or a placebo. A placebo is anything that seems to be a real medicine or medical treatment but is not. It can take many forms, such as a pill, an injection, or even a procedure. Placebos do not contain any active medicine. The main reason for a placebo group is to understand how much the study results are caused by the treatment versus other possible factors. The study results for the approved doses and placebo group are shown on the next page. Your results may vary. Week 12 study results of 81 patients given 300 mg of XOLAIR, 80 patients given 150 mg of XOLAIR, and 80 patients given a placebo: 66% Weekly hive count score was reduced by over two-thirds (67%) 300 mg 150 mg Placebo Weekly itch severity score * was reduced by two-thirds (66%) Before After Weekly itch severity score * was reduced by almost one-half (47%) Weekly hive count score was reduced by one-half (50%) Weekly itch severity score * was reduced by one-quarter (25%) Weekly hive count score was reduced by one-quarter (25%) What is XOLAIR? More than 1 in 3 patients (36%) were completely itch and hive free Nearly 1 in 6 patients (15%) were completely itch and hive free Less than 1 in 10 patients (9%) were completely itch and hive free XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. Talk to your doctor about whether XOLAIR may be right for you. Your doctor will decide what dose is appropriate for you. *To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score. To measure number of hives, patients were asked to count the number of hives on their bodies daily (0 = no hives; 1 = 1 to 6 hives; 2 = 7 to 12 hives; and 3 = more than 12 hives). The average daily score was then added together over 7 days for the weekly hive count score. Based on results from CIU Study 1, a 24-week clinical study. Important Safety Information (continued) Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. 20 xolair.com 21

13 Before and After Based on results of CIU Study 1,* XOLAIR has been shown to significantly reduce itch and hives in people whose CIU isn t controlled by antihistamines. Your results may vary. Possible level of reduction Before XOLAIR Typical CIU flare before treatment with XOLAIR. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. Complete Response Before XOLAIR Typical CIU flare before treatment with XOLAIR. After 12 weeks on XOLAIR At 300 mg, patients weekly hive count score was reduced by over two-thirds (67%). At 150 mg, patients weekly hive count score was reduced by one-half (50%) Individual results may vary. After 12 weeks on XOLAIR At 300 mg, more than 1 in 3 patients (36%) were completely itch - and hive -free. At 150 mg, nearly 1 in 6 patients (15%) were completely itch- and hive-free. Individual results may vary. Important Safety Information (continued) How should I receive XOLAIR? Simulation for illustrative purposes only. XOLAIR should be given by your healthcare provider, in a healthcare setting. XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. *Based on results from CIU Study 1, a 24-week clinical study. To measure number of hives, patients were asked to count the number of hives on their bodies daily (0 = no hives, 1 = 1 to 6 hives, 2 = 7 to 12 hives, and 3 = more than 12 hives). The average daily score was then added together over 7 days for the weekly hive count score. To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score. Simulation for illustrative purposes only. 22 xolair.com 23

14 Results From Another Study Week 12 study results of 79 patients given 300 mg of XOLAIR, 82 patients given 150 mg of XOLAIR, and 79 patients given a placebo. In CIU Study 2, a 12-week clinical study, severity of itch* and number of hives were measured weekly in patients with CIU who continued to have hives while on antihistamine therapy. A total of 322 patients already taking an antihistamine participated in the study. They were given different doses of XOLAIR or a placebo. (Please see page 20 to learn more about placebos.) The study results for the approved doses and placebo group are shown on the next page. Your results may vary. 70% Weekly hive count score was reduced by over two-thirds (73%) 300 mg 150 mg Placebo Weekly itch severity score * was reduced by over two-thirds (70%) Before After Weekly itch severity score * was reduced by over one-half (56%) Weekly hive count score was reduced by over one-half (57%) Weekly itch severity score * was reduced by over one-third (36%) Weekly hive count score was reduced by around one-third (31%) Important Safety Information (continued) What are the possible side effects of XOLAIR? XOLAIR may cause serious side effects, including: See, What is the most important information I should know about XOLAIR? regarding the risk of anaphylaxis. Cancer. Cases of cancer were observed in some people who received XOLAIR. Fever, muscle aches, and rash. Some people who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider. Parasitic infection. Some people who are at a high risk for parasite (worm) infections get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection. Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether this is caused by XOLAIR. More than 4 in 10 patients (44%) were completely itch- and hive-free Talk to your doctor about whether XOLAIR may be right for you. Your doctor will decide what dose is appropriate for you. What is XOLAIR? More than 1 in 5 patients (22%) were completely itch- and hive-free *To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score. To measure number of hives, patients were asked to count the number of hives on their bodies daily (0 = no hives, 1 = 1 to 6 hives, 2 = 7 to 12 hives, and 3 = more than 12 hives). The average daily score was then added together over 7 days for the weekly hive count score. Based on results from CIU Study 2, a 12-week clinical study. 1 in 20 patients (5%) were completely itchand hive-free XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. 24 xolair.com 25

15 How XOLAIR May Work To understand how XOLAIR may work in helping to reduce itch severity and number of hives in appropriate CIU patients, you should know about mast cells, histamine, and immunoglobulin E (IgE): Where does XOLAIR fit in? XOLAIR was designed to bind to IgE before it can attach to mast cells and also reduces the number of IgE receptors on the surface of mast cells. How this specifically improves CIU symptoms is not certain. XOLAIR IgE Mast cells are cells found in almost all tissues of the body, such as skin. They play an important role in CIU by releasing certain inflammatory chemicals. Mast cell Histamine is a chemical in the body that causes inflammation, leading to hives and itching associated with CIU. IgE IgE is a substance made by the body that attaches to receptors on mast cells, triggering them to release histamine and other inflammatory chemicals under certain conditions. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. Important Safety Information (continued) The most common side effects of XOLAIR: In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection. These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) or Novartis Pharmaceuticals Corporation at (888) XOLAIR is not used to treat other forms of urticaria. 26 xolair.com 27

16 Talking to Your Doctor About XOLAIR You may have a lot of questions, and you may not know where to begin. Here are some suggestions to get the conversation started with your doctor: You may have heard or read that XOLAIR is a biologic. Biologics are medical products or medicines that are made from living organisms. These can include microorganisms, or plant or animal cells. Talk to your doctor to learn more. Do I have CIU? I m taking H1 antihistamine treatment. Are my CIU symptoms still uncontrolled? Would XOLAIR be the right CIU treatment for me? How long does it take for XOLAIR to start working? What important safety information should I know about XOLAIR? Where would I go for XOLAIR injections? Will my insurance cover XOLAIR? What else can I do to manage my symptoms? Do you think it would be a good idea for me to see an allergist or a dermatologist? What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. 28 as well as Important Safety Information on pages xolair.com 29

17 How XOLAIR Is Given XOLAIR is given by an injection just under the skin (subcutaneous injection) every 4 weeks. This should be done by your healthcare provider, in a healthcare setting. You will get 1 or more injections per visit, depending on the dose your doctor has prescribed Each injection takes about 5-10 seconds to administer Your healthcare provider will monitor you closely during each injection and for a period of time after your injection(s). He or she will be looking for symptoms of a severe, life-threatening allergic reaction called anaphylaxis [an-uh-fuh-lak-sis]. You may not see improvement in your symptoms right after XOLAIR treatment In patients with CIU, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other hive medicines unless your healthcare providers tell you to. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. Important Safety Information What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider s office or treatment center. XOLAIR is not used to treat other forms of urticaria. 30 xolair.com 31

18 What You May Expect When Taking XOLAIR If you ve never received XOLAIR before, you may be wondering what will happen once you start treatment. That s a normal reaction when trying something new. You may have questions about where to go for injections or wonder what your XOLAIR journey will be like. Read on to find out. What to Expect Important Safety Information (continued) Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. 32 xolair.com 33

19 Going for Your XOLAIR Injections Once your doctor has prescribed XOLAIR and once you have health insurance approval, you will schedule your first injection with your doctor s office or the injection center they refer you to. Here s what may happen when you go. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. What to Expect Read the Medication Guide XOLAIR is prepped XOLAIR gets injected Wait before you leave The accompanying XOLAIR Medication Guide contains important information you should review before your injection. Your doctor or nurse prepares the XOLAIR dose. Your doctor or nurse gives you your injection(s) subcutaneously (under the skin). After your injection, you ll spend some time in the doctor s office in case you have a severe, life-threatening allergic reaction called anaphylaxis, that can lead to death. Important Safety Information (continued) Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have ever had a severe allergic reaction called anaphylaxis have or have had a parasitic infection have or have had cancer are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Get emergency medical treatment right away if you have any of these signs or symptoms of anaphylaxis after receiving XOLAIR: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing In clinical studies, patients taking XOLAIR for CIU had injection site reactions that included swelling, redness and inflammation, pain, bruising, itching, bleeding, and urticaria. 34 xolair.com 35

20 Starting on XOLAIR When you start on XOLAIR, keep a few things in mind: You may not see improvement in your symptoms right after starting XOLAIR treatment. Remember, too, that results may vary. Be sure to follow your doctor s instructions when it comes to XOLAIR. You may also want to talk to your doctor about when you might expect to see results. Take some time to read the Medication Guide before each injection. The most important information you should know about XOLAIR is that a severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. Anaphylaxis is life-threatening and can lead to death. Staying on XOLAIR You may have less itching and fewer hives if your XOLAIR treatment starts working. It s important to stick with your treatment as prescribed by your doctor. Only your doctor can tell you how long you ll need to take XOLAIR. He or she will assess from time to time if you need to continue treatment. Also keep in mind: XOLAIR is not something you take every day. Injections must be given in a doctor s office by a nurse or doctor every 4 weeks. XOLAIR is not a cure. Do not change or stop taking XOLAIR or any of your other hives medicines unless your doctor tells you to. Important Safety Information (continued) Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. 36 xolair.com 37

21 Your Safety is Important The makers of XOLAIR take safety very seriously. That s why we feel it s important that you take some time to read and understand the full Important Safety Information on the following pages. If there s anything here you re not sure about, don t hesitate to ask your doctor. Also, be sure to read the Medication Guide included in the back pocket of this brochure. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other forms of urticaria. Important Safety Information (continued) How should I receive XOLAIR? XOLAIR should be given by your healthcare provider, in a healthcare setting. XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. Important Safety Information 38 xolair.com 39

22 Important Safety Information Important Safety Information (continued) Important Safety Information What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider s office or treatment center. Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have ever had a severe allergic reaction called anaphylaxis have or have had a parasitic infection have or have had cancer are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. 40 xolair.com 41

23 Important Safety Information (continued) Important Safety Information (continued) How should I receive XOLAIR? The most common side effects of XOLAIR: XOLAIR should be given by your healthcare provider, in a healthcare setting. XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection. These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) or Novartis Pharmaceuticals Corporation at (888) What are the possible side effects of XOLAIR? XOLAIR may cause serious side effects, including: See, What is the most important information I should know about XOLAIR? regarding the risk of anaphylaxis. Cancer. Cases of cancer were observed in some people who received XOLAIR. Fever, muscle aches, and rash. Some people who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider. Parasitic infection. Some people who are at a high risk for parasite (worm) infections get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection. Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether this is caused by XOLAIR. 42 xolair.com 43

24 We re Here to Help With Financial Resources To help make it easier for you to get access to XOLAIR, we ve created a number of financial programs you may qualify for. Together, we can work with your doctor to make sure you get the treatment you ve been prescribed. Financial Resources 44 45

25 The XOLAIR Co-pay Assistance Program If you have commercial insurance (such as insurance you get from an employer) or don t have a health plan, you may be eligible for the XOLAIR Co-pay Assistance Program. Eligible patients pay Financial Resources If you qualify, you can use the XOLAIR Co-pay Assistance Program to help you with your co-pay. Patients who qualify for the XOLAIR Co-pay Assistance Program: Are taking XOLAIR for an approved use Get XOLAIR through a: XOLAIR specialty pharmacy Doctor s office Alternate injection center (AIC) Hospital outpatient department (HOPD) Are 18 years of age or older If you are between the ages of 12-17, a guardian over 18 must manage the card Are not getting help from the Genentech Access to Care Foundation (GATCF) Do not have a state or federal healthcare plan. This includes, but is not limited to, Medicare, Medicaid, and TRICARE To learn more and for complete terms and conditions, visit XOLAIRcopay.com. Getting XOLAIR while waiting for insurance approval If you need to start your treatment quickly, the XOLAIR Starter Program can help you get XOLAIR while you wait to get approved. Your health plan might take some time to decide if XOLAIR treatments are covered. If it s taking more than 7 days and your doctor wants you to start treatment right away, he or she may contact the XOLAIR Starter Program. Talk to your doctor to learn more. If you qualify, this program can provide XOLAIR for up to 12 weeks

26 XOLAIR Access Solutions Before you start taking XOLAIR, your doctor s office will check with your health plan to see if your XOLAIR treatment is covered. This can take about 2 weeks. XOLAIR Access Solutions can assist your doctor s office with this process. If you don t have insurance or coverage for XOLAIR The Genentech Access to Care Foundation (GATCF) helps qualified patients who do not have a health plan or whose plan won t pay for XOLAIR receive their medicine free of charge. We are committed to helping you get our medicines, regardless of your ability to pay. Visit to learn more. If you have private insurance or government-funded insurance (such as Medicare or Medicaid), we may be able to help. XOLAIR Access Solutions can: Perform a benefits investigation. Find out if your health plan requires prior authorization. Guide your doctor s office with appeals. What this means: This explains what your health plan covers. Sometimes, your health plan needs to approve your medicine first. This is known as prior authorization. Your health plan might not pay for XOLAIR. This is known as a denial, which can be appealed. We can help guide your doctor s office in this process, if needed. Co-pay Foundations If you are covered by government-funded insurance, such as Medicare, Medicaid, or TRICARE, or if you have certain commercial insurance, you may be able to get help from co-pay foundations. If you don t qualify for the XOLAIR Co-pay Assistance Program,* XOLAIR Access Solutions can refer you to a co-pay foundation. If you re denied coverage by one foundation, they may be able to help you get coverage from another one. You can contact XOLAIR Access Solutions with any questions at *Limitations apply and you must meet certain conditions. To learn more and for complete terms and conditions, visit XOLAIR and its logo are registered trademarks of Novartis AG. The Access Solutions logo is a registered trademark of Genentech, Inc

27 Getting Access to XOLAIR, Step by Step The steps here show you what may lie ahead if your doctor prescribes XOLAIR. In the back pocket of this brochure, you ll find a more complete list. If you d like, you can use it to keep track of where you are in the process. Or visit xolair.com/checklist. Remember to always return phone calls from the specialty pharmacy Signing forms Checking coverage Verifying information Shipping XOLAIR* Once your doctor prescribes XOLAIR and completes a Statement of Medical Necessity (SMN), you must sign the Patient Authorization and Notice of Release of Information (PAN) so that your health plan s coverage can be verified. You can expect your doctor s office to work with XOLAIR Access Solutions or a specialty pharmacy to check if your health plan covers XOLAIR and if pre-approval is needed. XOLAIR Access Solutions or the specialty pharmacy calls you to verify your information and lets you know if you have a co-pay for XOLAIR. (They may not mention XOLAIR in a message due to privacy laws.) If you have concerns about paying for XOLAIR, ask if you qualify for co-pay assistance. Once you pay your co-pay, the specialty pharmacy ships XOLAIR to the place where you tell them you will be treated. You will get a call to schedule an appointment for your treatment. *Please note: Your XOLAIR might not come from a specialty pharmacy. Instead, your doctor might buy XOLAIR and get paid by your health plan for the cost of the medicine. This process is called buy and bill. Assistance Programs If your health plan doesn t cover XOLAIR, XOLAIR Access Solutions can find out if you qualify for other patient assistance programs. To learn more, go to xolair.com/access-solutions

28 Living With CIU If you have CIU, there are steps you can take that may help. These include keeping a treatment diary, getting support from friends and loved ones, and taking advantage of resources that are available to you. The pages that follow can tell you more. Living With CIU 52 53

29 Steps That May Help if You re Living With CIU 1 Take your CIU medications as directed Antihistamines are often used to treat hives. Do not decrease or stop taking any of your CIU medicines unless your healthcare providers tell you to. Keep a CIU treatment diary It s a good idea to write down your CIU medicines and take pictures of how they affect your hives. This may help you and your doctor see what s working for you and what s not. 2 3 Tell family and friends about your CIU Talking to those closest to you about your condition opens them up to offer you their help and understanding. If you re not sure how to explain CIU or what you re going through, the tips provided on the next page may help. Living With CIU 54 55

30 How to Talk About CIU With Friends and Loved Ones If you re not sure how to explain your CIU to the people you love, here are some facts about CIU that may help you with the conversation: CIU has no known cause. Being diagnosed with CIU means your doctor has ruled out any possible causes, such as food and drug allergies. CIU symptoms can appear at any time without triggers. CIU is not contagious. This means you can t get hives by touching or being near someone with hives. If your friends or loved ones still have questions, you might also consider sharing this brochure with them

31 Resources and More The more you learn about CIU and XOLAIR, the more ready you may be to talk to your doctor about your CIU treatment options. These resources may help. To access important information at any time: Visit the XOLAIR CIU website at To speak with a live Support Representative: Call us toll-free at XOLAIR ( ) Monday through Friday, 8:30 AM to 5 PM ET. How you can help others by sharing your XOLAIR story If you are taking XOLAIR and would like to share your personal story to help others, we would love to hear from you. Please call us at or us at info@voices-of-inspiration.com for more information. What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. Important Safety Information What is the most important information I should know about XOLAIR? Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider s office or treatment center. XOLAIR is not used to treat other forms of urticaria. 58 xolair.com

32 Talk to your allergist or dermatologist for more information about treatment options today Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved. XOL/012215/0008(2) 11/17 Printed in the USA