start here Your asthma may

Transcription

1 start here Your asthma may When certain allergens like pet dander or dust mites bring on symptoms that can lead to attacks, that s allergic asthma. Learn more. Models in this brochure are for illustrative purposes only.

2 If you have asthma and are looking for help managing your condition or if you need guidance on how to best help a child with asthma this guide is a great starting point. It will tell you about allergic asthma and a treatment option called XOLAIR (for patients with moderate to severe allergic asthma). Table of Contents What is allergic asthma?... 2 A proper diagnosis may lead to fewer asthma attacks About XOLAIR How XOLAIR may help reduce allergic asthma attacks and symptoms in patients 12 years of age and older How XOLAIR may help reduce allergic asthma attacks in patients 6 to less than 12 years old How XOLAIR is designed to work GettingXOLAIR The XOLAIR Co-pay Card Program and other financial support What to expect on XOLAIR injection day Patient support Important Safety Information about XOLAIR What is XOLAIR? XOLAIR (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat patients 6 years of age and older with moderate to severe persistent asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. XOLAIR is not used to treat other allergic conditions, acute bronchospasm, or status asthmaticus. 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. xolair.com 1

3 Patients and caregivers start here Allergic Asthma What is allergic asthma? Allergic asthma is the most common type of asthma. It is a type of asthma brought on by breathing in an allergen. An allergen is a substance, such as pet dander or dust mites, that can cause an allergic reaction. Allergens that cause allergic reactions are commonly called allergic triggers. Whether you have allergic asthma or another type of asthma, the symptoms that can lead to an attack are the same: wheezing shortness of breath rapid breathing chest tightness coughing 25 million people in the U.S. have asthma. About 60% have allergic asthma. In school-age children with asthma, this number is closer to 80%. 2 3

4 Allergic Asthma Certain triggers make allergic asthma distinct from other types of asthma Pet dander When it comes to allergic asthma, the triggers set it apart from other types of asthma. Triggers that bring on allergic asthma attacks include: Pet dander Tiny flakes that shed from skin and fur, similar to human dandruff but harder to see. What you should know: It s easily spread through the air It can be found in places with and without pets There are no truly hypoallergenic breeds of dogs or cats ( hypoallergenic means unlikely to cause an allergic reaction) Dust mites Critters that are too small to be seen. They live in household dust. Tips to avoid it: Avoid being around dogs and cats; if you have a pet at home, take specific steps to limit exposure Wash your hands and face after being around pets Cockroaches Cockroach remains and debris are a major trigger of allergic asthma. Identifying your triggers can help you to get a diagnosis, know what triggers to avoid, explore treatment options, and better manage the symptoms that can lead to an attack. 4 5

5 Dust mites Cockroaches What you should know: They live in the bedroom more than anywhere else in the home They are impossible to completely get rid of, no matter how much you clean What you should know: They leave behind remains and debris when they die Their debris is easily swept up into the air and inhaled Tips to avoid them: Consider using allergen-resistant covers for your mattress and pillows Wash bedding, blankets, and stuffed animals in water that s at least 130ºF Replace wall-to-wall carpets with bare floors Use a vacuum cleaner with either a double-layered micro filter bag or a HEPA (high-efficiency particulate air) filter Tips to avoid them: Keep all food in closed containers Use a garbage can with a secure lid When cleaning, a damp cloth or mop will prevent roach debris from stirring up into the air Repair leaky faucets and pipes. Wet areas attract cockroaches If triggers like pet dander, dust mites, or cockroaches are bringing on asthma symptoms that can lead to an attack, you may want to talk to an asthma specialist about allergic asthma. 6 7

6 A proper diagnosis may ultimately lead to fewer asthma attacks Being diagnosed with a specific type of asthma, such as allergic asthma, may help you and your doctor decide on a treatment plan better suited to manage that specific type of asthma. So whether you re seeking a diagnosis for yourself or your child, the next page details what an asthma specialist may look for when diagnosing allergic asthma. In school-age children who have been diagnosed with asthma, 8 out of 10 have allergic asthma. 8 9

7 What is an asthma specialist? An asthma specialist has additional years of specialized education in understanding, diagnosing, and treating different types of asthma, including allergic asthma. Allergist A doctor who specializes in diseases of the immune system, including allergic diseases and asthma. Pulmonologist A doctor who specializes in diseases of the lungs and breathing, including asthma. When diagnosing allergic asthma, an asthma specialist may consider: Your personal medical history and a physical exam Your symptoms The results of your allergen test Talk to an asthma specialist about getting an allergen test. An allergen test is a blood test or skin test that can show whether you are allergic to specific allergens that may be causing your asthma symptoms

8 FOR PATIENTS 6 YEARS OF AGE AND OLDER WITH MODERATE TO SEVERE, PERSISTENT ALLERGIC ASTHMA UNCONTROLLED ON INHALED CORTICOSTEROIDS The possibility of fewer attacks starts here Ask your asthma specialist if XOLAIR may be right for you or your child If you or a child you care for has moderate to severe, persistent, uncontrolled allergic asthma, inhaled corticosteroids may not be enough. Adding XOLAIR has been shown to: Help reduce attacks and symptoms in appropriate allergic asthma patients 12 years of age and older. Help reduce attacks in appropriate patients 6 to less than 12 years old. In a study of these patients, there was no difference in symptom reduction between patients taking XOLAIR and patients not taking XOLAIR. Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have any other allergies (such as food allergy or seasonal allergies) have sudden breathing problems (bronchospasm) 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. Treatment Information 12 xolair.com 13

9 Treatment Information XOLAIR is the only FDA-approved biologic drug designed to treat allergic asthma Here is some more to know about XOLAIR: More than 200,000 patients 12 years of age and older have been treated with XOLAIR (based on U.S. data). This number refers to appropriate allergic asthma patients 12 years of age and older treated from June 2003 until July As of July 2016, XOLAIR has also been approved to treat appropriate allergic asthma patients 6 to less than 12 years old. XOLAIR is for injection, given under the skin every 2 or 4 weeks by a nurse or doctor who is prepared to manage anaphylaxis, which can be life-threatening. XOLAIR is not a medicine you inhale and it is not a corticosteroid. What is XOLAIR? XOLAIR for subcutaneous use is an injectable prescription medicine used to treat patients 6 years of age and older with moderate to severe persistent asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. XOLAIR is not used to treat other allergic conditions, acute bronchospasm, or status asthmaticus. A biologic drug, such as XOLAIR, is a medicine that is made from living organisms. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. 14 xolair.com 15

10 More patients taking XOLAIR had fewer asthma attacks even when their inhaled corticosteroid dose was lowered With patients taking XOLAIR, more had zero asthma attacks than patients not taking XOLAIR. Notice any of these? It may be time to talk with an asthma specialist. Any one of these signs may mean uncontrolled asthma: asthma symptoms occur more often than usual Fewer patients taking XOLAIR had 1 or more asthma attacks than patients not taking XOLAIR. asthma symptoms are worse than they used to be In Studies 1 and 2, patients taking XOLAIR had a significantly lower average number of attacks. asthma symptoms are more bothersome at night quick-relief inhaler is used more than 2 days a week What are the possible side effects of XOLAIR? XOLAIR may cause serious side effects, including: If your asthma is not controlled, your asthma specialist can prescribe a treatment plan that may help you better manage symptoms that can lead to attacks. 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. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your See healthcare how XOLAIR provider right may away help starting inside if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. The ACT tests RESULTS: Study 1 The Asthma Control Test (ACT ) is a short quiz for patients Percentage 12 years of patients of age and age older. 12 and It provides up who a had... numerical score to help you and your asthma specialist determine if your asthma symptoms Zero (0) are well controlled. One (1) 76.7 % Next 12 weeks: While lowering inhaled corticosteroid dose Did you know children XOLAIR 78.7 % with severe asthma 19.0 % who ve 2.2 % (n=268) had a recent* asthma attack are 3 times more likely Control to have a future attack 67.7 % in the next 6 months? 28.4 % 3.9 % (n=257) *Recent was defined as within the prior 3 months. RESULTS: Study 2 How Percentage should of I receive patients XOLAIR? age 12 and up who had... XOLAIR should Zero (0) be given by your One healthcare (1) provider, Two (2) or in more a healthcare asthma setting. attacks asthma attack asthma attacks XOLAIR First is given 16 weeks: in 1 While or more maintaining injections inhaled under corticosteroid the skin dose (subcutaneous), 1 time every 2 or 4 weeks. XOLAIR 87.6 % 11.3 % 1.1 % (n=274) In asthma patients, a blood test for a substance called IgE Control must be performed 69.9 % prior to starting XOLAIR 25.0 % to determine 5.1 % the (n=272) appropriate dose and dosing frequency. Do not decrease Next 12 weeks: or stop While taking lowering any of inhaled your corticosteroid other asthma dose medicine unless your healthcare providers tell you to. XOLAIR 83.9 % 14.2 % 1.8 % (n=274) You may not see improvement in your symptoms right away after XOLAIR treatment. Control (n=272) 70.2 % 16.7 % 26.1 % Two (2) or more asthma attacks asthma attacks asthma attack The Asthma Control Test Caregiver Report (ACT-CR ) First 16 weeks: While maintaining inhaled corticosteroid dose is for caregivers of patients 6 to less than 12 years of age. XOLAIR Go 85.8 % 11.9 % 2.2 % (n=268) to taketheacttest.com now then talk about your score with your asthma specialist. Control (n=257) 6.6 % 3.7 % 16 as well as Important Safety Information on pages xolair.com 17

11 FOR PATIENTS WITH MODERATE TO SEVERE, PERSISTENT ALLERGIC ASTHMA UNCONTROLLED ON INHALED CORTICOSTEROIDS Clinical Study 1 and 2 Patients 12 years of age and older XOLAIR was studied in two 28-week clinical studies (Studies 1 and 2) to see if it could help appropriate allergic asthma patients decrease their asthma attacks and symptoms. How the studies were done: The studies looked at 1071 patients 12 to 76 years old with moderate to severe, persistent allergic asthma uncontrolled on inhaled corticosteroids In addition to their regular inhaled corticosteroid treatment, patients were given either XOLAIR (the XOLAIR group) or a placebo (the Control group) In Study 1, 268 patients were in the XOLAIR group and 257 patients were in the Control group In Study 2, 274 patients were in the XOLAIR group and 272 patients were in the Control group During the first 16 weeks of each study, both groups of patients took their prescribed dose of inhaled corticosteroid treatment Then, over the next 12 weeks, patients inhaled corticosteroid dose was slowly reduced What is a Control group? In this group, patients received inhaled corticosteroid treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. How did we define asthma attack in these studies? Asthma attack meant that asthma symptoms got so bad, patients needed twice their inhaled corticosteroid dose and/or treatment with a systemic steroid. More patients taking XOLAIR had fewer asthma attacks even when their inhaled corticosteroid dose was lowered With patients taking XOLAIR, more had zero asthma attacks than patients not taking XOLAIR. Fewer patients taking XOLAIR had 1 or more asthma attacks than patients not taking XOLAIR. In Studies 1 and 2, patients taking XOLAIR had a significantly lower average number of attacks. 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. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. RESULTS: Study 1 Percentage of patients age 12 and up who had... XOLAIR (n=268) Control (n=257) XOLAIR (n=268) Control (n=257) XOLAIR (n=274) Control (n=272) XOLAIR (n=274) Control (n=272) Zero (0) asthma attacks 78.7 % 67.7 % RESULTS: Study 2 Percentage of patients age 12 and up who had... Zero (0) asthma attacks 87.6 % 69.9 % 83.9 % 70.2 % One (1) asthma attack 19.0 % 28.4 % One (1) asthma attack 11.3 % 25.0 % Next 12 weeks: While lowering inhaled corticosteroid dose 14.2 % 26.1 % Two (2) or more asthma attacks First 16 weeks: While maintaining inhaled corticosteroid dose 85.8 % 76.7 % 11.9 % 16.7 % 2.2 % 6.6 % Next 12 weeks: While lowering inhaled corticosteroid dose 2.2 % 3.9 % Two (2) or more asthma attacks First 16 weeks: While maintaining inhaled corticosteroid dose 1.1 % 5.1 % 1.8 % 3.7 % XOLAIR helped to significantly reduce asthma symptoms For patients 12 years of age and older. In Studies 1 and 2, asthma symptoms were defined as: Daytime Chest tightness Shortness of breath Coughing Wheezing Nighttime Awakenings Breathing problems requiring rescue medication What are the possible side effects of XOLAIR? (continued) 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. 18 xolair.com 21

12 FOR PATIENTS WITH MODERATE TO SEVERE, PERSISTENT ALLERGIC ASTHMA UNCONTROLLED ON INHALED CORTICOSTEROIDS Clinical Study 3 Patients 12 years of age and older with severe allergic asthma XOLAIR was studied for 32 weeks to see if it could help appropriate allergic asthma patients with severe allergic asthma. The study looked at 341 patients 12 to 75 years old with severe, persistent allergic asthma uncontrolled on inhaled corticosteroids. The patients were divided into 2 groups 176 who were given XOLAIR (the XOLAIR group) and 165 who were given a placebo (the Control group). Long-acting beta agonists (LABA) were also allowed. Each group was then divided into 2 smaller groups. Both were given inhaled corticosteroids. However, the second group was also given oral corticosteroids. For the first 16 weeks, patients continued their prescribed dose of inhaled corticosteroids. For the second 16 weeks, their inhaled corticosteroid dose was slowly reduced. The most common side effects of XOLAIR: In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears. In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds. RESULTS The number of asthma attacks in the XOLAIR group was similar to the number of asthma attacks in the Control group. Percentage of patients who had one or more asthma attacks... XOLAIR Control XOLAIR Control + Inhaled corticosteroids only Next 16 weeks: While lowering inhaled corticosteroid dose 22.2 % (n=126) 26.7 % (n=120) + Oral and inhaled corticosteroids First 16 weeks: While maintaining inhaled corticosteroid dose 15.9 % (n=126) 15.0 % (n=120) 32.0 % (n=50) 22.2 % (n=45) 42.0 % (n=50) 42.2 % (n=45) Not all clinical studies are the same. Many factors can play a role in the outcome of a clinical study. The possible reason why the results in Study 3 differ from those in Studies 1 and 2 may be related to the smaller number of patients studied, the types of patients studied, or other factors. Please see page 18 for definitions of Control group and asthma attack in this study. 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.com 23

13 FOR PATIENTS WITH MODERATE TO SEVERE, PERSISTENT ALLERGIC ASTHMA UNCONTROLLED ON INHALED CORTICOSTEROIDS Pediatric Study Children 6 to less than 12 years of age with moderate to severe allergic asthma XOLAIR was studied for 52 weeks to see if adding it to inhaled corticosteroid treatment could help decrease attacks in children with moderate to severe allergic asthma. The study looked at 628 children from 6 to less than 12 years of age with moderate to severe, persistent allergic asthma uncontrolled on inhaled corticosteroids 421 of the children were given XOLAIR (the XOLAIR group) 207 of the children were given a placebo (the Control group) During the first 24 weeks of the study, the children in both groups took their prescribed dose of inhaled corticosteroid treatment Over the next 28 weeks, adjustment of their inhaled corticosteroid dose was allowed Throughout this study, patients were allowed to take other controller medications What is a Control group? In this group, patients received inhaled corticosteroid treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. How did we define asthma attack in this study? Asthma attack meant that asthma symptoms got so bad, patients needed twice their inhaled corticosteroid dose and/or treatment with an oral corticosteroid for at least 3 days. For full study results, lift here Children who received XOLAIR had a lower rate of asthma attacks Children in this study were 6 to less than 12 years of age. RESULTS First 24 weeks: While maintaining inhaled corticosteroid dose Rate of asthma Rate of asthma attacks for attacks for children in the children in the 31 Important % Control group: Safety Information XOLAIR group: What is the most important information I should Relative know about XOLAIR? decrease Severe allergic reaction. A severe allergic reaction in called the risk of anaphylaxis can happen when you receive XOLAIR. asthma The reaction attacks for children can (n=192) occur after the first dose, or after many doses. It taking may also XOLAIR.64 (n=384).45 occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest Full emergency 52 weeks: room While right away maintaining if you have inhaled any of corticosteroid these symptoms dose of for an allergic the first reaction: 24 weeks and allowing adjustment of inhaled corticosteroid wheezing, dose shortness for the of breath, next 28 cough, weeks chest tightness, or trouble breathing 43 % low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom flushing, itching, hives, or feeling warm Relative decrease Rate swelling of asthma of the throat or tongue, throat tightness, hoarse voice, Rate of asthma attacks or trouble for swallowing in the risk of attacks for children in the children in the asthma attacks Your Control healthcare group: provider will XOLAIR monitor group: you closely for for symptoms children of an allergic reaction while you are receiving XOLAIR and taking for XOLAIR a period of time (n=192) 1.36 after your injection. Your healthcare (n=384).78provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider s In this study, office although or treatment patients center. on XOLAIR showed a decrease in asthma attacks, there was no difference in asthma symptom Do reduction not receive between XOLAIR those in if you the XOLAIR are group and those in the allergic Control to group. omalizumab or any of the ingredients in XOLAIR. 24 xolair.com 25

14 Children who received XOLAIR had a lower rate of asthma attacks Children in this study were 6 to less than 12 years of age. RESULTS First 24 weeks: While maintaining inhaled corticosteroid dose Rate of asthma attacks for children in the Control group: (n=192) Rate of asthma attacks for children in the XOLAIR group:.64 (n=384) % Relative decrease in the risk of asthma attacks for children taking XOLAIR Full 52 weeks: While maintaining inhaled corticosteroid dose for the first 24 weeks and allowing adjustment of inhaled corticosteroid dose for the next 28 weeks Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have any other allergies (such as food allergy or seasonal allergies) have sudden breathing problems (bronchospasm) 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. Rate of asthma attacks for children in the Control group: (n=192) 1.36 Rate of asthma attacks for children in the XOLAIR group: (n=384) % Relative decrease in the risk of asthma attacks for children taking XOLAIR In this study, although patients on XOLAIR showed a decrease in asthma attacks, there was no difference in asthma symptom reduction between those in the XOLAIR group and those in the Control group. xolair.com 27

15 Pam started here My allergist explained to me that inhaled corticosteroids treat the symptoms that can lead to an attack. They don t treat the underlying cause. The underlying cause [of allergic asthma in the body] is IgE. Pam XOLAIR patient living with allergic asthma Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Pam is a real patient. 28 xolair.com 29

16 What happens in an allergic asthma attack? A person with allergic asthma breathes in an allergen like pet dander, dust mites, or cockroach debris. How XOLAIR works XOLAIR is designed to capture most of the IgE in your body. It blocks IgE s role in the steps leading up to the allergic asthma response. XOLAIR is not used to treat other allergic conditions. XOLAIR IgE 1 In response, the body makes a substance called IgE (immunoglobulin E). Allergen Allergen IgE Inflammatory cell Moderate narrowing of airway Inflammatory cell 2 Blood vessels When the allergen is breathed in again, IgE attaches to the allergen and to the surface of inflammatory cells. This releases substances that may cause inflammation (swelling and narrowing) in the airways. 3 Severely narrowed airway in the lung Inflammatory substances This inflammation can cause asthma symptoms that can lead to an attack. What is IgE? If you have allergic asthma, your immune system overreacts to an allergen (trigger) by making IgE. IgE is the key player in the steps leading up to asthma symptoms and an attack. 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 2 or 4 weeks. In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency. Do not decrease or stop taking any of your other asthma medicine unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. 30 xolair.com 31

17 GettingXOLAIR Questions about what will happen once treatment starts? Read on to find out what the XOLAIR journey will be like and more. 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. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. 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. Getting Started 32 xolair.com 33

18 The steps to getting XOLAIR Getting Started Sign the PAN form (Patient Authorization and Notice) Patients 18 years old and over or caregivers of children aged 6-17 must sign the PAN form. Then it will be sent to XOLAIR Access Solutions. Signing the PAN form keeps your information secure and safe. Check health insurance XOLAIR Access Solutions will check your health insurance and help with payment options for XOLAIR. XOLAIR Access Solutions will: Check if XOLAIR is covered by your health insurance and what it may cost Check if pre-approval from your health insurance is needed Refer you to financial assistance options to help pay for XOLAIR Specialty Pharmacy phone call The Specialty Pharmacy will call you to make sure all of your personal and health information is correct. Answer the phone or return their call to keep your treatment schedule on track For privacy reasons, the Specialty Pharmacy may not say that the call is for XOLAIR medicine Ship XOLAIR to your injection location Give your Specialty Pharmacy the address where the injection will take place. The specialist s office can tell you this address You pay the XOLAIR co-pay to the Specialty Pharmacy when it s time for XOLAIR to be shipped The Specialty Pharmacy will ship XOLAIR for you What is a Specialty Pharmacy? Unlike your neighborhood pharmacy, a Specialty Pharmacy has expertise in certain medical conditions and injectable medicines, making them qualified for: Specialized storage, handling, and shipping of XOLAIR Connecting and coordinating with your doctor s office Managing the cost of XOLAIR 34 xolair.com 35

19 XOLAIR financial support options XOLAIR Access Solutions will help you get access to financial options that you qualify for whether you have health insurance or not. The XOLAIR Co-pay Assistance Program * Eligible patients might be able to get help paying their out-of-pocket XOLAIR costs with: $5 per drug co-pay Up to $10,000 of co-pay assistance per 12-month period For more information about the XOLAIR co-pay assistance program, call (855) XOLAIR-CARD ( ) or visit XOLAIRcopay.com Other co-pay assistance XOLAIR Access Solutions can connect you with other co-pay assistance If you need help with your co-pay for XOLAIR, XOLAIR Access Solutions can refer you to an independent co-pay assistance foundation. The Genentech Access to Care Foundation (GATCF) GATCF might be able to help you get your medicine for free. If you don t have health insurance, or if you have health insurance but can t afford your Genentech medicine, contact XOLAIR Access Solutions to learn more. Limitations apply and you must meet certain conditions. Learn more at xolair.com/financial-support, or call XOLAIR ( ) Monday through Friday, 9 AM to 9 PM ET. * Limitations apply and you must meet certain conditions. To learn more and for complete terms and conditions, visit The Access Solutions logo is a registered trademark of Genentech, Inc. Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you. Visit to learn more. 36 xolair.com 37

20 What to expect on XOLAIR injection day Read the Medication Guide XOLAIR is injected During and after the injection Before leaving Before every injection, patients or their caregivers should read the Medication Guide found in the back pocket of this brochure. A doctor or nurse who is prepared to manage anaphylaxis administers the injection. The doctor will watch for signs of anaphylaxis. Anaphylaxis is a severe, life-threatening allergic reaction. The doctor will remind you to continue to look for signs of anaphylaxis even during the following days and weeks when not receiving an injection. The most common side effects of XOLAIR: The XOLAIR injection is given under the skin (subcutaneous) and is a slightly clear, viscous fluid like syrup. In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears. In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds. 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.com 39

21 Preparing for the XOLAIR injection Here are some things to try when getting ready for the first XOLAIR injection: Learn as much as you can about the injection such as why it s important and how it may help manage allergic asthma. If you re a caregiver, share this information with your child Talk to friends or people you know who have gone for injections. A child may benefit from looking at role models or peers with you Reward yourself for getting the injection. Plan lunch with a friend after your appointment, or treat yourself to something you enjoy. For a child, a small toy or a homemade coupon for his or her favorite dessert may do nicely For children who have a fear of needles, create a coping card. Have your child write out brave statements on an index card ahead of injection day. For example, Other children with allergic asthma like me have gotten a needle. I can do it. During the injection, hold up the cards for your child to read XOLAIR dose and frequency IgE levels, body weight, and age determine how much XOLAIR is needed and if injections will be needed every 2 weeks or every 4 weeks Depending on the dose, 1, 2, or 3 injections may be given during each visit Doses should be adjusted for significant changes in body weight 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. 40 xolair.com 41

22 Patient support Support For You With Support For You, you can get tools and resources to help stay motivated and in the know about what to expect next on your XOLAIR treatment journey. Signing up is free. Once you do, you ll get a Care Pack that includes: Step-By-Step: The roadmap to getting started on XOLAIR Here to Help: Financial Resource Support Guide More information that may be helpful You ll also get updates, plus access to information, experts, and nurses to help with your questions. Start here Sign up at xolair.com/supportforyou Patient Support Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. 42 xolair.com 43

23 Tracking progress For patients 12 years of age and older Patient Support Tracking your allergic asthma symptoms and attacks may help you learn if XOLAIR is working for you. After some time, you may experience fewer symptoms, such as: Chest tightness Wheezing Waking during the night Shortness of breath Coughing Comparing symptoms you are having with symptoms you are not having may reveal how you re doing with XOLAIR. There is a Progress Tracker in the back pocket of this guide. You can download additional trackers at xolair.com/track. Progress takes time It may take some time for your condition to improve after starting XOLAIR. Keep these suggestions in mind: Follow the asthma specialist s instructions Stay on schedule with XOLAIR injections Do not stop taking any other asthma medicine unless the doctor tells you to Talk to the asthma specialist about when you may expect to see results Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have any other allergies (such as food allergy or seasonal allergies) have sudden breathing problems (bronchospasm) 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. 44 xolair.com 45

24 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. Important Safety Information 46 xolair.com 47

25 Important Safety Information 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 any other allergies (such as food allergy or seasonal allergies) have sudden breathing problems (bronchospasm) 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. 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 2 or 4 weeks. In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency. Do not decrease or stop taking any of your other asthma medicine unless your healthcare providers tell you to. You may not see improvement in your symptoms right away after XOLAIR treatment. 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. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. 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. 48 xolair.com 49

26 The most common side effects of XOLAIR: In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears. In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds. more here 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) Asthma Control Test (ACT ) 2002, 2004 QualityMetric Incorporated. All rights reserved. ACT is a trademark of QualityMetric Incorporated. 50 xolair.com

27 Talk to your doctor or an asthma specialist for more information about a treatment option today Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved. XOL/042815/0104(2) 10/17 Printed in the USA