A ragweed pollen as a treatment for a ragweed allergy? It s called immunotherapy.

Transcription

1 A ragweed pollen as a treatment for a ragweed allergy? It s called immunotherapy. RAGWITEK is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat ragweed pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. RAGWITEK may be prescribed for persons 18 through 65 years of age who are allergic to ragweed pollen. Not actual size RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout ragweed pollen season. RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK. For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine. The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. Please read the Medication Guide for RAGWITEK, including the information about severe allergic reactions, and discuss it with the doctor. The physician Prescribing Information also is available.

2 Understanding what causes your symptoms is the first step to managing your allergies In this brochure, you ll learn about: Why you react to an allergen Your immune system and allergic reactions Various treatment options, including immunotherapy If you re allergic to ragweed pollen, you may find yourself struggling with symptoms like stuffy nose, itchy eyes and sneezing. These symptoms can make your life more difficult during allergy season, especially when you re outdoors. What s more, it can be frustrating to suffer from the same symptoms each season. 1

3 What is an allergen? An allergen is a substance in the environment that causes an allergic reaction in some people. This brochure focuses on a specific allergen, ragweed pollen. Your immune system and allergic reactions When you suffer from ragweed allergies, the symptoms you experience are the result of your body s immune system reacting to ragweed allergens in the environment. When you breathe in these allergens, your immune system forms antibodies that trigger a chemical response causing symptoms like stuffy nose, runny nose, sneezing, or itchy eyes. These familiar allergy symptoms are actually signs of your immune system overreacting to the allergen. Pinpointing your allergy sensitivity People with allergies can be sensitive to many different allergens. Taking note of when and where you experience allergy symptoms can help you and your doctor figure out if you may be allergic to ragweed pollen. Ask yourself: Are symptoms at their worst during ragweed pollen season (late summer and fall)? Does avoiding outdoor activity during ragweed pollen season help your symptoms? Do symptoms go away when it s raining or when you go away on vacation? 2

4 Allergy testing Your doctor may determine what is causing your allergic reaction by listening to your allergy experiences and performing skin and/or blood tests. You may also be asked about how much your symptoms bother you and how well you can manage them. Together, the test results and your allergy experiences may help your doctor identify the allergen that triggers your symptoms. Treatment options Just as different people react differently to different allergens, they react differently to treatment, too. Some people may use more than one treatment. Once your doctor knows what allergens cause your symptoms, he or she will be able to help you plan the best approach for treating your symptoms. Try to avoid the allergens that are giving you trouble. But because this isn t always easy to do, you may consider treatment options. Generally, these fall into two categories: 1. Symptom-relieving medication During an allergic reaction, your immune system releases chemicals such as histamine that are responsible for the symptoms you experience. Many medications delivered in the form of pills, eye drops and nasal sprays are designed to help block those chemicals, helping to relieve your symptoms. These are available over the counter and by prescription. 2. Immunotherapy Immunotherapy is typically given as allergy shots and is designed to treat the underlying cause of your symptoms by giving you small amounts of the allergen over time. Immunotherapy may work with your immune system to help change how your body reacts to allergens. It may help gradually build tolerance to specific allergens. 3

5 RAGWITEK is ragweed allergy immunotherapy in a tablet RAGWITEK is a different form of allergy immunotherapy. Instead of a shot, it s a once-aday tablet that is made to dissolve quickly under Not actual size the tongue. Do not swallow for 1 minute after taking RAGWITEK. Made from small amounts of natural short ragweed pollen, RAGWITEK treats the ragweed allergies that cause eye and nose symptoms. It s the only oral immunotherapy tablet that s been approved by the FDA for adults 18 to 65 years of age. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK. RAGWITEK is a daily dose of immunotherapy Taking a tablet of natural short ragweed pollen daily may help you gradually build tolerance, so you become less sensitive to ragweed pollen. The first tablet of RAGWITEK must be taken in the doctor s office The ragweed pollen in RAGWITEK helps you become less sensitive to ragweed pollen Taking the first tablet in your doctor s office The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be observed for at least 30 minutes by a healthcare professional for symptoms of a serious allergic reaction. If the first dose is well tolerated, later doses will be taken at home. For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine. The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. 4

6 Why your doctor will prescribe epinephrine When you re taking RAGWITEK, your doctor will also prescribe auto-injectable epinephrine for you to use at home should you have a severe allergic reaction. You should discuss the proper use of auto-injectable epinephrine with your doctor. Possible side effects of RAGWITEK (Short Ragweed Pollen Allergen Extract) The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: Trouble breathing Throat tightness or swelling Trouble swallowing or speaking Dizziness or fainting Rapid or weak heartbeat Severe stomach cramps or pain, vomiting, or diarrhea Severe flushing or itching of the skin It is important that you talk to your doctor to make sure you understand what is a severe allergic reaction to RAGWITEK. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK. Stop RAGWITEK and contact your doctor if you have any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you develop any mouth infections, ulcers or cuts in the mouth or throat. RAGWITEK (Short Ragweed Pollen Allergen Extract) is clinically proven to help prevent ragweed allergy symptoms RAGWITEK was tested in clinical studies of adults with a history of ragweed allergy symptoms. In two clinical studies, RAGWITEK provided significant relief of ragweed allergy symptoms (sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes) throughout a ragweed pollen season, including when ragweed pollen counts were highest (sometimes known as the peak of the season). RAGWITEK also reduced the need for over-the-counter and prescription allergy medications throughout the same ragweed pollen season, including the peak of the season a. RAGWITEK was proven to provide significant relief of eye and nose symptoms throughout the entire ragweed pollen season a Standard allergy medications. These generally included systemic and topical antihistamines, topical steroids, and oral corticosteroids. The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening. Your doctor may decide that RAGWITEK is not the best treatment for you if you have asthma; plan to become pregnant or are breast-feeding; are unable or unwilling to administer epinephrine; or are taking certain medicines, including other allergen immunotherapy. 5

7 When to start RAGWITEK (Short Ragweed Pollen Allergen Extract) Although you may not be experiencing symptoms, the best time to start talking to your doctor about RAGWITEK is at least a few months before ragweed allergy season starts. Starting treatment early may give your body time to become less sensitive in preparation for the ragweed pollen season. It s recommended that you start taking RAGWITEK at least 12 weeks before the ragweed pollen season and continue daily until the end of the ragweed pollen season. The importance of taking RAGWITEK every day Immunotherapy is designed to repeatedly expose your body to small amounts of an allergen. That s why it s important to take RAGWITEK every day, as your doctor prescribes, even when you don t have symptoms. RAGWITEK dissolves under your tongue RAGWITEK tablets dissolve quickly when placed under the tongue. Do not swallow for 1 minute after taking RAGWITEK. Do not take with food or water. Tips to remember your RAGWITEK every day Is RAGWITEK right for me? When should I start taking RAGWITEK? How should I take RAGWITEK? More questions? Write them here. Remember to take RAGWITEK (Short Ragweed Pollen Allergen Extract) daily Make it a part of your daily routine Take it at the same time every day Put it somewhere visible that you return to every day? Ask your doctor these questions RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK. For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine. The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK. 6

8 How your immune system causes allergy symptoms Stop RAGWITEK and contact your doctor if you have any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you develop any mouth infections, ulcers or cuts in the mouth or throat. The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening. Your doctor may decide that RAGWITEK is not the best treatment for you if you have asthma; plan to become pregnant or are breast-feeding; are unable or unwilling to administer epinephrine; or are taking certain medicines, including other allergen immunotherapy. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin 7

9 RAGWITEK treats ragweed allergies that cause symptoms Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK. For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine. The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK. Stop RAGWITEK and contact your doctor if you have any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you develop any mouth infections, ulcers or cuts in the mouth or throat. 8

10 FAQs about RAGWITEK (Short Ragweed Pollen Allergen Extract) What is RAGWITEK? RAGWITEK is a prescription immunotherapy medicine used to treat ragweed pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. It can be prescribed for people 18 through 65 years old who are allergic to ragweed pollen. RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout ragweed pollen season. RAGWITEK does NOT provide immediate relief for ragweed allergy symptoms. How can I find out if RAGWITEK is right for me? Only a doctor can decide if RAGWITEK is right for you. Your doctor may do skin and/or blood tests to help determine which allergen causes your symptoms. If the test indicates that you are allergic to short ragweed pollen, your doctor will then decide if RAGWITEK is an appropriate treatment for you. To find out more about RAGWITEK, make an appointment with your allergy specialist. Who should not take RAGWITEK? You should not take RAGWITEK if: You have severe, unstable or uncontrolled asthma. You had a severe allergic reaction in the past that included any of these symptoms: m Trouble breathing m Dizziness or fainting m Rapid or weak heartbeat You have ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before. You have ever been diagnosed with eosinophilic esophagitis. You are allergic to any of the inactive ingredients contained in RAGWITEK. The inactive ingredients contained in RAGWITEK are: gelatin, mannitol and sodium hydroxide. The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening. Your doctor may decide that RAGWITEK is not the best treatment for you if you have asthma; plan to become pregnant or are breast-feeding; are unable or unwilling to administer epinephrine; or are taking certain medicines, including other allergen immunotherapy. What are the possible side effects of RAGWITEK? The most commonly reported side effects were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening. RAGWITEK can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to RAGWITEK include: trouble breathing; throat tightness or swelling; trouble swallowing or speaking; dizziness or fainting; rapid or weak heartbeat; severe stomach cramps or pain, vomiting, or diarrhea; or severe flushing or itching of the skin. For additional information on the possible side effects of RAGWITEK talk with your doctor or pharmacist. You may report side effects to the U.S. Food and Drug Administration (FDA) at FDA-1088 or When will RAGWITEK start to work? It takes time for RAGWITEK to treat your allergies. In clinical studies, people who started taking RAGWITEK at least 12 weeks before the start of the ragweed allergy season: Had fewer eye and nose symptoms throughout the same season Used less symptom-relieving allergy medications throughout the same season Experienced relief when pollen levels were their highest How long do I keep taking RAGWITEK? RAGWITEK is taken once daily for about 12 weeks before ragweed pollen season and throughout the ragweed pollen season. Talk to your doctor about how long you should take RAGWITEK. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin 9

11 FAQs about RAGWITEK (Short Ragweed Pollen Allergen Extract) (continued) How should I take RAGWITEK? Take the tablet from the blister package after carefully removing the foil with dry hands. Place the tablet under your tongue right away, where it will dissolve quickly. Do not swallow for 1 minute. Do not take RAGWITEK with food or beverage. Do not eat or drink for 5 minutes after taking the tablet. Wash hands after taking the tablet. Take the first tablet of RAGWITEK in your doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. If you tolerate the first dose of RAGWITEK, you will continue RAGWITEK therapy at home by taking 1 tablet every day. What happens if I miss a dose? If you forget to take RAGWITEK, do not take a double dose. Take the next dose at your normal scheduled time the next day. Take RAGWITEK as prescribed by your doctor until the end of the treatment course. If you miss more than one dose of RAGWITEK, contact your doctor before restarting. Do I need to take RAGWITEK with water? Do not use food or water to take the tablet. Do not drink or eat for 5 minutes after taking the tablet. Can I take other medications with RAGWITEK? You should tell your doctor if you are taking or have recently taken any other medicines, including non-prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. How do I store RAGWITEK? Keep RAGWITEK out of the reach of children. RAGWITEK should be stored at room temperature,15ºc to 30ºC (59ºF to 86ºF). Store RAGWITEK in original package and keep package and tablets dry. Keep tablets dry Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK. For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine. The first dose of RAGWITEK must be taken in the doctor s office. After taking the first tablet, you will be watched for at least 30 minutes for symptoms of a serious allergic reaction. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK. Stop RAGWITEK and contact your doctor if you have any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you develop any mouth infections, ulcers or cuts in the mouth or throat. 10

12 Make an appointment and ask your specialist if RAGWITEK is right for you. Visit ragwitek.com to learn more and sign up for helpful tools and resources. RAGWITEK is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat ragweed pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. RAGWITEK may be prescribed for persons 18 through 65 years of age who are allergic to ragweed pollen. RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout ragweed pollen season. RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy. RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have any of the following symptoms after taking RAGWITEK: m Trouble breathing m Throat tightness or swelling m Trouble swallowing or speaking m Dizziness or fainting m Rapid or weak heartbeat m Severe stomach cramps or pain, vomiting, or diarrhea m Severe flushing or itching of the skin Please read the Medication Guide for RAGWITEK, including the information about severe allergic reactions, and discuss it with the doctor. The physician Prescribing Information also is available. Learn more about RAGWITEK at ragwitek.com Copyright 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Printed in USA. RESP /14