MEDICATION GUIDE ODACTRA™ (OH-dack-trah) House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Sublingual Tablets

Carefully read this Medication Guide before you start taking ODACTRA and each time you get a refill. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or if you want to learn more about ODACTRA.

What is the Most Important Information I Should Know about ODACTRA? ODACTRA can cause severe allergic reactions that may be life-threatening. Stop taking ODACTRA and get medical treatment right away if you have any of the following symptoms after taking ODACTRA: 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 For home administration of ODACTRA, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you have a severe allergic reaction after taking ODACTRA. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine.

What is ODACTRA? ODACTRA is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat house dust mite allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. ODACTRA may be prescribed for persons 12 through 65 years of age who are allergic to house dust mites. ODACTRA is NOT a medication that gives immediate relief for symptoms of house dust mite allergy.

Who Should Not Take ODACTRA? You should not take ODACTRA if: You have severe, unstable or uncontrolled asthma You had a severe allergic reaction in the past that included any of these symptoms: ○ Trouble breathing ○ Dizziness or fainting ○ 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 ODACTRA. The inactive ingredients contained in ODACTRA are: gelatin, mannitol, and sodium hydroxide.

What Should I Tell My Doctor Before Taking ODACTRA? Your doctor may decide that ODACTRA is not the best treatment if: You have asthma, depending on how severe it is. You suffer from lung disease such as chronic obstructive pulmonary disease (COPD) You suffer from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled. You are pregnant, plan to become pregnant during the time you will be taking ODACTRA, or are breast-feeding. You are unable or unwilling to administer auto-injectable epinephrine to treat a severe allergic reaction to ODACTRA. You are taking certain medicines that enhance the likelihood of a severe reaction, or interfere with the treatment of a severe reaction. These medicines include: ○ beta blockers and alpha-blockers (prescribed for high blood pressure) ○ cardiac glycosides (prescribed for heart failure or problems with heart rhythm) ○ diuretics (prescribed for heart conditions and high blood pressure) ○ ergot alkaloids (prescribed for migraine headache) ○ monoamine oxidase inhibitors or tricyclic antidepressants (prescribed for depression) ○ thyroid hormone (prescribed for low thyroid activity). You are receiving allergy shots or other immunotherapy under the tongue. Use of more than one of these types of medicines together may increase the likelihood of a severe 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 ODACTRA. Ask your doctor or pharmacist for advice before taking ODACTRA. ODACTRA is not indicated for use in children under 12 years of age or adults over 65 years of age.

Are there any Reasons to Stop Taking ODACTRA? Stop ODACTRA and contact your doctor if you have any of the following after taking ODACTRA: 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 Dizziness or fainting Rapid or weak heartbeat Severe stomach cramps or pain, vomiting, or diarrhea Severe flushing or itching of the skin Heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens Also, stop taking ODACTRA following: mouth surgery procedures (such as tooth removal), or if you develop any mouth infections, ulcers or cuts in the mouth or throat.

How Should I Take ODACTRA? Take ODACTRA exactly as your doctor tells you. ODACTRA is a prescription medicine that is placed under the tongue. Take the tablet from the blister package after carefully removing the foil with dry hands. Place the tablet immediately under the tongue where it will dissolve within 10 seconds. Do not swallow for at least 1 minute. Do not take ODACTRA with food or beverage. Food and beverage should not be taken for the following 5 minutes. Wash hands after taking the tablet. Take the first tablet of ODACTRA 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 tablet of ODACTRA, you will continue ODACTRA therapy at home by taking one tablet every day. Take ODACTRA every day for as long as your doctor prescribes it, even if you have no allergy symptoms. If you forget to take ODACTRA, do not take two tablets. Take the next tablet at your normal scheduled time the next day. If you miss more than one tablet of ODACTRA, contact your doctor before restarting. You may begin to have relief of your house dust mite allergy symptoms within 2 to 3 months of starting ODACTRA.

What are the Possible Side Effects of ODACTRA? The most commonly reported side effects were throat irritation/tickle, itching in the mouth or ears, swelling of the back of the mouth, lips or tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, diarrhea, and food tastes different. These side effects, by themselves, were not dangerous or life-threatening. Typically, these common side effects begin within the first week of starting ODACTRA and may reoccur for up to two weeks. These common side effects experienced after taking the first tablet typically last up to one hour. ODACTRA can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ODACTRA 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 Severe flushing or itching of the skin For additional information on the possible side effects of ODACTRA talk with your doctor or pharmacist. You may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

How Should I Store ODACTRA? Keep ODACTRA out of the reach of children. Throw away any unused ODACTRA after the expiration date which is stated on the carton and blister pack after “EXP.” Store ODACTRA in a dry place at room temperature, 20ºC to 25ºC (68ºF to 77ºF), in the original package.

General Information about ODACTRA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ODACTRA for a condition for which it was not prescribed. Do not give ODACTRA to other people, even if they have the same symptoms. It may harm them. This Medication Guide summarizes the most important information about ODACTRA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ODACTRA that was written for healthcare professionals. For more information, go to: www.ODACTRA.com or call 1-855-782-9323 (toll-free).

Manufactured for: ALK-Abelló A/S ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm, Denmark U.S. License No. 1292 Manufactured by: Catalent Pharma Solutions Limited, Blagrove, Swindon, Wiltshire, SN5 8RU UK © 2023 ALK-Abelló A/S All rights reserved.

This Medication Guide has been approved by the U.S. Food and Drug Administration.       Revised: 1/2023