House Dust Mite (Dermatophagoides Pteronyssinus and Dermatophagocides) Allergen Extract

House dust mite allergen extract may cause severe, life-threatening allergic reactions such as anaphylaxis and throat swelling and closure. Tell your doctor if you have or have ever had respiratory disease such as asthma, mast cell disorder such as mast cell activation syndrome or systemic mastocytosis, or cardiovascular disease such as heart failure, myocardial infarction (heart attack), hypertension, arrhythmia (irregular rhythm), or unstable angina (chest pain). Tell your doctor and pharmacist what medications you are taking or plan to take. Some medications may prevent epinephrine from working effectively in the event of an allergic reaction.

Your first dose of house dust mite allergen extract will be given at a doctor office or clinic where you will be monitored for 30 minutes after you take it.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

House dust mite allergen extract is used to treat allergic rhinitis sneezing, runny nose, and itchy and watery eyes) that can occur due to proven allergy to house dust mite. House dust mite allergen extract is in a class of medications called oral immunotherapy. It works by gradually decreasing sensitivity to house dust mites over time.

House dust mite allergen extract comes as a tablet to place under the tongue. Take once a day. Take dust mite allergen extract at around the same time every day.

Take house dust mite allergen extract exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The first dose will be given at a doctor's office or clinic so you can be monitored closely to make sure you will tolerate the medicine. To take the medicine, follow these steps:

1. After removing the foil, take the tablet from the blister unit with dry hands.
2. Place the tablet under the tongue where it will dissolve within 10 seconds. Do not swallow for at least 1 minute.
3. Wash hands after handling the tablet.
4. Do not eat or drink anything with the medication or for 5 minutes after.

You will be provided with an epinephrine pen when you start treatment with house dust mite allergen extract. Keep this pen with you at all times and make sure you know how to use it.

House dust mite allergen extract controls allergic rhinitis from dust mite allergy but does not cure it. Continue to take house dust mite allergen extract even if you feel well. Do not stop taking dust mite allergen extract without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking house dust mite allergen extract,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with house dust mite allergen extract. Other medications may cause dosing changes or extra monitoring when taken with house dust mite allergen extract. Make sure you have discussed any medications you are currently taking or plan to take before starting house dust mite allergen extract with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dust mite allergen extract, please get the advice of your doctor or pharmacist.
• tell your doctor if you have or have ever had eosinophilic esophagitis (EoE; a condition when blood cells associated with allergy response build up in and damage the esophagus [tube that connects the mouth to the stomach). Your doctor may tell you not to take dust mite allergen extract.
• tell your doctor if you have or have ever had mouth ulcers, thrush (yeast infection in mouth or throat), oral lichen planus (chronic inflammatory condition affecting the mouth), or mouth wounds such as tooth abscess, tooth extraction, or missing teeth.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking house dust mite allergen extract, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dust mite allergen extract.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have missed more than 7 days of house dust mite allergen extract, call your doctor before restarting treatment.

House dust mite allergen extract may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itchy ears
• itchy mouth
• swelling of the uvula (small teardrop piece of flesh that hangs in the back of your throat) or back of the throat, tongue, lips or throat
• nausea, vomiting, diarrhea
• tongue pain
• ulcers or sores in the mouth or on the tongue
• stomach pain
• changes in taste
• throat irritation or tickling of throat

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• swelling of lips, mouth, tongue or throat; hives; rash; shortness of breath; difficulty swallowing
• difficulty or painful swallowing, chest pain or discomfort

House dust mite allergen extract may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• swelling of lips, tongue, mouth or throat
• difficulty swallowing
• difficulty breathing
• changes in voice
• feeling of fullness in the throat

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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