LEARN MORE ABOUT HOUSE DUST MITE ALLERGY AND HOW ODACTRA CAN HELP

LEARN MORE ABOUT HOUSE DUST MITE ALLERGY AND HOW ODACTRA CAN HELP

What is allergy immunotherapy for house dust mite allergy?

Allergy immunotherapy (im-yuh-noh-thAIR-uh-pee) is a type of prescription medicine used to treat the root cause of allergies—not just the symptoms. It’s made from natural ingredients—very small doses of what you are allergic to (known as an allergen). Over time, allergy immunotherapy can make you less sensitive to the allergen. You may also find that you need to take fewer medicines to help with your symptoms. There are 2 main forms of FDA-approved allergy immunotherapy:
  • Tablets that people with allergies place under their tongues every day in the convenience of their home (after taking the first dose in the health care professional’s office)
  • Shots that health care professionals give people with allergies approximately once a week to once a month
Your health care professional might talk with you about one or both of these options. It’s important to think about what works best for you.
There is an allergy immunotherapy tablet, called ODACTRA, made just for house dust mite allergy. ODACTRA is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat house dust mite allergy that may cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. ODACTRA may be prescribed for persons 18 through 65 years of age who are allergic to house dust mites. ODACTRA is NOT a medicine that gives immediate relief for symptoms of house dust mite allergy.
ODACTRA is almost always prescribed by an allergy doctor, allergist, or ENT (ear, nose, and throat) doctor.

What are some things I should discuss with my doctor about allergy immunotherapy?

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What is ODACTRA?

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How does ODACTRA work?

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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 18 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.

Selected Important Safety Information about ODACTRA

What is the most important information I should know about ODACTRA?

ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
  • 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 should prescribe auto-injectable epinephrine to treat a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

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.

Do 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 in 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)
  • If 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
Stop taking ODACTRA and contact your doctor if you have any mouth surgery procedures (such as tooth removal), develop any mouth infections, ulcers or cuts in the mouth or throat, or have heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.
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. These side effects, by themselves, are generally not dangerous or life-threatening.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
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Selected Important Safety Information about ODACTRA

What is the most important information I should know about ODACTRA?
ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
  • Trouble breathing

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 18 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.

Selected Important Safety Information about ODACTRA

What is the most important information I should know about ODACTRA?

ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
  • 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 should prescribe auto-injectable epinephrine to treat a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

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.

Do 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 in 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)
  • If 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
Stop taking ODACTRA and contact your doctor if you have any mouth surgery procedures (such as tooth removal), develop any mouth infections, ulcers or cuts in the mouth or throat, or have heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.
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. These side effects, by themselves, are generally not dangerous or life-threatening.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.