SUCCESS WITH ODACTRA

Everything you need to know about treating your house dust mite allergy with ODACTRA

SUCCESS WITH ODACTRA

Everything you need to know about treating your house dust mite allergy with ODACTRA

What do I need to know about starting ODACTRA?

3 simple tips
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Allow for extra time at your doctor’s appointment

The first dose of ODACTRA must be taken in your doctor’s office. This is so they can watch out for a rare but serious allergic reaction like anaphylaxis (an-a-phy-lax-is). Plan to allow for at least 30 minutes of observation.

Anaphylaxis can include trouble breathing, dizziness, nausea, vomiting, diarrhea, throat tightness, and hives. It was rare in clinical trials of ODACTRA. As part of your overall treatment plan, your doctor will prescribe auto-injectable epinephrine (epee-NEFF-rin) for the rare case of anaphylaxis. Your doctor, or someone in their office, will show you how to use it. Stop taking ODACTRA and get medical treatment right away if you experience any of these symptoms.
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Understand side effects

Because ODACTRA contains the very thing you are allergic to, reactions and side effects can occur. These tend to be limited to your mouth, and go away after an hour and with ongoing treatment. Rarely, these reactions may be serious or cause your body to have a systemic reaction. This is why you will be prescribed and trained on the use of an epinephrine autoinjector.

Some common side effects of ODACTRA are itching (in the ear and mouth), swelling (at the back of the mouth, lips, and tongue), nausea, tongue pain and tongue ulcers, stomach pain, mouth ulcers, food tasting different, throat irritation, and throat swelling.
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Take ODACTRA every day, as prescribed

Remember, ODACTRA is an allergy immunotherapy, and it works over time to help you become less likely to react to house dust mites. Tell your doctor if you stopped taking or need to stop taking ODACTRA for longer than 7 days—they may want you to restart therapy.
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How to take ODACTRA at home

3 simple steps
1
Tablet Pack Icon
With DRY hands, carefully remove the ODACTRA tablet from the blister pack.
The first dose of ODACTRA must be taken in your doctor’s office in case of an allergic reaction.
2
Place the ODACTRA® Tablet Under Your Tongue
Place the ODACTRA tablet under your tongue. It will dissolve in about 10 seconds.
DO NOT:
  • Swallow for at least 1 minute
  • Eat or drink for at least 5 minutes
3
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Wash your hands.
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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.