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KNOCK OUT ALLERGIES WITH YOUR OWN IMMUNE SYSTEM.

The only house dust mite immunotherapy tablet is in your corner.

FPO

The only house dust mite immunotherapy tablet is in your corner.

What is ODACTRA?

  • ODACTRA is the only once-daily sublingual (under-the-tongue) tablet that you take at home, year-round, for your house dust mite allergy—one of the most common indoor allergies. It's not an allergy shot. And it's not an over-the-counter medication that just temporarily relieves your allergy symptoms. It’s an allergy medicine that works differently.
  • ODACTRA is allergy immunotherapy—a treatment that helps build your resistance to what you’re allergic to in the long term. Over time, ODACTRA helps bring allergy relief by treating the underlying cause of your house dust mite allergy and can help significantly reduce your symptoms. This means it may also decrease your need for prescription and over-the-counter symptom-reducing medications, such as antihistamines and nasal corticosteroids.
  • ODACTRA helps reduce nose and eye symptoms—such as stuffy nose, runny nose, itchy nose, sneezing, and itchy and watery eyes—as it helps your body fight back. Plus, if you have other allergies in addition to a dust mite allergy, ODACTRA may help lower the total “allergic burden” your body has to deal with, helping you feel better overall.
  • ODACTRA is taken at home every day and works gradually, so you may not see results right away. Your health care provider will tell you how long to take ODACTRA based on your response to therapy.

Over-the-counter or prescription treatments for your symptoms may help quickly, but they only mask the problem temporarily. Allergy shots get to the cause of the problem, but can require frequent trips to your allergist and can take a year for you to feel results.

Finally, there’s ODACTRA.

In a clinical trial* of patients with allergic rhinitis (hay fever) due to house dust mites in a controlled environment, ODACTRA produced:

20.4% reduction in
allergy symptoms AT 8 WEEKS OF TREATMENT

48.6% reduction in
allergy symptoms AT 24 WEEKS OF TREATMENT

*Nolte H et al. J Allergy Clin Immunol. 2015;135:1494-1501.

How do I start ODACTRA?

Your first dose of ODACTRA will be given to you in your medical professional’s office so that you can be observed (for at least 30 minutes). This is to make sure you don’t have a serious allergic reaction. If you tolerate your first dose, you can take the rest of your doses at home—one tablet, every day, all year round. Please see the illustrations below to help you learn how to take ODACTRA.

How do I take ODACTRA at home?

Blister Pack

With dry hands, carefully remove the foil and then the tablet from the blister pack.

Taking Pill

Place the tablet under your tongue. It will dissolve in 10 seconds. DO NOT swallow for at least 1 minute.

Wash your hands after handling the tablet.

No Food

Don’t take the tablet with food or beverage.

Don’t have anything to eat or drink for at least 5 minutes after taking the tablet.

Remember to take your ODACTRA tablet every day as prescribed.

Keep in mind that because ODACTRA is an allergy immunotherapy, it makes you less likely to react to house dust mites. This is why you should continue to take ODACTRA every day, so that your immune system “remembers” not to react to house dust mites and you continue to avoid allergic symptoms.

What about side effects?

Because treatment with ODACTRA involves an allergen, it’s possible that you may have a local allergic reaction, such as itching or swelling of the mouth. These reactions may start within minutes of your first dose of ODACTRA. However, it’s likely that they will not last long and should resolve with continued treatment.

In clinical trials, the most frequent side effects included itching in the ear and mouth, swelling at the back of the mouth, swelling of the lips and tongue, nausea, tongue pain and tongue ulcers, stomach pain, mouth ulcers, food tasting different, throat irritation, and throat swelling.

As with all allergy immunotherapies, auto-injectable epinephrine [epi-neph-rine] is used to manage any serious reactions that may occur, such as anaphylaxis [an-a-phy-lax-is]. Anaphylaxis can include trouble breathing, dizziness, nausea, vomiting, diarrhea, throat tightness, and hives. In clinical trials, anaphylaxis was rare.

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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:

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:

Your doctor may decide that ODACTRA is not the best treatment if:

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.