Medical Studies Prove ORALAIR® Effectiveness

ORALAIR was studied in medical studies that included more than 2,500 adults and children with allergies to 1 or more of the 5 grass pollens in ORALAIR. Treatment was started about 4 months before the grass allergy season began and continued throughout the season.

  • In medical studies, ORALAIR improved grass allergy symptoms in the first allergy season it was taken
  • In another medical study, people who took ORALAIR before and during 3 grass allergy seasons in a row had their allergy symptoms improve even further in each year

Read on for more information about how ORALAIR has helped other people with their grass allergies.

You may have some side effects from ORALAIR. In medical studies, the most common side effects in children and adults were itching of the mouth, lips, tongue, or throat.

These side effects, by themselves, are not dangerous or life-threatening. They usually go away soon after treatment starts. If you have a side effect that bothers you or does not go away, talk with your allergy specialist. He or she may be able to help you manage it.

Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning and Medication Guide.

Reduced Grass Allergy Symptoms

There are many symptoms of grass allergies, and some of the most common include:

  • Sneezing
  • Runny or itchy nose
  • Nasal congestion
  • Itchy and watery eyes

In medical studies, people reported that these symptoms were improved during the first grass pollen season they took ORALAIR. They also took less allergy medicines than people who did not take ORALAIR. Those allergy medicines included over-the-counter and prescription allergy medicines like antihistamines, nasal sprays, and other allergy pills.

In medical studies of ORALAIR*

The effectiveness of ORALAIR was measured in medical studies by a daily combined score of how troublesome allergy symptoms were and how much other allergy medicine was used.

*ORALAIR is approved for use in people 10 to 65 years old.

Continued Improvement, Season After Season

ORALAIR has also been proven to help beyond the first grass allergy season. A medical study showed that people who took ORALAIR about 4 months before and during 3 grass allergy seasons in a row had more symptom improvement and took less allergy medicine in each year. Your allergy specialist will be able to tell you when you should start taking ORALAIR before the next grass allergy season.

ORALAIR improved allergy symptoms and use of other allergy medicines in 3 seasons in a row

ORALAIR improved allergy symptoms and use of other allergy medicines 3 seasons in a row when taken 4 months before grass allergy season began and continued to take it throughout the grass allergy season.

ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR 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

If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care. For home administration of ORALAIR, your doctor should prescribe auto-injectable epinephrine for you to keep at home for treating a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning and Medication Guide.

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*Eligibility restrictions, terms, and conditions apply.

ORALAIR offers a grass allergy patient support program

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How To Get Started On ORALAIR

ORALAIR is a prescription allergy medicine. Make an appointment with your allergy specialist to find out if ORALAIR is right for you. Because ORALAIR is a treatment that you start about 4 months before the grass allergy season begins, you should talk to your doctor to find out when that is.

See our Allergy Specialist Discussion Guide for questions you may want to ask during the appointment.

If you don't have an allergy specialist, visit these Web sites to find one near you:

If your allergy specialist has already prescribed ORALAIR for you, you can keep track of how it is helping you with the ORALAIR Treatment Tracker. Use it to record your grass allergy symptoms and use of other allergy medicines every day.

Important Safety Information

ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR 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

If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care. For home administration of ORALAIR, your doctor should prescribe auto-injectable epinephrine for you to keep at home for treating a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

Do not take ORALAIR if you or your child:

  • Has severe, unstable, or uncontrolled asthma;
  • Had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat;
  • Has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before;
  • Has ever been diagnosed with eosinophilic esophagitis; or
  • Is allergic to any of the inactive ingredients contained in ORALAIR.

Stop taking ORALAIR and contact your doctor if you or your child has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat, or has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.

In children and adults, the most commonly reported side effects were itching of the mouth, lips, tongue or throat. These side effects, by themselves, are not dangerous or life-threatening.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Talk to your doctor before using ORALAIR while pregnant or breastfeeding.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.

Important Safety Information

ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR 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

If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care. For home administration of ORALAIR, your doctor should prescribe auto-injectable epinephrine for you to keep at home for treating a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

Do not take ORALAIR if you or your child:

  • Has severe, unstable, or uncontrolled asthma;
  • Had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat;
  • Has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before;
  • Has ever been diagnosed with eosinophilic esophagitis; or
  • Is allergic to any of the inactive ingredients contained in ORALAIR.

Stop taking ORALAIR and contact your doctor if you or your child has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat, or has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.

In children and adults, the most commonly reported side effects were itching of the mouth, lips, tongue or throat. These side effects, by themselves, are not dangerous or life-threatening.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Talk to your doctor before using ORALAIR while pregnant or breastfeeding.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.