INDICATION

ORALAIR® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a prescription medicine used for sublingual (under the tongue) immunotherapy prescribed to treat sneezing, runny or itchy nose, nasal congestion or itchy and watery eyes due to allergy to these grass pollens. ORALAIR may be prescribed for persons 5 to 65 years old whose doctor has confirmed are allergic to any of these grass pollens.

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

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.

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ORALAIR® is a registered trademark of Stallergenes Greer or its affiliates.

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