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Initiate treatment with ORALAIR 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season.1

Indications and Usage

ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the 5 grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.

ORALAIR is not indicated for the immediate relief of allergy symptoms.

Important Safety Information

WARNING: SEVERE ALLERGIC REACTIONS

  • ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema.
  • Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma.
  • Observe patients in the office for at least 30 minutes following the initial dose.
  • Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
  • ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
  • ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

ORALAIR is contraindicated in patients with severe, unstable or uncontrolled asthma, patients with a history of any severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy or of eosinophilic esophagitis, or patients who are hypersensitive to any of the inactive ingredients.

ORALAIR can cause systemic allergic reactions, including anaphylaxis, and severe local reactions, including laryngopharyngeal swelling, which may be life-threatening. Severe and serious allergic reactions may require treatment with epinephrine. Patients who have a systemic allergic reaction to ORALAIR should stop taking the product. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ORALAIR in patients with persistent symptoms of eosinophilic esophagitis, including dysphagia or chest pain. ORALAIR treatment should be withheld if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.

In case of oral inflammation or wounds, such as following oral surgery or dental extraction, ORALAIR treatment should be discontinued to allow complete healing of the oral cavity. The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.

The most common adverse events reported in ≥5% of patients were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain. Patients who have escalating or persistent local reactions to ORALAIR should be reevaluated and considered for discontinuation of ORALAIR.

ORALAIR should be used during pregnancy or breastfeeding only if clearly needed.

Please click here for full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Stallergenes at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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