About ORALAIR 2017-07-27T09:59:42+00:00

Another way to treat grass allergies

ORALAIR is a 5-grass sublingual allergy immunotherapy tablet for1

  • patients ages 10-65 with grass pollen-induced allergic rhinitis with or without conjunctivitis
  • patients looking to get ahead of grass allergy symptoms before they start
  • patients who would prefer taking their allergy medication at home
Prevalence
Efficacy
Safety
Dosing
Patient Profiles

PREVALENCE

The only sublingual grass allergy immunotherapy tablet that contains 5 common grasses widely distributed throughout America1,2

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Prevalence of the 5 grasses contained in ORALAIR (Sweet vernal, orchard, perennial rye, timothy, and Kentucky blue grasses) across the contiguous United States

EFFICACY

SAFETY

Demonstrated safety profile

DOSING

Started 4 months before grass allergy season and maintained until season’s end

Dosage and administration for adults and children1

Important Considerations

  • Observe patients for 30 minutes for signs or symptoms of a severe systemic or severe local allergic reaction after providing the first dose in-office1
  • After tolerating the first in-office dose, patients can take subsequent doses at home1
  • If patients do not take ORALAIR for more than 1 day, instruct them to contact you before restarting1
  • Administer ORALAIR to children under adult supervision1
  • It is recommended that auto-injectable epinephrine be made available to patients prescribed ORALAIR. Patients who are prescribed epinephrine while receiving immunotherapy should be instructed in the proper use of emergency self-injection of epinephrine1

ORALAIR 100 IR is not available commercially.

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PATIENT PROFILES

BACKGROUND

  • 37-years-old, active mom of 2
  • Enjoys adventurous aVctivities with her family
  • Symptoms include sneezing and nasal pruritus

TREATMENT HISTORY

  • Over-the-counter antihistamines and nasal steroids
  • Has taken these for a few years, but is not satisfied

CONFIRMED ALLERGIES

Tested positive via skin prick testing for

  • Kentucky Blue Grass
  • Orchard Grass IgE antibodies

PRESENTATION

  • Discussed seasonal allergies with HCP at wellness visit prior to grass allergy season

ORALAIR IS AN OPTION FOR BONNIE

  • Tested positive for grass allergies
  • On-the-go patient may benefit from a grass allergy medication she can take at home

BACKGROUND

  • 15-years-old, student and roller hockey player
  • Spends time outdoors in the spring
  • Symptoms include sneezing, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes

TREATMENT HISTORY

  • History of antihistamine, eye drop, and nasal-steroid treatment
  • Third visit over the past 3 years; typically visits at the peak of grass season

CONFIRMED ALLERGIES

  • Tested positive for Timothy, Perennial Rye, and Kentucky Blue Grass IgE antibodies, as well as other allergens via in vitro (blood) testing

PRESENTATION

  • Experiences severe, uncontrolled allergy symptoms 4-5 times a week; especially while exploring outdoors during the spring
  • Dissatisfied with previous treatments for his grass allergies and looking for another treatment option

ORALAIR IS AN OPTION FOR MARK

  • Tested positive for grass allergies
  • Proactively seeking another treatment option
  • Symptoms worsen during the spring consistent with grass allergies, although also tested positive to other allergens
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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.

References: 1. ORALAIR® full Prescribing Information, Stallergenes SAS 2014. 2. Moingeon P, Pelte G, Bergmann KC. Rationale for a five-grass pollen vaccine. Clin Exp Allergy Rev. 2008;8:12-14. 3. Cox LS, Casale TB, Nayak AS, et al. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012;130(6):1327-1334. 4. ORALAIR® Food and Drug Administration Allergenic Products Advisory Committee briefing document. Stallergenes S.A. 2013. 5. Didier A, Worm M, Horak F, et al. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011;128(3):559-566. 6. Wahn U, Tabar A, Kuna P, et al. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009;123(1):160-166. 7. Halken S, Agertoft L, Seidenberg J, et al. Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents. Pediatr Allergy Immunol. 2010;21(6):970-976. 8. Data on file. Summary of clinical safety. Stallergenes S.A. 2013.
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