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About ORALAIR 2018-11-28T13:25:46-05:00

Another way to treat grass allergies

ORALAIR is a 5-grass sublingual allergy immunotherapy tablet for1

  • patients ages 5-65 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

Symptom relief during the first pollen season in adults

Significant improvement in efficacy measures during the pollen period1,3*†‡§

  • Rhinoconjuctivitis symptoms rated included sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes1‡

CS, Combined Score; IR, Index of reactivity; RTSS, Rhinoconjunctivitis Total Symptom Score; RMS, Rescue Medicine Score; LS, least-squares; RSS, Rhinoconjunctivitis Symptom Score.

*A multicenter clinical trial of 473 adults in the United States. Patients were treated with ORALAIR or placebo starting 4 months before the start of grass allergy season and for the duration of the pollen season.1
†Combined Score is a patient-specific measure that combines symptom and medication scores. It is calculated as CS=[(RTSS/6)+RMS]/2, ranging from 0 to 3.1,4
‡Participants graded each symptom daily using a 4-point descriptor scale for each symptom (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms).
Daily RTSS was the sum of the 6 individual RSSs.1
§Graded the intake of rescue medication as 0=no medication; 1=antihistamine (oral drops, eye drops, or both); 2=nasal corticosteroid; 3=oral corticosteroid.1

Symptom relief during the first pollen season
in children and adolescents

Significant improvement in efficacy measures during the pollen period in children and adolescents1,4*†

*A multicenter clinical trial of 278 children and adolescents. Patients were treated with ORALAIR or placebo starting 4 months before the start of grass allergy season and for the duration of the pollen season.1
†Combined Score is a patient-specific measure that combines symptom and medication scores. It is calculated as CS=[(RTSS/6)+RMS]/2, ranging from 0 to 3.1,4
‡Based on the average of the sum of patient ratings of the 6 most common symptoms of allergic rhinoconjunctivitis as measured individually by patients on a scale of 0 (no symptoms) to 3 (severe symptoms).1
§Graded the intake of rescue medication as 0=no medication; 1=antihistamine (oral drops, eye drops, or both); 2=nasal corticosteroid; 3=oral corticosteroid.1

Sustained efficacy year after year for 3 years

Improvement in combined score as measured during treatment1,4*

  • Data are insufficient to demonstrate efficacy for 1 or 2 years after discontinuation of ORALAIR1
*A 5-year, multicenter clinical trial of 426 adults in European countries. Patients were treated with ORALAIR or placebo starting 4 months before the start of grass allergy season for 3 years, followed by 2 years of immunotherapy-free follow-up.1,5

SAFETY

Demonstrated safety profile

Adverse reactions reported by ≥2% of 1038 adults 18 through 65 years of age receiving ORALAIR 300 IR and at a greater incidence than placebo1*

Adverse reactionsORALAIR 300 IR
(n=1038)		Placebo
(n=840)
Ear pruritus8.4%0.6%
Throat irritation22.0%3.7%
Cough7.3%5.9%
Oropharyngeal pain5.1%3.7%
Pharyngeal pain3.8%0.1%
Oral pruritus25.1%5.0%
Edema of the mouth8.2%0.6%
Tongue pruritus7.9%0.7%
Lip edema4.4%0.4%
Paraesthesia oral4.3%1.0%
Abdominal pain4.2%1.3%
Dyspepsia3.9%0.4%
Tongue edema2.7%0.1%
Hypoaesthesia oral2.2%0.1%
Stomatitis2.1%0.7%
Urticaria2.3%1.5%

IR, index of reactivity.

  • Additional adverse reactions of interest that occurred in <2% of ORALAIR recipients include dysphagia, nausea, vomiting, esophageal pain, gastritis, and gastroesophageal reflux1
  • ORALAIR should be used during pregnancy or breastfeeding only if clearly needed1
  • ORALAIR has not been studied in patients over 65 years of age1

Safety results from 6 placebo-controlled clinical trials of 1038 adults ages 18 through 65 receiving at least 1 dose of ORALAIR 300 IR.1

Additional adverse reactions reported by ≥2% of children and adolescents receiving ORALAIR 300 IR and at a greater incidence than placebo1

Adverse reactionsORALAIR 300 IR
(n=154)		Placebo
(n=158)
Tonsillitis5.8%3.2%
Upper respiratory tract infection3.9%1.9%
Asthma7.1%3.8%
Dysphonia2.6%1.3%
Lip pruritus3.2%0.0%
Atopic dermatitis3.2%0.6%
  • The safety profile in the pediatric population was generally similar to that of adults1
  • Efficacy and safety of ORALAIR have been established in children and adolescents 10 through 17 years of age. ORALAIR is not approved for use in children younger than 10 years of age because safety has not been established1
  • ORALAIR is indicated for pediatric patients over 10 years of age1

Adverse reactions in a pivotal multicenter, multinational clinical trial of 278 children and adolescents6

  • Localized treatment-emergent adverse reactions occurred in 54% of subjects treated with ORALAIR6
  • Adverse reactions in ≥5% of patients included oral pruritus (32.4%), edema of the mouth (12.9%), and throat irritation (7.9%) 6
  • Localized treatment-emergent adverse events were
    • usually mild to moderate6
    • transient, often resolving within the first week of treatment7
  • Only 7 ORALAIR-treated subjects discontinued due to adverse reactions6
  • 2 subjects who received ORALAIR reported serious adverse events, but they were not attributed to treatment6,8
    • These serious adverse events included asthma exacerbation and Burkitt lymphoma

Treatment-emergent adverse events were usually mild to moderate and often resolved within 1 week of treatment in adult and pediatric groups.3,7

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 5 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 the 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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