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Oralair Generic Name & Formulations
Legal Class
Rx
General Description
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract 100 IR (index of reactivity), 300 IR; sublingual tabs.
Pharmacological Class
Allergen extract.
How Supplied
Blisters (100IR, 300IR)—3; (300IR)—30
Manufacturer
Generic Availability
NO
Oralair Indications
Indications
Grass pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by a (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.
Oralair Dosage and Administration
Adult
Initiate 4 months before onset of grass pollen season and continue throughout season. Give 1st dose under physician supervision; observe ≥30mins for signs/symptoms of a severe allergic reaction; if tolerated, subsequent doses may be taken at home. ≥18–65yrs: 300 IR daily. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5mins after dosing.
Children
<5yrs: not established. Initiate 4 months before onset of grass pollen season and continue throughout season. Give 1st dose under physician supervision; observe ≥30mins for signs/symptoms of a severe allergic reaction; if tolerated, subsequent doses may be taken at home. 5–17yrs: 100 IR daily on Day 1; 200 IR daily on Day 2, then 300 IR daily on Day 3 and thereafter. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5mins after dosing.
Oralair Contraindications
Contraindications
Severe, unstable, or uncontrolled asthma. History of severe systemic allergic reaction or any local reaction to sublingual allergen immunotherapy. History of eosinophilic esophagitis.
Oralair Boxed Warnings
Boxed Warning
Severe allergic reactions.
Oralair Warnings/Precautions
Warnings/Precautions
Risk of severe allergic reactions (eg, anaphylaxis, laryngopharyngeal edema); discontinue if occurs. Prescribe auto-injectable epinephrine for emergency use. Underlying conditions that may reduce survival of a serious allergic reaction after epinephrine use (eg, compromised lung function, unstable angina, recent MI, significant arrhythmia, uncontrolled hypertension). Moderate or severe asthma. Withhold therapy in acute asthma exacerbation; consider discontinuing if recurrent. Interrupt therapy for oral inflammation or wounds to allow complete healing. Increased risk of Oralair if treatment is initiated during grass pollen season. Elderly (>65yrs). Labor & delivery. Pregnancy. Nursing mothers.
Oralair Pharmacokinetics
See Literature
Oralair Interactions
Interactions
Concomitant other allergen immunotherapy: not studied. Avoid concomitant drugs that can potentiate or inhibit effects of epinephrine (eg, beta-blockers, alpha-blockers, ergot alkaloids, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine, [cardiac glycosides, diuretics; monitor for arrhythmias]).
Oralair Adverse Reactions
Adverse Reactions
Pruritus (oral, tongue, ear), throat irritation, mouth edema, cough, asthma, oropharyngeal pain, tonsillitis, oral paresthesia; severe systemic or local allergic reactions, eosinophilic esophagitis (discontinue if occurs).
Oralair Clinical Trials
See Literature
Oralair Note
Not Applicable
Oralair Patient Counseling
See Literature
