Generic Name and Formulations:
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract 100 IR (index of reactivity), 300 IR; sublingual tabs.
GREER Laboratories, Inc.
Indications for ORALAIR:
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.
Initiate 4 months before onset of grass pollen season and continue throughout season. Give 1st dose under physician supervision; observe ≥30 mins 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 5 mins after dosing.
<10yrs: not established. Initiate 4 months before onset of grass pollen season and continue throughout season. Give 1st dose under physician supervision; observe ≥30 mins for signs/symptoms of a severe allergic reaction; if tolerated, subsequent doses may be taken at home. 10–17yrs: 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 5 mins after dosing.
Severe, unstable, or uncontrolled asthma. History of severe systemic allergic reaction or any local reaction to sublingual allergen immunotherapy. History of eosinophilic esophagitis.
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. Elderly (>65yrs). Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
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]).
Pruritus (oral, tongue, ear), throat irritation, mouth edema, cough, oropharyngeal pain; severe systemic or local allergic reactions, eosinophilic esophagitis (discontinue if occurs).
Blisters (100IR, 300IR)—3; (300IR)—30
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