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ORALAIR
Allergies
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Drug Name:

ORALAIR Rx

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.

Company:
GREER Laboratories, Inc.

Therapeutic Use:

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.

Adult:

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.

Children:

<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.

Contraindications:

Severe, unstable, or uncontrolled asthma. History of severe systemic allergic reaction or any local reaction to sublingual allergen immunotherapy. History of eosinophilic esophagitis.

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. Elderly (>65yrs). Labor & delivery. Pregnancy (Cat.B). Nursing mothers.

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]).

Pharmacological Class:

Allergen extract.

Adverse Reactions:

Pruritus (oral, tongue, ear), throat irritation, mouth edema, cough, oropharyngeal pain; severe systemic or local allergic reactions, eosinophilic esophagitis (discontinue if occurs).

How Supplied:

Blisters (100IR, 300IR)—3; (300IR)—30

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