Generic Name and Formulations:
Short ragweed pollen allergen extract (Ambrosia artemisiifolia) 12 Amb a 1-Unit; sublingual tablets.
Indications for RAGWITEK:
Short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.
Initiate at least 12 weeks before onset of ragweed pollen season and continue throughout the season. Give 1st dose under physician supervision; observe ≥30 mins for any signs/symptoms of severe allergic reaction; if tolerated, subsequent doses may be taken at home. 18–65yrs: 1 tab daily. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5 mins after dosing.
<18yrs: not established.
Severe, unstable, or uncontrolled asthma. History of any severe systemic or local allergic reaction. History of eosinophilic esophagitis.
Severe allergic reactions.
Risk of severe allergic reactions (eg, anaphylaxis, laryngopharyngeal restriction); 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, markedly compromised lung function, unstable angina, recent MI, significant arrhythmia, uncontrolled HTN). 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). Pregnancy (Cat.C). Nursing mothers.
Concomitant other allergen immunotherapy: not studied; may increase risk of local or systemic adverse reactions. Avoid concomitant drugs that can potentiate or inhibit effects of epinephrine (eg, beta-adrenergic blockers, alpha-adrenergic blockers, ergot alkaloids, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine, [cardiac glycosides, diuretics; monitor for arrhythmias]).
Throat irritation, pruritus (oral, ear, tongue), oral paresthesia, mouth edema; severe systemic or local allergic reactions, eosinophilic esophagitis (discontinue if occurs).