Generic Name and Formulations:
Timothy grass pollen allergen extract 2800 bioequivalent allergy units (BAUs); sublingual tabs.
Merck & Co., Inc.
Indications for GRASTEK:
Grass 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.
Adults and Children:
<5yrs: not established. Initiate at least 12 weeks 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. ≥5–65yrs: one tab (2800 BAUs) daily. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5 mins after dosing. May be taken daily for 3 consecutive years for sustained effectiveness.
Severe, unstable, or uncontrolled asthma. History of severe systemic or local allergic reaction. History of eosinophilic esophagitis.
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 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). Pregnancy (Cat.B). 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-blockers, alpha-blockers, ergot alkaloids, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine, [cardiac glycosides, diuretics; monitor for arrhythmias]).
Pruritus (oral, tongue, ear), mouth edema, throat irritation; severe systemic or local allergic reactions.