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GRASTEK
Allergies
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Drug Name:

GRASTEK Rx

Generic Name and Formulations:
Timothy grass pollen allergen extract 2800 bioequivalent allergy units (BAUs); sublingual tabs.

Company:
Merck & Co., Inc.

Therapeutic Use:

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.

Contraindications:

Severe, unstable, or uncontrolled asthma. History of severe systemic or local allergic reaction. History of eosinophilic esophagitis.

Warnings/Precautions:

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.

Interactions:

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]).

Pharmacological Class:

Allergen extract.

Adverse Reactions:

Pruritus (oral, tongue, ear), mouth edema, throat irritation; severe systemic or local allergic reactions.

How Supplied:

Blisters—30

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