FDA approves Grastek for grass pollen-induced Allergic Rhinitis - Merck Inc.,
Merck announced that the FDA has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced Allergic Rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Grastek is approved for use in persons 5 through 65 years of age. Grastek is not indicated for the immediate relief of allergic symptoms.
The prescribing information for Grastek includes a boxed warning regarding severe allergic reactions. Grastek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy Grass Pollen Allergen Extract is marketed in Europe as Grazax by Alk Abello since 2007.
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