Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 May 2017


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. (1)

Full Prescribing information

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Advisory information

• Severe, unstable or uncontrolled asthma. (4)
• History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy. (4)
• A history of eosinophilic esophagitis. (4)
• Hypersensitivity to any of the inactive ingredients contained in this product. (4)
Special warnings and precautions

See full prescribing information for complete boxed warning.
• GRASTEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. (5.1)
• Do not administer GRASTEK to patients with severe, unstable or uncontrolled asthma. (4)
• Observe patients in the office for at least 30 minutes following the initial dose. (5.1)
• Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. (5.2)
• GRASTEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.2)
• GRASTEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)

• Inform patients of the signs and symptoms of serious allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. (5.1)
• In case of oral inflammation or wounds, stop treatment with GRASTEK to allow complete healing of the oral cavity. (5.7)

Adverse reactions

• Adverse reactions reported in ≥5% of patients were: ear pruritus, oral pruritus, tongue pruritus, mouth edema, throat irritation. (6)

Usage information

Dosing and administration

For sublingual use only. (2)
• One tablet daily. (2.1)
• Initiate treatment at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. For sustained effectiveness for one grass pollen season
after cessation of treatment, GRASTEK may be taken daily for three consecutive years. (2.2)
• Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute. (2.2)
• Administer the first dose of GRASTEK under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. Observe patients in the office for at least 30 minutes following the initial dose. (2.2)

More information

Category Value
Authorisation number BLA125473
Orphan designation No
Product NDC 0006-4229
Date First Approved 11-04-2014
Marketing authorisation holder Merck Sharp & Dohme Corp