"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
GRASTEK® is an allergen extract indicated as immunotherapy for the treatment of grass polleninduced 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.
DOSAGE AND ADMINISTRATION
For sublingual use only.
One GRASTEK tablet daily.
Administer the first dose of GRASTEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of GRASTEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.
Administer GRASTEK to children under adult supervision.
Take the tablet from the blister unit after carefully removing the foil with dry hands.
Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved.
Do not swallow for at least 1 minute.
Wash hands after handling the tablet.
Do not take the tablet with food or beverage. Food or beverage should not be taken for the following 5 minutes after taking the tablet.
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 (including the intervals between the grass pollen seasons). The safety and efficacy of initiating treatment in season have not been established.
Data regarding the safety of restarting treatment after missing a dose of GRASTEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.
Dosage Forms And Strengths
GRASTEK is available as 2800 Bioequivalent Allergy Unit (BAU) tablets that are white to off-white, circular with a debossed round detail on one side.
Storage And Handling
GRASTEK 2800 BAU tablets are white to off-white, circular sublingual tablets with a debossed round detail on one side.
GRASTEK is supplied as follows:
3 blister packages of 10 tablets (30 tablets total). NDC 0006-4229-30
Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted between 15°C- 30°C (59°F-86°F). Store in the original package until use to protect from moisture.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Catalent Pharma Solutions Limited, Blagrove, Swindon, Wiltshire, SN5 8RU UK. Revised: April 2014
Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Grastek Information
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