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Side Effects & Adverse Reactions
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Uses
RAGWITEK™ is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age.
RAGWITEK is not indicated for the immediate relief of allergic symptoms.
History
There is currently no drug history available for this drug.
Other Information
RAGWITEK tablets contain pollen allergen extract from Short Ragweed (Ambrosia artemisiifolia). RAGWITEK is a sublingual orally disintegrating tablet that dissolves rapidly.
RAGWITEK is available as a tablet of 12 Amb a 1-U of short ragweed pollen allergen extract.
Inactive ingredients: gelatin NF (fish source), mannitol USP, and sodium hydroxide NF.
Sources
Ragwitek Manufacturers
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Merck Sharp & Dohme Corp.
Ragwitek | Merck Sharp & Dohme Corp.
For sublingual use only.
2.1 DoseOne RAGWITEK tablet daily.
2.2 AdministrationAdminister the first dose of RAGWITEK 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 RAGWITEK, 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.
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 ragweed pollen season and continue treatment throughout the season. 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 RAGWITEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.
Prescribe auto-injectable epinephrine to patients prescribed RAGWITEK and instruct them in the proper use of emergency self-injection of epinephrine [see Warnings and Precautions (5.2)].
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