"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"...
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.
DOSAGE AND ADMINISTRATION
For sublingual use only.
One RAGWITEK tablet daily.
Administer 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.
Dosage Forms And Strengths
RAGWITEK is available as 12 Amb a 1-Unit (Amb a 1-U) tablets that are white to off-white, circular with a debossed double hexagon on one side.
Storage And Handling
RAGWITEK 12 Amb a 1-U tablets are white to off-white, circular sublingual tablets with a debossed double hexagon on one side.
RAGWITEK is supplied as follows:
3 blister packages of 10 tablets (30 tablets total). NDC 0006-5420-30
9 blister packages of 10 tablets (90 tablets total). NDC 0006-5420-54
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 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/2/2014
Additional Ragwitek Information
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