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Hot Topic: FDA Approves Oral Immunotherapy for Allergy

Darrell Hulisz, RPh, PhamD

July 1, 2014

Ragwitek® was recently approved by the FDA on April 17, 2014. It is the first sublingual allergen therapy for the treatment of short ragweed pollen induced allergic rhinitis, also known as hay fever.¹ Ragwitek will offer a beneficial alternative for patients who have to see a physician for regular allergy shots for allery desensitivation. Ragwitek is indicated for patients with allergic rhinitis with or without conjunctivitis, and is approved for use in patients 18 to < 66 years old.® ² Ragwitek® joins two other sublingual allergen immunotherapies approved this year, which include Grastek® (timothy grass pollen) and Oralair® (5 grass pollen extract).

Ragweed pollen allergies are prevalent in the late summer to early fall, and Ragwitek® must be started 12 weeks before and taken the entire duration of ragweed season. A randomized, placebo controlled study completed in North America and Europe showed up to a 27% reduction in allergy symptoms and reduction in the use of additional allergy medications in patients taking ragweed pollen immunotherapeutic tablet compared to placebo.³ No deaths or systemic allergic reactions were observed in the study.

Ragwitek® is dissolved sublingually once daily. The tablet should be given about one minute to completely dissolve, after which the patient can swallow. Food and drink should be avoided for at least 5 minutes, and hands should be washed after administration. The first dose of Ragwitek® must be administered in a doctor's office, and the patient should be monitored for 30 minutes for signs of an allergic reaction. If no reaction occurs, the patient may take the medication at home on a daily basis. Every patient should be sent home with an epinephrine pen and counseled on proper use in case of anaphylaxis.¹


¹ FDA approves Ragwitek for short ragweed pollen allergies. Silver Spring (MD). U.S. Food and Drug Administration. 2014 April 17. Available from:

² FDA Clears Sublingual Ragwitek for Ragweed Allergy. Medscape. Apr 17, 2014.

³ Creticos PS, Maloney J, Bernstein DI, et al. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol 2013;131(5):1342-9.

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