Supplier News Breaks Archives
Merck set to launch Ragwitek
April 21st, 2014
WHITEHOUSE STATION, N.J. – Merck plans to release Ragwitek, a sublingual tablet for ragweed allergies, to U.S. pharmacies by the end of this month.
Ragwitek (short ragweed pollen allergen extract) is 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.
The medication is approved for people ages 18 to 65. The recommended dose of Grastek is one tablet daily placed under the tongue, where it will dissolve. Users are recommended to begin taking the medication at least 12 weeks before the expected onset of each grass pollen season and to continue treatment throughout the season.
Like Grastek, a sublingual tablet for the treatment of grass allergies introduced by Merck last week, Ragwitek is not indicated for the immediate relief of allergic symptoms.
"Ragwitek provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots," stated Dr. David Skoner, director, Division of Allergy and Immunology, Allegheny Health Network, and a clinical investigator in Merck's sublingual allergen immunotherapy tablet program. "While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options."
Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, a runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the ragweed pollen season.
"The FDA approval of Ragwitek brings an important new option for allergy specialists treating adults with allergic rhinitis with or without conjunctivitis caused by short ragweed pollen," commented Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. "Merck is proud to add this second sublingual allergen immunotherapy tablet to our respiratory portfolio."
Prescribing information for Ragwitek includes a boxed warning regarding severe allergic reactions. The product is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.