U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

IMPORTANT SAFETY INFORMATION ABOUT RAGWITEK

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RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.

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Do not administer RAGWITEK to patients with severe, unstable or uncontrolled asthma.

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Observe patientT in the office for at least 30 minutes following the initial dose.

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Prescribe auto-injectable epinephrine, instruct and train patients (or their parents/guardians) on its appropriate use, and instruct patients (or their parents/guardians) to seek immediate medical care upon its use.

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RAGWITEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.

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RAGWITEK is contraindicated in patients with:

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Severe, unstable or uncontrolled asthma

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A history of any severe systemic allergic reaction

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A history of any severe local reaction after taking any sublingual allergen immunotherapy

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A history of eosinophilic esophagitis

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Hypersensitivity to any of the inactive ingredients [gelatin, mannitol and sodium hydroxide] contained in this product

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RAGWITEK can cause systemic allergic reactions including anaphylaxis which may be life-threatening and severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening. Educate patients (or their parents/guardians) to recognize the signs and symptoms of these allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. Allergic reactions may require treatment with epinephrine.

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Prescribe auto-injectable epinephrine to patients receiving RAGWITEK. Instruct patients (or their parents/guardians) to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients (or their parents/guardians) to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with RAGWITEK. Review the epinephrine package insert for complete information.

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Administer the initial dose of RAGWITEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of RAGWITEK.

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Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of RAGWITEK. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue RAGWITEK and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.

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RAGWITEK has not been studied in subjects with severe asthma. Immunotherapy with RAGWITEK should be withheld if the patient is experiencing an acute asthma exacerbation.

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RAGWITEK has not been studied in subjects who are receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.

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Stop treatment with RAGWITEK to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers or thrush) or oral wounds, such as those following oral surgery or dental extraction.

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The most common adverse reactions reported in adults treated with RAGWITEK vs placebo included throat irritation (16.6% vs 3.3%), oral pruritus (10.9% vs 2.0%), ear pruritus (10.4% vs 1.1%), oral paraesthesia (10.0% vs 4.0%), mouth edema (6.1% vs 0.5%), and tongue pruritus (5.1% vs 0.5%).

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The most common solicited adverse reactions reported in children and adolescents 5 through 17 years of age treated with RAGWITEK vs placebo included throat irritation/tickle (48.3% vs 17.7%), itching in the mouth (47.8% vs 11.2%), itching in the ear (33.9% vs 6.3%), mouth pain (18.9% vs 4.5%), swelling of the lips (13.8% vs 1.2%), nausea (11.5% vs 3.3%), swelling of the tongue (11.3% vs 0.8%), throat swelling (10.7% vs 1.6%), and stomach pain (10.1% vs 4.5%).

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The most common unsolicited adverse reactions reported in children and adolescents 5 through 17 years of age treated with RAGWITEK vs placebo included oral pruritus (7.8% vs 1.0%), throat irritation (7.6% vs 1.6%), ear pruritus (4.5% vs 0.2%), and tongue pruritus (4.5% vs 0.4%).

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Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, RAGWITEK should be used during pregnancy only if clearly needed.

Before prescribing RAGWITEK, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.