ODACTRA^® is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)–induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in individuals 5 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.

Important Safety Information

• ODACTRA 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
• Hypersensitivity to any of the inactive ingredients contained in this product

• ODACTRA can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, ODACTRA can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening.
• Prescribe epinephrine to patients receiving ODACTRA. Instruct patients (or parents/guardians) to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency epinephrine. Instruct patients (or parents/guardians) to seek immediate medical care and to stop treatment upon use of epinephrine.
• Administer the initial dose of ODACTRA in a healthcare setting under the supervision of a healthcare professional 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.
• Consider discontinuation of ODACTRA in patients who experience persistent and escalating adverse reactions in the mouth or throat.
• Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ODACTRA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
• Withhold immunotherapy with ODACTRA if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation.
• ODACTRA has not been studied in participants 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.
• Stop treatment with ODACTRA 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, tooth loss or dental extraction.
• The most common solicited adverse reactions reported in ≥10% of adult participants (18 through 65 years of age) treated with ODACTRA were throat irritation/tickle, itching in the mouth, itching in the ear, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, mouth ulcer/sore in the mouth, and food tastes different.
• The most common solicited adverse reactions reported in ≥10% of adolescent participants (12 through 17 years of age) treated with ODACTRA were throat irritation/tickle, itching in the mouth, itching in the ear, tongue pain, stomach pain, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, throat swelling, nausea, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, and diarrhea.
• The most common solicited adverse reactions reported in ≥10% of pediatric participants (5 through 11 years of age) treated with ODACTRA were itching in the mouth, throat irritation/tickle, itching in the ear, stomach pain, swelling of the lips, tongue pain, food tastes different, nausea (feel like throwing up), swelling in the back of the mouth, swelling of the tongue, and mouth ulcer.
• Available data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy. Data are not available to assess the effects of ODACTRA on the breastfed child or on milk production and excretion in the nursing woman.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.

Learn more at ODACTRA.com

Selected Important Safety Information About RAGWITEK

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

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

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.

Learn more at RAGWITEK.com