ODACTRA is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.
Important Safety Information
WARNING: SEVERE ALLERGIC REACTIONS
ODACTRA can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer ODACTRA to patients with severe, unstable or uncontrolled asthma. Observe patients in the ofﬁce for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. ODACTRA may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. ODACTRA may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
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 [gelatin, mannitol and sodium hydroxide] 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. Educate patients 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 ODACTRA. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with ODACTRA. Review the epinephrine package insert for complete information.
Administer the initial dose of ODACTRA 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 ODACTRA.
Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of ODACTRA.
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 of ODACTRA.
ODACTRA 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 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 or dental extraction.
The most common solicited adverse reactions reported in clinical studies for subjects 18 through 65 years of age treated with ODACTRA vs placebo included throat irritation/tickle (67.0% vs 20.8%), itching in the mouth (61.3% vs 14.1%), itching in the ear (51.7% vs 11.7%), and swelling of the uvula/back of the mouth (19.8% vs 2.4%).
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy.
Before prescribing ODACTRA, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.