Now approved for adolescent patients aged 12 to 17 years
Now approved for adolescent patients aged 12 to 17 years
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Treat an underlying cause of allergic rhinitis with ODACTRA®

Targeting house dust mites—a predominant contributor to year-round allergies—may provide the control patients are looking for
ODACTRA® is the first and only FDA-approved sublingual tablet for HDM-induced AR, with or without conjunctivitis
AR=allergic rhinitis; HDM=house dust mite.
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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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians 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.

Indication

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 persons 12 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians 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.
  • Prescribe auto-injectable 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 auto-injectable epinephrine. Instruct patients (or parents/guardians) to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with ODACTRA. See the auto-injectable 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% placebo), itching in the mouth (61.3% vs. 14.1%), itching in the ear (51.7% vs. 11.7%), swelling of the uvula/back of the mouth (19.8% vs. 2.4%), swelling of the lips (17.7% vs. 2.7%), swelling of the tongue (15.8% vs. 2.1%).
  • The most common unsolicited adverse reactions reported in clinical studies for subjects 18 through 65 years of age treated with ODACTRA vs. placebo included paresthesia oral (9.2% vs. 3.2%), tongue pruritus (4.7% vs. 1.1%), oral pain (2.7% vs. 0.6%), stomatitis (2.5% vs. 1.1%), dyspepsia (2.2% vs. 0.0%).
  • The most common solicited adverse reactions reported in clinical studies for adolescents 12 through 17 years of age treated with ODACTRA or placebo included throat irritation/tickle (73.4% vs. 35.8% placebo), itching in the mouth (73.4% vs. 14.7%), itching in the ear (50.0% vs. 11.6%), tongue pain (24.5% vs. 4.2%), stomach pain (23.4% vs. 15.8%), swelling of the uvula/back of the mouth (20.2% vs. 3.2%), swelling of the lips (20.2% vs. 1.1%), swelling of the tongue (19.1% vs. 3.2%), throat swelling (18.1% vs. 8.4%), nausea (17.0% vs. 9.5%).
  • The most common unsolicited adverse reactions reported in clinical studies for adolescents 12 through 17 years of age treated with ODACTRA vs placebo included paraesthesia oral (5.3% vs. 0.0%), oral pain (4.3% vs. 0.0%), tongue pruritus (3.2% vs. 0.0%), pruritus (2.1% vs. 1.1%), stomatitis (2.1% vs. 1.1%), and chest discomfort (2.1% vs. 0.0%).
  • 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.

Indication

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 persons 12 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians 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.
  • Prescribe auto-injectable 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 auto-injectable epinephrine. Instruct patients (or parents/guardians) to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with ODACTRA. See the auto-injectable 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% placebo), itching in the mouth (61.3% vs. 14.1%), itching in the ear (51.7% vs. 11.7%), swelling of the uvula/back of the mouth (19.8% vs. 2.4%), swelling of the lips (17.7% vs. 2.7%), swelling of the tongue (15.8% vs. 2.1%).
  • The most common unsolicited adverse reactions reported in clinical studies for subjects 18 through 65 years of age treated with ODACTRA vs. placebo included paresthesia oral (9.2% vs. 3.2%), tongue pruritus (4.7% vs. 1.1%), oral pain (2.7% vs. 0.6%), stomatitis (2.5% vs. 1.1%), dyspepsia (2.2% vs. 0.0%).
  • The most common solicited adverse reactions reported in clinical studies for adolescents 12 through 17 years of age treated with ODACTRA or placebo included throat irritation/tickle (73.4% vs. 35.8% placebo), itching in the mouth (73.4% vs. 14.7%), itching in the ear (50.0% vs. 11.6%), tongue pain (24.5% vs. 4.2%), stomach pain (23.4% vs. 15.8%), swelling of the uvula/back of the mouth (20.2% vs. 3.2%), swelling of the lips (20.2% vs. 1.1%), swelling of the tongue (19.1% vs. 3.2%), throat swelling (18.1% vs. 8.4%), nausea (17.0% vs. 9.5%).
  • The most common unsolicited adverse reactions reported in clinical studies for adolescents 12 through 17 years of age treated with ODACTRA vs placebo included paraesthesia oral (5.3% vs. 0.0%), oral pain (4.3% vs. 0.0%), tongue pruritus (3.2% vs. 0.0%), pruritus (2.1% vs. 1.1%), stomatitis (2.1% vs. 1.1%), and chest discomfort (2.1% vs. 0.0%).
  • 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.