More than Extracts

Sublingual Allergy Tablets

ODACTRA®

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 about ODACTRA

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.

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

Learn more at ODACTRAHCP.com

GRASTEK®

GRASTEK® is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age. GRASTEK is not indicated for the immediate relief of allergic symptoms.

Selected Important Safety Information About GRASTEK

WARNING: SEVERE ALLERGIC REACTIONS

  • GRASTEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
  • Do not administer GRASTEK 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.
  • GRASTEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
  • GRASTEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
  • GRASTEK 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

  • GRASTEK 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 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 GRASTEK. 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 GRASTEK. Review the epinephrine package insert for complete information.
  • Administer the initial dose of GRASTEK 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 GRASTEK.
  • Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of GRASTEK.
  • Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue GRASTEK and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
  • GRASTEK has not been studied in subjects with moderate or severe asthma or any subjects who required daily medication to treat asthma. Immunotherapy with GRASTEK should be withheld if the patient is experiencing an acute asthma exacerbation.
  • GRASTEK 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 GRASTEK 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 clinical studies for subjects 18 through 65 years of age treated with GRASTEK vs placebo included oral pruritus (26.7% vs 3.5%), throat irritation (22.6% vs 2.8%), ear pruritus (12.5% vs 1.1%), and mouth edema (11.1% vs 0.8%).
  • The most common adverse reactions for GRASTEK vs placebo in clinical studies for pediatric subjects between 5 and 17 years of age included oral pruritus (24.4% vs 2.1%), throat irritation (21.3% vs 2.5%), and mouth edema (9.8% vs 0.2%).
  • Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, GRASTEK 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 GRASTEK.com

RAGWITEK®

RAGWITEK is an allergen extract 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 pollens. RAGWITEK is approved for use in adults 18 through 65 years of age.
RAGWITEK is not indicated for the immediate relief of allergic symptoms.

Selected Important Safety Information About RAGWITEK

WARNING: SEVERE ALLERGIC REACTIONS

  • RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
  • Do not administer RAGWITEK 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.
  • RAGWITEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
  • RAGWITEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
  • 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 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 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 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 moderate or severe asthma or any subjects who required daily medication to treat asthma. Immunotherapy with GRASTEK 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 immuno-therapy.
  • 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 subjects 18 years of age and older 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%).
  • 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

Last updated: 2019.05.20