GRASTEK®, RAGWITEK®, and ODACTRA® are allergen extracts indicated as immunotherapy for the treatment of grass (GRASTEK), ragweed pollen-induced (RAGWITEK), and house dust mite (HDM)-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), short ragweed pollens (RAGWITEK), and Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts (ODACTRA). GRASTEK is approved for use in persons 5 through 65 years of age. RAGWITEK and ODACTRA are approved for use in persons 18 through 65 years of age. GRASTEK, RAGWITEK, and ODACTRA are not indicated for the immediate relief of allergic symptoms.
Important Safety Information
WARNING: SEVERE ALLERGIC REACTIONS
GRASTEK, RAGWITEK, and ODACTRA can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer GRASTEK, RAGWITEK, or 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. GRASTEK, RAGWITEK, and ODACTRA may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. GRASTEK, RAGWITEK, and ODACTRA may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
GRASTEK, RAGWITEK, and ODACTRA are 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, RAGWITEK, and ODACTRA can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, GRASTEK, RAGWITEK, and 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 GRASTEK, RAGWITEK, or 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 GRASTEK, RAGWITEK, or ODACTRA. Review the epinephrine package insert for complete information.
Administer the initial dose of GRASTEK, RAGWITEK, or 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 GRASTEK, RAGWITEK, or ODACTRA.
Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of GRASTEK, RAGWITEK, or ODACTRA.
Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue GRASTEK, RAGWITEK, or ODACTRA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
GRASTEK and RAGWITEK have not been studied in subjects with moderate or severe asthma or any subjects who required daily medication to treat asthma.
Immunotherapy with GRASTEK, RAGWITEK, or ODACTRA should be withheld if the patient is experiencing an acute asthma exacerbation.
Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of GRASTEK, RAGWITEK or ODACTRA.
GRASTEK, RAGWITEK, and ODACTRA have 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, RAGWITEK, or 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 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%).
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%).
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%).
Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, GRASTEK and RAGWITEK should be used during pregnancy only if clearly needed.
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 GRASTEK, RAGWITEK, or ODACTRA, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.