近日，美国食品和药物管理局（FDA）已批准治疗屋尘螨（house dust mites，HDM）过敏的舌下免疫含片Odactra，这是首个通过舌下（sublingually）含服给药的过敏原提取物，用于18-65岁成人，治疗由屋尘螨（HDM）引起的伴或不伴眼部炎症（结膜炎）的鼻腔炎症（过敏性鼻炎）。
FDA生物制品评估和研究中心主任Peter Marks博士表示，屋尘螨过敏性疾病会对一个人的生活质量带来负面影响，Odactra的获批上市，将为患者提供一种除过敏针剂之外的新治疗选择，帮助解决患者的症状。
Odactra是一种每日一次的舌下含片，全年服用，置于舌下后能够快速溶化。Odactra使患者暴露于屋尘螨过敏原，随着时间的推移，逐步训练机体免疫系统停止对所接触免疫原的异常反应，降低鼻部和眼部过敏症状的频率和严重程度。需要指出的是，患者在初次用药时，需在具有过敏性疾病诊断和治疗经验的医疗保健专家的监督下服用，同时需要观察至少30分钟，观测潜在的不良反应。如果首次服药的耐受性良好，患者后续可以在家自行服药。另外，在开始Odactra治疗后，患者应每日坚持服药，大约8-14周开始经历明显的症状缓解。为首个舌下免疫含片Odactra获美国FDA批准治疗屋尘螨
批准日期：2017年3月2日 公司：默沙东
ODACTRA House Dust Mite（粉尘螨和尘螨[Dermatophagoides farinae andDermatophagoides pteronyssinus]）变应原提取物舌下含片
首次美国批准：2017
警告：
严重的过敏反应
见完整处方信息完整盒装警告。
ODACTRA可引起危及生命的过敏反应，如过敏反应和严重喉咽限制。
不要对患有严重、不稳定或不控制哮喘的患者实施ODACRA。
在最初的剂量下观察办公室内的病人至少30分钟。
处方自动注射肾上腺素，指导和培训病人适当的使用，并指导病人立即使用其医疗保健。
ODACTA可能不适用于某些潜在的医疗条件，可能会降低他们在严重过敏反应中的生存能力。
ODACTA可能不适合那些对肾上腺素或吸入支气管扩张剂过敏的患者，例如服用β受体阻滞剂的患者。
作用机理
过敏原免疫治疗作用的确切机制尚未完全建立。
适应症及用法
ODACTA是一种变应原提取物，被认为是对尘螨（HDM）引起的过敏性鼻炎的免疫治疗，具有或不伴有结膜炎，经体外试验证实为嗜皮尘螨或尘螨屋尘螨的IgE抗体，或对持牌侯侯的皮肤试验。硒尘螨变应原提取物。ODACTA被批准用于18至65岁的成年人。
剂量与给药
仅供舌下使用。
每天一片。
将片剂立即放在舌下，在10秒内溶解。不要吞咽至少1分钟。
在具有过敏性疾病诊断和治疗经验的医生的监督下施用第一剂ODACTRA。在最初的剂量下观察办公室内的病人至少30分钟。
剂型和强度
片剂，12平方赫兹。
禁忌症
严重、不稳定或不可控制的哮喘。
任何严重的全身过敏反应或任何舌下过敏原免疫治疗的严重局部反应的历史。
嗜酸细胞性食管炎病史。
对本产品所含的任何非活性成分过敏。
警告和注意事项
告知患者严重过敏反应的体征和症状，并指示他们立即就医，如有任何过敏反应发生，停止治疗。
在口腔炎症或伤口的情况下，停止治疗奥达克特拉，以允许完全愈合的口腔。
不良反应
在≥10%接受ODACTRA治疗的受试者中，最常见的不良反应是：喉咙发炎/发痒、口腔发痒、耳朵发痒、悬雍垂/口背肿胀、嘴唇肿胀、舌头肿胀、恶心、舌痛、喉咙肿胀、舌头。舌、胃、疼痛，口腔溃疡/口腔溃疡，味觉改变/食物味道不同。
包装供应/储存和储运
ODACTRA 12SQ-HDM片为白色至灰白色的圆形冷冻干燥舌下片，一侧为腺体五边形细节。
ODACTA提供如下：3泡罩包装10片（总共30片）。NDC527 091701-3
室温贮藏，20℃C-25℃（68～0.77μF）。储存在原来的包装，直到使用，以防止水分。

完整说明资料附件：https://www.odactra.com/assets/pdf/odactra-full-pi.pdf
ODACTRA™ House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract
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.