Ragwitek含有一种矮豚草（艾叶破布草）花粉提取物。这款药物是一种片剂，通过舌下使用，日用一次，它在舌下可以迅速溶解。Ragwitek要在豚草花粉季节开始之前12周开始使用，直到豚草花粉季节结束。初次用药要在卫生保健专业人员办公室进行，患者在那里要被观察至少30分钟，看是否存在潜在不良反应。初次用药之后，患者可以在家使用Ragwitek。

“Ragwitek的批准为美国成千上万的矮豚草花粉过敏成年患者提供了一种过敏注射的替代选择，帮助他们管理自己的疾病，”FDA生物制剂评价与研究办公室主任、医学博士Karen Midthun称。

有或没有结膜炎的过敏性鼻炎个体患者可能会经历一个流鼻涕、反复打喷嚏、鼻痒、鼻塞、眼睛痒及流泪的过程。矮豚草花粉过敏是一种最常见的季节性过敏，在美国夏天晚些时候及初秋时节比较盛行。矮豚草花粉诱导的过敏通常通过避免花粉、使用药物减轻症状或过敏疫苗注射来进行管理。

Ragwitek的安全性及有效性通过在美国及其它国家进行的研究得到评价。安全性在大约1700名成人患者身上进行了评价。Ragwitek用药患者报道最常见的不良反应是嘴和耳朵发痒及喉咙发炎。在1700名成人患者中，大约有760人被用来评价确定这款药物的有效性。

试验中一些患者接受Ragwitek治疗，另一些患者接受非活性物质（安慰剂）治疗。患者报告了他们的症状及为度过过敏季而对其它药物的需求。在一个草花粉季治疗期间，与使用安慰剂的患者相比，Ragwitek用药患者在症状及药物需求上下降大约26%。

处方信息中包含一项黑框警告，告知可能会发生严重过敏反应，并且一些过敏反应可能会危及生命。Ragwitek还有一项用药指南用来指导患者的配药。Ragwitek由英国Catalent制药为默沙东生产。

FDA approves Ragwitek for short ragweed pollen allergies  

The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.

Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.

“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics eva1uation and Research.  

Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is preva1ent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots.  

The safety and effectiveness of Ragwitek was eva1uated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, ab0ut 760 were eva1uated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo.  

The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient.

Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.

免责声明： 

      本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。 

      如有侵权，请联系我们删除