FDA批准第一个舌下药物Oralair治疗花粉过敏性鼻炎

来源: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391458.htm

节选翻译如下:

2014年4月2日美国FDA批准Oralair治疗10---65岁的人因草花粉引起的伴有或无结膜炎(眼炎症)的过敏性鼻炎(花草热)。 Oralair是第一个在美国批准的舌下过敏原(变应原)提取物药物。在花粉季节开始的前4个月开始服用并继续直到花粉季节结束。在医生办公室使用首次剂量，在那里待至少30分钟以观察可能潜在的不良反应。然后回家自己每天舌下服用。

Oralair是含5种草花粉的冷冻干燥混合物，包括蓝草(Kentucky Blue Grass)，果园草(Orchard)，多年生黑麦草(Perennial Rye), 香黄花茅(Sweet Vernal)和猫尾草(Timothy)。

处方资料包括一个黑框警告可能发生的严重过敏反应(如危及生命的过敏反应)。Oralair还有一个分发给患者的用药指南。成年人中报告的最常见不良反应为耳/口/舌瘙痒 ，及口肿胀和喉刺激。儿童中最常被报告的不良反应为口痒和肿胀及喉刺激。

Oralair由法国Antony的Stallergenes SA制造。

 

The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.
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Oralair is a once-daily tablet that rapidly dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season. The first dose is taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions.
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Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.
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The prescribing information includes a boxed warning that severe allergic reactions (such as anaphylaxis, which can be life-threatening) can occur. Oralair also has a medication guide for distribution to the patient. The most common adverse reactions reported by adults were itching in the ears and mouth and of the tongue, as well as swelling of the mouth and throat irritation. In children, the most commonly reported adverse reactions were itching and swelling in the mouth and throat irritation.
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Oralair is manufactured by Stallergenes S.A. of Antony, France.

Allergic Rhinitis

Indicated as immunotherapy for grass pollen-induced allergic rhinitis (with or without conjunctivitis) confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the 5 grass species contained in the product

Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season

18-65 years: 300 IR SL qDay; give 1st dose in physician’s office and observe for 30 min

>65 years: Not approved

Dosing Considerations

Allergen contents

• Kentucky bluegrass (Poa pratensis)
• Orchard grass (Dactylis glomerata)
• Perennial Ryegrass (Lolium perenne)
• Sweet Vernal grass (Anthoxanthum odoratum)
• Timothy grass (Phleum pratense)

Administration

Instruct patients to avoid swallowing for about 1 minute following SL administration

Wash hands after handling the tablet

Do not take with food or beverage; avoid food or beverages for 5 minutes after taking the SL tablet
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全美过敏原最严重的城市排名

See the top ten below and check out the full list  here.

1. Louisville, Kentucky
2. Memphis, Tennessee
3. Baton Rouge, Louisiana
4. Oklahoma City, Oklahoma
5. Jackson, Mississippi
6. Chattanooga, Tennessee
7. Dallas, Texas
8. Richmond, Virginia
9. Birmingham, Alabama
10. McAllen, Texas

Read more at: http://www.aafa.org/pdfs/FINAL_public_LIST_Spring_2014.pdf