來源: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391458.htm
節選翻譯如下:
2014年4月2日美國FDA批準Oralair治療10---65歲的人因草花粉引起的伴有或無結膜炎(眼炎症)的過敏性鼻炎(花草熱)。 Oralair是第一個在美國批準的舌下過敏原(變應原)提取物藥物。在花粉季節開始的前4個月開始服用並繼續直到花粉季節結束。在醫生辦公室使用首次劑量，在那裏待至少30分鍾以觀察可能潛在的不良反應。然後回家自己每天舌下服用。
Oralair是含5種草花粉的冷凍幹燥混合物，包括藍草(Kentucky Blue Grass)，果園草(Orchard)，多年生黑麥草(Perennial Rye), 香黃花茅(Sweet Vernal)和貓尾草(Timothy)。
處方資料包括一個黑框警告可能發生的嚴重過敏反應(如危及生命的過敏反應)。Oralair還有一個分發給患者的用藥指南。成年人中報告的最常見不良反應為耳/口/舌瘙癢 ，及口腫脹和喉刺激。兒童中最常被報告的不良反應為口癢和腫脹及喉刺激。
Oralair由法國Antony的Stallergenes SA製造。
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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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
