英文药名: Exubera(Insulin Human [rDNA origin]-Insulin for Inhalation)

中文药名: 人胰岛素[rDNA源]-吸入用胰岛素

药品简介
美国食品与药物管理局（FDA）批准了第一种吸入型胰岛素（Exubera）上市，用于治疗患1型和2型糖尿病的成年患者。FDA称，自19世纪20年代发现胰岛素以来，还是首次采用这种新的胰岛素给药方式——重组人胰岛素（rDNA）吸入粉剂。
FDA的批准文件中要求制造商在配送Exubera时须附带用药指南。指南中含有为患者所写的、经FDA批准的信息。
根据FDA的要求， Exubera不能用于吸烟者和戒烟后前6个月的患者。也不推荐将药物用于哮喘、支气管炎和肺气肿的患者。但感冒或其他上呼吸道感染的患者还是可以使用Exubera，尽管可能会引起咳嗽。
FDA建议患者在接受吸入型胰岛素治疗之前应先进行肺功能检查，并在以后的每6至12个月检查一次。
这种新的治疗方式是由辉瑞、赛诺菲-安万特和Nektar制药公司共同努力，经过10年的研究后发明的。本月初辉瑞公司购买了赛诺菲-安万特公司的Exubera使用权。
“在此之前，需要胰岛素治疗的糖尿病患者都只有一种可以选择的治疗方式，” FDA药物审查及研究中心负责人Steven Galson, MD在新的发言中表示，“我们希望吸入型胰岛素的上市可以给患者提供更多的选择以更好地控制血糖。”
吸入型胰岛素地给药装置比治疗哮喘地吸入器大。经过折叠以后体积接近于一个标准的手电筒大小。从装置的体部可以伸出一个可回缩的吸入管，吸入管展开后可以从胸部延伸到口里。在装置启动之前必须先装入泡包装的胰岛素。就Exubera的使用还将对患者和医生进行大量培训。
吸入型胰岛素并不是唯一一种研究中的备选胰岛素剂型。其他的还有胰岛素口喷雾剂、胰岛素贴剂甚至口服剂型的胰岛素。其他制药公司也在加速研制自己的吸入型胰岛素——尤其以Eli Lilly & Co和Alkermes公司合作的研究进展最快。
*对肺安全性的考虑
FDA是在专家咨询小组以7:2的投票结果得出推荐药物的结论后批准药物上市的。咨询小组（投票结果为5:4）还号召对Exubera进行进一步研究考察药物在有潜在肺脏疾病患者中的安全性。
FDA的批准文件上要求制造商进行长期研究以证实Exubera的安全性。
药物被批准用于1型和2型糖尿病的治疗。但临床试验发现，只有不到30％的患者在接受了6个月的吸入型胰岛素治疗后能够在将血糖降至推荐的水平。
辉瑞和赛诺菲-安万特没有申请FDA批准将Exubera用于儿童和青少年。早期在儿童中开展的临床试验由于考虑到Exubera对儿童呼吸的影响而中途停止了。公司计划在与FDA协商后再重新进行儿童患者方面的研究。
欧盟也已在1月26日批准将Exubera用于患1型和2型糖尿病成年患者的治疗。
辉瑞公司的人胰岛素（rDNA源）粉末吸入剂（商品名：Exubera），用于治疗成人1型和2型糖尿病。本品是首个胰岛素吸入型制剂，体现了治疗糖尿病药物制剂的重大发展。
奈克塔（Nektar）公司与辉瑞公司合作开发了此吸入器和胰岛素粉末制剂。辉瑞公司负责Exubera的销售、生产和临床开发。奈克塔公司提供Exubera胰岛素生产工艺和吸入装置制备技术。
Exubera系人胰岛素速效干粉吸入剂（1 mg/剂，3 mg/剂），餐前可简便地将药物释至肺部。吸入器重124 g，大小像一副眼镜，每次均可释出精确剂量的胰岛素。
研制Exubera是迄今最热门和创新的治疗糖尿病药物制剂开发计划之一，辉瑞公司已投资10亿多美元，并投资开设了2个生产企业：德国法兰克福世界上日前规模最大的胰岛素原料生产厂和美国印第安纳州特雷霍特的高技术制剂生产厂。

人胰岛素[rDNA源]-吸入用胰岛素|Exubera(Insulin Human [rDNA origin]-Insulin for Inhalation) -第一种吸入型胰岛素FDA批准上市

Exubera Uses:
Before taking Exubera
Before using Exubera, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).
You should not use Exubera if you have a lung disease that is not well controlled with medication or other treatments.
If you have type 1 diabetes, you should use Exubera in addition to another long-acting type of insulin.
If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.
Exubera is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.
FDA pregnancy category C. Exubera may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Exubera can pass into breast milk and may harm a nursing baby. Do not use Exubera without telling your doctor if you are breast-feeding a baby.
How should I take Exubera?
Use Exubera exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.
Your doctor may occasionally change your dose to make sure you get the best results from Exubera.
If you use Exubera as a meal-time insulin, use it no more than 10 minutes before eating the meal.
To be sure Exubera is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Continue using Exubera if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.
Exubera is a powder that is supplied in “dose blisters” on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.
Each 1-milligram dose blister of Exubera powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.
If you are combining 1-mg and 3-mg dose blisters to get your correct dose of insulin, always use the least number of blisters possible. For example, if your dose is 4 mg, use a 1-mg blister and a 3-mg blister (a total of two blisters). Do not use four 1-mg blisters or you may receive too much Exubera.
The inhaler unit supplied with Exubera includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.
Store the medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Protect the medicine from moisture and humidity at all times. Do not store the medicine in a bathroom where you shower.
Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.
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产地国家: 美国
原产地英文商品名:
Exubera Combination
中文参考商品译名:
Exubera胰岛素吸入剂15
生产厂家中文参考译名:
默克公司
生产厂家英文名:
Merck
该药品相关信息网址1:
http://www.Exubera.com