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  药店国别: 美国药房
产地国家: 美国
所属类别: 激素内分泌药物->降糖药物
处方药:处方药
包装规格: 10微克/剂 250微克/毫升 2.4毫升/60剂/支笔
计价单位:
  点击放大  
生产厂家中文参考译名:
AMYLIN
生产厂家英文名:
AMYLIN
该药品相关信息网址1:
http://www.byetta.com/index.jsp
该药品相关信息网址2:
http://www.medicinenet.com/exenatide/article.htm
原产地英文商品名:
Byetta 10mcg/dose 250mcg/ml 2.4ml/60dose/pen
原产地英文药品名:
Exenatide
中文参考商品译名:
Byetta 10微克/剂 250微克/毫升 /2.4毫升/60剂/支笔
中文参考药品译名:
艾塞那肽
原产地国家批准上市年份:
2005/04/28
英文适应病症1:
Type 2 Diabetes
临床试验期:
完成
中文适应病症参考翻译1:
II型糖尿病
药品信息:

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 详细处方信息以本药内容附件PDF文件(201261819315710.PDF)的“原文Priscribing Information”为准
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 部分中文Byetta处方资料(仅供参考)

GENERIC NAME: exenatide
BRAND NAME: Byetta
DRUG CLASS AND MECHANISM: Exenatide is an injectable drug that reduces the level of sugar (glucose) in the blood. It is used for treating type 2 diabetes. Exenatide belongs in a class of drugs called incretin mimetics because these drugs mimic the effects of incretins. Incretins, such as human-glucagon-like peptide-1 (GLP-1), are hormones that are produced and released into the blood by the intestine in response to food. GLP-1 increases the secretion of insulin from the pancreas, slows absorption of glucose from the gut, and reduces the action of glucagon. (Glucagon is a hormone that increases glucose production by the liver.) All three of these actions reduce levels of glucose in the blood. In addition, GLP-1 reduces appetite. Exenatide is a synthetic (man-made) hormone that resembles and acts like GLP-1. In studies, exenatide-treated patients achieved lower blood glucose levels and experienced weight loss. Exenatide was approved by the FDA in May, 2005.

PRESCRIPTION: Yes.

GENERIC AVAILABLE: No.

PREPARATIONS: Multiple dose pre-filled pen: 1.2 mL, 5 mcg per dose (60 doses) or 2.4 mL, 10 mcg per dose (60 doses)

STORAGE: Exenatide should be refrigerated between 2-8 (36-46) and protected from light. After first use, it may be stored at room temperature and should not be frozen or used if frozen. The pen should be discarded 30 days after its first use.

PRESCRIBED FOR: Exenatide is used in combination with other drugs for reducing blood glucose in patients with type 2 diabetes who have not achieved adequate blood glucose reduction while taking metformin (Glucophage) or a combination of metformin (Glucophage) and a sulfonylurea (glyburide, glipizide etc). Exenatide should not be used in patients with type 1 diabetes or as a substitute for insulin in patients who require insulin. .

DOSING: The initial dose of exenatide is 5 mcg injected under the skin (subcutaneously) twice daily, 60 minutes before breakfast or dinner. Exenatide should not be administered after a meal. Each dose should be injected in the thigh, abdomen or upper arm. The dose can be increased to 10 mcg twice daily after 1 month of therapy.

DRUG INTERACTIONS: Exenatide slows down transit of food and drugs through the intestine and, therefore, can reduce the absorption of drugs that are taken orally. To avoid this interaction, administer oral medications one hour before exenatide is administered. Orally administered drugs that need to be administered with food should be given with a light meal or snack when exenatide is not administered.

PREGNANCY: There are no adequate studies of exenatide in pregnant women. Most experts agree that insulin is the drug of choice in pregnant women with diabetes.

NURSING MOTHERS: There are no adequate studies of exenatide in nursing mothers, and it is not known whether exenatide is excreted in human breast milk.

SIDE EFFECTS: The most common side effect of exenatide is nausea. Nausea from exenatide is more common with the higher doses and decreases over time. Other common side effects include hypoglycemia (excessively low blood glucose), vomiting, diarrhea, headache, nervousness and stomach discomfort. Patients may also experience decreased appetite, acid reflux and increased sweating.?There have been reports of acute pancreatitis associated with the use of exenatide.?Patients developing severe, persistent abdominal pain should seek prompt medical attention.?If pancreatitis is suspected, exenatide should be discontinued and not started again until pancreatitis has been excluded.

Chemistry and Pharmacology
Exenatide is manufactured and marketed by Amylin Pharmaceuticals and Eli Lilly and Company. Exenatide is a synthetic version of exendin-4, a hormone found in the saliva of the Gila monster. It displays biological properties similar to human glucagon-like peptide-1 (GLP-1), a regulator of glucose metabolism and insulin secretion. According to the package insert, exenatide enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying, although the mechanism of action is still under study.

Exenatide is a 39-amino-acid peptide an insulin secretagogue with glucoregulatory effects. Exenatide was approved by the FDA on April 28, 2005 for patients whose diabetes was not well-controlled on other oral medication.[2] The medication is injected subcutaneously twice per day using a pre-filled pen device. The abdomen is a common injection site, after the area is cleaned with an alcohol pad. A new pen must first be tested to see if the medicine is flowing

The incretin hormones GLP-1 (glucagon-like peptide-1) and GIP are produced by the endocrine cells of the intestine following ingestion of food. GLP-1 and GIP stimulate insulin secretion from the beta cells of the islets of Langerhans in the pancreas. Only GLP-1 causes insulin secretion in the diabetic state; however; GLP-1 itself is ineffective as a clinical treatment for diabetes as it has a very short half-life in vivo. Exenatide bears a 50% amino acid homology to GLP-1 and it has a longer half-life in vivo. Thus, it was tested for its ability to stimulate insulin secretion and lower blood glucose in mammals and was found to be effective in the diabetic state. In studies on rodents it has also been shown to increase the number of beta cells in the pancreas.

Commercially, exenatide is produced by direct chemical synthesis. Historically, exenatide was discovered as a protein naturally secreted in the saliva and concentrated in the tail of the Gila monster. While the exenatide protein was structurally analogous to GLP-1, it had a much longer half-life after injection; this enabled consideration and development of exenatide as a diabetes mellitus treatment strategy. Given this history, exenatide is sometimes referred to as "lizard spit". Subsequent clinical testing lead to the discovery of the also desirable glucagon and appetite-suppressant effects.

Exenatide is approved "as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a biguanide, or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control". It has now been approved for use with thiazolidinediones such as pioglitazone or rosiglitazone.

Exenatide raises insulin levels quickly (within about ten minutes of administration) with the insulin levels subsiding substantially over the next hour or two. A dose taken after meals has a much smaller effect on blood sugar than one taken beforehand. The effects on blood sugar diminish after 6–8 hours.[1] The medicine is available in two doses: 5 mcg and 10 mcg. Treatment often begins with the 5 mcg dosage, which is increased if adverse effects are not significant.[3]

According to the manufacturer, the exenatide (Byetta) autoinjector must be stored in a refrigerator between 36 °F (2 °C) and 46 °F (8 °C) before first use, and then at a temperature between 36 °F (2 °C) and 77 °F (25 °C). In hot weather, therefore, they should be refrigerated.[4] Exenatide (Byetta) pens contain sixty doses designed to be used twice a day for 30 days.

Exenatide received US Patent 5,424,286 which was filed May 24, 1993.

[edit] Mode of action
Exenatide is believed to facilitate glucose control in at least four ways:

Exenatide augments pancreas response (i.e. increases insulin secretion) in response to eating meals; the result is the release of a higher, more appropriate amount of insulin that helps lower the rise in blood sugar from eating. Once blood sugar levels decrease closer to normal values, the pancreas response to produce insulin is reduced; however, other drugs (like injectable insulin) are effective at lowering blood sugar, but can "overshoot" their target and cause blood sugar to become too low, resulting in the dangerous condition of hypoglycemia.
Exenatide also suppresses pancreatic release of glucagon in response to eating, which helps stop the liver from overproducing sugar when it is unneeded, which prevents hyperglycemia (high blood sugar levels).
Exenatide helps slow down gastric emptying and thus decreases the rate at which meal-derived glucose appears in the bloodstream.
Exenatide has a subtle yet prolonged effect to reduce appetite, promote satiety via hypothalamic receptors (different receptors than for amylin). Most people using Exenatide slowly lose weight, and generally the greatest weight loss is achieved by people who are the most overweight at the beginning of exenatide therapy. Clinical trials have demonstrated that the weight reducing effect continues at the same rate through 2.25 years of continued use. When separated into weight loss quartiles, the highest 25% experience substantial weight loss, and the lowest 25% experience no loss or small weight gain.
Exenatide reduces liver fat content. Fat accumulation in the liver or non-alcoholic fatty liver disease (NAFLD) is strongly related with several metabolic disorders, in particular low HDL cholesterol and high triglycerides, present in patients with type 2 diabetes. It became apparent that exenatide reduced liver fat in mice[5] and more recently in man.
In an open-label randomized controlled trial of 551 patients, exenatide treatment for 26 weeks was associated with 2.3 kg weight loss; however, gastrointestinal symptoms were more common in the exenatide group, including nausea (57.1%), vomiting (17.4%) and diarrhea (8.5%). For most patients, the nausea is mild to moderate and goes away entirely after a few days or weeks. Medical professionals who work with exenatide have stated that much of what is reported as nausea is actually a feeling of fullness. It is speculated that exenatide makes most patients need to eat less and until an adjustment is made to smaller portions, the result is the fullness feeling.

Advantages: While other treatment options share one or more of the first three characteristics, some diabetics specialists view exenatide as a significant improvement over other available diabetic medications, although most doctors do not use it as primary therapy at this time. Except for metformin and acarbose, all other available drugs for improving glucose control have been associated with weight gain.

Disadvantages: In addition to gastrointestinal adverse reactions, a relative disadvantage of exenatide is that it is administered by injection.

Reference: FDA Prescribing Information

美国食品和药物管理局近期审批通过了Byetta™(exenatide)。该药是激素类似物这一新型品中的第一个产品,主要用于二甲双胍和/或磺脲类降糖药不能良好控制血糖的2型糖尿病患者。预计2005年6月1日起可用于临床治疗。

Byetta能有效降低患者餐后和空腹血糖,对改善糖化血红蛋白水平也有一定的帮助。主要的作用机制可能是在血糖升高时促进胰岛素分泌,同时还有助于恢复进餐后第一相的胰岛素分泌,而后者的缺乏在2型糖尿病患者中非常常见。

目前Byetta有5mg和10mg两种剂型,以预混的形式在早餐和晚餐前经皮下注射给药。三项为期30周的对照研究表明,Byetta的副作用较少,剂量相关性的轻至重度恶心感是最常见的副反应,但随着治疗的继续,恶心感发生的频率和严重程度均会有所改善。联合Byetta和磺脲类药物治疗的患者发生低血糖的风险会有所增加,且存在剂量依赖性,因此减少磺脲类药物的剂量是一种可行的措施。大多数低血糖事件都可通过进食碳水化合物而纠正。目前的临床研究表明,Byetta联合二甲双胍治疗并不会增加低血糖事件的发生。此外,应用Byetta治疗的患者会出现诸如食欲减退、进食减少和/或体重减轻等情况,但专家认为无须因此而调整Byetta用量。

1型糖尿病患者及糖尿病酮症患者禁用Byetta治疗,Byetta也不可作为胰岛素的替代品用于治疗。不推荐存在终末期肾病或严重肾功能损害及严重胃肠道疾病的患者使用Byetta。同时服用可加快胃肠道吸收药物的患者须慎用Byetta。

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 详细处方信息以本药内容附件PDF文件(201261819315710.PDF)的“原文Priscribing Information”为准
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更新日期: 2013-7-31
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