英文药名: Byetta(Exenatide Injection) 中文药名: 艾塞那肽注射液 品牌药生产厂家: Eli Lilly 药品说明 生产厂家: Amylin Pharmaceuticals, Inc. 和Eli Lilly. 艾塞那肽注射液（Byetta，百泌达） Byetta的®（艾塞那肽）注射液 最初美国批准：2005   最近的重大变化 剂量和给药方法 警告和注意事项，使用与已知药物引起低血糖   适应症 Byetta的是1胰高血糖素样肽1（GLP-1）受体激动剂作为辅助饮食和运动改善血糖控制与2型糖尿病的成年人表示。 重要的使用限制 不代替胰岛素。 Byetta的不应该被用于治疗1型糖尿病或糖尿病酮症酸中毒。 餐后胰岛素同时使用尚未研究，并不能推荐。 尚未在胰腺炎病史的患者进行了研究。考虑其他糖尿病治疗的胰腺炎病史的患者。 剂量和用法 在60分钟内注入皮下前早晚两餐（或前一天的主餐，约6小时或更外）。 在5微克每剂量，每日两次启动;根据临床反应的1个月后提高到10微克，每日两次。   剂型和优势 Byetta的供给为250微克/毫升艾塞那肽在： 5微克每剂1.2毫升，60剂量预充笔 每剂10微克，60剂量2.4毫升预装笔   禁忌 艾塞那肽或任何产品组件严重过敏史。   注意事项： 胰腺炎： 与exenatide，包括致命和非致命的出血性或坏死性胰腺炎的上市后报告。立即停止Byetta的。 Byetta的，不应该被重新启动。考虑其他糖尿病治疗的胰腺炎病史的患者。 Byetta的已知会导致低血糖（如胰岛素或胰岛素分泌）的药物组合使用时，低血糖的风险增加。考虑减少剂量的胰岛素或胰岛素分泌。 艾塞那肽，有时需要血液透析和肾移植的肾功能损害：上市后报告。 Byetta的不应该被用于严重肾功能不全或终末期肾脏疾病患者，应在肾移植患者谨慎使用。注意启动时，应适用于Byetta的Byetta的或升级的剂量，中度肾功能衰竭患者. 严重胃肠道疾病：Byetta的使用，不建议在患者严重的胃肠道疾病（如胃轻瘫）。 过敏反应： 过敏反应（如过敏性休克和血管神经性水肿）艾塞那肽上市后的报告。患者应停止Byetta的和其他犯罪嫌疑人的药物，并及时就医。 大血管病变的结果：有没有确凿的证据建立Byetta的或任何其他降糖药物与大血管风险减少的临床研究。   不良反应 最常见（≥5％）比安慰剂在临床试验中发生更频繁恶心，低血糖，呕吐，腹泻，感觉紧张，头晕，头痛，消化不良，便秘，乏力。恶心通常随着时间的推移降低。 艾塞那肽增加国际标准化比值（INR），同时使用华法林，有时出血上市报告。   药物相互作用 可能会影响口服药物的吸收 华法林：上市后增加的INR有时与出血相关的报告。监控卢比经常，直到稳定Byetta的治疗后，启动或改建。   在特殊人群中使用 怀孕：Byetta的基于动物试验数据，可能会对胎儿造成伤害。 Byetta的，应在怀孕期间使用，只有在潜在利益大于对胎儿的潜在风险。报告在怀孕期间接触毒品，请致电1-800-633-9081。 哺乳母亲：Byetta的管理，哺乳妇女时，应谨慎行事。 更新日期：12/2011 包装规格： 10mcg/剂  1 x 60（剂） 5mcg/剂   1 x 60（剂） FDA批准Byetta注射剂单药治疗2型糖尿病 2009年10月30日，Eli Lilly宣布美国食品药品管理局(FDA)已批准扩大Byetta (exenatide)注射剂的适应证。Byetta现已获准用于成年2型糖尿病患者的单药治疗，在饮食控制和运动疗法的基础上进一步改善患者的血糖控制情况。之前，该药仅获准作为联合治疗的一部分，用于那些经其他常用降糖药物治疗后达不到血糖控制目标的2型糖尿病患者。 之所以批准Byetta用于2型糖尿病的单药治疗是基于一项试验结果，该试验是在经单纯饮食控制和运动疗法后血糖控制不佳的2型糖尿病患者中展开的。结果显示，经Byetta 5 µg或10 µg单药治疗后，患者的血红蛋白A1c水平分别下降了0.7%和0.9%，体重分别下降了6.0磅和6.4磅。该试验结果发表于《临床治疗学》(Clinical Therapeutics)2008年8月刊上。   临床试验报告称，在所有治疗引发不良事件中，恶心的发生率最高(5 µg组3%；10 µg组13%)。5 µg组和10 µg组分别有5%和4%的患者出现了低血糖，但没有出现重度低血糖事件。   除了批准Byetta用于单药治疗的适应证外，FDA还批准修改Byetta的产品标签，补充更新后的安全性信息包括在警告与注意事项部分增加有关胰腺炎的文字说明。这次更新解答了FDA 2008年8月提出的警示信息。新的产品标签还进一步补充了有关Byetta用于肾功能不全患者的文字说明。   Byetta表现出来的许多效应都与人肠降血糖素胰高血糖素样肽-1(GLP-1)的作用相似。在体内，GLP-1可作用于胃、肝脏、胰腺和大脑而发挥多重效应，进而改善餐后血糖水平。   Byetta不适用于1型糖尿病或糖尿病酮症酸中毒患者。 Medication name Generic name: Exenatide - Injection Brand name(s): Byetta Uses Exenatide is used along with other oral diabetes medications (e.g., metformin, chlorpropamide, glipizide, glyburide) and a proper diet and exercise program to control high blood sugar in people with Type 2 diabetes (non-insulin dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.Exenatide acts like the natural blood sugar-lowering hormone called incretin. It works in several ways, especially by stimulating the release of the body's natural insulin in response to high sugar levels after a meal, thereby lowering your blood sugar.Exenatide is not a substitute for insulin if you require insulin treatment. This medication should not be used in patients with Type 1 diabetes or for the treatment of extremely high blood sugars (diabetic ketoacidosis). How to use Read the Medication Guide and the Pen User Manual provided by your pharmacist before you start using exenatide and each time you get a refill. If you have questions regarding the information, consult your doctor or pharmacist.Exenatide is injected under the skin (subcutaneous-SC) in the thigh, abdomen, or upper arm usually twice daily within the hour before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Exenatide should not be injected after a meal since it will be much less effective at that time.Antibiotics and birth control pills should be taken at least 1 hour before exenatide, since exenatide may decrease their effectiveness if used at the same time. If the antibiotic or birth control pill needs to be taken with food then take it with a meal or snack when exenatide is not injected (such as lunch). (See also Drug Interactions section)Make sure you learn the technique and procedures for preparing the drug and for self-injection. Consult your doctor or pharmacist if you have any questions. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid problem areas under the skin. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Do not mix exenatide with insulin in the same syringe or vial even if you take them at the same time.The dosage is based on your medical condition and your response to therapy. Use this medication regularly in order to get the most benefit from it. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.Tell your doctor if your condition persists or worsens (blood sugar levels are too high or low). Precautions Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, severe stomach/intestinal disorders (e.g., digestion problems such as gastroparesis, or pancreatitis).You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages since alcohol can affect your blood sugar.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.During times of severe stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication or how often you test your blood sugar may be required.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.It is unknown if this medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Drug interactions Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-diabetic drugs (e.g., sulfonylureas such as glipizide, glyburide, chlorpropamide), birth control pills (see also How To Use section), oral antibiotics, warfarin.Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.While exenatide does not cause low blood sugar (hypoglycemia) itself, it may increase the risk of low blood sugar when used in combination with certain other diabetes medications (such as insulin, pioglitazone, rosiglitazone, sulfonylureas such as chlorpropamide, glipizide, glyburide).Be sure you are aware of the signs of low blood sugar and how to prevent and treat it (see your other diabetes medication leaflet for more details). Talk with you doctor or pharmacist about whether your dose of sulfonylurea needs to be lowered or not.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Side effects Nausea, vomiting, diarrhea, nervousness or upset stomach may occur as your body adjusts to the medication. Nausea usually lessens as you continue to use exenatide. Other side effects include decreased appetite/food intake or decreased body weight. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rare but serious pancreas problems (pancreatitis) can occur while using exenatide. Get immediate medical attention if you develop severe/persistent stomach/abdominal pain, or persistent severe nausea/vomiting. Do not restart exenatide treatment without first talking with your doctor.Tell your doctor immediately if this rare but serious side effect occurs: a change in the amount of your urine.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose If a dose is missed, skip the missed dose and resume your usual dosing schedule with the next scheduled dose. Do not double the dose to catch up. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe nausea, severe vomiting and rapidly dropping blood sugar levels (hypoglycemia), resulting in confusion, fainting, sweating, fast heartbeat. Notes Do not share this medication, the pens or the needles with others.You should attend a diabetes education program to understand diabetes, its complications, and all the important aspects of its treatment including meals/diet, exercise, personal hygiene, medications and getting regular eye, foot and medical exams.Keep all medical appointments. Laboratory and/or medical tests (e.g., kidney function tests, fasting blood glucose, hemoglobin A1c) should be performed periodically to monitor for side effects and response to therapy. Check your blood sugar levels regularly as directed by your doctor or pharmacist. Medical alert Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Storage Before using the exenatide pen for the first time, store it in the refrigerator at 36-46 degrees F (2-8 degrees C). Do not freeze. After first use, exenatide can be stored at room temperature at or below 77 degrees F (25 degrees C). Protect from light at all times. Discard 30 days after first use, even if some drug remains in the pen. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Photos by medication strength Click the "Photos" link to see sample photographs for a specific medication strength. Byetta 10 mcg/0.04 mL per dose Sub-Q Pen Injector *Photos   Byetta 10 mcg/0.04 mL per dose Sub-Q Pen Injector PrintThe photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.   Byetta 5 mcg/0.02 mL per dose Sub-Q Pen Injector *The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Important note HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Information last revised December 2011 Copyright(c) 2011 First DataBank, Inc. Subcutaneous Pen Injector exenatide| Additional Medication for Diabetes Type 2 Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.