小瓶（白色至灰白色粉末）
•一个预装注射器，输送0.65mL稀释剂
•一个样品瓶连接器
•两个特定于此输送系统的定制针（23G，5/16“）（一个是备用针）
BYDUREON Pen，提供纸箱，包含四个单剂量笔和一个备用针（NDC 0310-6530-04）。每支单剂量笔包含：
•一支含有2毫克艾塞那肽（白色至灰白色粉末）的单剂量笔，并输送0.65毫升稀释剂。
•一个特定于此输送系统的定制针（23G，9/32“）。
请勿替换BYDUREON提供的针头或任何其他组件。
存储和处理
•BYDUREON应储存在36°F至46°F（2°C至8°C）的冰箱中，直至失效日期或直至准备使用。 BYDUREON不应在失效日期之后使用。有效期可以在纸箱，单剂量托盘的盖子上或笔标签上找到。
•不要冻结BYDUREON。如果已冻结，请勿使用BYDUREON。避光。
•如果需要，BYDUREON可以在室温下保持不超过77°F（25°C）[参见USP受控室温]，总共不超过4周。
•只有在清洁且无颗粒物质的情况下才使用稀释剂。
•悬浮后，混合物应为白色至灰白色和混浊。
•必须在艾塞那肽粉末悬浮于稀释剂后立即给予BYDUREON。
•使用防刺穿容器在仍然连接针头的情况下丢弃BYDUREON。不要重复使用或共用针头或注射器。
•放在儿童接触不到的地方。
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71fe88be-b4e6-4c2d-9cc3-8b1864467776
BYDUREON(exenatide extended-release)for injectable suspension, for subcutaneous use
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF THYROID C-CELL TUMORS
Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON or BYDUREON BCise cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined
BYDUREON and BYDUREON BCise are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON or BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON or BYDUREON BCise
CONTRAINDICATIONS
For BYDUREON and BYDUREON BCise: Personal or family history of MTC, patients with MEN 2
Prior serious hypersensitivity reactions to exenatide or product components
WARNINGS AND PRECAUTIONS
Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
Never Share Injection Device or Needle Between Patients Sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed
Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON, BYDUREON BCise or BYETTA
Acute Kidney Injury and Impairment of Renal Function May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. BYDUREON or BYDUREON BCise are not recommended in patients with eGFR <45 mL/min/1.73 m2. BYETTA should not be used in patients with severe renal impairment or end-stage renal d |
