注射用阿必鲁肽 TANZEUM (albiglutide) FDA药品说明书翻译.pdf

FULL PRESCRIBING INFORMATION WARNING: RISK OF THYROID C-CELL TUMORS 警告：甲状腺C细胞肿瘤风险 • Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether TANZEUM™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans [see Warnings and Precautions (5.1)]. 啮齿动物试验中，使用酰化人胰高血糖素样肽-1(GLP-1)受体激动药在临床相关暴露量下已 观察到甲状腺C细胞肿瘤。尚不明确人类使用本药是否引起甲状腺C细胞肿瘤，包括甲状腺 髓样癌(MTC)。 • TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with TANZEUM. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications (4.1), Warnings and Precautions (5.1)]. 有MTC 病史或家族史者、2 型多发性内分泌肿瘤综合征(MEN 2)患者禁用本药。尚不明确 使用本药患者常规监控血清降钙素或超声监控甲状腺的价值。应告知患者甲状腺肿瘤的风 险和症状。 1 INDICATIONS AND USAGE 适应症和用途 TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. 本药用于2型糖尿病成年患者，作为饮食和运动的辅助疗法以改善血糖控制。 Limitations of Use:使用限制 • TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise [see Warnings and Precautions (5.1)] . 本药不推荐用于饮食和运动控制不佳患者的一线治疗。 • TANZEUM has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . Consider other antidiabetic therapies in patients with a history of pancreatitis. 尚无有胰腺炎病史者用药的研究，有胰腺炎病史者应考虑其他抗糖尿病治疗。 • TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients. 本药不可用于1型糖尿病或酮症酸中毒患者，在这些患者中本药不可作为胰岛素的替代药物。 • TANZEUM has not been studied in pati