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

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