| 简介：
近日，美国食品药品监督管理局（FDA）已批准Tepezza（teprotumumab-trbw）用于治疗甲状腺眼病（TED）。Tepezza是首个也是唯一一个获得FDA批准的用于治疗TED的药物，TED是一种严重的，进行性的和威胁视力的罕见自身免疫性疾病，其与眼球突出（眼胀），复视（复视），视力模糊，疼痛，炎症和面部毁容。Tepezza是一种完全人单克隆抗体（mAb）和胰岛素样生长因子1受体（IGF-1R）的靶向抑制剂，每三周对患者给药一次，共八次输注。
批准日期：2020年2月21日 公司：Horizon Therapeutics plc
TEPEZZA（teprotumumab-trbw）注射，静脉内使用
美国初次批准：2020年
作用机理
Teprotumumab-trbw在甲状腺眼病患者中的作用机制尚未完全阐明。Teprotumumab-trbw与IGF-1R结合并阻断其激活和信号传导。
适应症和用途
TEPEZZA是一种胰岛素样生长因子-1受体抑制剂，适用于甲状腺疾病的治疗。
剂量和给药
•首次输注时以10mg/kg的剂量开始给药，随后每3周以20mg/kg的剂量进行7次额外输注
•在60至90分钟内静脉输注TEPEZZA
剂量形式和强度
注射用：500mg冻干粉装在单剂量小瓶中，以进行重建。
禁忌症
没有
警告和注意事项
•输液反应：如果发生输液反应，请中断或减慢输液速度，并采取适当的医疗措施。
•加剧先前存在的炎症性肠病（IBD）：
监测患有IBD的患者的疾病发作；如果IBD恶化，则停止使用TEPEZZA。
•高血糖：监测所有患者的血糖水平；用降糖药治疗高血糖症。
不良反应
最常见的不良反应（发生率大于5％）是肌肉痉挛，恶心，脱发，腹泻，疲劳，高血糖，听力障碍，皮肤干燥，消化不良和头痛。
要报告可疑的不良反应，请致电1-866-479-6742或联系Horizon，致电1-800-FDA-1088或访问www.fda.gov/medwatch。
在特定人群中的使用
女性生殖潜力：应在开始服用TEPEZZA之前，治疗期间和最后一次服用TEPEZZA后的6个月内采取适当的避孕方式。
包装供应/存储和处理方式
注射用TEPEZZA（teprotumumab-trbw）是无菌，无防腐剂的白色至灰白色冻干粉末，可用于以下场合：
装有一个500mg单剂量小瓶的纸箱NDC 75987-130-15
在原始纸箱中冷藏至2°C至8°C（36°F至46°F），直到使用时避光。 不要冻结。
完整说明资料附件：
https://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf
TEPEZZA (teprotumumab-trbw) for injection, for intravenous use
Initial U.S. Approval: 2020
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.
Adverse Reactions
The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, and dry skin.
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
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