促甲状腺素-α冻干粉注射剂Thyrogen 1.1mg(Thyrotropin alfa)

药店国别:

产地国家:美国

处方药:是

所属类别: 1.1毫克/瓶 2瓶/套

包装规格: 1.1毫克/瓶 2瓶/套

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Genzyme

原产地英文商品名:THYROGEN 1.1MG PWD DPSH 2/PAC

原产地英文药品名:thyrotropin alfa

中文参考商品译名:THYROGEN冻干粉 1.1毫克/瓶 2瓶/套

中文参考药品译名:促甲状腺素α

曾用名:

简介:近日,美国食品和药物管理局(FDA)批准了Thyrogen(thyrotropin alfa)的补充适应症与放射性碘联合使用,以消除或破坏已除去癌性甲状腺的患者的剩余甲状腺组织。残余消融是患者在接受甲状腺癌治疗时通常接受的手术。“这一新的适应症扩展了甲状腺癌患者在甲状腺癌初期治疗期间的显着益处,此外还有目前用于检测复发的后续诊断程序”Genzyme公司高级副总裁兼总经理Mike Heslop说。“这是我们不断努力扩大Thyrogen临床应用以改善患者护理的重要里程碑。”批准日期:2007年12月17日 公司:GenzymeTHYROGEN(注射用促甲状腺素α[thyrotropin alfa])注射,用于肌肉注射最初的美国批准:1998年作用机制促甲状腺素(TSH)是一种垂体激素,可刺激甲状腺产生甲状腺激素。 促甲状腺激素α与正常甲状腺上皮细胞或分化良好的甲状腺癌组织上的TSH受体的结合刺激碘摄取和组织,以及甲状腺球蛋白(Tg),三碘甲腺原氨酸(T3)和甲状腺素(T4)的合成和分泌。甲状腺刺激激素激活甲状腺细胞的作用是增加放射性碘的摄取,以允许扫描检测或放射性碘杀死甲状腺细胞。 TSH活化还导致甲状腺细胞释放甲状腺球蛋白。 甲状腺球蛋白作为肿瘤标志物起作用,其在血液样本中被检测到。

适应症和用法

THYROGEN®是一种促甲状腺激素,适用于:诊断:在先前接受过甲状腺切除术的高分化甲状腺癌患者的随访中,用作血清甲状腺球蛋白(Tg)测试的辅助诊断工具,有或没有放射性碘成像。使用限制:甲状腺激素戒断后,THYROGEN刺激的Tg水平通常低于,并且与Tg水平无关。即使当THYROGEN-Tg测试与放射性碘成像结合进行时,仍然存在错过甲状腺癌诊断或低估疾病程度的风险。抗Tg抗体可能使Tg测定混淆并使Tg水平无法解释。消融:用于对甲状腺组织残留物进行放射性碘消融的辅助治疗,这些患者接受了接近全部或完全甲状腺切除术的分化良好的甲状腺癌,并且没有远处转移性甲状腺癌的证据。使用限制:尚未确定THYROGEN对长期甲状腺癌结局的影响。

剂量和给药

THYROGEN应该由熟悉甲状腺癌患者管理的医生使用。建议采用双注射方案:肌肉注射THYROGEN 0.9mg,24小时后肌内注射0.9mg。含有1.1毫克促甲状腺激素α的冻干粉末,用无菌注射用水重建后一次性使用。

禁忌症

没有

警告和注意事项

THYROGEN诱发甲状腺功能亢进的风险。 对于有风险的患者,应考虑给予THYROGEN住院治疗和行政后观察。女性患者的中风以及中枢神经系统转移患者的其他神经系统事件。远处转移性甲状腺癌突然,迅速和疼痛的扩大。

不良反应

临床试验中报告的最常见的不良反应是恶心和头痛。

用于特定人群肾功能损害:

在透析依赖性终末期肾病患者中,消除THYROGEN显着较慢,导致TSH水平持续升高。

包装提供/存储和处理

THYROGEN(注射用促甲状腺素α)作为无菌,无热原的冻干产品提供。 它可作为双瓶套件提供。 含有1.1毫克的THYROGEN。NDC 58468-0030-2(2瓶试剂盒)THYROGEN用于肌肉注射臀部。 冻干粉末应在使用前立即用1.2mL注射用无菌水USP [见剂量和用法]进行重建。 每瓶THYROGEN和每瓶稀释剂(如果提供)仅供一次性使用。THYROGEN应储存在2-8ºC(36-46ºF)。如有必要,重组溶液可在2℃至8℃的温度下储存长达24小时,同时避免微生物污染。

促甲状腺素α英文版说明书

SAFETY INFORMATIONThere have been reports of events that led to death in patients who not had surgery to have their thyroid gland removed, and in patients with thyroid cancer cells that have spread to other parts of the body.Patients over 65 years old with large amounts of leftover thyroid tissue after surgery, or with a history of heart disease, should discuss with their physicians the risks and benefits of Thyrogen.Thyrogen can be administered in the hospital for patients at risk for complications from Thyrogen administration.Since Thyrogen was first approved for use, there have been reports of central nervous system problems such as stroke in young women who have a higher chance of having a stroke, and weakness on one side of the body.Patients should remain hydrated prior to treatment with Thyrogen.Leftover thyroid tissue after surgery and cancer cells that have spread to other parts of the body can quickly grow and become painful after Thyrogen administration.Patients with cancer cells near their windpipe, in their central nervous system, or in their lungs may need treatment with a glucocorticoid (a medication to help prevent an increase in the size of the cancer cells before using Thyrogen.)ADVERSE REACTIONSIn clinical studies, the most common side effects reported were nausea and headache.USE IN SPECIFIC PATIENT POPULATIONSPregnant patients: Thyrogen should be given to a pregnant woman only if the doctor thinks there is a clear need for it.Breastfeeding patients: It is not known whether Thyrogen can appear in human milk. Breastfeeding women should discuss the benefits and risks of Thyrogen with their physician.Children: Safety and effectiveness in young patients (under the age of 18) have not been established.Elderly: Studies do not show a difference in the safety and effectiveness of Thyrogen between adult patients less than 65 years and those over 65 years of age.Patients with kidney disease: Thyrogen exits the body much slower in dialysis patients and can lead to longer high TSH levels.INDICATIONS AND USAGEThyrogen is used to help identify thyroid disease by testing the blood for a hormone called thyroglobulin in the follow up of patients with a certain type of thyroid cancer known as well differentiated thyroid cancer.It is used with or without a radiology test using a form of iodine.

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