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Thyrogen(促甲状腺素α 注射剂)

2012-02-07 00:46:37  作者:新特药房  来源:中国新特药网天津分站  浏览次数:971  文字大小:【】【】【
简介:近日表示美国FDA已批准了Thyrogen(促甲状腺素α 注射剂)与放射疗法联用于除去或破坏已进行甲状腺癌切除手术后患者的残余甲状腺组织,可降低复发风险与更好的监测病情。甲状腺癌术后剩余甲状腺组织去除 ...

近日表示:美国FDA已批准了Thyrogen(促甲状腺素α 注射剂)与放射疗法联用于除去或破坏已进行甲状腺癌切除手术后患者的残余甲状腺组织,可降低复发风险与更好的监测病情。甲状腺癌术后剩余甲状腺组织去除治疗常用在甲状腺癌治疗中都会进行。
公司官员说道:“这项新适应症扩大了Thyrogen对于那些甲状腺癌初始治疗者的益处:Thyrogen之前在检测癌症是否复发的后继诊断过程中使用。”
美国癌症协估计在2007年,约有33550例患者诊断出甲状腺癌,其中90%的甲状腺癌是完全分化的,这些患者可接受剩余甲状腺组织去除治疗。
Thyrogen于1998年初次在美国获得批准,2001年在欧洲获得批准用于作为诊断试剂,用于检测完全分化型甲状腺癌的复发。2005年欧洲批准了Thyrogen用于剩余甲状腺组织去除过程中。

 

通用名称为THYROGEN
促甲状腺激素阿尔法1.1mg/vial;冻干即时注射后重建PWD;含有甘露醇。

法律分类:
RX

药理类为THYROGEN
促甲状腺激素(重组)。

对THYROGEN制造商
Genzyme公司

主治为THYROGEN
辅助诊断血清thyroglobin的工具(TG)测试或分化良好的甲状腺癌患者的无碘的后续成像。谁经历了几乎完全为分化良好的甲状腺癌或甲状腺全没有转移性甲状腺癌的证据的患者在甲状腺组织残余的放射性碘消融的辅助治疗。

成人剂量为THYROGEN
≥16yrs:由肌肉注射给到臀部。 0.9mg,24小时后第二0.9mg注射。对碘造影或残消融,给最终thyrogen注射后24小时碘。

儿童剂量为THYROGEN
<16yrs:不推荐。

为THYROGEN注意事项
见文献。心脏疾病,广泛转移性疾病,或其他严重的基础疾病;的Thyrogen诱发甲状腺功能亢进症的风险增加,考虑管理和后期管理观察住院。甲状腺球蛋白(TG)抗体可能会导致TG水平无法解释,考虑进一步的评估与甲状腺激素撤出扫描。以前的牛TSH治疗。残余甲状腺组织。终末期肾脏疾病。老人(风险增加心脏的影响)。怀孕(Cat.C)。哺乳的母亲。

为THYROGEN不良反应
恶心,头痛,疲劳,流感样症状。

THYROGEN如何提供?
2小瓶KIT-2瓶Thyrogen
4小瓶试剂盒2瓶Thyrogen2瓶稀释剂

 
Product Name: Thyrogen™
Company Name: Genzyme Corporate
Product Info -Thyrogen
Thyrogen® is a highly purified recombinant source of human thyroid stimulating hormone (rhTSH) developed for use in well-differentiated thyroid cancer patients who have had near-total or total thyroidectomy, and who must therefore take thyroid hormones and undergo periodic testing for recurrent or persistent cancer. Thyrogen raises serum TSH levels, stimulating I-131 uptake and thyroglobulin (Tg) production and release by cells of thyroid origin.

Thyrogen is indicated for use as an adjunctive diagnostic tool for serum Tg testing with or without radioiodine whole body scans (WBS) in the follow-up of patients with well-differentiated thyroid cancer.
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PrTHYROGEN® (thyrotropin alfa for injection) Reimbursement / Coverage (Cancer)
THYROGEN® thyrotropin alfa for injection
Lyophilized Powder for Reconstitution and Intramuscular Injection (0.9 mg/mL)
THYROGEN® is an eligible benefit through most private insurance plans, provincial/ territorial drug benefit programs and federal drug plans. Please choose the appropriate drug plan/program from the sidebar menu for specific information on THYROGEN® reimbursement.

Indications

THYROGEN® (thyrotropin alfa for injection) is indicated for:

Use as an adjunctive treatment as pre-therapeutic stimulation for radioiodine ablation of thyroid tissue remnants in patients maintained on thyroid hormone suppression therapy who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer without evidence of distant metastatic thyroid cancer.

Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing, with or without radioiodine imaging, in the follow-up of patients with well-differentiated thyroid cancer.

Potential Clinical Uses:

1) THYROGEN® treatment may be used in combination with radioiodine (131I) to ablate thyroid remnants following near-total or total thyroidectomy in patients without evidence of distant metastatic thyroid cancer.

2) THYROGEN® Tg testing may be used in patients with an undetectable Tg on thyroid hormone suppressive therapy, to exclude the diagnosis of residual or recurrent thyroid cancer.

3) THYROGEN® testing may be used in patients requiring serum Tg testing and radioiodine imaging, who are unwilling to undergo thyroid hormone withdrawal testing.

4) THYROGEN® treatment and testing may be used in patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated.

Warnings and Precautions
THYROGEN® (thyrotropin alfa for injection) is indicated for use as an adjunctive treatment as a pre-therapeutic stimulation for radioiodine ablation of thyroid tissue remnants in patients maintained on thyroid hormone suppression therapy who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer without evidence of distant metastatic thyroid cancer. THYROGEN® is also indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing, with or without radioiodine imaging, in the follow-up of patients with well-differentiated thyroid cancer. THYROGEN® injections should be supervised by a healthcare professional knowledgeable in the management of thyroid cancer. THYROGEN® should only be administered intramuscularly in the gluteal muscle. It should not be administered intravenously. Very common adverse events (> 10%) reported in a clinical trial in patients undergoing radioiodine thyroid remnant ablation were insomnia (15.2%), nausea (12.1%), fatigue (12.1%), nasopharyngitis (12.1%) and anxiety (12.1%). Adverse events should be reported promptly to Genzyme Medical information at 1-800-745-4447.

责任编辑:admin


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