適諾進凍晶注射劑 Thyrogen 0.9 mg powder for solution for injection 甲狀腺分化癌治療之輔助診斷製劑
THYROGEN(THYROTROPIN ALFA)
THYROGEN（0.9MG/ML）1.1MG/VIAL
商品名THYROGEN（0.9MG/ML）1.1MG/VIAL
英文品名：Thyrogen
中文品名：適諾進凍晶注射劑
成份名：Thyrotropin Alfa
劑型：凍晶注射劑
劑量單位：1.1mg/vial
規格包裝：2vial/box
適應症/用途：甲狀腺分化癌治療之輔助診斷製劑
How is THYROGEN supplied
2-vial kit—2 vials of Thyrogen
4-vial kit—2 vials of Thyrogen + 2 vials of diluent
欧洲药审委已批准Genzyme公司的促甲状腺素α粉针(thyrotropin alfa，Thyrogen ）与放射性碘联合用于甲状腺癌患者摘除残余的甲状腺组织。
Genzyme公司正在美国申请本品的这一新适应证。在美国和欧洲每年要进行3.5万例甲状腺癌摘除术，本品有可能用于80%的患者。
欧洲批准的新适应证可使本品与放射性碘联用作为治疗甲状腺癌最普通的疗法，包括手术切除甲状腺癌，随后是摘除手术期间未切除干净的残留甲状腺残留组织，包括在甲状腺内的任何癌细胞。
以往，摘除残留组织，患者需服用放射性碘溶液或含放射性碘的胶囊，以使残留甲状腺细胞吸收。为提高放射性碘的摄取量，必须提高患者血液中的促甲状腺激素（TSH）浓度。如此，常造成甲状腺功能减退，如乏力、嗜眠、思想难以集中、短期记忆力损伤和抑郁等。患者现在可停止服用甲状腺激素补充剂来提高TSH浓度。本品系一供注射用的重组TSH，使患者继续补充激素，避免停用激素后出现的症状。
本品现已在40多个国家上市。本品目前开发用于甲状腺已切除的甲状腺癌患者。这些患者必须采用甲状腺激素抑制治疗，还可进行周期检测癌症复发或转移。本品使患者维持其激素抑制治疗，避免临床出现甲状腺功能减退的衰弱症状。
本品与其他试剂合用检测甲状腺癌患者甲状腺癌细胞是否复发或存留。本品肌肉注射，仅处方用药。临床研究中报道最常见的不良反应是恶心、头痛、无力和呕吐。
Thyrogen (α-促甲状腺素)，既可作为辅助诊断工具又可用于治疗甲状腺癌[肌内(IM)注射]。
[附件:/uploadfile/article/uploadfile/201005/20100526031137367.pdf]
Thyrogen 0.9 mg powder for solution for injection
1. Name of the medicinal product
Thyrogen 0.9 mg powder for solution for injection
2. Qualitative and quantitative composition
Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa. Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection.
White to off-white lyophilised powder.
4. Clinical particulars
4.1 Therapeutic indications
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.
Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
4.2 Posology and method of administration
Therapy should be supervised by physicians with expertise in thyroid cancer.
Posology
The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only.
Paediatric population
Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Elderly population
Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes.
No dose adjustment is necessary in the elderly popul
