CHMP推荐批准Docefrez人用医疗产品委员会（CHMP）推荐批准Sun Pharmaceutical Industries Europe B．V公司的Docefrez（I）20mg和80mg粉针剂用于治疗乳腺癌、非小细胞肺癌、前列腺癌、胃腺癌及头颈部癌。
多西他赛[docetaxel]
适应症：参见用法用量。
成人常用量：静脉给药 乳腺癌 初始剂量：60-100 mg/m2体表面积 ，每3周一次。 胃腺癌；头颈部癌；非小细胞肺癌；前列腺癌 75mg/m2体表面积，每3周1次。
禁忌：
禁用于既往对本药、其溶剂或聚山梨酯80严重过敏者，严重嗜中性白细胞缺乏症、严重肝功能损伤患者，及妊娠期妇女。
注意事项：
慎用于哺乳期妇女和肝脏损伤者。定期监测肝功能和血细胞计数。在本药治疗前1天，开始口服地塞米松，每天16 mg，连续3天。
不良反应：
皮肤红斑、皮疹、硬皮病、甲松离、脱发、恶心、呕吐、腹泻、口腔炎，肝脏转氨酶升高、胆红素和碱性磷酸酶升高，粘膜炎、衰弱、关节痛。肌痛、阵发性房性心动过速、房扑、心律失常、高血压、心力衰竭。
严重不良反应:
中性粒细胞减少，液体潴留，贫血。
药物相互作用：与诱导、抑制细胞色素P450同功酶的药物或经该酶代谢的药物同用，会影响本药的代谢。
严重药物相互作用:
与诱导、抑制细胞色素P450同功酶的药物或经该酶代谢的药物同用，会影响本药的代谢。
FDA妊娠分级          
D级:
有明确证据显示，药物对人类胎儿有危害性，但尽管如此，孕妇用药后绝对有益（例如用该药物来挽救孕妇的生命，或治疗用其他较安全的药物无效的严重疾病）。
MIMS药物分类：化疗用药 (Cytotoxic Chemotherapy)
ATC编码：L01CD02 
What is Docefrez?
Docefrez is a powder and solvent that is made up to a solution for infusion (drip into a vein). It contains the active substance docetaxel.
Docefrez is a ‘generic medicine’. This means that Docefrez is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere.
What is Docefrez used for?
Docefrez is used to treat the following types of cancer:breast cancer. Docefrez can be used on its own after other treatments have failed. It can also be used with other anticancer medicines(doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;non-small cell lung cancer.
Docefrez can be used on its own after other treatments have failed. It can also be used with cisplatin(another anticancer medicine) in patients who have not yet received any treatment for their cancer;prostate cancer, when the cancer does not respond to hormonal treatment. Docefrez is used with prednisone or prednisolone(anti-inflammatory medicines);gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docefrez is used with cisplatin and 5-fluorouracil (other anticancer medicines);head and neck cancer in patients whose cancer is advanced (has started to spread). Docefrez is used with cisplatin and 5-fluorouracil.
For full details, see the Summary of Product Characteristics (also part of the EPAR).
The medicine can only be obtained with a prescription.
How is Docefrez used?
Docefrez should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Docefrez is given as a one-hour infusion every three weeks.
The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docefrez is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docefrez infusion.
For more information, see the Summary of Product Characteristics.
How does Docefrez work?
The active substance in Docefrez, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ‘skeleton’ that allows them to divide and multiply.
With the skeleton still in place, the cells cannot divide and they eventually die.
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
How has Docefrez been studied?
Because Docefrez is a generic medicine, the company provided data on docetaxel from the published literature. No additional studies in patients were needed as Docefrez is given by infusion and contains the same active substance as the reference medicine, Taxotere.
What are the benefit and risk of Docefrez?
Because Docefrez is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Why has Docefrez been approved?
The CHMP concluded that, in accordance with EU requirements, Docefrez has been shown to be comparable to Taxotere. Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docefrez be given marketing authorisation.
Other information about Docefrez
The European Commission granted a marketing authorisation valid throughout the European Union for Docefrez to Sun Pharmaceutical Industries Europe B.V. on 15 May 2010. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Docefrez, read the Package Leaflet (also part of the EPAR).
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附件:

201232220115737.PDF