英文药名: HERCEPTIN（Trastuzumab(Genetical Recombination)）

中文药名: 赫赛汀(曲妥珠单抗冻干粉针剂)

生产厂家: 中外制药

ハーセプチン注射用60／ハーセプチン注射用150

治疗类别名称
抗HER2注1）人源化单克隆抗体的抗癌药
注1）HER2：人类表皮生长因子受体2型（人表皮生长因子受体2型，也称为：中c-erbB-2）
商標名
HERCEPTIN
一般名
トラスツズマブ(遺伝子組換え)
(Trastuzumab(Genetical Recombination))(JAN)
结构式
碳水化合物蛋白质包含氨基酸214或轻链的2分子和氨基酸449的重链分子的2或
分子式
轻链（C1032H1603N277O335S6）
重链（C2192H3387N583O671S16）
分子量
148000
审批条件
批准的时间（HER2过表达证实转移性乳腺癌）
对于临床有效性和安全性在日本这种药物用于该适应症更清楚，目的来执行在日本适当上市后的临床试验，据报道上市后监测的结果，包括结果。
药理作用
赫赛汀是一种重组DNA衍生的人源化单克隆抗体，选择性地作用于人表皮生长因子受体-2(HER2)的细胞外部位。在原发性乳腺癌患者中观察到有25%-30%的患者HER2过度表达。研究表明，HER2过度表达的肿瘤患者较无过度表达的无病生存期短。赫赛汀在体外及动物实验中均显示可抑制HER2过度表达的肿瘤细胞的增殖。另外，赫赛汀是抗体依赖的细胞介导的细胞毒反应(ADCC)的潜在介质。在体外研究中，赫赛汀介导的ADCC被证明在HER2过度表达的癌细胞中比HER2非过度表达的癌细胞中更优先产生。
适应症
赫赛汀适用于治疗HER2过度表达的转移性乳腺癌。
a) 作为单一药物治疗已接受过1个或多个化疗方案的转移性乳腺癌.
b) 与紫杉类药物合用治疗未接受过化疗的转移性乳腺癌.
c) HER2-过度表达的转移胃或胃食管连接部腺癌是治疗
用法用量
初次负荷剂量：建议赫赛汀初次负荷量为4mg/kg。90分钟内静脉输入。
维持剂量：建议每周赫赛汀用量为2mg/kg。如初次负荷量可耐受，则此剂量可于30分钟内输完赫赛汀可一直用到疾病进展。根据国外市场调查资料显示：接受治疗的患者平均约连续使用24至26周。
HERCEPTIN Injection（Trastuzumab(genetical recombination)）
HERCEPTIN Injection 150（ハーセプチン注射用150）
Brand name : HERCEPTIN Injection 150
　Active ingredient: Trastuzumab(genetical recombination)
　Dosage form: injection
　Print on wrapping:
HERCEPTIN Injection 60（ハーセプチン注射用60）
Brand name : HERCEPTIN Injection 60
　Active ingredient: Trastuzumab(genetical recombination)
　Dosage form: injection
　Print on wrapping:
Effects of this medicine
This medicine suppresses growth of cancer cells by selectively suppressing the actions of protein named HER2 necessary for growth of cancer cells.
It is usually used to treat breast cancer overexpressing HER2 and advanced or recurrent gastric cancer overexpressing HER2, not amenable to curative resection.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have or have previously experienced heart disease.
If you have been previously diagnosed with high blood pressure or hypertension.
If you are having difficulty breathing even at rest or have previously experienced such a symptom.
If you are treated with radiation therapy.
If you have previously been treated with anthracycline drugs.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is<<to be written by a healthcare professional>>
•For breast cancer: In general, administer by intravenous infusion once a day at an interval of once every week or every three weeks.
For advanced or recurrent gastric cancer, not amenable to curative resection: In general, administer by intravenous infusion once a day at an interval of every three weeks.
•Dosage and treatment interval depend on the results from checking on the patient's conditions.
Precautions while taking this medicine
•Since serious cardiac disorder such as cardiac failure may occur, your cardiac function may be checked by echocardiography.
•If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine. Also avoid pregnancy for at least seven months after you discontinue this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, vomiting, chill, malaise, asthenia, nausea, pain, headache, fatigue, nail disorder, loss of appetite, diarrhea, palmar plantar erythema perception deficiency syndrome, stomatitis, hiccup and constipation. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•fever, general dullness, dizziness on standing up, dizziness, swelling, easy breathing in upright position, breathlessness, shortness of breath, chest pain, pounding heart, palpitation, irregular heartbeat, slow pulse, nausea, vomiting, loss of appetite, impaired judgment/mind, decreased/confused consciousness, loss of consciousness [cardiac disorder]
•general dullness, lightheadedness, decreased consciousness, impaired judgment/mind, glow, swelling around the eye and lips, hoarseness, breathing difficulty, shortness of breath, palpitation, hives [anaphylactoid symptoms]
•chills, fever, cough, phlegm, breathing difficulty, shortness of breath, rapid breathing with difficulty, pale lips, pale nails on limbs [interstitial pneumonia, pulmonary disorder]
•fever, sore throat, nose bleeding, gum bleeding, subcutaneous bleeding, blue spot, continuous bleeding, general dullness, dizziness, headache, ear ringing, palpitation, shortness of breath [leukopenia, neutropenia, thrombopenia, anemia]
•general dullness, itch, nausea, vomiting, loss of appetite, tremor of hands like flapping, yellowing of white of the eyes and/or the skin, dark urine [liver failure, jaundice, hepatitis, liver dysfunction]
•headache, swollen face/eyelids, decreased urinary volume [renal disorder]
•loss of consciousness, dizziness, impaired judgment/mind, decreased/confused consciousness, headache, vomiting, paralysis on one side of the body, difficulty talking, decreased visual acuity, hyperventilation, tremor of the limbs [coma, cerebrovascular disease, brain edema]
•chills, sudden high fever with shivering, joint/muscle pain [sepsis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Chugai Pharmaceutical Co., Ltd.Injection
Revised: 12/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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产地国家:日本
原产地英文商品名:
HERCEPTIN（ハーセプチン注射用）150mg/Lyoph. 1vial+solvent7.2ml(Cold storage required: Temp 2-8 degree Celsius)
原产地英文药品名:
Trastuzumab(Genetical Recombination)
中文参考商品译名:
赫赛汀（ハーセプチン注射用）150毫克/瓶+溶液7.2毫升(需要冷藏：温度2-8摄氏度)
中文参考药品译名:
曲妥珠单抗
生产厂家中文参考译名:
中外制药
生产厂家英文名:
Chugai Pharmaceutical Co., Ltd.

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产地国家:日本
原产地英文商品名:
HERCEPTIN（ハーセプチン注射用）60mg Lyoph. 1vial + solvent3.0ml(Cold storage required: Temp 2-8 degree Celsius)
原产地英文药品名:
Trastuzumab(Genetical Recombination)
中文参考商品译名:
赫赛汀（ハーセプチン注射用）60毫克/瓶+溶液3.0毫升(需要冷藏：温度2-8摄氏度)
中文参考药品译名:
曲妥珠单抗
生产厂家中文参考译名:
中外制药
生产厂家英文名:
Chugai Pharmaceutical Co., Ltd.

美国批准罗氏抗癌药Herceptin治疗晚期胃癌
近日，美国FDA已批准罗氏乳腺癌治疗药赫赛汀（Herceptin）的最新适应症，即作为靶向药物治疗晚期胃癌。
今年年初，欧盟委员会也刚刚作出了类似的审批决定。紧随其后，FDA也认为Herceptin可以安全有效地治疗那些癌细胞已发生转移的胃癌或胃食管交界癌患者。
但适用范围仅限于那些呈现HER2表达的患者，HER2是一种具有致癌可能性的特定基因产生的一种蛋白质。此外，根据批准内容，只有之前未采用过任何晚期癌症治疗药的患者才可使用该药。
这次FDA做出批准决定的依据是在一项III 期临床实验中获取的数据，该实验名为ToGA，共有594名患者参加。所得数据证实，与单用化疗相比较，HER-2阳性患者在化疗的基础上辅以Herceptin之后，生存时间更长。
结果显示，联合治疗组的中位总生存时间较单纯化疗组显著延长（13.5月 vs 11.1月，P=0.0048），客观有效率分别为47.3%和34.5%(p=0.0017)。本试验结果显示对于胃癌患者中表达HER2的亚群，Herceptin是一种新型有效、安全的药物，首次在大样本胃癌临床研究中使晚期胃癌患者生存时间超过13个月，并在个体化治疗层面开启了胃癌靶向治疗的新篇章。
罗氏相关负责人哈尔•贝伦表示，Herceptin已成为该公司的一种畅销药物，仅在美国市场的销售额就已超过10亿美元。目前罹患这类致命性疾病的患者可选的治疗方案非常少，对于他们来说，Herceptin可谓是一种重要的个性化疗法，给他们带来了新的希望。随着扩大适应症的获准，药物的销量有望进一步增长。