Herceptin (Trastuzumab): Targeted Therapy for HER2-Positive Cancers

曲妥珠单抗（读作 [tras TU zoo mab]）的商品名是 Herceptin。Herceptin 是一种抗肿瘤（抗癌）药物，属于一类名为 抗HER2. It is a targeted monoclonal antibody therapy that works by blocking the HER2 receptor, which slows or stops the growth of HER2-positive cancer cells and promotes affected cell death.

How Does Herceptin Differ From Chemotherapy?

While both are used to treat cancer, they work in different ways:

• 化疗 uses cytotoxic (cell-killing) drugs to attack all rapidly dividing cells in the body. Because it affects healthy cells as well as cancer cells, it often causes side effects like hair loss.
• Herceptin (Targeted Therapy) is a monoclonal antibody. It acts like a “guided missile” that specifically seeks out and attaches to the HER2 protein on the surface of cancer cells. This blocks the signals that tell the cancer to grow, often sparing more healthy cells than traditional chemotherapy.

Herceptin 如何使用？

Herceptin has been approved by the Food and Drug Administration (FDA) to treat HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction cancers. It can be prescribed alone or with other 抗癌药物.

可用配方

Herceptin is available as a solution for intravenous injection only. Brand-name Herceptin is supplied as a 150 mg single-dose vial, though other biosimilar formulations are available in different-sized vials. The total duration of therapy typically should not exceed 1 year (52 weeks), but this may vary depending on the patient’s condition and cancer severity.

使用方法

Herceptin is typically dosed to be given once every 1 to 3 weeks, depending on cancer type and severity. The dose and schedule are determined by the prescribing provider and should be followed exactly. The dose is determined using the patient’s body weight. The initial dose (also known as the loading dose) is typically infused over 90 minutes if tolerated, and subsequent infusions (maintenance doses) can be infused over 30 – 90 minutes.

请勿将 Herceptin 与 葡萄糖水溶液（D5W） 或与任何其他药物合用。本品应仅与抑菌水或无菌注射用水混合，并用生理盐水稀释。Herceptin 不应静脉推注或快速推注。曲妥珠单抗可单独使用或与其他药物联合使用。不同的曲妥珠单抗产品不可互换；仅可按处方指定剂量使用。

漏服剂量

此药需按时服用。如果您漏服，请立即联系医生获取进一步指导。 

If a scheduled dose is delayed by 一周或更短, the usual maintenance dose should be administered as soon as possible. Subsequent maintenance doses should be administered 1 to 3 weeks later (based on the patient’s normal maintenance dose schedule).

如果错过剂量 超过一周应尽快在90分钟内给予再次负荷剂量。然后，在1至3周后给予常规维持剂量（基于患者的正常维持剂量方案）。

贮存

As there are lots of different variations of trastuzumab, storage times vary by product; refer to the individual product labeling for details. Prior to reconstitution, vials should be stored in the refrigerator. Some products should be stored in intact vials in the original carton to protect from light. Some solutions are preservative-free, and therefore, they should be used immediately. Others can be refrigerated for up to 24 hours (depending on the product or vial size). Do not freeze or shake Herceptin vials. Always refer to the specific product labeling for storage and stability information, as requirements may differ between brand-name Herceptin and other trastuzumab biosimilar products.

服用 Herceptin 期间应避免什么

在接受Herceptin治疗期间，您必须遵循一些预防措施。请务必告知您的医生您正在服用的任何药物。 未经医生或药剂师事先同意，请勿服用任何药物（即使是草药、维生素或非处方药）。它们可能与 Herceptin 有一些显著的相互作用。

怀孕和 Herceptin

妊娠期间接触 Herceptin 可能导致羊水减少，从而严重影响胎儿，导致生长迟缓和畸形。育龄女性在开始 Herceptin 治疗前必须检查妊娠状况，并在治疗期间及最后一次服药后 7 个月内采取有效的避孕措施。Herceptin 可能对胎儿造成损害，因此不建议哺乳期女性在治疗期间使用。最后一次服药后至少 7 个月内也应避免哺乳。 

副作用

与任何其他药物一样，服用 Herceptin 时可能会出现副作用。需要注意以下几点：

• 您可能不会出现以下列出的所有副作用。许多人可能几乎没有副作用。
• 副作用的严重程度可能因人而异，因此不要将您的副作用与其他人的经历进行比较。
• 停止治疗后，大多数副作用都会改善。
• Many side effects are manageable with supportive care or dose adjustments. Consult with your physician or pharmacist to explore available options.
• 不要隐瞒任何症状；如果您感到任何不适，请毫不犹豫地告诉您的医生或药剂师。

笔记：此列表并未涵盖所有副作用。如有任何疑问，请咨询医生。 

Herceptin 的一些更严重的副作用如下：

减肥

服用 Herceptin 此药物时，由于食欲下降，通常会导致体重减轻。 

心脏并发症 

使用 Herceptin 可能会出现心脏并发症，如高血压、左心室心力衰竭 (LVHF)、 心律失常， 或者 血栓栓塞 （可能包括心脏病发作或中风）。高血压可以通过抗高血压疗法控制。治疗开始前、治疗期间每3个月以及治疗结束后2年内每6个月监测左心室收缩功能（LVHF）。 

肾脏并发症

Herceptin 可能导致肾脏并发症，导致一种称为 肾小球病, and can lead to fluid imbalance and additional strain on the heart if left untreated. Glomerulopathy is a syndrome where protein leaks out of the kidneys and is found in the urine. This can be detected by taking a urine test at the doctor’s office. 

It is essential to screen for hepatitis B prior to initiating Herceptin therapy. Signs of hepatitis B include yellowing of the skin and eyes or excessive tiredness. If you have any of these symptoms, seek medical advice from your physician immediately.

肺损伤

在某些情况下，Herceptin 可能会导致肺损伤和急性呼吸窘迫综合征 (ARDS) 等症状， 肺纤维化, pulmonary edema (fluid in lungs), and others. Lung effects may occur during or shortly after infusion, though delayed reactions have also been reported. Patients with preexisting lung conditions may be at a higher risk. If you experience difficulty breathing, seek medical help immediately.

骨骼、关节、背部和肌肉疼痛

另一个常见的副作用是骨骼、关节、背部或肌肉疼痛。充足的休息和补充水分可能有助于减轻潜在的疼痛。服用任何非处方止痛药前，请先获得医生的批准。

输液相关反应

Herceptin 治疗的输液相关反应最常发生在治疗期间或首次输液后 24 小时内。输液反应可能包括发热和寒战，也可能表现为恶心、呕吐、头痛、呼吸困难、头晕、皮疹、低血压和虚弱。如果出现呼吸急促、口腔或舌头肿胀或血压下降，应立即停止输液。如果出现严重的输液反应，可在输液前使用适当的药物，例如泰诺或苯海拉明，重新尝试输液。

其他常见的副作用可能包括：

• 恶心或呕吐
• 腹泻
• 流感或感冒症状
• 腹痛
• 口味改变
• 睡眠困难
• 口腔溃疡或刺激

防范措施

除非得到医生的批准，否则通常不建议有心脏并发症风险的患者使用 Herceptin。

• 患有其他疾病（如糖尿病、肥胖症、吸烟和 60 岁或以上）的患者也可能面临更高的心脏并发症风险。
• 风险因素包括心脏病史、高血压、血液中脂肪或胆固醇含量高（血脂异常）、心脏病发作或中风史等。
• Herceptin is known for causing left ventricular cardiac problems. If signs of left ventricular ejection fraction(LVEF) are apparent, discontinuation may be warranted.

常见问题解答

Herceptin 是化学药剂吗？

Technically, no. Herceptin is classified as a targeted immunotherapy. However, because it is used to treat cancer and is often administered in a chemotherapy infusion center, many people refer to it as “chemo” for simplicity. It is frequently given in combination with traditional chemotherapy to provide a two-pronged attack against the cancer.

Herceptin该如何服用？

Herceptin is available as an intravenous injection only and is administered on a fixed schedule determined by the prescribing provider.