適用於治療RAS原生型（wild-type）之轉移性直腸結腸癌病人：

• 與 FOLFIRI (Folinic acid/ 5-FU/ Irinotecan)合併使用之第一線治療。
• 與 FOLFOX合併使用之第一線治療。
• 併用 encorafenib，用於治療帶有BRAF V600E 突變且曾接受過治療之轉移性直腸結腸癌 (CRC) 成人病人。

與放射線療法合併使用，治療局部晚期之口咽癌、下咽癌及喉癌病人。

與內含platinum類之化學療法合併使用，治療復發及/或轉移性頭頸部鱗狀細胞癌病人。

Indicated for the treatment of patients with RAS wild-type metastatic colorectal cancer:

• First-line treatment in combination with FOLFIRI (Folinic acid/ 5-FU/ Irinotecan).
• First-line treatment in combination with FOLFOX.
• In combination with encorafenib for the treatment of adult patients with BRAF V600E mutation-positive metastatic colorectal cancer (CRC) who have received prior therapy.

In combination with radiation therapy for the treatment of locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, and larynx.

In combination with platinum-based chemotherapy for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Erbituxx（Cetuximab）是一種嵌合單克隆抗體，能夠結合於上皮生長因子受體（EGFR）上，抑制EGFR介導的信號傳導路徑，從而抑制腫瘤細胞的生長、侵襲和轉移。

Erbituxx (Cetuximab) is a chimeric monoclonal antibody that binds to the epidermal growth factor receptor (EGFR), inhibiting EGFR-mediated signal transduction pathways, thereby inhibiting tumor cell growth, invasion, and metastasis.

Erbituxx的藥物動力學包括以下特點：

• 生物利用度：靜脈輸注後完全生物利用。
• 分布：主要分布於血漿和腫瘤部位。
• 代謝：主要通過蛋白白降解。
• 排泄：主要通過腎臟排泄。

The pharmacokinetics of Erbituxx include the following characteristics:

• Bioavailability: Complete bioavailability after intravenous infusion.
• Distribution: Primarily distributed in plasma and tumor sites.
• Metabolism: Mainly degraded by proteases.
• Excretion: Primarily excreted through the kidneys.

• 已知對Cetuximab有嚴重過敏反應的病人。
• Erbituxx與內含oxaliplatin之化學治療的合併治療禁用於具RAS突變型之轉移性直腸結腸癌病人或其RAS突變狀態未知的轉移性直腸結腸癌病人。

Patients with known severe hypersensitivity reactions to Cetuximab (Grade 3 or 4; National Cancer Institute – Common Terminology Criteria for Adverse Events, CTCAE).

Erbituxx in combination with oxaliplatin-containing chemotherapy is contraindicated in patients with RAS-mutant metastatic colorectal cancer or if RAS mutation status is unknown.

Erbituxx在懷孕期間的安全性尚未確立，應在權衡利弊後謹慎使用，建議懷孕期間避免使用。

The safety of Erbituxx during pregnancy has not been established. It should be used with caution and only if the potential benefits justify the potential risks. Avoid use during pregnancy.

尚不清楚Cetuximab是否會分泌至人乳，應考慮停止哺乳或停止藥物，取決於藥物的重要性。

It is not known whether Cetuximab is excreted in human milk. Consider discontinuing nursing or the drug, taking into account the importance of the drug to the mother.

• 常見副作用包括皮膚反應（如皮疹）、輸注相關反應、呼吸困難。
• 嚴重副作用可能包括過敏反應、間質性肺疾病（ILD）、次發性感染。

Common adverse reactions include skin reactions (e.g., rash), infusion-related reactions, and dyspnea.

Serious adverse reactions may include hypersensitivity reactions, interstitial lung disease (ILD), and secondary infections.

轉移性直腸結腸癌 (Metastatic Colorectal Cancer)：

• 起始劑量：每平方公尺體表面積400毫克，建議的輸注時間是120分鐘。
• 後續劑量：每平方公尺體表面積250毫克，每週一次輸注60分鐘。
• 每兩週一次給藥：初始劑量400 mg/m²後，建議劑量為500 mg/m²，每兩週輸注一次，時間約為120分鐘。

• Initial dose: 400 mg per square meter of body surface area, with a recommended infusion time of 120 minutes.
• Subsequent doses: 250 mg per square meter of body surface area, administered once a week with an infusion time of 60 minutes.
• Bi-weekly dosing: After an initial dose of 400 mg/m², the recommended dose is 500 mg/m², administered every two weeks with an infusion time of approximately 120 minutes.

頭頸部鱗狀細胞癌 (Squamous Cell Carcinoma of the Head and Neck)：

• 起始劑量：每平方公尺體表面積400毫克，建議的輸注時間是120分鐘。
• 後續劑量：每平方公尺體表面積250毫克，每週一次輸注60分鐘。
• 與放射治療併用時，應在開始放射治療的一周之前給予初始劑量。
• 每兩週一次給藥：初始劑量400 mg/m²後，建議劑量為500 mg/m²，每兩週輸注一次，時間約為120分鐘。

• Initial dose: 400 mg per square meter of body surface area, with a recommended infusion time of 120 minutes.
• Subsequent doses: 250 mg per square meter of body surface area, administered once a week with an infusion time of 60 minutes.
• When used in combination with radiation therapy, the initial dose should be administered one week prior to the start of radiation therapy.
• Bi-weekly dosing: After an initial dose of 400 mg/m², the recommended dose is 500 mg/m², administered every two weeks with an infusion time of approximately 120 minutes.

Erbituxx尚未確立在小兒患者中的安全性和有效性，建議謹慎使用。

The safety and efficacy of Erbituxx in pediatric patients have not been established. Use with caution.

目前尚無Erbituxx在腎功能不全患者中的劑量調整建議，應根據患者的腎功能狀況進行監測和調整。

Currently, there are no specific dosage adjustment recommendations for Erbituxx in patients with renal impairment. Monitor

目前尚無Erbituxx在肝功能不全患者中的劑量調整建議，應根據患者的肝功能狀況進行監測和調整。

Currently, there are no specific dosage adjustment recommendations for Erbituxx in patients with hepatic impairment. Monitor and adjust according to the patient's hepatic function status.