Antineoplastic Agents: Immunotherapeutic Agents
IERBI2 “Erbitux injection” 5 mg/ml; 20 ml/vial
適應症：Erbitux與irinotecan合併使用，治療經內含irinotecan之細胞毒性治療失敗且具有表皮生長因子受體表現型的轉移性直腸結腸癌的病患。Erbitux與放射線療法合併使用，治療局部晚期之口咽癌、下咽癌及喉癌患者。Erbitux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患者。
Usual dose:
Head and neck cancer, locally or regionally advanced squamous cell, in combination with radiation therapy: 400 mg/m2 initial IV loading dose over 120 min administered 1 wk prior to the start of radiation therapy, followed by weekly doses of 250 mg/m2 IV over 60 min for the duration of radiation therapy (6-7 wks); administer 1 h prior to radiation, if possible.
Head and neck cancer, metastatic or recurrent squamous cell; refractory to platinum-based therapy; as monotherapy: 400 mg/m2 initial IV loading dose over 120 min, followed by weekly doses of 250 mg/m2 IV over 60 min until disease progression or unacceptable toxicity.
Metastatic colorectal cancer, EGFR-expressing, as monotherapy, in p’ts intolerant to irinotecan-based chemotherapy: 400 mg/m2 initial IV loading dose over 120 min, followed by weekly doses of 250 mg/m2 IV over 60 min.
Metastatic colorectal cancer, EGFR-expressing, in combination with irinotecan, in p’ts refractory to irinotecan-based chemotherapy: 400 mg/m2 initial IV loading dose over 120 min, followed by weekly doses of 250 mg/m2 IV over 60 min.
Adverse effect:
Mild or moderate infusion-related reactions, fever, chills, nausea, vomiting, headache, dizziness or dyspnoea; mild to moderate mucositis.
Severe infusion-related reactions, rapid onset of airway obstruction, urticaria, hypotension, loss of consciousness and/or stenocardia may occur during or within 1 h of initial infusion. Skin reactions, mainy as acne-like rash, renal impairment, conjunctivitis, mild to moderate increase in liver enzyme levels.
健保使用規範：(96/3/1、98/7/1、98/8/1、99/10/1、101/12/1、104/11/1)
1.直腸結腸癌治療部分：
(1)與FOLFIRI(Folinic acid/5-fluorouracil/irinotecan)合併使用於治療具表皮生長因子受體表現型(EGFR expressing)，KRAS基因及NRAS基因沒有突變之轉移性直腸結腸癌病患之第一線治療。(101/12/1、104/11/1)
I.本藥品需經事前審查核准後使用，每次申請事前審查之療程以12週為限，再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用。
II.使用總療程以24週為上限。
III.本藥品不得與bevacizumab併用。
(2)本藥需經事前審查核准後使用，每次申請事前審查之療程以9週為限，再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用。使用總療程以18週為上限。
2.口咽癌、下咽癌及喉癌治療部分：(98/7/1、99/10/1)
(1)限與放射線療法合併使用於局部晚期之口咽癌、下咽癌及喉癌患者，且符合下列條件之一：
I.年齡 ≧ 70歲；
II.Ccr ＜50ml/min；
Ⅲ.聽力障礙者(聽力障礙定義為500Hz、1000Hz、2000Hz平均聽力損失大於25分貝)；
Ⅳ.無法耐受platinum-based化學治療。
(2)使用總療程以接受8次輸注為上限。
(3)需經事前審查核准後使用。