Antineoplastic Agents: Miscellaneous
ONEXA1 “Nexavar FC tablet” 200 mg/tab
適應症：晚期腎細胞癌且已接受interferon alfa或interleukin-2治療失敗，或不適合以上兩種藥物治療之病患。
Usual dose:
Renal cell carcinoma, advanced: 400 mg bid at least 1 h before or 2 h after eating; continue until p’t no longer benefits or until unacceptable toxicity.
Liver carcinoma, unresectable: 400 mg bid at least 1 h before or 2 h after eating; continue until p’t no longer benefits or until unacceptable toxicity.
Adverse effect:
Common: hypertension, alopecia, hand-foot syndrome due to cytotoxic therapy, rash, hypophosphatemia, weight loss, abdominal pain, diarrhea, increased amylase level, increased lipase level, loss of appetite, nausea, headache, fatigue, pain.
Serious: congestive heart failure, hypertensive crisis, ischemic heart disease, myocardial infarction, erythema multiforme, gastrointestinal hemorrhage, gastrointestinal perforation, pancreatitis, hemorrhage, thromboembolic disorder, cerebral hemorrhage, reversible posterior leukoencephalopathy syndrome, acute renal failure, pulmonary hemorrhage.
健保使用規範：(98/10/1、100/6/1、101/8/1、104/12/1)
1.晚期腎細胞癌部分：
(1)晚期腎細胞癌且已接受interferon -alpha或interleukin-2治療失敗，或不適合以上兩種藥物治療之病患。不適合以上兩種藥物治療之病患，須符合cytokine禁忌症者得直接使用sorafenib。但須列舉出所符合之禁忌症及檢附相關證明。(100/6/1)
(2)無效後則不給付temsirolimus及其他酪胺酸激酶阻斷劑（tyrosine kinase inhibitor,TKI）。
(3)需檢送影像資料，每3個月評估一次。(104/12/1)
2.晚期肝細胞癌部分：(101/8/1)
(1)轉移性或無法手術切除且不適合局部治療或局部治療失敗之晚期肝細胞癌，並符合下列條件之一：
Ⅰ.肝外轉移（遠端轉移或肝外淋巴結侵犯）的Child-Pugh A class患者。
Ⅱ.大血管侵犯（腫瘤侵犯主門靜脈或侵犯左/右靜脈第一分支）的Child-Pugh A class患者。
(2)需經事前審查核准後使用，每次申請之療程以2個月為限，送審時需檢送影像資料，每2個月評估一次。