報告者:林婉薇 指導藥師:林梅芳 學姊 案例協助:靜卉,安儀 學姊 特別感謝☆一起幫我留意處方的同事們 門診處方討論 TEMODAL 報告者:林婉薇 指導藥師:林梅芳 學姊 案例協助:靜卉,安儀 學姊 特別感謝☆一起幫我留意處方的同事們

目錄 門診處方案例 本院現有劑量劑型 作用 適應症 用法用量 最新健保規範 MICROMEDEX® Healthcare Series 參考文獻

門診處方案例 78歲,羅女士,就診科別:腦神經外科 出院診斷:Gliosarcoma(神經膠肉瘤) 用藥:Acetaminophen 500mg/tab 1#QID 21days Haloperidol 5mg/tab 1#HS 21days Mgo 1#QID 21days Sennoside 2#HS 21days Temozolomide 100mg/cap 1#QD 21days Valproic acid 500mg/tab 1#BID 21days

其他案例比較 劉先生,就診科別:腦神經外科 診斷:顳葉惡性腫瘤 主要用藥: Temozolomide 100mg/cap 3# QD 5days Temozolomide 20mg/cap 1# QD 5days

其他案例比較 吳女士,就診科別:腦神經外科 診斷:腦惡性腫瘤,放射線所致之影響 主要用藥: Temozolomide 100mg/cap 3# HS 5days

TEMODAL (Temozolomide) 規格：20mg/cap 顏色：白/黃色 劑型：膠囊 形狀：長圓柱形 標記：有TEMODAL/20mg字樣 規格：100mg/cap 顏色：白/粉紅色 劑型：膠囊 形狀：長圓柱形 標記：有TEMODAL/100mg字樣

TEMODAL作用 具抗腫瘤活性,含有imidazotetrazine環的烷基化作用劑 它在全身循環中會在生理酸鹼值的狀態下,快速地透過化學轉化作用形成活性化合物MTIC(Monomethyl triazeno imidazole carboxamide)

TEMODAL適應症 新診斷的多形神經膠母細胞瘤,與放射治療同步進行,然後作為輔助性治療 給予標準治療後復發性或惡化之惡性神經膠質瘤,例如多形神經膠母細胞瘤或退行性星狀細胞瘤

TEMODAL用法用量 一.新診斷的多形神經膠母細胞瘤的成年病人

同步治療期 1. TEMODAL口服投與42天（75mg/㎡體表面積 /day),與放射治療同步進行 CTC非血液學毒性（禿髮,噁心,嘔吐除 外）≦第一級 ＊治療期間每週需測量一次全血球計數　　　　　　

輔助性治療期 4. 完成TEMODAL與放射治療同步治療之後四週,再給予六個療程的TEMODAL輔助性治療 a. 第一個（輔助性）療程的劑量是TEMODAL口服150mg/㎡體表面積,每天1次,投與5天,接著23天不用服藥 b. 開始第二個療程時,如果符合☆便可將治療劑量增加為200mg/㎡體表面積 ＊如果劑量在第二個療程沒有增加,以後的療程就不應該增加劑量 c. 以後每個療程最初5天的劑量要保持在200mg/㎡體表面積,除非毒性出現 ＊在治療期間,第22天（投與第1次TEMODAL 劑量的21天後）要測量全血球計數

二.患有復發性或進行性神經膠質瘤的成人 1.先前未曾接受過化療的病人:每28天為一個療程,投與5天,每天1次,口服TEMODAL 200mg/㎡體表面積 2.先前接受過化療的病人:在第一個療程投與初始劑量TEMODAL 150mg/㎡體表面積,在第二個療程的第一天,如果絕對嗜中性白血球計數≧15億個/L,血小板計數≧1000億個/L,便可將治療劑量增加為200mg/㎡體表面積

三.患有復發性或進行性神經膠質瘤的兒童病人 1.三歲或更大的兒童病人:每28天為一個療程,投與5天,每天1次,口服TEMODAL 200mg/㎡體表面積 2.先前接受過化療的兒童病人:在第一個療程投與初始劑量150mg/㎡體表面積,投與5天,如果沒有毒性,在第二個療程便可以將治療劑量增加為200mg/㎡體表面積,投與5天 ＊可以持續使用至疾病進行治療期最長為2年

「全民健康保險藥品給付規定」修正規定 第9章 抗癌瘤藥物 Antineoplastics drugs （自97年1月1日起實施） 修正後給付規定 9.25. temozolomide (如Temodal)：（94/3/1、97/1/1） 1. 限用於經手術或放射線治療後復發之AA(anaplastic astrocytoma) 或GBM (Glioblastoma multiforme)之病人。 ★2. 新診斷的多型性神經膠母細胞瘤，與放射線治療同步進行，然後作為輔助性治療。（97/1/1） 3. 需經事前審查核准後使用。 備註：劃線部份為新修訂之規定。 原給付規定 9.25. temozolomide (如Temodal)：(94/3/1) 1. 限用於經手術或放射線治療後復發之AA(anaplastic astrocytoma) 或GBM (Glioblastoma multiforme)之病人。 2. 需經事前審查核准後使用。

TEMOZOLOMIDE Adult Dosing  

Anaplastic astrocytoma of brain, Refractory (following disease progression on nitrosourea and procarbazine): initial dose: 150 mg/m(2) ORALLY every day for 5 days; cycle every 28 days; if the absolute neutrophil count and platelet count on day 29 (day 1 of next cycle) and day 22 are equal to or greater than 1.5 x 10(9)/L and 100 x 10(9)/L respectively, increase dose to 200 mg/m(2)/day for 5 days Glioblastoma multiforme of brain, Newly diagnosed, concomitantly with radiotherapy and then as maintenance: concomitant to standard radiotherapy: initial dose, 75 mg/m(2) ORALLY daily for 42 days; cycle every 28 days beginning 4 weeks after completion of initial therapy

Glioblastoma multiforme of brain, Newly diagnosed, concomitantly with radiotherapy and then as maintenance: maintenance, cycle 1: 150 mg/m(2) orally once daily for 5 days followed by 23 days without treatment; cycles 2-6 (each 28-days): 200 mg/m(2) orally daily for the first 5 days of the cycle if common toxicity criteria (CTC) grade less than or equal to 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) greater than or equal to 1.5 x 10(9)/L, and the platelet count is greater than or equal to 100 x 10(9)/L; The dose remains at 200 mg/m(2) per day for the first 5 days of each subsequent cycle except if toxicity occurs; if the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles Metastatic melanoma, Monotherapy: 200 mg/m(2) ORALLY daily for 5 consecutive days, every 28 days .

Dose Adjustments   hematologic, astrocytoma: (absolute neutrophil count (ANC) <1,000/mcL or platelets <50,000/mcL): hold dose until ANC >1,500/mcL and platelets >100,000/mcL; then reduce dose by 50 mg/m(2)/day for subsequent cycles, but not below 100 mg/m(2) hematologic, astrocytoma: (absolute neutrophil count (ANC) 1,000-1,500/mcL or platelets 50,000-100,000/mcL): hold therapy until ANC is greater than 1,500/mcL and platelets >100,000/mcL; maintain initial dose hematologic, astrocytoma: (absolute neutrophil count >1,500/mcL and platelets >100,000/mcL): increase or maintain dose at 200 mg/m(2)/day ORALLY for 5 days for subsequent cycles

hematologic and non-hematologic (glioblastoma): concomitant phase; DISCONTINUE if absolute neutrophil count (ANC) is less than 0.5 x 10(9)/L, or the platelet count is less than 10 x 10(9)/L, or if a common toxicity criteria (CTC) grade 3 or 4 non-hematological toxicity (except for alopecia, nausea, vomiting) occurs; INTERRUPT therapy if the ANC is at least 0.5 x 10(9)/L but less than 1.5 x 10(9)/L, or the platelet count is at least 10 x 10(9)/L but less than 100 x 10(9)/L, or if a CTC grade 2 non-hematological toxicity (except for alopecia, nausea, vomiting) occurs

hematologic and non-hematologic (glioblastoma): maintenance phase; REDUCE dose by 50 milligrams/square meter/day (mg/m(2)/day) if the absolute neutrophil count (ANC) is less than 1 x 10(9)/L, the platelet count is less than 50 x 10(9)/L, or if a common toxicity criteria (CTC) grade 3 non-hematological toxicity (except for alopecia, nausea, vomiting) occurs; DISCONTINUE therapy if a dose reduction to less than 100 mg/m(2)/day is required, a CTC grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting) occurs, or if the same CTC grade 3 toxicity occurs after dose reduction

資料來源 義大藥劑科網站http://www2.edah.org.tw/ph/index01.htm TEMODAL藥品仿單 MICROMEDEX® Healthcare Series

感謝各位的 ☆耐心聆聽☆