Antineoplastic Agents: Miscellaneous
OGLIV1 “Glivec tablet” 100 mg/tab
適應症：治療正值急性轉化期(Blast crisis)、加速期或經interferon alfa治療無效之慢性期的慢性骨髓性白血病(CML)患者。治療成年人無法手術切除或轉移的惡性胃腸道基質瘤。用於治療初診斷為慢性骨髓性白血病的病人。治療初診斷為費城染色體陽性急性淋巴性白血病（Ph+ ALL)且併用化療之成年人。做為治療成人復發性或難治性費城染色體陽性急性淋巴性白血病(Ph+ ALL)之單一療法。治療患有與血小板衍生生長因子受體（PDGER)基因重組相關之骨髓發育不全症候群(MDS)/骨髓增生性疾病(MPD)之成人患者。治療嗜伊紅性白血球增加症候群(HES)與或慢性嗜伊紅性白血病(CEL)且有血小板衍生生長因子受體基因重組之成人患者。治療患有無法手術切除、復發性或轉移性且有血小板衍生生長因子受體基因重組之隆突性皮膚纖維肉瘤(DFSP)之成人患者。
Usual dose:
Chronic myelogenous leukemia-chronic phase: 400 mg PO qd; in the absence of significant toxicity, a higher dose (600 mg PO qd) may be given to p’ts failing to achieve satisfactory hematologic response or experiencing disease progression.
Chronic myelogenous leukemia-accelerated phase/blast crises: 600 mg PO qd; in the absence of significant toxicity, a higher dose (400 mg PO bid) may be given to p’ts failing to achieve satisfactory hematologic response or experiencing disease progression.
Gastrointestinal stromal tumors (GIST): 400 or 600 mg PO qd.
Dose adjustment:
Fluid retention: if severe fluid retention develops, imatinib should be held until the event has resolved and then restarted as appropriate depending on the severity.
Hematologic, chronic phase CML or GIST:
If the starting dose of imatinib is 400 mg and the ANC is <1×109/L and/or the platelet count is <50×109/L: stop the imatinib until the ANC is >1.5×109/L and the platelet count is >75×109/L. Restart imatinib at a dose of 400 mg. If recurrence, stop the imatinib until the ANC is >1.5×109/L and the platelet count is >75×109/L and decrease dose to 300 mg.
Adverse effect:
Common: fluid retention (pleural/pericardial effusion, ascites), muscle cramps, nausea/vomiting, diarrhea.
Serious: hepatoxicity, myelosuppression (neutropenia, thrombocytopenia).
健保使用規範：限用於
- 治療正值急性轉化期 (blast crisis)、加速期或經ALPHA-干擾素治療無效之慢性期的慢性骨髓性白血病 (CML) 患者使用。
- 用於治療初期診斷為慢性骨髓性白血病（CML）的病人。
- 惡性胃腸道基質瘤(GIST)：
(1)治療成年人無法手術切除或轉移的惡性胃腸道基質瘤。
(2)作為GIST切除術之術後輔助治療，惟腸胃道基質瘤須大於等於6公分且使用期間為一年，須事前審查核准後使用。(100/2/1)
4.治療初診斷為費城染色體陽性急性淋巴性白血病（Ph+ ALL)且併用化療之成年人。(99/6/1)
5.未曾使用imatinib 治療之成人復發性或難治性費城染色體陽性急性淋巴性白血病(Ph+ ALL)之單一療法。(99/6/1)
6.下列適應症患者必須在第一線的藥物如hydroxyurea；corticosteroid等無效後，經事前審查核准才可使用，且每6個月需重新申請審查。(99/6/1)
(1)治療患有與血小板衍生生長因子受體（PDGFR)基因重組相關之骨髓發育不全症候群(MDS)/骨髓增生性疾病(MPD)之成人。
(2)治療嗜伊紅性白血球增加症候群(HES)與/或慢性嗜伊紅性白血病(CEL)且有血小板衍生生長因子受體(PDGFR)基因重組之成人患者，且存在器官侵犯証據者。
7.治療患有無法手術切除、復發性或轉移性且有血小板衍生生長因子受體(PDGFR)基因重組之隆突性皮膚纖維肉瘤(DFSP)之成人患者。(99/ 6/1)