Gefitinib【D】

Antineoplastic Agents: Miscellaneous
OIRES1 “Iressa tablet” 250 mg/tab

適應症:限於單獨使用於先前已使用過platinum類及docetaxel或paclitaxel化學治療後,但仍局部惡化或轉移之非小細胞肺癌之第三線用藥。

Usual dose:

Adult: 250 mg PO qd.

Dose adjustment:

Dermatologic toxicities: consider holding (for up to 2 wks) gefitinib in p’ts with severe skin reactions; re-institute at 250 mg/day; increasing the dose of gefitinib to 500 mg in p’ts on concurrent potent enzyme inducers (CYP3A4) (ie. rifampicin, phenytoin); gastrointestinal toxicities: consider holding (for up to 2 wks) gefitinib in p’ts with poorly tolerated diarrhea; re-institute at 250 mg/day; ocular toxicities: p’ts who experience new onset eye symptoms should be medically evaluated and have gefitinib therapy interrupted; remove aberrant eyelash if present (a clinical decision to re-institute gefitinib 250 mg therapy should be made); pulmonary toxicities: interrupt gefitinib therapy, investigate, and treat p’ts who experience acute onset/worsening of pulmonary symptoms; discontinue therapy if a diagnosis of interstitial lung disease is confirmed.

Adverse effect:

Common: anorexia, nausea, vomiting, acne, dry skin, pruritus, asthenia.

Serious: diarrhea, ocular toxicities, interstitial lung disease (interstitial pneumonia, pneumonitis, and alveolitis), rash.

健保使用規範:(93/11/1、96/8/1、96/11/1、100/6/1、101/5/1、101/10/1、103/5/1)

1.限單獨使用於

(1)具有EGFR-TK基因突變之局部侵犯性或轉移性(即第ⅢB期或第Ⅳ期)之肺腺癌病患之第一線治療。(100/6/1)

(2)先前已使用過第一線含鉑化學治療,或70歲(含)以上接受過第一線化學治療,但仍局部惡化或轉移之肺腺癌。(96/11/1、100/6/1)

2.需經事前審查核准後使用:

(1)用於第一線用藥:檢具確實患有肺腺癌之病理或細胞檢查報告,及EGFR-TK基因突變檢測報告。(100/6/1)

(2)用於第二線以上用藥:檢具確實患有肺腺癌之病理或細胞檢查報告,並附曾經接受第一線含鉑化學治療,或70歲(含)以上接受過第一線化學治療之證明,及目前又有疾病惡化之影像診斷證明(如胸部X光、電腦斷層或其他可作為評估的影像),此影像證明以可測量(measurable)的病灶為優先,如沒有可以測量的病灶,則可評估(evaluable)的病灶亦可採用。(96/11/1、100/6/1、101/10/1)

(3)每次申請事前審查之療程以三個月為限,每三個月需再次申請,再次申請時並需附上治療後相關臨床資料,如給藥四週後,需追蹤胸部X光或電腦斷層等影像檢查一遍,評估療效,往後每四週做胸部X光檢查,每隔八週需追蹤其作為評估藥效的影像(如胸部X光或電腦斷層)(101/5/1)。

3.醫師每次開藥以4週為限。(101/10/1)

4.本藥品與erlotinib(如Tarceva)及afatinib(如Giotrif)不得併用。(96/8/1、103/5/1)

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