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See related Glivec film-coated tab[基利克 膜衣錠] information |
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製造商 |
Novartis |
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代理/經銷商 |
Novartis |
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成份 |
Imatinib mesylate |
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適應症 |
Adult & pediatrics with newly diagnosed chronic myeloid leukemia (CML), CML in blast crisis, accelerated phase or chronic phase after failure of interferon-α therapy. Adult with newly diagnosed Philadelphia chromosome +ve acute lymphoblastic leukemia (Ph+ALL) integrated with chemotherapy; with relapsed or refractory Ph+ALL as montherapy; myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; systemic mastocytosis (SM) without D816V c-Kit mutation or with c-Kit mutation status unknown; hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukemia (CEL); unresectable &/or metastatic, malignant GI stromal tumors (GIST); unresectable, recurrent &/or dermatofibrosarcoma protuberans (DFSP). Systemic mastocytosis (SM) with FIPILI-PDGFR mutation without D816V c-Kit mutation. Adjuvant treatment of adult following resection of GIST & tumor size is > 3 cm. |
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用量 |
Adult CML 400 mg/day in chronic phase CML & 600 mg/day in accelerated phase or blast crisis. Dose increase to 600-800 mg daily in chronic phase or 800 mg daily in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction & severe nonleukemia-related neutropenia or thrombocytopenia in: disease progression (at any time); failure to achieve a satisfactory hematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved hematological &/or cytogenetic response. Children > 2 years Chronic & advanced phase CML 340 mg/m2 daily in 1-2 divided doses. Max: 600 mg daily. Ph+ ALL 600 mg/day. MDS/MPD 400 mg/day. SM 400 mg/day. For patients with SM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR-α Initially, 100 mg/day. Dose may be increased to 400 mg. HES/CEL 400 mg/day. Patients with demonstrated FIP1L1-PDGFR-α fusion kinase, a starting dose of 100 mg/day is recommended. Dose may be increased to 400 mg. Unresectable &/or metastatic, malignant GIST 400 mg/day. Dose may be increased to 600-800 mg. DFSP 800 mg/day. |
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過量 |
View Glivec[基利克] overdosage for action to be taken in the event of an overdose. |
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用法 |
Should be taken with food |
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美國食品藥物管理局之懷孕等級 |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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禁忌 |
[Click for Glivec[基利克] detailed prescribing infomation] |
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注意事項 |
Hepatic or severe renal impairment. Monitor hepatic function, FBC & weight status regularly. Cardiac disease or risk factors for cardiac failure. Women of childbearing potential should use effective contraception during treatment. Pregnancy & lactation (avoid). Coadministration with paracetamol. May impair ability to drive or operate machinery. |
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不良反應 |
Neutropenia, thrombocytopenia, anemia, pancytopenia, febrile neutropenia, anorexia, insomnia, headache, dizziness, paresthesia, taste disturbance, hypoaesthesia, eyelid edema, increased lacrimation, conjunctival hemorrhage, conjunctivitis, dry eye, blurred vision, flushing, hemorrhage, dyspnea, epistaxis, cough, GI disturbances, increased hepatic enzymes, periorbital edema, dermatitis/eczema/rash, pruritus, face edema, dry skin, erythema, alopecia, muscle spasm & cramps, musculoskeletal pain, joint swelling, fluid retention, edema, fatigue, weight changes.
View ADR Monitoring Website[參閱藥物不良反應監測表格] |
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交互作用 |
CYP3A4 inhibitors (eg ketoconazole, itraconazole, erythromycin, clarithromycin) & inducers (eg dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, St. John's Wort). Simvastatin, warfarin, paracetamol, CYP3A4 substrates with narrow therapeutic window (eg cyclosporin or pimozide).
View more drug interactions with Glivec[基利克] |
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描述 |
View Glivec[基利克] description for details of the chemical structure and excipients (inactive components). |
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作用 |
View Glivec[基利克] mechanism of action for pharmacodynamics and pharmacokinetics details. |
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本商品之市售規格 |
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劑型 |
包裝 |
圖片 |
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Glivec 膜衣錠 |
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Glivec 100 mg x 120's |
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Manufacturer: |
Novartis |
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Distributor: |
Novartis |
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