Antineoplastic Agents: Cytotoxic Agents: Mitotic Inhibitors
IFORM1 “Formoxol injection” 6 mg/ml; 5 ml/vial
IPHYX1 “Phyxol injection” 6 mg/ml; 15 ml/vial
ITAXO1 “Taxol Multidose injection” 6mg/ml;5ml/vial
適應症：晚期卵巢癌、腋下淋巴轉移之乳癌，作為接續含杜薩魯比辛（doxorubicin）在內之輔助化學療法、已使用合併療法（除非有禁忌，至少應包括使用anthracycline抗癌藥）失敗的轉移乳癌、非小細胞肺癌、愛滋病相關卡波西氏肉瘤之第二線療法；與cisplatin併用，作為晚期卵巢癌之第一線療法。與gemcitabine併用，可使用於曾經使用過anthracycline之局部復發且無法手術切除或轉移性之乳癌病患、與herceptin併用時，用於治療未接受過化學治療之轉移性且乳癌過度表現HER-2之病人。
Usual dose:
Advanced ovarian cancer (untreated): 135-175 mg/m2 IV over 3-24 h, respectively, followed by cisplatin 75 mg/m2 q3w; (previously treated): 135-175 mg/m2 IV over 3 h q3w.
AIDS-related Kaposi’s sarcoma: 135 mg/m2 IV over 3 h q3w or 100 mg/m2 IV q2w.
Breast cancer (adjuvant or metastatic): 175 mg/m2 IV over 3 h q3w; (metastatic; non-FDA approved dosing): 80 mg/m2 IV over 1 h qw.
Lung cancer, non-small cell: 135 mg/m2 IV over 24 h followed by cisplatin 75 mg/m2 q3w.
Dose adjustment:
Hepatic impairment: 24-h infusion and first course of therapy, for transaminase levels of 2 to < 10 x the upper limit of normal (ULN) and bilirubin levels of 1.5 mg/dL or less, give 100 mg/m2; for transaminase levels less than 10 x ULN and bilirubin levels of 1.6-7.5 mg/dL, give 50 mg/m2; for transaminase levels of 10 x ULN or greater or bilirubin greater than 7.5 mg/dL, do not administer.
Hepatic impairment: 3-h infusion and first course of therapy, for transaminase levels less than 10 x the upper limit of normal (ULN) and bilirubin levels of 1.26-2 x ULN, give 135 mg/m2; for transaminase levels less than 10 x ULN and bilirubin levels of 2.01-5 x ULN, give 90 mg/m2; for transaminase levels of 10 x ULN or greater or bilirubin levels of greater than 5 x ULN, do not administer.
Peripheral neuropathy: decrease dose by 20% on subsequent cycles.
Contraindication:
Baseline neutrophil counts of less than 1500 cells/mm(3) in patients with solid tumors or less than 1000 cells/mm(3) in patients with AIDS-related Kaposi’s sarcoma.
Hypersensitivity to paclitaxel or to other drugs formulated in polyoxyl 35 castor oil.
Precautions
Black Box Warning: Hypersensitivity reactions, some severe (eg, anaphylaxis, dyspnea, hypotension, angioedema) and fatal, have occurred; premedication with corticosteroids, diphenhydramine, and H2 antagonists is recommended; if severe hypersensitivity reaction occurs, immediately discontinue and avoid rechallenge.
Black Box Warning: Myelotoxicity, primarily neutropenia, has been commonly reported, so frequent monitoring is recommended for all patients; do not re-treat until neutrophil and platelet counts recover reduce dose of subsequent courses if severe neutropenia occurs.
Adverse effect:
Common: abnormal liver function tests, alopecia, arthralgia, myalgia, peripheral neuropathy, nausea/vomiting.
Serious: bradycardia/hypotension, myelosuppression-neutropenia, anaphylaxis.
健保使用規範：限1. 晚期卵巢癌，作為第一線治療時須與cisplatin併用(94/1/1)；2. 非小細胞肺癌，作為第一線用藥時須與cisplatin併用(94/1/1)；3.已使用合併療法（除非有禁忌症、至少應包括使用anthracycline）失敗的轉移性乳癌患者（91/4/1、94/1/1)；4. 腋下淋巴轉移之乳癌且動情素受體為陰性之患者，本藥可作為接續含doxorubicin在內之輔助化學治療（91/4/1、94/1/1、98/8/1)；5. 卡波西氏肉瘤第二線用藥（88/11/1）。