Antineoplastic Agents: Cytotoxic Agents: Antimetabolites
IAVAS2 “Avastin injection” 25 mg/ml; 4 ml/vial
適應症：轉移性大腸直腸癌(mCRC)Avastin(bevacizumab)與含有irinotecan/5-fluorouracil/leucovorin或5-fluorouracil/leucovorin 的化學療法合併使用，可以作為轉移性大腸或直腸癌患者的第一線治療。Avastin與含有5-fluorouracil/leucovorin/oxaliplatin的化學療法合併使用，可以作為先前接受過以fluoropyrimidine為基礎的化學療法無效且未曾接受過Avastin治療的轉移性大腸或直腸癌患者的治療。轉移性乳癌(mBC)Avastin與paclitaxel合併使用，可以做為HER2 (-) 轉移性乳癌患者的第一線治療。說明：1. avastin與paclitaxel併用在治療轉移性乳癌患者之療效，僅在無疾病進展存活期方面可達統計上顯著優於paclitaxel單獨使用，目前並無以整體存活期為主要療效指標之臨床試驗證實Avastin與paclitaxel併用延長整體存活期之效果。2. Avastin不適用於經anthracycline及taxane治療轉移性乳癌又出現疾病進展的病患。惡性神經膠質瘤(WHO第4級) – 神經膠母細胞瘤Avastin 單獨使用可用於治療曾接受標準放射線治療且含Temozolomide 在內之化學藥物治療失敗之多型性神經膠母細胞瘤(Glioblastoma multiforme)復發之成人患者。晚期、轉移性或復發性非鱗狀非小細胞肺癌 (NSCLC)Avastin 與carbolatin及paclitaxel合併使用，可以作為無法切除的晚期、轉移性或復發性非鱗狀非小細胞肺癌患者的第一線治療。
Usual dose:
Metastatic colorectal cancer, First- or second-line therapy, in combination with 5-fluorouracil-based chemotherapy: with bolus-IFL (irinotecan, fluorouracil, leucovorin), 5 mg/kg IV over 90 min q2w; if tolerated, the infusion may be given over 60 min for the second infusion and 30 min for subsequent infusions.
Dose adjustment:
Hypertension, severe, not controlled: temporarily suspend bevacizumab; discontinue with hypertensive crisis or hypertensive encephalopathy.
Proteinuria, moderate to severe: temporarily suspend bevacizumab; discontinue for nephrotic syndrome.
Surgery: suspend treatment with bevacizumab at least 28 days prior to elective surgery; do not restart until the surgical incision has completely healed; do not give for at least 28 days following major surgery; discontinue if wound healing complications require medical intervention.
Precaution: p’ts with major surgery within 28 days, CVD, immunogenicity and infusion reations.
Adverse effect:
Common: hypertension, alopecia, abdominal pain, constipation, diarrhea, loss of appetite, stomatitis, asthenia, dizziness, headache, proteinuria, dyspnea, epistaxis, upper respiratory infection.
Serious: arterial thromboembolism, congestive heart failure, hypertensive encephalopathy, myocardial infarction, impaired wound healing, wound dehiscence, gastrointestinal hemorrhage, gastrointestinal perforation, tracheoesophageal fistula, deep venous thrombosis, febrile neutropenia, hemorrhage, neutropenia, thromboembolism of vein, fistula of bile duct, complication of infusion, cerebral artery occlusion, hemorrhagic cerebral infarction, reversible posterior leukoencephalopathy syndrome, subarachnoid hemorrhage, transient ischemic attack, bladder fistula, nephrotic syndrome, vaginal fistula finding, bronchopleural fistula, hemoptysis, perforation of nasal septum, pulmonary hemorrhage, pulmonary hypertension.
健保給付規範：（100/6/1）(101/05/1)
1.轉移性大腸或直腸癌：
(1)Bevacizumab 與含有irinotecan/ 5-fluorouracil/ leucovorin或5-fluorouracil/ leucovorin的化學療法合併使用，作為轉移性大腸或直腸癌患者的第一線治療。
(2)使用總療程以24週為上限。
2.惡性神經膠質瘤(WHO第4級) – 神經膠母細胞瘤：單獨使用可用於治療曾接受標準放射線治療且含temozolomide 在內之化學藥物治療失敗之多型性神經膠母細胞瘤(Glioblastoma multiforme)復發之成人患者。(101/05/1)
3.本藥須經事前審查核准後使用，每次申請事前審查之療程以12週為限，再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用。