Antineoplastic Agents: Immunotherapeutic Agents
IHERC2 “Herceptin injection” 440 mg/vial
適應症：Herceptin應使用於下列HER2過度表現或HER2基因amplification之早期乳癌、轉移性乳癌患者：1.早期乳癌(EBC)：(1)經外科手術、化學療法(術前或術後)之輔助療法。(2)以doxorubicin與cyclophosphamide治療，再合併pactlitaxel或docetaxel之輔助療法。(3)與docetaxel及carboplatin併用之輔助療法。(4)術前與化學療法併用和術後之輔助療法使用於治療局部晚期(包括炎症)乳癌或腫瘤(直徑>2厘米)。2.轉移性乳癌(MBC)：(1)單獨使用於曾接受過一次(含)以上化學療法之轉移性乳癌；除非患者不適合使用anthracyclin或taxane，否則先前之化學治療應至少包括anthracyclin或taxane。使用於荷爾蒙療法失敗之荷爾蒙受體陽性之患者，除非患者不適用荷爾蒙療法。(2)與pactlitaxel或docetaxel併用於未曾接受過化學療法之轉移性乳癌。(3)與芳香環酶抑制劑併用於荷爾蒙受體陽性之轉移性乳癌。3.轉移性胃癌(MGC)：Herceptin合併capecitabine(或5-fluorouracil)及cisplatin適用於未曾接受過化學治療之HER2過度表現轉移性胃腺癌(或胃食道接合處腺癌)的治療。
Usual dose:
Breast cancer, (Adjuvant):
Monotherapy:
Loading dose, 8 mg/kg IV over 90 minutes;
Subsequent doses, 6 mg/kg IV over 30 to 90 minutes every 3 weeks.
Combination regimen:
(During and following paclitaxel or docetaxel, as part of a treatment regimen containing doxorubicin and cyclophosphamide)
Loading dose, 4 mg/kg IV over 90 minutes;
Subsequent doses, 2 mg/kg IV over 30 minutes weekly.
Gastric cancer:
Initial dose, 8 mg/kg IV over 90 minutes; subsequent doses, 6 mg/kg IV over 30 to 90 minutes every 3 weeks.
Metastatic breast cancer, HER2 overexpression:
Loading dose, 4 mg/kg IV over 90 minutes; subsequent doses, 2 mg/kg IV weekly over 30 minutes.
Dose adjustment:
Infusion reactions: (mild to moderate) decrease the rate of IV infusion; (dyspnea or clinically significant hypotension) hold therapy until symptoms resolve; (severe or life-threatening) discontinue therapy.
Left ventricular ejection fraction (LVEF), absolute decrease of 16% or greater from pretreatment values or a LVEF that is below the institutional limits of normal and a LVEF absolute decrease of 10% or greater from pretreatment values: interrupt therapy for at least 4 weeks.Resume therapy if LVEF returns to normal limits and the LVEF absolute decrease is 15% or less within 4 to 8 weeks;Discontinue therapy (>8 weeks) LVEF decline or if therapy is held on more than 3 occasions for cardiomyopathy.
Precaution:
Cardiomyopathy and cardiac failure increased risk and severity with concurrent anthracycline-containing chemotherapy regimens. Serious/fatal infusion reactions have been reported during or within 24 hours of trastuzumab administration.
Adverse effect:
Common: Edema, Tachycardia, Rash, Weight decreased, Abdominal pain, Diarrhea, Loss of appetite, Nausea, Stomatitis, Vomiting, Anemia, Neutropenia, Thrombocytopenia, Arthralgia, Backache, Myalgia, Asthenia, Dizziness, Headache, Insomnia, Renal impairment, Cough, Dyspnea, Nasopharyngitis, Pharyngitis, Rhinitis, Upper respiratory infection, Fatigue, Fever, Inflammatory disease of mucous membrane, Shivering.
Serious: cardiomyopathy, heart failure, febrile neutropenia, neutropenia, thrombocytopenia, thrombosis, hepatotoxicity, hypersensitivity reaction, nephrotic syndrome, renal failure, interstitial pneumonia, pneumonitis, pulmonary toxicity, respiratory failure, infusion reaction.
健保使用規範：(91/4/1、93/8/1、95/2/1、99/1/1、99/8/1、99/10/1、101/1/1)
1.早期乳癌(99/1/1、99/8/1、99/10/1、101/1/1)
(1)外科手術前後、化學療法(術前輔助治療或輔助治療)治療後，具HER2過度表現(IHC 3+或FISH+)，且具腋下淋巴結轉移但無遠處臟器轉移之早期乳癌患者，作為輔助性治療用藥。(99/10/1、101/1/1)
(2)使用至多以一年為限(99/8/1)。
2.轉移性乳癌
(1)單獨使用於治療腫瘤細胞上有HER2過度表現(IHC 3+或FISH+)，曾接受過一次以上化學治療之轉移性乳癌病人。(91/4/1、99/1/1)
(2)與paclitaxel或docetaxel併用，使用於未曾接受過化學治療之轉移性乳癌病患，且為HER2過度表現(IHC 3+或FISH+)者。(93/8/1、95/2/1、99/1/1)
(3)轉移性乳癌且HER2過度表現之病人，僅限先前未使用過本藥品者方可使用。(99/1/1)
3.經事前審查核准後使用。