Antineoplastic Agents: Miscellaneous
IVELC9 “Velcade powder for solution for injection” 3.5 mg/vial
適應症:1. Velcade可合併其他癌症治療藥品使用於未接受過治療的多發性骨髓瘤(Multiple myeloma)病人及2. 曾接受過至少一種治療方式且已經接受或不適宜接受骨髓移植的進展性多發性骨髓癌病人3. 曾接受過至少一種治療方式的被套細胞淋巴瘤Muantle Cell Lymphoma(MCL)病人。
Usual dose:
Adult: 1.3 mg/m2/dose administered as a 3-5 second bolus intravenous injection twice weekly for 2 wks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21). For extended therapy of > 8 cycles, may be administered on the standard schedule or on maintenance schedule of once weekly for 4 wks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35). At least 72 h should elapse between consecutive doses.
Adverse effect:
Common: hypotension, rash, constipation, decrease in appetite, diarrhea, nausea, anemia, arthralgia, bone pain, cramp, myalgia, asthenia, peripheral neuropathy, blurred vision, mental disorder, lower respiratory tract infection, fever.
Serious: congestive heart failure, heart disease, toxic epidermal necrolysis, vomiting, neutropenic disorder, thrombocytopenia, hepatic failure, angioedema, postherpetic neuralgia, transient ischemic attack, acute respiratory distress syndrome, interstitial pneumonia, pneumonitis.
健保使用規範:(96/6/1、98/2/1、99/3/1、99/9/1、100/10/1、101/6/1、105/5/1)
1.合併其他癌症治療藥品使用於多發性骨髓瘤病人:(99/3/1、100/10/1、101/6/1)
(1)每人以8個療程為上限(99/9/1)。
(2)需經事前申請後使用,每次申請4個療程。(101/6/1)
(3)使用4個療程後,必須確定藥物使用後paraprotein (M-protein)未上升 (即表示為response或stable status),或對部分non-secretory type MM病人以骨髓檢查plasma cell之比率為療效依據,方可申請使用後4個療程。(101/6/1)
(4)若病患於前4個療程符合前項規定(3)之療效,則後續4個療程可保留,於疾病復發時,再行申請使用。(101/6/1)
2.被套細胞淋巴瘤(Mantle Cell Lymphoma, MCL)病人:(98/2/1、105/5/1)
(1)每人以8個療程為上限。(99/9/1)
(2)每日最大劑量1.5mg/m2/day;每個療程第1, 4, 8, 11日給藥。
(3)第一線使用過復發者,不得申請再次使用。(105/5/1)
(4)需經事前審查核准後使用。