Daratumumab

Darzalex

兆科注射劑

100mg/5ml/vial

04. ANTINEOPLASTIC AGENTS; ;

04.05. MONOCLONAL ANTIBODIES;;

Anti-CD38

標靶藥物

X 動物或人體的試驗中或使用經驗發現對胎兒有害，而造成的傷害明顯大於可能的益處。

Unknown

Multiple myeloma(relapsed/refractory)
1.Monotherapy or in combination with lenalidomide/pomalidomide and low-dose dexamethasone (DRd/DPd regimen)
Weeks 1 to 8: 16 mg/kg once weekly for 8 doses.
Weeks 9 to 24: 16 mg/kg once every 2 weeks for 8 doses.
Weeks 25 and beyond: 16 mg/kg once every 4 weeks until disease progression.
2.In combination with bortezomib and dexamethasone (DVd regimen)
Weeks 1 to 9: 16 mg/kg once weekly for 9 doses.
Weeks 10 to 24: 16 mg/kg once every 3 weeks for 5 doses.
Weeks 25 and beyond: 16 mg/kg once every 4 weeks until disease progression.
Multiple myeloma (newly diagnosed)
1.In combination with bortezomib, melphalan, and prednisone (D-VMP regimen)
Weeks 1 to 6: 16 mg/kg once weekly for 6 doses
Weeks 7 to 54: 16 mg/kg once every 3 weeks for 16 doses
Weeks 55 and beyond: 16 mg/kg once every 4 weeks until disease progression
2.In combination with thalidomide, bortezomib, and dexamethasone (DVTd regimen)
Induction:
Weeks 1 to 8: 16 mg/kg once weekly for 8 doses.
Weeks 9 to 16: 16 mg/kg once every 2 weeks for 4 doses.
Consolidation:
Weeks 1 to 8: 16 mg/kg once every 2 weeks for 4 doses.
3.In combination with carfilzomib and dexamethasone (DKd regimen)
Week 1: 8 mg/kg on days 1 and 2.
Weeks 2 to 8:16 mg/kg once weekly for 7 doses.
Weeks 9 to 24:16 mg/kg once every 2 weeks for 8 doses.
Weeks 25 and beyond: 16 mg/kg once every 4 weeks until disease progression.

Upper respiratory tract infection, diarrhea, anemia, infusion related reaction

1.其他藥物勿以同一管線同時輸注
2.藥品應存放於2-8℃冷藏
3.具生育能力婦女，治療期間應採取有效避孕措施，停止治療後亦應繼續避孕3個月
4.使用本品治療的病人中，少於1%的病人被通報有B型肝炎病毒再活化的情形
5.輸注後用藥:
(1)COPD病人最初四次輸注,應考慮處方短效型或長效型支氣管擴張劑及吸入性皮質類固醇
(2)治療後的一周類開始施行抗病毒預防療法,以防帶狀皰疹再活化,治療結束後亦應持續施行三個月
6.本品與實驗室試驗之藥物交互作用：(1)干擾間接抗球蛋白試驗 (間接Coombs試驗)(2)干擾血清蛋白電泳試驗與免疫固定試驗

建立者

103617

建立時間

2020-07-02 08:37:06

維護者

103617

維護時間

2024-02-24 09:58:37