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藥品參考

Ciltacabtagene autoleucel

Ciltacabtagene autoleucel is a medicine in the class miscellaneous. It is used for multiple myeloma.

最後更新 來源: US FDA label

僅供醫療專業人員參考。本頁為簡要摘要,並非醫療建議,亦不能取代官方仿單或臨床判斷。開立處方或調劑前請務必核實。

本頁的臨床內容僅提供英文版。

重點資訊

藥物類別
Miscellaneous
ATC 代碼
L01XL05
已知交互作用
68 (嚴重: 46 · 中度: 21 · 輕微: 1)
商品名
1
國家與市場
1

用途

作用方式

BCMA-directed, genetically modified autologous T cell immunotherapy. The CAR has two BCMA-targeting single-domain antibodies, a 4-1BB co-stimulatory domain and a CD3-zeta signaling domain. On binding BCMA-expressing cells, the CAR promotes T cell activation, expansion and elimination of target cells.

成人常用劑量(仿單摘要)

Relapsed or refractory multiple myeloma: single IV infusion of 0.5–1.0×10^6 CAR-positive viable T cells per kg body weight; maximum 1×10^8 CAR-positive viable T cells per single infusion

僅摘錄仿單中第一行劑量說明;完整的劑量內容請見 App。

懷孕與哺乳

懷孕
Unsafe No data in pregnancy. CAR-T cells may cross the placenta and cause fetal B-cell depletion and low antibody levels. Not recommended in pregnancy or without contraception; confirm a negative pregnancy test before treatment.
哺乳
Unknown No information on presence in milk or effects on the infant. Weigh breastfeeding benefits against the mother's need; follow the guidance for the lymphodepleting chemotherapy.

已通報的副作用

  • Pyrexia
  • Cytokine release syndrome
  • Hypogammaglobulinemia
  • Hypotension
  • Musculoskeletal pain
  • Fatigue

黑框警語

  • Fatal or life-threatening CRS occurred; do not give to patients with active infection or inflammatory disorders; treat severe CRS with tocilizumab or tocilizumab and corticosteroids. Fatal or life-threatening ICANS, parkinsonism and Guillain-Barré syndrome occurred; monitor for neurologic events. HLH/MAS, prolonged and recurrent cytopenias, immune effector cell-associated enterocolitis, and secondary hematological malignancies (MDS, AML, T-cell malignancies) have occurred.

哪些人需要特別留意

  • Increased early mortality in CARTITUDE-4: 14% of deaths in the CARVYKTI arm versus 12% in the control arm within 10 months
  • Monitor at least daily for 7 days for CRS and neurologic toxicities; confirm that a minimum of two doses of tocilizumab are available before infusion
  • Prolonged and recurrent cytopenias; monitor blood counts before and after infusion

請告知藥師或醫師您是否懷孕或哺乳、是否患有腎臟或肝臟疾病、是否有過敏,以及您正在使用的所有其他藥物或保健品。

重要交互作用 (68)

All 68 interactions, with severity and what to do

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  • Dosing by age, kidney and liver function, and further dose lines
  • Renal and hepatic dose adjustments
  • Dosing in older adults
  • How to give it
  • Pharmacokinetics
  • Patient counselling points
  • IV preparation and dilution

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常見問題

What is Ciltacabtagene autoleucel used for?

Ciltacabtagene autoleucel is a medicine in the class miscellaneous. It is used for Multiple myeloma.

What side effects have been reported with Ciltacabtagene autoleucel?

Pyrexia, Cytokine release syndrome, Hypogammaglobulinemia, Hypotension, Musculoskeletal pain, Fatigue. Serious warning: Fatal or life-threatening CRS occurred; do not give to patients with active infection or inflammatory disorders; treat severe CRS with tocilizumab or tocilizumab and corticosteroids.

Can Ciltacabtagene autoleucel be taken in pregnancy or while breastfeeding?

Pregnancy: Unsafe. No data in pregnancy. CAR-T cells may cross the placenta and cause fetal B-cell depletion and low antibody levels. Not recommended in pregnancy or without contraception; confirm a negative pregnancy test before treatment. Breastfeeding: Unknown. No information on presence in milk or effects on the infant. Weigh breastfeeding benefits against the mother's need; follow the guidance for the lymphodepleting chemotherapy.

What does Ciltacabtagene autoleucel interact with?

MediHelp lists 68 known interactions for Ciltacabtagene autoleucel. Major: 46 · Moderate: 21 · Minor: 1. The most serious include Adalimumab, Anti-thymocyte, Azathioprine.

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