Fludarabine
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-FLUDARABINE |
|---|---|
| Тип | Препарат |
| Синоніми | FludaraФлударабін |
| Статус | переглянуто 2026-04-25 | очікує клінічного підпису |
| Хвороби | DIS-B-ALL DIS-DLBCL-NOS DIS-FL DIS-HGBL-DH DIS-MCL DIS-MELANOMA DIS-MM |
| Джерела | SRC-NCCN-AML-2025 SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | Purine analog antimetabolite (adenosine analog) |
|---|---|
| Механізм дії | Fluorinated purine nucleoside analog of adenosine. Phosphorylated intracellularly to active triphosphate (F-ara-ATP); incorporated into DNA + RNA, inhibits ribonucleotide reductase + DNA primase + DNA polymerase α → S-phase arrest + apoptosis. Profoundly immunosuppressive (T-cell depletion → ideal for CAR-T lymphodepletion). Historically used in CLL (FCR), salvage lymphoma regimens, alloHCT conditioning. |
| Типове дозування | CAR-T lymphodepletion: 30 mg/m² IV daily × 3-4 days. CLL FCR: 25 mg/m² IV days 1-3 every 28 days × 6 cycles. Salvage lymphoma (FluMel conditioning): 30 mg/m² IV days 1-5. Renal dose adjust: CrCl 30-70 mL/min reduce 25%; CrCl <30 mL/min consider avoiding or reduce 50%. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Severe + prolonged myelosuppression
- Severe immunosuppression (CD4 lymphopenia + opportunistic infection — PJP, CMV, HSV reactivation)
- Transfusion-associated GVHD — irradiate ALL blood products lifelong post-fludarabine
- Autoimmune hemolytic anemia (in CLL particularly)
- Neurotoxicity at high doses (encephalopathy, cortical blindness)
Нотатки
Backbone of CAR-T lymphodepleting conditioning (Flu/Cy). Also historic CLL backbone (FCR), now largely supplanted by BTKi / BCL2i. CRITICAL: irradiate ALL blood products LIFELONG after fludarabine exposure to prevent transfusion-associated GVHD. PJP + viral prophylaxis mandatory during + ≥6 months after treatment. Renal dose adjustment essential. Ukraine: registered + НСЗУ-reimbursed.
Де використовується
Regimens
REG-CAR-T-AXICEL- Axicabtagene ciloleucel (axi-cel) CAR-T — single infusion after lymphodepletionREG-CAR-T-AXICEL-FL- Axicabtagene ciloleucel (axi-cel) CAR-T for r/r FL — single infusion after lymphodepletio...REG-CAR-T-AXICEL-HGBL- Axicabtagene ciloleucel (axi-cel CAR-T) for relapsed/refractory HGBL-DHREG-CAR-T-BREXUCEL-MCL- Brexucabtagene autoleucel (brexu-cel) CAR-T for r/r MCL — single infusion after lymphodep...REG-CILTACEL-LYMPHODEPLETION-FLU-CY- Lymphodepleting fludarabine + cyclophosphamide conditioning before ciltacabtagene autoleu...REG-CILTACEL-MM-2L- Ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T for lenalidomide-refractory R/R multiple...REG-CILTACEL-MM-3L- Ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T for R/R multiple myeloma after ≥3 prior...REG-IDECEL-LYMPHODEPLETION-FLU-CY- Lymphodepleting fludarabine + cyclophosphamide conditioning before idecabtagene vicleucel...REG-IDECEL-MM-3L- Idecabtagene vicleucel (ide-cel) BCMA CAR-T for triple-class-exposed R/R multiple myeloma...REG-LIFILEUCEL-TIL-MELANOMA- Lifileucel TIL therapy (Amtagvi, melanoma 3L+)REG-TISAGENLECLEUCEL-B-ALL- Tisagenlecleucel CD19 CAR-T for R/R B-ALL ≤25 yearsREGIMEN-LISOCEL-DLBCL-2L- Lisocabtagene maraleucel (liso-cel) CAR-T 2L for primary-refractory or early-relapse LBCL...REGIMEN-LISOCEL-DLBCL-3L- Lisocabtagene maraleucel (liso-cel) CAR-T for r/r LBCL ≥3L (TRANSCEND NHL 001)