CPX-351 (liposomal cytarabine + daunorubicin 5:1)
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| ID | DRUG-CPX-351 |
|---|---|
| Tipo | Fármaco |
| Alegais | CPX-351 (ліпосомний цитарабін + даунорубіцин 5:1)Liposomal cytarabine-daunorubicinLiposomal daunorubicin-cytarabineAçúcar |
| Estado | reviewed 2026-04-25 | pending_clinical_signoff |
| Doenças | DIS-AML |
| Fontes | SRC-ELN-AML-2022 SRC-NCCN-AML-2025 |
Fatos sobre as drogas
| Classe | Liposomal-encapsulated cytarabine + daunorubicin (5:1 molar ratio) |
|---|---|
| Mecanismo | Bilayer liposome co-encapsulating cytarabine + daunorubicin in a pharmacologically synergistic 5:1 molar ratio, prolonging intracellular drug exposure. Demonstrated OS benefit vs standard 7+3 specifically in older patients with secondary AML (therapy-related AML or AML with myelodysplasia-related changes, AML-MRC). |
| Dose típica | Induction: 100 units/m² IV (= cytarabine 100 mg/m² + daunorubicin 44 mg/m²) on days 1, 3, 5 of cycle 1 (re-induction days 1, 3 if needed). Consolidation: 65 units/m² IV on days 1, 3 every 5-8 weeks for up to 2 cycles. Strict ECHO before each cycle (cumulative anthracycline tracking). |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-27 |
Avisos
- Not interchangeable with other cytarabine or daunorubicin products — fatal dosing errors reported
- Cardiotoxicidade — rastreamento cumulativo de antraciclinas obrigatório
- Mielossupressão grave + prolongada
Notas
Pivotal: Lancet et al. (J Clin Oncol 2018) phase-3 in older (60-75) patients with AML-MRC, t-AML, or AML-CMML history; median OS 9.56 vs 5.95 mo (HR 0.69) vs standard 7+3. Approved FDA Aug 2017 specifically for "newly-dx tAML or AML-MRC" — narrow population. Ukraine: NOT registered — access via named-patient import / EAP Jazz / cross-border. CRITICAL: dosing units are "units/m²" NOT "mg/m²" — labeling errors fatal (each unit = 1 mg cytarabine + 0.44 mg daunorubicin in fixed liposomal ratio). Verify each prescription with pharmacy + nursing.
Usado por
Esquema terapêutico
REG-CPX351-AML- CPX-351 (Vyxeos) para tAML / AML-MRC 1L