Daratumumab
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | DRUG-DARATUMUMAB |
|---|---|
| Tipo | Fármaco |
| Aliaces | DarzalexDarzalex Faspro (SC)Даратумумаб |
| Situación | reviewed 2026-04-26 | pending_clinical_signoff |
| Enfermedades | DIS-MM |
| Fuentes | SRC-NCCN-MM-2025 |
Datos sobre drogas
| Clase | monoclonal_antibody — anti-CD38 IgG1κ (fully human) |
|---|---|
| Mecanismo | Binds CD38, which is highly expressed on plasma cells. Induces myeloma cell death through complement-dependent cytotoxicity (CDC), antibody- dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), apoptosis, and immunomodulation via depletion of CD38+ regulatory T-cells. |
| Dosificación típica | IV: 16 mg/kg weekly cycles 1-2, every 2 weeks cycles 3-6, then every 4 weeks. SC (Faspro): 1800 mg with hyaluronidase, same schedule — preferred where available due to shorter administration time and fewer infusion reactions. |
| Ucrania registrada | Cierto |
| NSZU reembolsado | Cierto |
| Ucrania verificada por última vez | 2026-04-27 |
Notas
Reimbursement under НСЗУ in Ukraine is currently NOT in place — this is a meaningful access constraint. Patients selected for D-VRd in 1L need documented funding pathway (clinical trial, charitable scheme, or out-of-pocket). HBV screening (HBsAg + anti-HBc) mandatory before first dose; entecavir prophylaxis if HBsAg+ or anti-HBc+. Type and screen for red-cell antibodies BEFORE first dose to avoid daratumumab interference with crossmatching.
Utilizado por
Contraindications
CI-HBV-NO-PROPHYLAXIS- CI-HBV-NO-PROPHYLAXIS
Esquema terapéutico
REG-D-RD-MAIA- Daratumumab + Lenalidomide + Dexamethasone (D-Rd, MAIA — MM 1L transplant-ineligible)REG-DARA-LEN-MAINTENANCE- Daratumumab + Lenalidomide mantenimiento después deASCT (PERSEUS de la lista)REG-DARA-VRD- Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRD), 4-6 ciclos de inducciónREG-DKD- Daratumumab + Carfilzomib + Dexamethasone (DKd / D-Kd / Isa-Kd analógico), 28- ciclos de días