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Daratumumab

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDDRUG-DARATUMUMAB
TypeMédicament
Alias
DarzalexDarzalex Faspro (SC)Даратумумаб
Étatreviewed 2026-04-26 | pending_clinical_signoff
MaladiesDIS-MM
SourcesSRC-NCCN-MM-2025

Faits sur les drogues

Catégoriemonoclonal_antibody — anti-CD38 IgG1κ (fully human)
MécanismeBinds 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.
Dose typiqueIV: 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.
Ukraine enregistréeVrai
NSZU rembourséVrai
Ukraine vérifiée pour la dernière fois2026-04-27

Notes

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.

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Contraindications

Protocole thérapeutique