Isatuximab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-ISATUXIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | SarclisaІсатуксімаб |
| Статус | переглянуто 2026-04-27 | очікує клінічного підпису |
| Хвороби | DIS-MM |
| Джерела | SRC-ESMO-MM-2023 SRC-NCCN-MM-2025 |
Дані про препарат
| Клас | monoclonal_antibody — anti-CD38 IgG1κ (chimeric, mouse-human) |
|---|---|
| Механізм дії | Binds a distinct, allosteric epitope on CD38 (different from daratumumab's binding site) on plasma cells and other CD38+ populations. Induces myeloma cell death through complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), direct apoptosis (Fc-independent — distinguishes from daratumumab), and immunomodulation via depletion of CD38+ regulatory T-cells and inhibition of CD38 enzymatic activity (NAD+/cADPR axis). Cross- reactivity with daratumumab is partial — clinical activity has been observed after daratumumab failure in some patients but the two agents are treated as the same effective class for sequencing purposes (one-shot anti-CD38 line per CHARTER hierarchy). |
| Типове дозування | IV: 10 mg/kg every week during cycle 1 (4 doses), then every 2 weeks from cycle 2 onward. Cycle length 28 days. Pre-medication mandatory before each infusion: dexamethasone (40 mg PO or IV — also part of combination), acetaminophen 650-1000 mg PO, diphenhydramine 25-50 mg IV/PO, H2 blocker (ranitidine or famotidine), and montelukast 10 mg PO (optional, reduces IRRs). Infusion durations: first dose 3-4 hours with rate escalation; subsequent doses 75-90 minutes if first dose tolerated. IV-only — no SC formulation available (contrast with daratumumab Faspro). |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Hepatitis B virus reactivation — class effect for anti-CD38 monoclonal antibodies; screen HBsAg + anti-HBc total before first dose; entecavir (or tenofovir if entecavir resistance) prophylaxis if HBsAg+ or anti-HBc+; monitor HBV-DNA periodically through therapy and ≥6 months after last dose
Нотатки
Clinical positioning: anti-CD38 mAb in the same class as daratumumab. Two are not concurrently used; choice driven by access, infusion tolerance (lower first-dose IRR with isatuximab), and combination partner. Distinct epitope rationale supports salvage activity after daratumumab failure in selected cases (limited evidence; not protocol-default). Primary trials (citations TBD — see flag in final report): - ICARIA-MM (Attal et al., Lancet 2019) — Isa-Pd vs Pd in relapsed/refractory MM, ≥2 prior lines: PFS 11.5 vs 6.5 months (HR 0.596). - IKEMA (Moreau et al., Lancet 2021) — Isa-Kd vs Kd in relapsed/refractory MM, 1-3 prior lines: PFS not reached vs 19.2 months (HR 0.531); deeper MRD-negativity. - IMROZ (Facon et al., NEJM 2024) — Isa-VRd vs VRd in transplant-ineligible newly-diagnosed MM: PFS benefit (HR ~0.60). Reimbursement under НСЗУ in Ukraine: NOT in place — same access constraint as daratumumab. Patients selected for any isatuximab- containing combination need a 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+ (BBW). Type and screen for r...
Де використовується
Regimens
REG-ISA-KD-MM-3L- Isatuximab + Carfilzomib + Dexamethasone (Isa-Kd), 28-day cycles