Rituximab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-RITUXIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | MabTheraRiabni (biosimilar)RituxanRuxience (biosimilar)Truxima (biosimilar)Ритуксимаб |
| Статус | переглянуто 2026-04-26 | очікує клінічного підпису |
| Хвороби | DIS-B-ALL DIS-BURKITT DIS-CLL DIS-DLBCL-NOS DIS-FL DIS-HCL DIS-HCV-MZL DIS-HGBL-DH DIS-MCL DIS-NLPBL DIS-NODAL-MZL DIS-PCNSL DIS-PMBCL DIS-PTLD DIS-SPLENIC-MZL DIS-T-ALL DIS-WM |
| Джерела | SRC-ESMO-MZL-2024 SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | monoclonal_antibody — anti-CD20 chimeric IgG1κ |
|---|---|
| Механізм дії | Chimeric (mouse-human) monoclonal antibody binding the CD20 antigen on B lymphocytes (pre-B through mature B; sparing pro-B and plasma cells). Depletes CD20+ B cells via three mechanisms: complement-dependent cytotoxicity (CDC, dominant in CLL), antibody-dependent cellular cytotoxicity (ADCC, dominant in lymphoma), and direct apoptosis via CD20 cross-linking. Recovery of normal B cells takes 6-12 months after the last dose. |
| Типове дозування | R-CHOP / R-CVP / R-Bendamustine (DLBCL, FL): 375 mg/m² IV day 1 of each 21- or 28-day cycle × 6-8 cycles. R-monotherapy / FL maintenance: 375 mg/m² IV every 8-12 weeks × 2 years (PRIMA / RESORT schedules). CLL (R-FC, R-Ben): 375 mg/m² IV cycle 1 day 1, then 500 mg/m² IV day 1 cycles 2-6. SC formulation (FL, DLBCL): 1400 mg fixed-dose SC over ~5 minutes from cycle 2 onward (after first IV dose for tolerability). |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Fatal infusion reactions (within 24 h of first dose; mostly cycle 1)
- Severe mucocutaneous reactions (Stevens-Johnson, TEN, paraneoplastic pemphigus)
- Hepatitis B virus reactivation — fulminant hepatic failure possible; screen HBsAg + anti-HBc before first dose; entecavir prophylaxis if positive
- Progressive multifocal leukoencephalopathy (PML, JC-virus reactivation)
Нотатки
Foundation anti-CD20 therapy in B-cell lymphomas. Premedication (acetaminophen + diphenhydramine ± methylprednisolone) before each infusion; first-dose infusion rate escalation per protocol (50 mg/h start, doubled q30min to max 400 mg/h). HBV screening (HBsAg + anti-HBc + anti-HBs) is mandatory before first dose; entecavir or tenofovir prophylaxis throughout therapy and ≥12 months post for any HBV-positive serology. SC formulation reduces administration time from 4-6 h to 5-7 minutes and is preferred from cycle 2 onward in FL / DLBCL. For HCV-MZL, reserved for cases not responding to antiviral therapy alone, or aggressive phenotype where immediate cytoreduction is indicated. Biosimilars are clinically interchangeable in UA per НСЗУ guidance.
Де використовується
Contraindications
CI-HBV-NO-PROPHYLAXIS- CI-HBV-NO-PROPHYLAXIS
Regimens
REG-ACALABRUTINIB-RITUXIMAB- Acalabrutinib + Rituximab (continuous BTKi + R)REG-BR-STANDARD- Bendamustine + Rituximab (BR), 6 cyclesREG-CARFILZOMIB-WM- Carfilzomib + Rituximab + Dexamethasone (CaRD) × 6 cycles — for CXCR4-WHIM-mutated WM (BT...REG-CODOX-M-IVAC- CODOX-M / IVAC alternating × 4 (Magrath protocol)REG-DA-EPOCH-R- Dose-Adjusted EPOCH + Rituximab (DA-EPOCH-R), 6 cyclesREG-DRC-WM- Dexamethasone + Rituximab + Cyclophosphamide (DRC) × 6 cyclesREG-HYPER-CVAD-R- Hyper-CVAD + Rituximab (CD20+) — alternating courses A/B, 8 cycles totalREG-MATRIX- MATRix (HD-Methotrexate + HD-Cytarabine + Thiotepa + Rituximab), 4 cyclesREG-MCL-INTENSIVE-RDHAP-AUTOSCT- Intensive 1L MCL: alternating R-CHOP / R-DHAP × 6 cycles + autoSCT consolidation + R main...REG-POLA-R-BENDAMUSTINE- Polatuzumab vedotin + Rituximab + Bendamustine (Pola-BR), 6 cyclesREG-POLA-R-CHP- Polatuzumab vedotin + Rituximab + CHP (Pola-R-CHP), 6 cycles + 2× rituximabREG-R-BENDAMUSTINE-RELAPSED-MZL- R-Bendamustine for relapsed marginal zone lymphoma (post-rituximab failure)REG-R-CHOP- Rituximab + CHOP (R-CHOP), 6 cyclesREG-R-ICE-PMBCL- R-ICE salvage with autoSCT consolidation (relapsed/refractory PMBCL)REG-R-MPV- R-MPV (Rituximab + HD-Methotrexate + Procarbazine + Vincristine), 5 cycles q14dREG-R-MPV-SALVAGE-PCNSL- Salvage HD-MTX-based re-induction for relapsed PCNSLREG-RDHAP-BURKITT- R-DHAP (Rituximab + Dexamethasone + HD-Cytarabine + Cisplatin) × 2-3 cycles → ASCT/alloSC...REG-RICE-BURKITT- R-ICE (Rituximab + Ifosfamide + Carboplatin + Etoposide) × 2-3 cycles → ASCT in CR2 (r/r...REG-RITUXIMAB-LENALIDOMIDE-R2- Rituximab + Lenalidomide (R²/AUGMENT)REG-RITUXIMAB-MAINTENANCE-FL- Rituximab maintenance post-induction (PRIMA schedule)REG-RITUXIMAB-MAINTENANCE-MCL- Rituximab maintenance post-induction MCL (LyMa schedule)REG-RITUXIMAB-MAINTENANCE-PTLD- Rituximab maintenance after EBV+ B-PTLD response (PTLD-1 sequential approach)REG-RITUXIMAB-MONO- Rituximab monotherapy (375 mg/m² weekly × 4, then maintenance)REG-VEMURAFENIB-HCL-RELAPSED- Vemurafenib + rituximab for relapsed/refractory BRAF-V600E HCLREG-VENETOCLAX-RITUXIMAB- Venetoclax + Rituximab (VenR), 24-month fixed-duration (MURANO schedule)REG-VRD-WM- Bortezomib + Rituximab + Dexamethasone (BDR) × 6-8 cycles — chemo-free alternative for r/...