Alemtuzumab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-ALEMTUZUMAB |
|---|---|
| Тип | Препарат |
| Синоніми | CampathLemtradaMabCampathАлемтузумаб |
| Статус | переглянуто 2026-04-26 | очікує клінічного підпису |
| Хвороби | DIS-T-PLL |
| Джерела | SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | monoclonal_antibody — anti-CD52 humanized IgG1κ |
|---|---|
| Механізм дії | Humanized monoclonal antibody binding CD52, a glycoprotein densely expressed on B and T lymphocytes, monocytes, NK cells, and most lymphoid malignancies. Engagement triggers antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytolysis (CDC), and direct apoptosis. Profound and prolonged depletion of CD4+ T-cells (median recovery >12 months) drives both efficacy in CD52+ malignancies (notably T-PLL) and the high opportunistic-infection burden. |
| Типове дозування | T-PLL: dose escalation 3 mg → 10 mg → 30 mg IV over first week to limit cytokine release; then 30 mg IV three times weekly × 12 weeks (Keating 2002). Premedicate with acetaminophen + diphenhydramine + hydrocortisone before each infusion for first 2 weeks. CLL (historical): same induction schedule; SC 30 mg three times weekly is alternative with lower infusion-reaction rate. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Cytopenias — severe pancytopenia, autoimmune hemolytic anemia, ITP, pure red-cell aplasia
- Infusion reactions — premedication and first-dose escalation mandatory; cytokine-release syndrome possible
- Infections — CMV reactivation, PJP, HSV/VZV, fungal; antimicrobial prophylaxis required during and ≥2 months post
- Malignancies — secondary thyroid cancer, melanoma, lymphoproliferative disorders
Нотатки
T-PLL is the principal oncologic indication retained after Campath was withdrawn from US oncology market in 2012. Mandatory infection prophylaxis: TMP-SMX (PJP), acyclovir or valacyclovir (HSV/VZV), weekly CMV PCR for the duration of therapy and ≥2 months post. Hold for ANC <250 or platelets <25K during therapy. Salvage CD52- directed therapy is being supplanted by JAK1/2 inhibitors and venetoclax-based combinations in T-PLL trials.
Де використовується
Contraindications
CI-ACTIVE-INFECTION-FOR-ALEMTUZUMAB- CI-ACTIVE-INFECTION-FOR-ALEMTUZUMAB
Regimens
REG-ALEMTUZUMAB-IV- Alemtuzumab IV — disease-defining anti-CD52, 12 weeks inductionREG-VENETOCLAX-ALEMTUZUMAB-TPLL- Venetoclax + alemtuzumab combination for r/r T-PLL (investigational)
Supportive Care
SUP-CMV-MONITORING- CMV PCR surveillance during T-cell-depleting therapy