L-Asparaginase (E. coli or Erwinia)
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| ID | DRUG-L-ASPARAGINASE |
|---|---|
| Тип | Препарат |
| Синоніми | AsparaginaseAsparlas (calaspargase pegol)Crisantaspase (Erwinia)Elspar (E. coli native — discontinued US 2012)Erwinase (Erwinia chrysanthemi)L-AsparaginaseOncaspar (pegaspargase, PEG-E. coli)Pegaspargase (PEG-form)Rylaze (asparaginase erwinia chrysanthemi recombinant)Л-Аспарагіназа |
| Статус | переглянуто 2026-04-26 | очікує клінічного підпису |
| Хвороби | DIS-NK-T-NASAL |
| Джерела | SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | enzyme — asparagine-depleting bacterial enzyme |
|---|---|
| Механізм дії | Hydrolyzes circulating L-asparagine to aspartic acid + ammonia, depleting the systemic pool. Lymphoblasts and NK/T-malignant cells lack adequate asparagine synthetase (ASNS) and are uniquely dependent on the exogenous supply; depletion arrests protein synthesis and triggers apoptosis. PEG- asparaginase has prolonged plasma half-life (5-7 days vs ~30 h for native) and lower immunogenicity. Erwinia preparation is used after E. coli hypersensitivity (no antigenic cross-reactivity). |
| Типове дозування | ALL induction (pediatric): native E. coli 6,000-10,000 IU/m² IM/IV 3× weekly × 6-9 doses; or pegaspargase 2,500 IU/m² IM/IV every 2 weeks × 1-4 doses. Adult ALL (HOVON / GMALL / CALGB 10403): pegaspargase 2,000-2,500 IU/m² IV every 2-4 weeks during induction + post-remission. SMILE (NK/T-nasal): native E. coli or Erwinia 6,000 IU/m² IM days 2, 4, 6, 8 combined with dexamethasone + methotrexate + ifosfamide + etoposide every 28 days × 2-6 cycles. AspaMetDex (R/R NK/T): pegaspargase 2,000 IU/m² IM day 2 with HD-MTX + dexamethasone, every 21 days. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Anaphylaxis — risk increases with each dose; resuscitation equipment at bedside
- Pancreatitis — can be hemorrhagic / fulminant; permanent discontinuation if severe
- Coagulopathy — depletes antithrombin III, plasminogen, fibrinogen → both thrombosis and bleeding risk
- Hepatotoxicity — transaminitis, hyperbilirubinemia, hepatic steatosis
Нотатки
Switch native E. coli → Erwinia or pegaspargase after grade ≥2 hypersensitivity (no antigenic cross-reactivity between E. coli and Erwinia). Monitor lipase + amylase + glucose + fibrinogen + PT/aPTT + transaminases before each dose; hold for clinical pancreatitis. SMILE for NK/T-nasal lymphoma is the reference regimen (Yamaguchi 2008/2011) with ~80% ORR in newly-diagnosed advanced disease. Antithrombin III replacement when ATIII <60% is institutional; fibrinogen replacement (cryo or fibrinogen concentrate) when <100 mg/dL with active bleeding. Avoid prophylactic FFP — does not reduce thrombosis. Silent inactivation: monitor asparaginase activity level (target trough >0.1 IU/mL at day 7-14 post-dose) where lab access exists; switch preparations if subtherapeutic.
Де використовується
Regimens
REG-P-GEMOX-NK-T- P-GEMOX (pegaspargase + gemcitabine + oxaliplatin) for NK/T-cell nasal lymphomaREG-SMILE- SMILE (Steroid + MTX + Ifosfamide + L-asparaginase + Etoposide), 2-4 cycles