L-Asparaginase (E. coli or Erwinia)
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.
| ID | DRUG-L-ASPARAGINASE |
|---|---|
| Type | Médicament |
| Alias | AsparaginaseAsparlas (calaspargase pégol)Crisantaspase (Erwinia)Elspar (natif d'E. coli — discontinué aux États-Unis 2012)Erwinase (Erwinia chrysanthemi)L-AsparaginaseOncaspar (pégaspargase, PEG-E. coli)Pégaspargase (formule PEG)Rylaze (asparaginase erwinia chrysanthemi recombinant)Л-Аспарагіназа |
| État | reviewed 2026-04-26 | pending_clinical_signoff |
| Maladies | DIS-NK-T-NASAL |
| Sources | SRC-NCCN-BCELL-2025 |
Faits sur les drogues
| Catégorie | enzyme bactérienne appauvrissant la couche d'asparagine |
|---|---|
| Mécanisme | 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). |
| Dose typique | 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. |
| Ukraine enregistrée | Vrai |
| NSZU remboursé | Vrai |
| Ukraine vérifiée pour la dernière fois | 2026-04-27 |
Avertissements
- Anaphylaxie — augmentation du risque à chaque dose; équipement de réanimation au chevet
- Pancréatite — peut être hémorragique / fulminante; arrêt permanent si sévère
- Coagulopathie — décompresses antithrombine III, plasminogène, fibrinogène → à la fois thrombose et risque de saignement
- Hépatotoxicité – transaminite, hyperbilirubinémie, stéatose hépatique
Notes
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.
Utilisé par
Protocole thérapeutique
REG-P-GEMOX-NK-T- P-GEMOX (pegaspargase + gemcitabine + oxaliplatin) for NK/T-cell nasal lymphomaREG-SMILE- SMILE (Stéroïde + MTX + Ifosfamide + L-asparaginase Etoposide), 2-4 cycles