Temozolomide
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | DRUG-TEMOZOLOMIDE |
|---|---|
| Tipo | Fármaco |
| Aliaces | El TemodalTemodarТемозоломід |
| Situación | reviewed 2026-04-26 | pending_clinical_signoff |
| Enfermedades | DIS-GBM |
| Fuentes | SRC-EANO-GBM-2024 SRC-NCCN-CNS-2025 |
Datos sobre drogas
| Clase | Agente alquilante oral (imidazotetrazina) |
|---|---|
| Mecanismo | Methylates DNA at O6/N7 of guanine. Crosses blood-brain barrier efficiently — backbone of Stupp protocol for newly-diagnosed glioblastoma (concurrent + adjuvant). MGMT promoter methylation predicts response (methylated → ~3× longer OS benefit vs unmethylated). |
| Dosificación típica | GBM Stupp concurrent: 75 mg/m² PO daily during RT (6 weeks). GBM Stupp adjuvant: 150-200 mg/m² PO days 1-5 of every 28-d cycle × 6 cycles (start at 150, escalate to 200 if tolerated). |
| Ucrania registrada | Cierto |
| NSZU reembolsado | Cierto |
| Ucrania verificada por última vez | 2026-04-27 |
Advertencias
- Mielosupresión (nadir demorado 21-28 días)
- Secondary malignancies (MDS / AML long-term risk)
Notas
PJP prophylaxis (TMP-SMX 1 SS Mon/Wed/Fri or atovaquone 1500 mg daily, alternative dapsone 100 mg daily after G6PD screen) during concurrent RT + TMZ phase and adjuvant TMZ phase — universal lymphopenia (typically CD4 <200) creates opportunistic-infection risk window persisting weeks after the last cycle. MGMT promoter methylation testing is critical for treatment decision (Stupp NEJM 2005; Hegi NEJM 2005): methylated → ~3× greater OS benefit vs unmethylated. NOA-08 + Nordic trials: in elderly (>65) unmethylated → consider hypofractionated RT alone; methylated → TMZ-only or short-course RT + TMZ. CCNU + TMZ doublet (CeTeG/NOA-09) showed OS benefit in MGMT-methylated newly-dx GBM. Premedicate with 5-HT3 (ondansetron 8 mg) 1 hour before each dose; Mon-Fri schedules ease antiemetic burden. CBC weekly during concurrent RT, q2 weeks during adjuvant. UA: registered; НСЗУ-reimbursed for GBM (Stupp) + anaplastic glioma.
Utilizado por
Esquema terapéutico
REG-STUPP-TMZ- El protocolo de Stupp... Temozolomide Simultáneamente + adyuvanteREG-TMZ-MONO- Temozolomide monoterapia