Temozolomide
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| ID | DRUG-TEMOZOLOMIDE |
|---|---|
| Tipo | Fármaco |
| Alegais | TemodalApresentação de um pedido de autorização de autorizaçãoТемозоломід |
| Estado | reviewed 2026-04-26 | pending_clinical_signoff |
| Doenças | DIS-GBM |
| Fontes | SRC-EANO-GBM-2024 SRC-NCCN-CNS-2025 |
Fatos sobre as drogas
| Classe | 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). |
| Dose 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). |
| Ucrânia registada | Verdade |
| NSZU reembolsado | Verdade |
| Ucrânia verificada pela última vez | 2026-04-27 |
Avisos
- Myelossupressão (nadir tardio 21-28 dias)
- 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.
Usado por
Esquema terapêutico
REG-STUPP-TMZ- Protocolo Stupp - Temozolomide concomitante + adjuvanteREG-TMZ-MONO- Temozolomide monoterapia