Nilotinib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-NILOTINIB |
|---|---|
| Type | Drug |
| Aliases | TasignaНілотиніб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-CML |
| Sources | SRC-ELN-CML-2020 SRC-NCCN-MPN-2025 |
Drug Facts
| Class | BCR-ABL1 TKI (2nd-generation) |
|---|---|
| Mechanism | Selective TKI of BCR-ABL1 (~30× more potent than imatinib). Active against most imatinib-resistant mutations except T315I, V299L, F317L. Vascular adverse-event profile (PAOD, MI, stroke) is the dose-limiting concern long-term. |
| Typical dosing | CML chronic phase 1L: 300 mg PO BID on empty stomach (≥1 h before / ≥2 h after meals). 2L: 400 mg BID. Strict fasting requirement increases QT prolongation if violated. |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- QT prolongation, sudden death (boxed)
- Strict fasting requirement
Notes
Preferred 2nd-gen TKI for younger CML patients without CV risk factors targeting deep molecular response + TFR. AVOID in cardiovascular disease (PAOD, prior MI, uncontrolled hypertension), pancreatitis history, diabetes, hyperlipidemia. Strict fasting requirement is non-trivial adherence burden.
Used By
Regimens
REG-2GEN-TKI-CML- 2nd-generation TKI (dasatinib OR nilotinib OR bosutinib by comorbidity matrix) — CML chro...