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FLT3 Inhibitor

Gilteritinib

Brand names: Xospata

Gilteritinib is an oral FLT3 inhibitor used to treat relapsed or refractory acute myeloid leukaemia with an FLT3 mutation in adults.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It inhibits FLT3 receptor tyrosine kinase signalling, reducing proliferation and survival of FLT3-mutated leukaemic cells.

Prescribing in practice

  • It can prolong the QT interval and rarely cause differentiation syndrome and posterior reversible encephalopathy syndrome, so cardiac and clinical monitoring is essential.
  • Liver enzyme elevations and pancreatitis can occur and require monitoring.
  • It interacts with strong CYP3A inducers and inhibitors and with some other agents, so co-medication should be reviewed.

Monitoring

Monitor ECG and electrolytes, liver function and the full blood count, and watch for differentiation syndrome during treatment.

Counselling the patient

  • Report palpitations, fainting, breathlessness, swelling, fever or unexplained weight gain.
  • Attend for regular ECG and blood test monitoring.
  • Tell your team about all other medicines you take.

Evidence & guidelines

Gilteritinib improves survival in relapsed or refractory FLT3-mutated acute myeloid leukaemia, supported by the ADMIRAL trial and NICE appraisal.

Reference: ADMIRAL trial (Perl et al. NEJM 2019); NICE TA666; MHRA SPC Xospata; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.