Gilteritinib (Specialist drug)

How it works

It inhibits FLT3 (including internal tandem duplication and tyrosine kinase domain mutations) and AXL, blocking proliferative signalling in FLT3-mutated leukaemic cells.

Prescribing in practice

• Gilteritinib can prolong the QT interval, so correct electrolytes, perform baseline and periodic ECGs, and use caution with other QT-prolonging drugs.
• Differentiation syndrome and posterior reversible encephalopathy syndrome (PRES) can occur and require prompt recognition, supportive treatment and possible interruption.
• It is restricted to confirmed FLT3-mutated disease and carries a risk of fetal harm, so effective contraception is required.

Monitoring

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

Counselling the patient

• Report palpitations, fainting, fever, breathlessness, rapid weight gain or swelling promptly.
• Seek urgent help for severe headache, visual changes, confusion or seizures.
• Use reliable contraception and keep all blood-test and ECG appointments.

Evidence & guidelines

Gilteritinib improves outcomes in relapsed/refractory FLT3-mutated acute myeloid leukaemia on the basis of randomised trial evidence and is reflected in its licensed indication and NICE appraisal.