Drug Action
Gilteritinib is a FMS-like tyrosine kinase-3 (FLT3) inhibitor.
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Drug reference
Gilteritinib is a FMS-like tyrosine kinase-3 (FLT3) inhibitor.
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FLT3 mutation-positive acute myeloid leukaemia (specialist use only) ▶BY MOUTH ▶Adult: 120 mg once daily, for dose adjustments, treatment interruption, or discontinuation due to side- effects—consult product literature, if no response is observed after 4 weeks, dose may be increased to 200 mg once daily. Up to 6 months treatment may be required before a clinical response is seen
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Risk factors for QT-interval prolongation (including hypokalaemia or hypomagnesaemia)
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The manufacturer of Xospata ® has provided a Risk minimisation materials document for healthcare professionals.
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→Appendix 1: gilteritinib
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▶Common or very common Acute kidney injury. anaphylactic reaction. arthralgia. asthenia. constipation. cough. diarrhoea. differentiation syndrome. dizziness. dyspnoea. heart failure. hypotension. malaise. myalgia. nausea. pain. pericardial effusion. pericarditis. peripheral oedema. QT interval prolongation ▶Uncommon Posterior reversible encephalopathy syndrome (PRES) ▶Frequency not known Pancreatitis
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Manufacturer advises perform pregnancy test in females of childbearing potential within 7 days prior to treatment initiation; effective contraception should be used during treatment and for at least 6 months after last treatment— additional barrier method recommended in those using hormonal contraceptives. Male patients should use effective contraception during treatment and for at least 4 months after last treatment if their partner is of childbearing potential. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises discontinue breast-feeding during treatment and for at least 2 months after stopping—present in milk in animal studies.
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Manufacturer advises avoid in severe impairment (no information available).
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Immune system and malignant disease ▶Manufacturer advises monitor blood chemistry, including creatine phosphokinase, before treatment, on day 15 of treatment, and then monthly during treatment. ▶Manufacturer advises monitor ECG before treatment, on days 8 and 15 of treatment, and then prior to the start of the next three subsequent months of treatment—consult product literature for dose modifications if QT-interval prolonged.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 A ▶Xospata (Astellas Pharma Ltd) Gilteritinib (as Gilteritinib fumarate) 40 mg Xospata 40mg tablets | 84 tablet P £14,188.00 (Hospital only)
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Vomiting Manufacturer advises if vomiting occurs after taking tablets, no additional dose should be taken on that day and the next dose should be taken at the usual time. A patient alert card should be provided. Missed doses Manufacturer advises if a dose is missed or not taken at the usual time, the missed dose should be taken as soon as possible on the same day. The next dose should be taken at the usual time. Driving and skilled tasks Manufacturer advises patients and their carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of dizziness.
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120 mg once daily, for dose adjustments,
First-line fragment. Read the complete Indications and Dose section above.
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