- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of gilteritinib.
Acute myeloid leukaemia with FLT3 mutation
Monotherapy for adults with relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
120mg once daily.
Additional Dosage Information
If the patient does not achieve composite complete remission after 4 weeks of treatment, the dose can be increased to 200mg once daily.
Dose reduction 80mg or 120mg once daily.
Differentiation syndrome Severe differentiation syndrome: Interrupt if symptoms persist for more than 48 hours after initiation of corticosteroids. Resume treatment at the same dose upon improvement to Grade 2 or lower.
Posterior reversible encephalopathy syndrome Discontinue if symptoms of posterior reversible encephalopathy syndrome occur.
QT prolongation Interrupt treatment if QTc interval is greater than 500 msec. Resume treatment at a reduced dose when QTc interval returns to within 30 msec of baseline or is less than or equal to 480 msec. Consider reducing dose if QTc interval is increased by more than 30 msec on day 8 of cycle 1 and is confirmed by an ECG on day 9.
Pancreatitis Interrupt treatment if symptoms of pancreatitis until pancreatitis is resolved. Resume at reduced dose.
Other adverse reactions Other Grade 3 or higher toxicity related to treatment: Interrupt treatment until toxicity resolves or improves to Grade 1. Resume treatment at a reduced dose.
Planned Haematopoietic stem cell transplant (HSCT) Interrupt treatment one week prior to administration of the conditioning regimen for HSCT. Treatment can be resumed 30 days after HSCT if engraftment was successful, the patient did not have greater than or equal to grade acute graft versus host disease and was in composite complete remission (CRc).
Children under 18 years
Long QT syndrome
Severe hepatic impairment
Severe renal impairment
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
History of torsade de pointes
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Confirm FLT3 mutation status prior to treatment
Treatment to be initiated and supervised by a specialist
Ensure negative pregnancy test in week preceding initiation of treatment
Monitor ECG before, at days 8 and 15 of 1st cycle and before next 3 cycles
Monitor for signs and symptoms of pancreatitis
Monitor serum electrolytes
If retinoic-acid syndrome occurs initiate treatment with dexamethasone
Consider interrupting treatment if severe differentiation syndrome occurs
Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
Interrupt treatment and/or reduce dose for any grade 3 toxicity
Interrupt treatment if QTc exceeds 500msec and consider dose modification
Interrupt/reduce dose if signs and symptoms of pancreatitis occur
Advise patient not to take St John's wort concurrently
Female: Contraception required during and for 6 months after treatment
Male & female: Two methods of contraception required (including barrier)
Male: Contraception required during and for 4 months after treatment
Breastfeeding: Do not breastfeed during and for 2 months after treatment
Pregnancy and Lactation
Gilteritinib is contraindicated during pregnancy.
The manufacturer recommends that gilteritinib is not used during pregnancy. At the time of writing there are no or limited data from the use of gilteritinib in pregnant women. Gilteritinib can cause foetal harm when administered to pregnant women. Animal studies have shown suppressed foetal growth, embryo-foetal death and teratogenicity.
Gilteritinib is contraindicated during lactation and for at least 2 months after the final dose.
The manufacturer recommends that breastfeeding should be discontinued during gilteritinib treatment. It is unknown whether gilteritinib is excreted in human breast milk and therefore a risk to newborns/infants cannot be excluded. Animal data shows excretion if gilteritinib and its metabolites in animal milk and distribution to the tissue in the infants.
Acute febrile dermatosis (Sweet's syndrome)
Acute kidney injury
Alanine aminotransferase increased
Aspartate aminotransferase increased
Creatine phosphokinase increased
Increase in serum alkaline phosphatase (reversible)
Posterior reversible encephalopathy syndrome (PRES)
Prolongation of QT interval
Retinoic acid syndrome
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management. The following number will direct the caller to the relevant local centre (0844) 892 0111 Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2019
Summary of Product Characteristics: Xospata 40mg film-coated tablets. Astellas Pharma Ltd. Revised October 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.