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Gilteritinib oral

Updated 2 Feb 2023 | Gilteritinib


Oral formulations of gilteritinib.

Drugs List

  • gilteritinib 40mg tablets
  • XOSPATA 40mg tablets
  • Therapeutic Indications


    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.
    Dose modifications

    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
    Electrolyte imbalance
    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.

    Side Effects

    Acute febrile dermatosis (Sweet's syndrome)
    Acute kidney injury
    Alanine aminotransferase increased
    Anaphylactic reaction
    Aspartate aminotransferase increased
    Cardiac failure
    Creatine phosphokinase increased
    Extremity pain
    Increase in serum alkaline phosphatase (reversible)
    Musculoskeletal pain
    Pericardial effusion
    Peripheral oedema
    Pleural effusion
    Posterior reversible encephalopathy syndrome (PRES)
    Prolongation of QT interval
    Retinoic acid syndrome
    Weight gain


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2019

    Reference Sources

    Summary of Product Characteristics: Xospata 40mg film-coated tablets. Astellas Pharma Ltd. Revised October 2019.

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