Active Ingredient: Gilteritinib
Gilteritinib is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 120 milligrams gilteritinib, once daily.
The recommended starting dose is 120 mg gilteritinib once daily.
Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment.
An electrocardiogram (ECG) should be performed before initiation of gilteritinib treatment, on day 8 and 15 of cycle 1 and prior to the start of the next three subsequent months of treatment.
Treatment should continue until the patient is no longer clinically benefiting from gilteritinib or until unacceptable toxicity occurs. Response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response. In the absence of a response [patient did not achieve a composite complete remission (CRc)] after 4 weeks of treatment, the dose can be increased to 200 mg once daily, if tolerated or clinically warranted.
Gilteritinib dose interruption, reduction and discontinuation recommendations in patients with relapsed or refractory AML:
| Criteria | Gilteritinib dosing |
|---|---|
| Differentiation syndrome | • If differentiation syndrome is suspected, administer corticosteroids and initiate hemodynamic monitoring. • Interrupt gilteritinib if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids. • Resume gilteritinib at the same dose when signs and symptoms improve to Grade 2a or lower. |
| Posterior reversible encephalopathy syndrome | • Discontinue gilteritinib. |
| QTcF interval >500 msec | • Interrupt gilteritinib. • Resume gilteritinib at a reduced dose (80 mg or 120 mgb) when QTcF interval returns to within 30 msec of baseline or ≤480 msec. |
| QTcF interval increased by >30 msec on ECG on day 8 of cycle 1 | • Confirm with ECG on day 9. • If confirmed, consider dose reduction to 80 mg. |
| Pancreatitis | • Interrupt gilteritinib until pancreatitis is resolved. • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb). |
| Other Grade 3a or higher toxicity considered related to treatment. | • Interrupt gilteritinib until toxicity resolves or improves to Grade 1a. • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb). |
| Planned HSCT | • Interrupt treatment with gilteritinib 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 grade ≥2 acute graft versus host disease and was in CRcc. |
a Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.
b The daily dose can be reduced from 120 mg to 80 mg or from 200 mg to 120 mg.
c. CRc is defined as the remission rate of all CR, CRp [achieved CR except for incomplete platelet recovery (<100 × 109/L)] and CRi (achieved all criteria for CR except for incomplete haematological recovery with residual neutropenia <1 × 109/L with or without complete platelet recovery).
Gilteritinib should be administered at about the same time each day. If a dose is missed or not taken at the usual time, the dose should be administered as soon as possible on the same day, and patients should return to the normal schedule the following day. If vomiting occurs after dosing, patients should not take another dose but should return to the normal schedule the following day.
Gilteritinib can be taken with or without food.
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