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Systemic Anti-Cancer Therapy Regimen Library

LEU AML Relapsed - gilteritinib [FLT3 mutated]

Treatment Overview

Treatment may need to be continued for up to 6 months to allow time for clinical response.

Cycle 1 (and all further cycles) - 84 days

Cycle length:
84

Consider increasing gilteritinib dose to 200 mg orally ONCE daily if clinically indicated and tolerated.


May prolong QTc interval and close monitoring is recommended. Avoid or reduce risk factors for QTc prolongation. Consult prescribing information.

Monitor closely for differentiation syndrome in the first 12 weeks of treatment. Consult prescribing information.

Cycle details

Cycle 1 (and all further cycles) - 84 days

Medication Dose Route Days Max Duration
gilteritinib 120 mg Once daily oral administration 1 to 84

Consider increasing gilteritinib dose to 200 mg orally ONCE daily if clinically indicated and tolerated.


May prolong QTc interval and close monitoring is recommended. Avoid or reduce risk factors for QTc prolongation. Consult prescribing information.

Monitor closely for differentiation syndrome in the first 12 weeks of treatment. Consult prescribing information.

Full details

Cycle 1 (and all further cycles) - 84 days

Day: 1

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 2

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 3

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 4

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 5

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 6

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 7

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 8

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 9

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 10

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 11

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 12

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 13

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 14

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 15

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 16

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 17

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 18

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 19

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 20

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 21

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 22

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 23

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 24

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 25

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 26

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 27

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 28

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 29

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 30

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 31

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 32

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 33

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 34

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 35

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 36

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 37

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 38

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 39

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 40

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 41

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 42

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 43

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 44

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 45

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 46

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 47

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 48

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 49

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 50

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 51

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 52

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 53

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 54

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 55

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 56

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 57

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 58

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 59

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 60

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 61

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 62

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 63

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 64

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 65

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 66

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 67

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 68

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 69

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 70

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 71

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 72

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 73

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 74

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 75

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 76

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 77

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 78

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 79

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 80

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 81

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 82

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 83

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Day: 84

Medication Dose Route Max duration Details
gilteritinib 120 mg Once daily oral administration
Instructions:

Serious hypersensitivity reactions, including anaphylaxis, have been reported. 

Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist. 

Swallow whole with a glass of water, do not crush, chew.

Consider increasing dose to 200 mg if clinically indicated and tolerated.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis may be considered
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis may be considered
Emetogenicity: Minimal to low
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis is recommended

Antifungal prophylaxis: Caution with azole antifungals and risk of QTc prolongation.

Antiviral hepatitis B prophylaxis: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess the individual patient risk for other anti-cancer medicines.

Growth factor support: Consider if patient in complete remission develops cytopenias.

References

Perl, A. E., G. Martinelli, J. E. Cortes, et al. 2019. "Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML." N Engl J Med 381(18):1728-1740., PMID: 31665578

Astellas Pharma Australia Pty Ltd Xospata® Australian Product Information 2 April 2020 –https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-01414-1&d=20220713172310101 (accessed 14 July 2022).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.