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How it is administered
Gilteritinib is taken by mouth as a tablet. Each tablet contains 40 mg of the active ingredient. The recommended dose is 120 mg (three tablets) taken once daily, with or without food. Tablets should be swallowed whole with a cup of water and should not be broken, crushed, or chewed.
If you miss a dose, take it as soon as possible on the same day, at least 12 hours before your next scheduled dose. Do not take two doses within 12 hours.
How it works
Gilteritinib is a type of medication called a kinase inhibitor. It works by blocking the activity of certain proteins known as receptor tyrosine kinases, specifically FMS-like tyrosine kinase 3 (FLT3). Many patients with acute myeloid leukemia (AML) have mutations in the FLT3 gene, which can cause the leukemia cells to grow and multiply uncontrollably.
By inhibiting FLT3 and related kinases, gilteritinib helps to stop the growth and survival of leukemia cells that have this mutation. This can slow down or stop the progression of the disease. Gilteritinib is especially effective in patients whose AML has returned (relapsed) or has not responded to previous treatments (refractory), and who have a FLT3 mutation detected by an FDA-approved test.
Common side effects
- Increased liver enzymes (transaminase increased)
- Muscle or joint pain (myalgia/arthralgia)
- Fatigue or malaise
- Fever
- Mouth sores (mucositis)
- Swelling (edema)
- Rash
- Diarrhea (not caused by infection)
- Shortness of breath (dyspnea)
- Nausea
- Cough
- Constipation
- Eye disorders
- Headache
- Dizziness
- Low blood pressure (hypotension)
- Vomiting
- Kidney problems (renal impairment)
Serious side effects can include differentiation syndrome, posterior reversible encephalopathy syndrome (PRES), prolonged QT interval (heart rhythm changes), pancreatitis, and hypersensitivity reactions.
Who Should take it
Gilteritinib is indicated for adult patients with acute myeloid leukemia (AML) who have relapsed (the disease has come back) or are refractory (the disease has not responded to previous treatments) and whose leukemia cells have a FLT3 mutation. The presence of this mutation must be confirmed by an FDA-approved test before starting treatment.
It is not used as a first-line treatment for AML or for patients without a FLT3 mutation. Your healthcare provider will determine if gilteritinib is appropriate for you based on your specific diagnosis and test results.
Who should not take it
Gilteritinib should not be taken by anyone who has had a hypersensitivity (allergic) reaction to gilteritinib or any of its ingredients. Signs of a serious allergic reaction can include rash, swelling, difficulty breathing, or anaphylaxis.
Gilteritinib can cause harm to an unborn baby. It should not be used during pregnancy, and women of childbearing potential should use effective contraception during treatment and for 6 months after the last dose. Men with female partners of childbearing potential should also use effective contraception during treatment and for 4 months after the last dose. Women should not breastfeed during treatment and for 2 months after the last dose.
Commonly used with
Gilteritinib is usually used alone for the treatment of relapsed or refractory AML with FLT3 mutations. It is not typically combined with other chemotherapy agents, but your healthcare provider may use supportive medications such as corticosteroids if you develop differentiation syndrome or other complications.
It may also be used as a bridge to stem cell transplantation in some patients, depending on your response and overall treatment plan.
Commonly tested with
In clinical studies, gilteritinib has been compared to standard chemotherapy regimens for relapsed or refractory AML, including high-intensity regimens (such as mitoxantrone, etoposide, and cytarabine or FLAG-IDA) and low-intensity regimens (such as low-dose cytarabine or azacitidine).
It has also been studied in patients who have previously received other FLT3 inhibitors, and in combination with supportive care medications as needed.