The U.S. FDA approved Gilteritinib on 28/11/2018 to treat acute myeloid leukaemia (AML) in patients with altered genes (FLT3).

The 2019 ADMIRAL study found that Gilteritinib significantly prolonged survival in patients with FLT3-mutated relapsed or refractory acute myeloid leukaemia (AML) across all mutation cohorts.

It is used to treat the acute myeloid leukemia in adults, which are linked with a change in the gene (FLT3). It can be used to treat recurrent AML in patients.

Gilteritinib is available as syringes in a 40 mg tablet which is administered orally. Your physician will decide the correct dosage and duration based on age, body weight, and disease condition. Only stop taking the medicine if your doctor advises you to stop.

The common side effects that are experienced while you are on the treatment with Gilteritinib are diarrhea, nausea, constipation, tiredness, swelling or oedema, weakness, abnormal liver function results, pain in limbs, joint pain, muscle pain, cough, shortness of breath, dizziness, low blood pressure, passing less urine, discomfort, muscle stiffness. Report your doctor immediately, if you experience a severe life-threatening allergic reaction (swelling in the mouth, tongue, face and throat, itching, hives) and heart failure or heart problem (fluid formation around the heart).

Inform your doctor if you are allergic to giltertinib or any of the ingredients present in them. Consult your doctor if you have an arrhythmia or heart disorder, a history of low potassium or magnesium levels, or severe abdomen pain with pancreatitis. Your doctor may suggest you monitor the heart function and take regular blood tests before or during the medication.

The precautions while taking Gilteritinib are:

• Differentiation syndrome: Initiate corticosteroid therapy and monitor hemodynamics immediately if Differentiation Syndrome is suspected, as it can be fatal if not treated.
• Posterior reversible encephalopathy syndrome (PRES): Discontinue Gilteritinib if the patient develops PRES.
• Prolonged QT interval: Interrupt and reduce the Gilteritinib dosage if the QTcF exceeds 500 msec. Correct any hypokalemia or hypomagnesemia before and during Gilteritinib administration.
• Pancreatitis: Interrupt and reduce the Gilteritinib dosage if pancreatitis develops.
• Embryo-fetal toxicity: Advise patients of the risk of fetal harm and ensure effective contraception is used to prevent pregnancy during treatment.

Drink sufficient amounts of water and take electrolytes to compensate for the water loss caused by the drug. Avoid spicy or junk foods, which can worsen the gastrointestinal problem. Take enough rest during the medication to manage the weakness, muscle stiffness, or joint pain caused by the medicine's adverse effects. Your healthcare provider may advise you to monitor your blood pressure and heart function before using the medicine. Consult your doctor promptly if you have any unusual symptoms during the medication.

1. Delpharm Meppel B.V., Electronic medicines compendium (EMC), [Revised on April 2024], [Accessed on  April 2024], pil.10832.pdf (medicines.org.uk)
2. Astellas Pharma US, Inc, US Food and Drug Administration, [Revised on May 2019], [Accessed on Mar 2024], https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf
3. Gilteritinib Effective Across Mutation Cohorts of AML - The ASCO Post

The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.