GILTERITINIB
Background and Date of Approval
The U.S. FDA approved Gilteritinib on 28 November 2018 for the treatment of acute myeloid leukaemia (AML) in patients with FLT3 mutations. The 2019 ADMIRAL study demonstrated that Gilteritinib significantly extended overall survival in patients with FLT3-mutated relapsed or refractory acute myeloid leukaemia (AML) across all mutation cohorts.
Uses
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.
How is it administered?
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.
Side Effects
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).
Warnings
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.
Precautions
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.
Word of Advice
Maintain adequate water intake and electrolyte supplementation to offset fluid loss associated with this medication. Avoid spicy and processed foods, which may exacerbate gastrointestinal effects. Allow sufficient rest during treatment to manage weakness, muscle stiffness, or joint pain that may occur as adverse effects of the medicine. Your healthcare provider may recommend monitoring your blood pressure and cardiac function prior to commencing therapy. Report any unusual symptoms to your doctor during the course of medication.
References
Delpharm Meppel B.V., Electronic medicines compendium (EMC), [Revised on April 2024], [Accessed on April 2024], pil.10832.pdf (medicines.org.uk) 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 Gilteritinib Effective Across Mutation Cohorts of AML - The ASCO Post
Frequently Asked Questions
Can gilteritinib be used in individuals with a history of seizures?
Gilteritinib is generally not recommended for individuals with a history of seizures. Consult your doctor before using the medicine.
Can you drive while taking the gilteritinib medication?
People may experience side effects, including dizziness, drowsiness, or fatigue, after using gilteritinib. In that case, avoid driving or operating heavy machinery.
Can I experience diarrhea during the gilteritinib medication?
Yes, you may experience diarrhea during the medication. Drink sufficient amounts of water and take electrolytes to compensate for the water loss caused by the drug. It is recommended to avoid spicy or junk foods, which can worsen the gastrointestinal problem.
Is it safe to use gilteritinib if I am pregnant?
Consult your healthcare provider if you plan to get pregnant. However, the medication has not been given to expectant mothers, and it should only be used when the projected advantages outweigh any possible hazards to the fetus. It is recommended to use an effective contraceptive for women who are of childbearing age.
How does gilteritinib medicine work?
Gilteritinib works by blocking the enzyme (protein kinases), which is involved in the abnormal growth and multiplication of the white blood cell. It also induces the apoptosis process in White blood cells that express the gene (FLT3-ITD) mutations.