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Gilteritinib

About Gilteritinib

Gilteritinib is a prescription medication used to treat adults with a specific type of blood and bone marrow cancer called acute myeloid leukemia. This medicine is also available under the brand name Xospata. Depending on your prescription or pharmacy, you may see either the brand name or the generic name (gilteritinib) on the medicine label. It is specifically prescribed when the cancer cells have a unique genetic change known as a FLT3 mutation. This medicine is typically used when the cancer has returned or has not improved after previous treatments. Before starting treatment, your doctor will confirm that your leukemia has a FLT3 mutation using a validated laboratory test. This medicine is only effective for AML with this specific genetic change, so testing is an essential step before treatment begins.

To get the best results, you must take this medicine exactly once every day at the same time. You can take it either with food or on an empty stomach, but keeping a consistent routine is key. Making healthy adjustments to your daily routine, such as staying well-hydrated and eating balanced meals, can also support your body during treatment.

While taking this medicine, you may experience common side effects like tiredness, joint pain, or mild nausea. However, it is vital to contact your healthcare provider immediately if you experience serious symptoms like extreme shortness of breath, sudden weight gain, severe headaches, or unusual rhythm changes in your heart.

Before you begin treatment, tell your doctor if you have a history of heart rhythm problems, liver issues, or kidney disease. Do not take this if you are pregnant, as this medication can harm an unborn baby. Women who can get pregnant must use effective birth control during treatment and for several months afterwards. This medicine may also affect male fertility. If you plan to have children in the future, talk to your doctor about fertility preservation options, such as sperm banking, before starting treatment.

Some medicines can interfere with how this drug works, so it is important to share a complete list of your current prescriptions with your pharmacist. Avoid drinking alcohol or smoking while on this treatment, as they can put extra stress on your liver and heart. If you are breastfeeding or are an older adult, talk to your doctor about the specific precautions you need to take.

Uses of Gilteritinib

Gilteritinib is used in the treatment of acute myeloid leukaemia (AML). The detailed uses of Gilteritinib are as follows: • Treatment of Acute Myeloid Leukemia (AML): Gilteritinib helps slow the progression of leukemia by inhibiting cancer cell growth. • Improves Survival Rates in AML Patients: Gilteritinib is used in relapsed or refractory AML cases and helps control leukemia cell proliferation, improving treatment outcomes.

Medicinal Benefits

  • Targeted Cancer Cell Control & Improved Quality of Life: This medication offers targeted relief by focusing directly on mutated cancer cells rather than all fast-growing cells in the body. By blocking the abnormal proteins that feed the leukemia, it helps stop the disease from spreading. This can lead to a significant reduction in cancer cells in your blood and bone marrow, helping you work toward remission. Over time, managing the cancer effectively can help you regain your physical strength, reduce severe fatigue, and improve your overall quality of life. For some eligible patients, this treatment may also help control the leukemia while they are being prepared for an allogeneic stem cell transplant. Your doctor will discuss whether this is an appropriate treatment goal based on your individual condition. 

Directions for Use

  • Gilteritinib can be taken with or without food.
  • Follow your doctor’s instructions on the dosage and timing of this medication to ensure safe and effective use.
  • Swallow Gilteritinib as a whole with a glass of water.
  • Do not crush, chew or break it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Gilteritinib

Common Side Effects (Usually mild):

  • Feeling extremely tired or weak
  • Muscle, joint, or bone pain
  • Nausea, diarrhea, or constipation
  • Sores or pain inside your mouth and throat
  • Swelling in your hands, ankles, or feet


Serious Side Effects (Consult your doctor right away):

  • Fever, cough, trouble breathing, or rapid weight gain (signs of a serious blood cell reaction called differentiation syndrome)
  • Dizziness, feeling lightheaded, or a fast, fluttering, or irregular heartbeat
  • Severe headache, confusion, seizures, or sudden changes in your vision, as these may be signs of a rare but serious brain condition called posterior reversible encephalopathy syndrome (PRES)
  • Severe stomach pain that spreads to your back, accompanied by nausea or vomiting

Drug Warnings

  • Get regular heart checks: Your doctor will perform electrocardiograms (ECGs) to monitor your heart rhythm while you are on this medicine.
  • Monitor your blood work: Regular monitoring helps your doctor see how well the treatment is working and identify side effects early. You may also have electrocardiograms (ECGs) and other tests at scheduled intervals throughout your treatment, and your doctor will adjust your care based on these results.
  • Do not touch broken tablets: Pregnant women or those planning to become pregnant should not handle broken or damaged tablets.
  • Watch for sudden breathing changes: Seek immediate help if you experience a cough, fever, and difficulty breathing, as this can be a life-threatening reaction.
  • Avoid driving if dizzy: This medicine can make you feel dizzy or lightheaded. Do not drive or operate heavy machinery until you know how it affects you.

Drug Interactions

  • Strong CYP3A inhibitors: Certain medicines used to treat fungal or bacterial infections can slow down how your body processes Gilteritinib, increasing the risk of serious side effects.
  • Strong CYP3A inducers: Some medications used to treat seizures or tuberculosis can speed up how your body breaks down Gilteritinib, making it less effective.
  • Heart rhythm medicines: Taking this medication with other drugs that affect your heart's electrical activity (such as certain antiarrhythmics or antipsychotics) can increase the risk of dangerous heart rhythm changes.

Drug-Drug Interactions Checker List:

  • KETOCONAZOLE
  • LITHIUM
  • CLARITHROMYCIN
  • AMIODARONE
  • CHLOROQUINE
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is not known if alcohol affects Gilteritinib. Please consult your doctor.

    • Safety Warning

      Pregnancy

      unsafe

      Gilteritinib is not recommended during pregnancy as it may harm your unborn baby. If you are pregnant or planning to become pregnant, consult your doctor for guidance and advice.

    • Safety Warning

      Breast Feeding

      unsafe

      Gilteritinib may harm the baby; do not breastfeed during treatment with Gilteritinib for at least 2 months after the final dose.

    • Safety Warning

      Driving

      caution

      Gilteritinib may cause dizziness and vertigo. Be cautious while driving or operating machinery.

    • Safety Warning

      Liver

      consult your doctor

      If you have a history of liver disease, inform your doctor before taking Gilteritinib. Your doctor may adjust your dosage or recommend a different medication based on your individual needs and condition.

    • Safety Warning

      Kidney

      caution

      Gilteritinib exposure may be increased in patients with severe renal impairment or end-stage renal disease. Therefore, inform your doctor if you have any renal impairment.

    • Safety Warning

      Children

      unsafe

      The safety and effectiveness of Gilteritinib in children below 18 years have not been established.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Avoid grapefruit products: Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit can increase the amount of the drug in your body to unsafe levels.
    • Stay hydrated: Drink plenty of water throughout the day to help manage potential side effects like diarrhea or nausea.
    • Practice gentle mouth care: Use a soft-bristled toothbrush and rinse your mouth regularly with salt water or a baking soda solution to help prevent or soothe mouth sores. Avoid harsh, alcohol-based mouthwashes.
    • Protect your immune system: Since this medication can temporarily lower your white blood cell count, wash your hands frequently and avoid close contact with people who are sick.
    • Eat small, frequent meals: If you experience nausea or a loss of appetite, eating smaller portions throughout the day rather than three large meals can help maintain your nutrition and energy levels.

    Special Advise

    • Avoid consuming alcohol along with Gilteritinib as it could lead to increased dizziness,
    • Avoid driving or operating machinery if you feel dizzy.

    Patients Concern

    Disease/Condition Glossary

    Acute myeloid leukaemia: Acute Myeloid Leukemia (AML) is fast-progressing cancer that begins in the bone marrow, where it produces abnormal myeloid cells. These cells disrupt the production of healthy blood cells, leading to symptoms such as fatigue, fever, bruising, frequent infections, and bone pain. The causes of AML can be diverse, including genetic mutations, exposure to chemicals like benzene, radiation, and previous chemotherapy treatments. Certain blood disorders and genetic conditions can also increase the risk of developing AML.

    FAQs

    Gilteritinib is used in the treatment of acute myeloid leukaemia (AML).

    Gilteritinib contains gilteritinib, which inhibits the activity of the enzyme FLT3 (FMS-like tyrosine kinase 3). This enzyme is crucial for the growth and survival of certain cancer cells. By blocking the activity of FLT3, gilteritinib helps stop the growth and division of cancer cells, leading to their death. This targeted approach makes gilteritinib an effective treatment for AML patients with FLT3 mutations.

    If you miss a dose of Gilteritinib, take your next dose at the scheduled time. Do not take an extra dose to compensate for a missed dose.

    Continue taking Gilteritinib even if you feel well. Do not stop taking Gilteritinib without talking to the doctor.

    Take Gilteritinib with or without food. Swallow the medicine whole with a full glass of water without crushing or chewing it.

    The common side effects of Gilteritinib are fatigue, fever, mucositis (inflammation of the mucosa), edema, rash, non-infectious diarrhoea, dyspnea (feeling short of breath), nausea, cough, constipation, eye disorders, headache, dizziness, vomiting. If these side effects persist or worsen, please consult your doctor.

    If you vomit after taking your dose, do not take an extra tablet to make up for it. Simply wait and take your next dose at your regularly scheduled time the next day. Talk to your doctor or pharmacist for further guidance.

    Even after treatment ends, your doctor will continue to monitor your recovery with follow-up appointments and blood tests to check how your leukemia is responding and to watch for any ongoing or returning side effects. Always attend your scheduled follow-up visits and contact your healthcare team if you develop new or worsening symptoms after stopping treatment.

    No, you must avoid grapefruit and grapefruit juice because they can significantly increase the concentration of the medication in your body, raising your risk of dangerous side effects.

    Hair thinning or loss is not a commonly reported side effect of this specific medication, though everyone reacts differently. Talk to your doctor or pharmacist if you notice unusual changes in your hair.

    No, you should not take this medicine if you are pregnant or planning a pregnancy, as it can cause serious harm to an unborn baby. Both men and women should use effective birth control during treatment. Talk to your doctor for specific advice.

    One of the most serious conditions is differentiation syndrome, which affects your blood cells. Call your doctor immediately if you develop a fever, cough, trouble breathing, or sudden weight gain.

    No, you must swallow the tablet whole with a glass of water. Do not crush, break, or chew the tablet, as it may affect how the drug is absorbed. Talk to your doctor or pharmacist if you have trouble swallowing pills.

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