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Gilteritinib

Generic Name: gilteritinib ([GIL te RI-ti nib])
Trade name: Xospata
Drug class: multikinase inhibitors

What is Gilteritinib?

Gilteritinib can be used to treat AML in adults who have an abnormal FLT3 genetic mutation. You will be tested for this gene by your doctor. Gilteritinib can be given when other cancer treatments have failed or stopped working. Gilteritinib can be used in other ways not mentioned in this guide.

Side effects of Gilteritinib

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or throat. Gilteritinib may cause a condition known as differentiation syndrome. This can affect blood cells and be fatal if untreated. This condition can occur between 2 days and 3 months after starting gilteritinib.

If any of the following symptoms arise, seek medical help immediately:

  • Difficulty breathing; fever; ______?
  • Bone pain
  • Rapid weight gain
  • You may experience swelling of your legs, arms, groins, underarms, or neck.

Gilteritinib can cause serious side effects. If you experience:

  • Headache, confusion, mental status changes, vision loss and seizure/convulsions; are symptoms to watch out for when traveling overseas.
  • Fever, chills, and coughs with mucus;
  • Flu symptoms: mouth and throat ulcers
  • Nausea, and vomiting.
  • Feeling lightheaded? Symptoms could include fatigue or dizziness that leads to fainting episodes.
  • You may experience rapid or pounding pulses, shortness of breath, and sudden dizziness.

If you experience certain side effects, your cancer treatment may be stopped or delayed.

Some of the common side effects associated with gilteritinib include:

  • Nausea, vomiting, diarrhea, and constipation;
  • Pain or sores on the tongue or throat
  • Shortness of breath, cough
  • Headache, dizziness;
  • Eye problems
  • Joint or muscle pain
  • low blood pressure
  • Swelling of the arms or legs
  • Fever, tiredness;
  • Reduced urination
  • Rash;
  • Abnormal liver function tests

There may be other side effects.Need advice about side effects? Seek medical assistance immediately by consulting your physician.The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Warnings

Gilteritinib may cause a condition known as differentiation syndrome. This can affect blood cells, and if left untreated, it can be fatal. This condition can occur between 2 days and 3 months after starting gilteritinib. If you experience any of the following symptoms, seek medical attention immediately: Fever, cough, trouble breathing, bone pain, rapid weight gain, swelling in your arms, legs, underarms, groin, or neck

Before you take this drug

If you have an allergy to gilteritinib, it is best not to use it.

Tell your doctor about any of the following:

  • Heart problems
  • Long-QT syndrome
  • An electrolyte imbalance can occur when there is a low level of magnesium or potassium in the blood.

You may need an ECG or electrocardiogram (also called an EKG) to check your heart function before you start taking gilteritinib.

Gilteritinib may harm a baby in utero or cause birth defects if either the mother or father uses this medicine.

  • Do not take gilteritinib while pregnant if you're a woman. Before starting treatment, you may need to take a pregnancy test. Use birth control while taking this medication and for 6 months following your last dose.
  • Use effective birth control if you're a man and your partner can get pregnant. Continue to use birth control for at least four months after your last dose.
  • If you become pregnant while using gilteritinib, tell your doctor immediately.

Do not breastfeed for 2 months after the last dose of this medication.

How to take Gilteritinib?

Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label. It may be necessary to have frequent medical tests in order to ensure that this medication does not have any harmful side effects. The results may delay your cancer treatment. Gilteritinib can be taken once a day. This medicine should be taken with a glass of water at the same time, every day. Take gilteritinib either with or without food. Avoid crushing, chewing, or breaking a tablet of gilteritinib. Swallow the tablet whole. You may need to take gilteritinib for several months before you see the full benefits. The length of treatment with gilteritinib will be determined by your doctor. Do not stop taking gilteritinib or change the dose without consulting your doctor. Keep this medicine at room temperature and away from heat, moisture, and

Details on dosage

Adult dose for acute myeloid leukemia:
Oral 120 mg once daily until disease progression occurs or toxicities are unacceptable
Comments:
Responses may be delayed. Patients should be treated for at least 6 months if there is no disease progression or unacceptable toxicities. This will allow for time to develop a response.
Select patients for treatment with this drug for AML based on the presence or absence of FLT3 mutations within the blood and bone marrow.
Use: To treat adult patients with relapsed or refractory acute myeloid leukemia who have an FMS-like Tyrosine Kinase 3 mutation.

What happens if I miss the dose?

Take the missed dosage on the day that you remember. If your next dose is less than 12 hours away, skip the missed dose. Use no more than two doses in a 12-hour time period.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Other drugs, such as vitamins and herbal remedies, may also affect gilteritinib. Inform your doctor of all the medicines you are taking and those that you stop or start using.