Gilteritinib Oral Tablet (GILTERITINIB - ORAL)

For treating cancer.

Brand Name(s): Xospata

Generic Name: Gilteritinib

Instructions

Swallow the medicine without crushing or chewing it.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

You may take with food to prevent stomach upset.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

If possible, avoid using with marijuana or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 months after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 6 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 4 months after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • agitated feeling or trouble sleeping
  • decreased appetite
  • constipation
  • dizziness
  • swelling of the legs, feet, and hands
  • lack of energy and tiredness
  • headaches
  • mouth sores or irritation
  • joint or muscle pain
  • nausea and vomiting
  • stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • severe or persistent abdominal pain
  • changes in memory, mood, or thinking
  • confusion
  • cough that does not go away
  • fainting
  • fever or chills
  • fast or irregular heart beats
  • signs of kidney damage (such as change in urine color or bubbly urine)
  • lightheadedness
  • seizures
  • shortness of breath
  • sore throat
  • blurring or changes of vision
  • severe or persistent vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.