Gilteritinib (gil-te-RI-ti-nib)

Treats acute myeloid leukemia.

Brand Name(s):

Xospata

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the tablet whole with water. Do not break, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 12 hours or more until your next dose, take the missed dose then go back to your regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines may affect how gilteritinib works. Tell your doctor if you are using cephalexin, escitalopram, fluconazole, fluoxetine, itraconazole, midazolam, rifampin, or sertraline.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 4 months after the last dose. Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant.
• Do not breastfeed during treatment and for at least 2 months after the last dose.
• Tell your doctor if you have heart or heart rhythm problems or electrolyte imbalance.
• This medicine may cause the following problems:
  • Differentiation syndrome, which may be life-threatening
  • Posterior reversible encephalopathy syndrome (PRES)
  • Heart rhythm problems (including QT prolongation)
  • Pancreatitis (swelling of the pancreas)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain, trouble breathing
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling of your arms or legs
• Seizures, headache, confusion, vision problems, drowsiness, tiredness or weakness
• Sudden and severe stomach pain, nausea, vomiting

If you notice these less serious side effects, talk with your doctor:

• Constipation, decreased appetite, diarrhea
• Joint or muscle pain
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088