Gilteritinib Tablets

What is this medication?

GILTERITINIB (GIL te RI ti nib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): XOSPATA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• History of irregular heartbeat or rhythm
• History of low levels of potassium or magnesium in the blood
• An unusual or allergic reaction to gilteritinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. You should always take it the same way. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is less than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Fluconazole
• Pimozide
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Apalutamide
• Certain antibiotics such as clarithromycin, chloramphenicol, telithromycin, dalfopristin; quinupristin
• Certain antivirals for HIV or hepatitis
• Certain medications for depression, such as escitalopram, fluoxetine, sertraline
• Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, fosphenytoin/phenytoin, phenobarbital, primidone
• Conivaptan
• Grapefruit juice
• Idelalisib
• Lumacaftor; ivacaftor
• Mifepristone
• Nefazodone
• Other medications that cause heart rhythm changes
• Ribociclib
• Rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while taking this medication.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 6 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form on contraception is recommended while taking this medication and for 6 months after the last dose. Do not father a child while taking this medication or for 4 months after the last dose. Use a condom while having sex during this time period. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication and for 2 months after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fever, cough, dizziness, feeling faint or lightheaded, shortness of breath, bone pain, sudden weight gain, swelling of the ankles, hands, or feet, which may be signs of differentiation syndrome
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Bone, joint, or muscle pain
• Constipation
• Diarrhea
• Dizziness
• General discomfort and fatigue
• Pain, redness, or swelling with sores inside the mouth or throat
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.