Gilteritinib tablets

What is this medication?

GILTERITINIB (gil te ri ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat acute myelogenous leukemia.

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:

• an unusual or allergic reaction to gilteritinib, other medicines, foods, dyes, or preservatives
• heart disease
• history of irregular heartbeat
• history of low levels of potassium or magnesium in the blood
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. However, you should always take it the same way. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine 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. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fluconazole
• pimozide
• saquinavir
• thioridazine

This medicine may also interact with the following medications:

• apalutamide
• antiviral medicines for HIV or AIDS
• certain antibiotics like clarithromycin, chloramphenicol, telithromycin, and dalfopristin; quinupristin
• certain antidepressants like escitalopram, fluoxetine, and sertraline
• certain antifungals like itraconazole, ketoconazole, posaconazole, and voriconazole
• certain medicines for seizures like carbamazepine, fosphenytoin/phenytoin, phenobarbital, and primidone
• conivaptan
• grapefruit juice
• idelalisib
• lumacaftor; ivacaftor
• mifepristone
• nefazodone
• 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 health care provider for regular check on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their health care provider if they wish to become pregnant. Men should not father a child while taking this medicine or for 4 months after stopping it. There is a potential for serious harm to an unborn child. Talk to your health care provider for more information.

Do not breast-feed an infant while taking this medicine or for 2 months after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blurred vision
• breathing problems
• changes in vision
• confusion
• cough
• fever or chills, sore throat
• seizures
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast, irregular heartbeat; palpitations; feeling faint or lightheaded; falls, breathing problems
• stomach pain
• swelling of arms and legs
• trouble passing urine or change in the amount of urine

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

• constipation
• joint pain
• muscle pain
• nausea
• tiredness

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 medicine in the original container. Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine 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.