Xospata 40 mg tablet

Generic name:
Gilteritinib - oral

Pronunciation
(GIL-te-RI-ti-nib)

Brand name(s)
Xospata

Gilteritinib has rarely caused a serious (possibly fatal) condition called differentiation syndrome. Get medical help right away if you develop any signs of differentiation syndrome, such as fever, cough, shortness of breath, trouble breathing, rapid weight gain, swelling of arms/legs, signs of kidney problems (such as change in the amount of urine), or dizziness/lightheadedness.

Gilteritinib is used to treat acute myeloid leukemia (AML). It works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start taking gilteritinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or split the tablets.

The dosage is based on your medical condition and response to treatment.

Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

See also Warning section.

Tiredness, constipation, nausea/vomiting, diarrhea, mouth sores, decreased appetite, changes in taste, headache, trouble sleeping, or muscle/joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• nausea/vomiting that doesn't stop
• stomach/abdominal pain
• vision changes (such as blurred vision, decreased vision)
• mental/mood changes (such as confusion)

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking gilteritinib, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Gilteritinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using gilteritinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using gilteritinib safely.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using gilteritinib. Gilteritinib may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of gilteritinib from your body, which may affect how gilteritinib works. Examples include itraconazole, rifamycins (such as rifampin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is within 12 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Keep this medication in the container provided by your pharmacist at room temperature away from light and moisture. Do not store in a different container, such as a pill box. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.