Generic Name: Gilteritinib (GIL te RI ti nib)
Brand Name: Xospata
Medically reviewed by Drugs.com. Last updated on Nov 6, 2019.
- A health problem called differentiation syndrome has happened. This may cause organ problems and can be deadly if not treated. Call your doctor right away if you have bone pain, cough, fever, shortness of breath or other breathing problems, sudden weight gain, swelling in the arms or legs, or swollen gland. Call your doctor right away if you have signs of liver problems like dark urine or yellow skin or eyes; signs of kidney problems like unable to pass urine, change in amount of urine passed, or blood in the urine; or signs of low blood pressure like dizziness or passing out.
Uses of Xospata:
- It is used to treat a type of leukemia.
What do I need to tell my doctor BEFORE I take Xospata?
- If you are allergic to Xospata (gilteritinib); any part of Xospata (gilteritinib); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Low potassium or magnesium levels.
- If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with Xospata (gilteritinib).
- If you are breast-feeding. Do not breast-feed while you take Xospata (gilteritinib) or for 2 months after your last dose.
This is not a list of all drugs or health problems that interact with Xospata (gilteritinib).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xospata (gilteritinib) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Xospata?
- Tell all of your health care providers that you take Xospata (gilteritinib). This includes your doctors, nurses, pharmacists, and dentists.
- High triglyceride levels have happened with Xospata (gilteritinib). Tell your doctor if you have ever had high triglyceride levels.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- You will need an ECG before starting Xospata (gilteritinib) and during treatment. Talk with your doctor.
- Men with a partner who may get pregnant must use birth control while taking Xospata (gilteritinib) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.
- This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Xospata (gilteritinib) to show that you are NOT pregnant.
- Women must use birth control while taking Xospata (gilteritinib) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
How is this medicine (Xospata) best taken?
Use Xospata (gilteritinib) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- Swallow whole. Do not chew, break, or crush.
- Take with a full glass of water.
- Take Xospata (gilteritinib) at the same time of day.
- Keep taking Xospata (gilteritinib) as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it on the same day you missed the dose.
- If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Fast breathing.
- Skin irritation.
- Redness or irritation of the palms of hands or soles of feet.
- Change in eyesight, eye pain, or very bad eye irritation.
- A burning, numbness, or tingling feeling that is not normal.
- A type of abnormal heartbeat (prolonged QT interval) can happen with Xospata (gilteritinib). Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
- A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Xospata (gilteritinib). Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
What are some other side effects of Xospata?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Back, bone, joint, muscle, or neck pain.
- Feeling tired or weak.
- Mouth irritation or mouth sores.
- Change in taste.
- Stomach pain.
- Trouble sleeping.
- Constipation, diarrhea, throwing up, and upset stomach are common with Xospata (gilteritinib). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Xospata?
- Store in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer information use
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Xospata (gilteritinib) is refilled. If you have any questions about Xospata (gilteritinib), please talk with the doctor, pharmacist, or other health care provider.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Xospata (gilteritinib)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: multikinase inhibitors
- FDA Approval History