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Xospata is used to treat a certain kind of blood cancer. Common side effects include increased liver function blood tests, muscle and joint pain, and tiredness. Call your health care provider right away if you get a fever, have severe stomach or side pain, shortness of breath, or chest pain. Xospata is a tablet that you will swallow.

Uses

What is Xospata used for?

Xospata (gilteritinib) is commonly used to treat certain kinds of acute myeloid leukemia (AML).

Xospata may also be used for other conditions as determined by your health care provider.

How does Xospata work (mechanism of action)?

Your health care provider can run a test to see if your cancer may respond to Xospata. Xospata is a type of medicine known as a tyrosine kinase inhibitor (TKI). It works by targeting specific proteins on cancer cells. By blocking the action of these proteins, Xospata can cause cancer cells to die and prevent them from growing or spreading.

How is Xospata supplied (dosage forms)?

Brands and other names

  • Xospata

Dosage forms and strengths

  • 40 mg oral tablets

How should I store Xospata?

Xospata should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 Cand 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep Xospata in the original container to protect it from light and moisture.

Side Effects

What are the most common side effects of Xospata?

The most common side effects of Xospata are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Changes in liver function tests
  • Joint and muscle pain
  • General feeling of being unwell, tired, or not having your usual energy
  • Fever
  • Mouth sores
  • Fluid retention
  • Rash
  • Diarrhea
  • Shortness of breath
  • Nausea and vomiting
  • Constipation
  • Eye problems
  • Headache
  • Dizziness
  • Low blood pressure
  • Low amounts of urine (pee)

There may be other side effects of Xospata that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Xospata?

While less common, the most serious side effects of Xospata are described below, along with what to do if they happen.

Severe Allergic Reactions. Xospata may cause allergic reactions, which can be serious. Stop taking Xospata and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Differentiation Syndrome. Xospata can cause a dangerous side effect known as differentiation syndrome. This can cause severe organ damage and even organ failure if not treated. Tell your health care provider or get emergency help right away if you have any of the following symptoms. 

  • Swelling in your feet, ankles, or legs
  • Low blood pressure
  • Trouble breathing or shortness of breath
  • Reduced need to pee
  • Fever
  • Rapid weight gain

Posterior Reversible Encephalopathy Syndrome (PRES). Xospata may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

  • Changes in thinking or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision
  • Sudden severe headache
  • Seizures

Heart Rhythm Changes. Xospata may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Inflammation of the Pancreas (Pancreatitis). Xospata may cause inflammation of the pancreas, which is called pancreatitis. Stop taking Xospata and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Warnings & Precautions

Who should not use Xospata?

Allergies to Ingredients. People who are allergic to any of the following should not take Xospata.

  • Gilteritinib
  • Xospata
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Xospata.

What should I know about Xospata before using it?

Do not take Xospata unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Xospata with other people, even if they have the same condition as you. It may harm them.

Keep Xospata out of the reach of children.

Take Xospata whole. Do not open, crush, or chew Xospata. 

What should I tell my health care provider before using Xospata?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Xospata is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems, including cardiomyopathy, an abnormal heartbeat, heart failure, and QT prolongation
  • Any family members who have heart problems, such as QT prolongation
  • Electrolyte problems, including low or high levels of sodium, potassium, or magnesium
  • Prior pancreatitis or problems with your pancreas

Other Medicines and Supplements. Xospata may interact with other medicines and supplements. Before taking Xospata, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Xospata may cause harm to a fetus. Your health care provider may give you a test to make sure you are not pregnant before you start taking Xospata. If you can get pregnant, you should use birth control while taking Xospata and for six months after your last dose. If you are able to get a partner pregnant, you should use condoms while taking Xospata and for four months after your last dose. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Xospata passes into breast milk. Do not breastfeed while taking Xospata and for two months after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Xospata?

For more information about Xospata, you can visit the manufacturer’s website at www.xospata.com or call them at 800-727-7003.

Interactions

Does Xospata interact with foods or drinks?

Grapefruit interacts with Xospata. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Xospata. This is because grapefruit can interfere with your body’s ability to break down Xospata, which can lead to high levels of the medicine and an increased risk of side effects.

It is unknown if drinking alcohol will affect Xospata, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Xospata interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Xospata.

  • St. John’s wort, which is a supplement that may be used for depression
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, escitalopram, or sertraline, which is a medicine commonly used for anxiety and depression
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Itraconazole or fluconazole, which are medicines used for fungal infections
  • Midazolam, a medicine used to relieve anxiety before surgery
  • Cephalexin, a medicine used to treat bacterial infections

Some other medicines may alter the blood levels of Xospata and vice versa. Tell your health care provider about all medicines you take or have recently taken.

This may not be a complete list of medicines that can interact with Xospata. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Xospata?

If you or someone else has used too much Xospata, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Xospata?

If you miss a dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.