Xospata (gilteritinib) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat acute myeloid leukemia in certain adults.

Here are some fast facts about Xospata:

  • Active ingredient: gilteritinib
  • Drug class: kinase inhibitor
  • Drug form: oral tablet
  • FDA approval year: 2018

If Xospata works for you, your doctor will likely recommend that you take it as a long-term treatment.

As with other drugs, Xospata can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Xospata, including details about its uses, see this article.

Xospata can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Xospata in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Xospata. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Xospata’s prescribing information.

Mild side effects that have been reported with Xospata include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Xospata and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Xospata may cause serious side effects. Though serious side effects were not common in people taking Xospata, they can occur. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Xospata’s prescribing information.

If you develop serious side effects while taking Xospata, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see the “Side effect specifics” section below.
† Xospata has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA).

Xospata may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Will I lose my hair during treatment with Xospata?

No, you should not lose your hair from Xospata treatment. Hair loss was not a side effect of Xospata in clinical trials.

However, other AML treatments, such as chemotherapy, may cause hair loss. These drugs work by killing cells that grow quickly. Since cancer cells and hair cells both grow quickly, chemotherapy kills both of these cell types. This can cause hair loss during cancer treatment.

Xospata is a targeted therapy that works specifically on cancer cells. So this type of treatment typically has fewer side effects than chemotherapy.

If you notice hair loss during treatment with Xospata, talk with your doctor. They may recommend ways to decrease your hair loss. For example, they may recommend you use Rogaine (minoxidil).

If I have side effects from Xospata, how will they be treated?

If you have any side effects from Xospata, tell your doctor. Depending on what side effects you experience, your doctor will recommend the best treatment for you.

Some people may experience common or mild side effects.* These may include headache, joint or muscle pain, nausea, or vomiting. If you experience any of these side effects, your doctor will likely recommend you take an additional drug to treat them.

It’s also possible to experience more serious side effects, such as heart rhythm changes or pancreatitis (inflammation of the pancreas).† If you develop serious side effects, your doctor may recommend pausing your Xospata treatment. Then, they may restart your treatment after the side effects have eased. In most cases, they will likely recommend restarting Xospata treatment at a lower dose. This is to help prevent side effects from happening again.

Be sure to tell your doctor about any side effects you have from taking Xospata. They can help determine the best treatment option for any side effects you may experience.

* To learn more about these side effects, see the “More common side effects of Xospata” and “Mild side effects of Xospata” sections above.
† For additional information about serious side effects, see the “Serious side effects of Xospata” section above.

Are long-term side effects of Xospata possible?

Yes, it’s possible to develop long-term side effects from taking Xospata. However, most side effects reported in clinical trials of the drug were not long term.

Examples of long-term side effects that you may experience during treatment with Xospata include:

If you have concerns about any long-term side effects from Xospata treatment, talk with your doctor. They can tell you what symptoms you should watch for. You can also view the “Serious side effects of Xospata” section above to learn about some of these long-term side effects.

Learn more about some of the side effects that Xospata may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Xospata.

Low blood pressure

It’s possible to develop low blood pressure during Xospata treatment. Low blood pressure was a common side effect in clinical trials of this drug.

It’s important to be aware of the symptoms of low blood pressure. This is so you can tell your doctor right away if you develop it.

Some symptoms of low blood pressure can include:

What you can do

If you think you have low blood pressure, contact your doctor. They’ll check your blood pressure and help you determine how it should be increased.

In some cases, low blood pressure can be a sign of another condition, such as differentiation syndrome.* Your doctor will help determine what’s causing your low blood pressure and the best way to treat it.

* Xospata has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Differentiation syndrome” section below.

Muscle or joint pain

Some people may have muscle or joint pain during treatment with Xospata. These were common side effects that were reported in clinical trials of the drug.

What you can do

If you experience muscle or joint pain during treatment with Xospata, tell your doctor. In some cases, they may recommend you take over-the-counter pain medications. These may include Tylenol (acetaminophen) or Advil (ibuprofen) to treat your pain.

Nausea

It’s possible to experience nausea during treatment with Xospata. Nausea was a very common side effect in clinical trials of the drug.

What you can do

If you become nauseous during treatment with Xospata, be sure to tell your doctor. They may recommend ways to decrease your nausea, such as using ginger candies or ginger ale.

If your nausea is more severe, your doctor may recommend you take a nausea medication.

Differentiation syndrome

Some people may develop differentiation syndrome from Xospata treatment. In fact, Xospata has a boxed warning for this condition. A boxed warning is a serious warning from the FDA. The purpose of this boxed warning is to make doctors and patients aware of the serious risks of taking certain medications. Differentiation syndrome was not a common side effect in clinical trials of Xospata.

With differentiation syndrome, cancer cells release a large number of proteins called cytokines. This causes certain symptoms.

Symptoms may include:

  • fever
  • trouble breathing
  • weight gain
  • swelling of the arms or legs
  • low blood pressure
  • cough
  • skin rash
  • dizziness
  • decrease in the amount of urine or how often you urinate

Differentiation syndrome can occur in people with leukemia who are taking certain medications. It can happen as quickly as 1 day after you start taking Xospata. However, in some cases, you may not notice this side effect until months after beginning treatment.

What you can do

In some cases, differentiation syndrome can be severe or even life threatening. Due to this risk, it’s important to be aware of the above symptoms of the condition.

If you have any symptoms of differentiation syndrome, tell your doctor or go to the hospital right away to get immediate treatment.

If you have differentiation syndrome from taking Xospata, your doctor will likely prescribe you a steroid medication. You’ll take this drug until your symptoms are relieved. If your symptoms continue while you’re taking a steroid medication, your doctor may pause your Xospata treatment until your symptoms ease.

Allergic reaction

As with most drugs, Xospata can cause an allergic reaction in some people. Serious allergic reactions were reported in clinical trials of Xospata.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Xospata. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to tell your doctor about any other medications that you take or any medical conditions that you have before starting treatment with Xospata. They can help you determine if Xospata may be a safe treatment option for you.

Boxed warning: Differentiation syndrome

This drug has a boxed warning for the risk of differentiation syndrome. This is a serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Xospata. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Heart problems. If you have heart problems, including long QT syndrome, tell your doctor before starting Xospata treatment. This medication may cause long QT syndrome (a change in your heart rhythm). So taking Xospata if you already have a heart condition may make your condition worse. Your doctor can help you determine if it’s safe for you to take this drug with your heart condition.

Allergic reaction. If you’ve had an allergic reaction to Xospata or any of its ingredients, your doctor will likely not prescribe Xospata. Ask your doctor what other medications may be better options for you.

Electrolyte problems. Tell your doctor if you have any problems with electrolyte levels. These electrolytes include sodium, potassium, or magnesium. Xospata may cause changes to your heart rhythm, which may worsen if your electrolyte levels are low. Your doctor will likely measure these levels before you start taking the drug. If your electrolyte levels are low, your doctor may recommend you take medication to increase them before starting Xospata treatment.

Pancreas problems. Before starting Xospata treatment, tell your doctor if you have any pancreas problems, including pancreatitis. This medication may increase the risk of developing pancreatitis, especially if you’ve had it before. In this case, your doctor can help determine if Xospata is safe for you.

Alcohol with Xospata

There are no known interactions between Xospata and alcohol.

However, both alcohol and Xospata may cause similar side effects. So it’s possible for alcohol to worsen these side effects if you experience them with Xospata treatment.

Examples of side effects that both Xospata and alcohol may cause include:

  • dizziness
  • headache
  • nausea
  • vomiting

In addition, drinking large amounts of alcohol may increase the risk of pancreatitis (inflammation of the pancreas). This is also a possible side effect of Xospata. So drinking a lot of alcohol during Xospata treatment may increase this risk even more.

If you’d like to drink alcohol during treatment with Xospata, talk with your doctor. They can help determine if it’s safe for you to drink alcohol during treatment and how much is safe.

Pregnancy and breastfeeding while taking Xospata

Xospata is not safe to take during pregnancy or while you’re breastfeeding. There haven’t been any clinical trials with pregnant people taking Xospata to determine whether the drug is safe for this group.

However, animal studies show that Xospata may cause congenital anomalies (commonly known as birth defects). It may also cause pregnancy loss. It’s important to note animal studies do not always indicate what may happen in humans.

Due to these risks, your doctor will recommend you take a pregnancy test before starting Xospata treatment. If you’re female* and can become pregnant, they’ll also recommend using birth control during Xospata treatment. And they’ll recommend using it for at least 6 months after taking your last dose.

If you’re male* and have partners who can become pregnant, you should use birth control while taking Xospata. And you should use it for at least 4 months after your last dose of the drug.

There haven’t been any human clinical trials looking at whether Xospata passes into breast milk or what effects the drug may have on a child who is breastfed. However, in animal studies, breastfed offspring were exposed to the drug from the milk. It’s important to note that animal studies do not always indicate what may happen in humans.

Due to the possible risks of exposing your child to Xospata while breastfeeding, your doctor will not recommend breastfeeding during Xospata treatment. And they will not recommend breastfeeding for at least 2 months after you stop taking the medication.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

You may experience side effects from taking Xospata. Most side effects are mild, though it’s possible for serious side effects to occur as well. You should be aware of the possible side effects that may occur during treatment before starting Xospata.

If you’d like to learn more about Xospata, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Xospata. For details about other aspects of Xospata, refer to this article.
  • Dosage. For information about Xospata’s dosage, see this article.
  • Drug comparison. To learn how Xospata compares with Nexavar, read this article.
  • A look at acute myeloid leukemia. For information about your condition, our cancer hub might be helpful, as well as this list of leukemia articles.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.