If you have acute myeloid leukemia (AML), your doctor might suggest Xospata as a treatment option. It’s a prescription drug used to treat AML in adults that:

* AML with the FLT3 gene is usually aggressive. Your doctor will order a blood test before prescribing Xospata to determine if your AML has this gene.

You’ll likely take Xospata for at least 6 months, unless you have severe or bothersome side effects. The drug may be taken long term until your cancer spreads or you have unacceptable side effects during treatment.

Xospata comes as a tablet you swallow. It contains the active ingredient gilteritinib. (An active ingredient is what makes a drug work.) For more information about this drug, including details about its uses, see this in-depth article.

Like other drugs, Xospata can cause mild to serious side effects. Keep reading to learn more.

Some people may experience mild to serious side effects during Xospata treatment.

A few of the more commonly reported side effects from Xospata’s studies include:

* To learn more about this side effect, see the “Side effects explained” section below.

Keep in mind that these side effects won’t happen to everyone who takes Xospata. The following sections contain more information, including serious side effects this drug may cause.

Like most drugs, Xospata can cause mild side effects. They are fairly common with this drug, but in some cases, your treatment may be paused temporarily or your dose may be reduced to help them go away.

Examples of mild side effects that have been reported with Xospata include:

* To learn more about this side effect, see the “Side effects explained” section below.

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bother you, talk with your doctor or pharmacist. Do not stop taking Xospata unless your doctor recommends it.

Xospata may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Xospata, visit MedWatch.

While Xospata may cause serious side effects, these were rare in the drug’s studies.

Serious side effects that have been reported with Xospata include:

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.

* To learn more about this side effect, see the “Side effects explained” section below.
† Xospata has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see “Side effects explained” just below.

Learn more about some of the side effects Xospata may cause.

Risk of differentiation syndrome

While rare, Xospata can cause a side effect called differentiation syndrome. It has a boxed warning about this risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Differentiation syndrome is a serious side effect that affects your blood cells. Without treatment, it can cause organ failure and can even be fatal in extreme cases.

In Xospata’s studies, differentiation syndrome happened as early as 1 day after starting treatment and as late as 82 days after the first dose.

Symptoms of differentiation syndrome may include:

What might help

Immediately call your doctor or seek medical help if you think you’re having symptoms of differentiation syndrome. You’ll likely need treatment in a hospital, including treatment with a corticosteroid called dexamethasone for at least 3 days.

Depending on how severe your symptoms are, your doctor may have you stop taking Xospata temporarily until they ease. This was effective at eliminating symptoms in most people who had differentiation syndrome in the drug’s studies. If this occurs, your doctor will then help you determine whether it’s safe for you to continue taking Xospata long term.

Posterior reversible encephalopathy syndrome

Posterior reversible encephalopathy syndrome (PRES) was a rare side effect reported in Xospata’s studies. With PRES, you have swelling in your brain. PRES is a life threatening condition that needs immediate treatment.

Symptoms of PRES can occur suddenly, and can include:

What might help

Call your doctor right away if you think you’re having symptoms of PRES. Your doctor will order a test to check. When treated quickly, this condition usually goes away in about a week. If your doctor confirms you have PRES as a side effect from Xospata, they’ll have you stop taking it.

Changes in liver function tests

Changes in liver function tests were the most common side effect in Xospata’s studies, with just over half of people having this side effect.

Changes in liver function tests were also the most common side effect that caused people to temporarily stop taking Xeloda in these studies. In rare cases, this side effect has caused people to stop treatment.

Changes in liver function tests caused by Xospata are usually mild and won’t cause symptoms. In rare cases, changes in these tests can be a sign of liver problems, including liver damage. But it’s not clear whether anyone taking Xospata in studies developed liver damage.

What might help

During Xospata treatment, your doctor will order blood tests to monitor your health, including tests to monitor your liver function. If the tests show changes in your liver function, your doctor may suggest pausing Xospata treatment until these tests show regular results.

Pancreatitis

Rarely, treatment with Xospata can cause pancreatitis. But this wasn’t common in the drug’s studies.

Symptoms of pancreatitis can include:

What might help

Call your doctor right away if you notice symptoms of pancreatitis while taking Xospata. Treatment for this condition often requires hospitalization. But with quick, correct treatment, you’ll usually feel better within a few days to a couple of weeks.

If your doctor confirms you have pancreatitis from taking Xospata, they’ll have you temporarily stop taking it until your symptoms resolve. Then they’ll have you resume taking Xospata at a lower dose.

Allergic reaction

Like most drugs, Xospata can cause an allergic reaction in some people. But this was rare in the drug’s studies.

Symptoms can be mild to serious, and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, usually in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an over-the-counter oral antihistamine, such as Benadryl (diphenhydramine)
  • a topical product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Xospata, they’ll decide if you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Xospata, they may have you switch to a different treatment.

Keeping track of side effects

During Xospata treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how it affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Xospata affects you. They can then use this information to adjust your treatment plan if needed.

Get answers to some frequently asked questions about Xospata’s side effects.

Will Xospata cause any long-term side effects?

It’s rare but possible for Xospata to cause long-term side effects. These are side effects that:

  • happen after you’ve taken the drug for a long time, or
  • start during treatment and don’t go away even if you stop taking the drug

In Xospata’s studies, the reported long-term side effects include:

* Xospata has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section above.

Your doctor or pharmacist can tell you more about long-term side effects of Xospata.

Does Xospata cause hair loss?

No, Xospata isn’t expected to cause hair loss. This side effect wasn’t reported in the drug’s studies.

Hair loss is a common side effect caused by chemotherapy (traditional drugs used to treat cancer). And chemotherapy drugs are commonly used to treat acute myeloid leukemia (AML). Xospata is prescribed for AML that has come back or gotten worse despite treatment, such as with chemotherapy.

Talk with your doctor if you’re concerned about hair loss and your cancer treatment plan. They can review whether any of your treatments could cause this side effect. They can also recommend ways to help you manage this side effect if it does happen.

Can Xospata cause nerve problems?

It’s possible. Specifically, peripheral neuropathy was reported in Xospata’s studies. With peripheral neuropathy, certain nerves become damaged or destroyed and stop working correctly.

Symptoms can include:

  • a prickling or tingling (“pins and needles”) sensation in your arms, legs, hands, or feet
  • muscle cramps or weakness
  • numbness, burning, or sharp pain in your limbs, hands, or feet

Chemotherapy drugs can also cause peripheral neuropathy. Xospata is usually prescribed for AML that has worsened or returned despite treatment with chemotherapy. So it’s possible for other AML drugs you may take to cause this side effect as well.

Let your doctor know right away if you notice symptoms of peripheral neuropathy while taking Xospata. They can evaluate which medications you’re taking or have taken that could be causing this side effect. If your doctor confirms you have peripheral neuropathy, they may suggest you stop taking Xospata. In this case, they’ll recommend possible other treatments for your AML.

Before starting Xospata treatment, there are important things to discuss with your doctor. These include a boxed warning about differentiation syndrome.

Boxed warning: Risk of differentiation syndrome

Xospata has a boxed warning for the risk of differentiation syndrome. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Differentiation syndrome is a serious side effect that affects your blood cells. Without treatment, it can cause organ failure, and can even be fatal in extreme cases.

To learn more, see the “Side effects explained” section above.

Other warnings

Xospata may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before starting treatment. Below are a few factors to consider.

Electrolyte problems. Electrolytes are essential minerals found in your body. Having problems with them, such as low sodium, potassium, or magnesium, can increase your risk of heart-related side effects from Xospata. Your doctor can determine whether this drug is safe for you and may recommend treatment for the electrolyte problems. They may also decide to monitor your heart health closely if they prescribe Xospata for your condition.

Heart problems, including long QT syndrome. Rarely, treatment with Xospata can cause heart-related side effects. This includes an abnormal heart rhythm called long QT syndrome. If you already have heart problems, including long QT syndrome, you may be at increased risk of heart-related side effects from this drug. Taking Xospata could also worsen your existing heart problems. Your doctor can determine whether this drug is safe for you and may monitor your heart health closely if they prescribe it for you.

Allergic reaction. If you’ve had an allergic reaction to Xospata or any of its ingredients, your doctor will likely not prescribe it for you. Ask them about other medications that might be better treatment options.

Alcohol and Xospata

There are no known interactions between consuming alcohol and taking Xospata. But Xospata and alcohol can cause similar side effects, such as:

So drinking alcohol while you’re taking Xospata could increase your risk of these side effects or cause them to be severe. If you consume alcohol, talk with your doctor about whether it’s safe to drink while you’re taking Xospata.

Pregnancy and breastfeeding while taking Xospata

There haven’t been any studies to determine whether it’s safe to take Xospata while pregnant. But based on how the drug works, it’s thought it could cause harm if taken during pregnancy. If you can become pregnant, your doctor will order a pregnancy test to confirm it’s negative before prescribing this drug for you.

It’s also not known if it’s safe to breastfeed while taking Xospata. But based on how the drug works, it’s recommended you do not breastfeed during treatment. You’ll also need to avoid breastfeeding for at least 2 months following your last dose. Your doctor can suggest safer feeding options for your child instead.

Mild side effects are common with Xospata. And in rare cases, serious side effects can occur. You should call your doctor right away if you notice symptoms of serious side effects, including those described in “Side effects explained” above.

Before you begin treatment with Xospata, talk with your doctor. Ask questions to help you feel more comfortable about side effects the drug may cause. Some examples to get you started are:

  • Does my medical history put me at an increased risk of side effects if I take Xospata?
  • Will any of the other drugs I take interact with Xospata? Will this increase my risk of side effects if so?
  • If I have side effects with Xospata, is there a lower dosage you can prescribe?

Q:

Is it safe for older adults ages 65 years and over to take Xospata? Are there differences in side effects compared with younger adults taking this drug?

Anonymous

A:

In general, yes. Xospata is safe for older adults to take. In the drug’s studies, there weren’t differences in side effects in older adults.

But before starting treatment, be sure to talk with your doctor about your medical history and all drugs you take. Older adults are more likely to take multiple medications, which may interact with Xospata in a way that increases their risk of side effects. And as we age, certain body functions, such as kidney and liver function, tend to become less efficient. This may also increase the risk of side effects from Xospata.

The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

Disclaimer: Healthline 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.