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Xospata

gilteritinib
Used for Leukemia
Used for Leukemia

Xospata (gilteritinib) treats adults with acute myeloid leukemia (AML) that has a specific FLT3 mutation. This medication is approved for people who’ve tried other treatments before to treat their leukemia. Xospata (gilteritinib) is a targeted cancer medication that’s taken by mouth once daily, but you have to take 3 tablets each time for a full dose. Side effects can include muscle pain, tiredness, and a serious condition called differentiation syndrome.

Reviewed by:
reviewer
Allison Baxley, PharmD, BCOP
reviewer
Cydnee Ng, PharmD
Last reviewed on May 21, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageAlternativesImagesReferencesPricesMedicare
basics-icon

What is Xospata (gilteritinib)?

What is Xospata (gilteritinib) used for?

How Xospata (gilteritinib) works

Some people with AML have a mutation in a protein called FLT3. This protein is found on stem cells and it normally sends signals to the cells to divide and spread. Having an FLT3 mutation causes the cells to grow uncontrollably, leading to leukemia.

Xospata (gilteritinib) is a tyrosine kinase inhibitor known as an FLT3 inhibitor. It blocks the mutated FLT3 protein from sending signals to cancer cells to grow. When these signals are blocked, the leukemia cells can’t grow and spread as well.

Drug Facts

Common BrandsXospata
Drug ClassFLT3 inhibitor
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Xospata (gilteritinib)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Other Side Effects

  • Nausea
  • Diarrhea
  • Fever
  • Dizziness
  • Headache
  • Rash

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Differentiation syndrome: fever, sudden weight gain, trouble breathing, chest pain, swelling in legs
  • Nervous system problems: vision changes, confusion, seizures, loss of consciousness
  • Changes in heart rhythm: lightheadedness, irregular heartbeat, blurry vision, fainting, loss of consciousness, seizures

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Fever, cough, dizziness, feeling faint or lightheaded, shortness of breath, bone pain, sudden weight gain, swelling of the ankles, hands, or feet, which may be signs of differentiation syndrome
  • Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
  • Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
  • Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Xospata (gilteritinib)

thumbs-up

Pros

Is a tablet that’s taken by mouth

Works in a more specific, targeted way than traditional chemotherapy

Less likely to cause nausea

thumbs-down

Cons

Commonly causes muscle pain and tiredness

Requires regular EKGs and blood work to check for side effects

Risk for a rare, but serious condition called differentiation syndrome

pharmacist-tips

Pharmacist tips for Xospata (gilteritinib)

pharmacist

  • You can take Xospata (gilteritinib) with or without food. Swallow the tablets whole; don’t crush or chew them.

    • It’s important to go to your appointments for lab work whenever your oncologist tells you to. Xospata (gilteritinib) has a risk for side effects that are detected through your blood work. These can include pancreatitis, low white blood cells, and changes to your liver health. Your oncologist makes sure the medication is safe for you by checking your lab work.

      • Check your temperature often, preferably once a day. Call your healthcare team right away if you have a fever (a temperature of 100.4 degrees Fahrenheit or higher). Your care team will want to check your blood cell counts if you have a fever. This is because having a fever with very low white blood cell levels can be a side effect of Xospata (gilteritinib), and it can put you at risk for infection.

        • Tell your healthcare team about any new medications while you’re taking Xospata (gilteritinib). Some medications can interact with Xospata (gilteritinib). And these interactions can affect how well the medications work or affect your risk of side effects. Your healthcare team can make sure your medications are safe to take together.

          • If you or your partner can become pregnant and you’re sexually active, use birth control during your treatment with Xospata (gilteritinib). This medication can harm an unborn baby. Continue using birth control for 4 months (if you’re male) or for 6 months (if you’re female) after your last dose of Xospata (gilteritinib). Contact your healthcare team if you or your partner becomes pregnant during treatment.

            • Avoid breastfeeding while you’re taking Xospata (gilteritinib)] and for 2 more months after your last dose. We don’t know whether the medication gets into breast milk and whether it affects breastfed babies. But there’s a possible risk of harm to a baby.

              • Ask your oncologist about the best and safest way to handle and throw away Xospata (gilteritinib) when it expires or when your treatment ends. Anticancer medications can be harmful to people who handle or come in contact with them. Store the medication up and away, so children and pets can’t reach it.

                faqs

                Frequently asked questions about Xospata (gilteritinib)

                Is Xospata (gilteritinib) chemotherapy?
                No, Xospata (gilteritinib) isn’t a chemotherapy medication. Chemotherapy works by attacking any cell in the body that’s growing quickly (including cancer cells). But Xospata (gilteritinib) works in a more specific, targeted way. This medication blocks a protein called FLT3 that’s often mutated in AML. By blocking this mutated FLT3 protein, Xospata (gilteritinib) helps stop these leukemia cells from growing and spreading. Usually, people take Xospata (gilteritinib) after they’ve already tried chemotherapy.
                Can I take Xospata (gilteritinib) if I have AML but I don’t have an FLT3 mutation?
                No. Xospata (gilteritinib) is only approved for people with AML who also have a specific FLT3 mutation. There are other medications, such as certain chemotherapy, that can treat AML that aren’t specific to a mutation. Talk with your oncologist about the treatment options that are best for you if you have AML without an FLT3 mutation.
                Does Xospata (gilteritinib) cause differentiation syndrome?
                Though rare, some people who took Xospata (gilteritinib) have had a serious immune reaction to the medication called differentiation syndrome. This immune response causes too much inflammation in the body, leading to potentially life-threatening reactions. Differentiation syndrome is a medical emergency, so get help right away if you notice symptoms, including fever, trouble breathing, sudden weight gain, chest pain, and low blood pressure. You’ll need treatment to help these symptoms get better. Your oncologist will determine whether you should continue Xospata (gilteritinib) or take a break from the cancer medication as your symptoms improve.
                What medications should I not take with Xospata (gilteritinib)?
                Speak with your oncologist about the medications that you might want to avoid while you’re taking Xospata (gilteritinib). Certain medications can interact with Xospata (gilteritinib). Some medications, like carbamazepine (Tegretol) and St. John’s wort, can make your cancer treatment work less well. And other medications, like clarithromycin and diltiazem (Cardizem), can make Xospata (gilteritinib) reach higher levels in the body and raise your risk for side effects from the cancer medication. What’s more, Xospata (gilteritinib) might also make certain antidepressants work less well. It’s important for your healthcare team to review your medication list to make sure all your medications are safe to take together. They might suggest alternative medications, dose adjustments, and more frequent follow-ups.
                Why do I need an electrocardiogram (EKG) to take Xospata (gilteritinib)?
                Some people who take Xospata (gilteritinib) can develop changes in their heart rhythm. This doesn’t always cause symptoms. So the best way for your oncologist to check for this side effect is through a test called an electrocardiogram (ECG or EKG), which looks at the electrical activity of your heart. You’ll need an EKG before you start taking Xospata (gilteritinib), once a week for 2 weeks after you start, and then once a month for the next two months. Your oncologist might decide to pause your treatment or lower your dose if you have heart rhythm changes on your EKG.
                How long should I take Xospata (gilteritinib) for?
                Typically, your oncologist will recommend that you continue Xospata (gilteritinib) as long as it’s working for you and as long as you’re not having any bothersome or serious side effects. Your oncologist will keep track of how well the medication is working and how safe it is for you from your blood test and bone marrow biopsy results. Keep in mind that it can take at least 6 months of treatment before there’s noticeable improvement in your test results. During your regular visits, your healthcare team will ask you how you’re feeling. Let your care team know if you have severe side effects such as muscle pain, mouth sores, or tiredness. For some side effects, you might need to take a break from the medication until your symptoms get better. But in general, don’t stop taking Xospata (gilteritinib) without first discussing with your oncologist.
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                What are the risks and warnings for Xospata (gilteritinib)?

                Xospata (gilteritinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                risk-warning

                Differentiation syndrome

                Rarely, people who took Xospata (gilteritinib) developed a serious condition called differentiation syndrome. It’s an immune reaction that causes too much inflammation throughout the body, leading to possibly life-threatening problems. In studies, cases of differentiation syndrome happened as early as a day and up to 3 months after the start of treatment.

                Call 911 right away if you have symptoms of differentiation syndrome such as fever, trouble breathing, rapid weight gain, chest pain, and low blood pressure. Differentiation syndrome is a medical emergency so it’s important to get treated as soon as possible.

                You’ll typically need treatment with corticosteroids, such as dexamethasone, and sometimes other medications to keep your blood pressure up. If your symptoms are severe or if they last for more than a few days, you might need to stop Xospata (gilteritinib) until they get better with treatment.

                risk-warning

                Serious nervous system problem

                Some people who took Xospata (gilteritinib) developed a rare condition called posterior reversible encephalopathy syndrome (PRES). This condition affects the brain and can lead to symptoms such as vision changes, confusion, seizures, and sometimes loss of consciousness or coma. Get medical help right away if you have these symptoms so you can get examined. You’ll need to completely stop taking Xospata (gilteritinib) if you develop PRES.

                risk-warning

                Heart rhythm changes

                • Risk factors: History of abnormal heart rhythms | Taking other medications that can affect heart rhythm

                  It’s possible for Xospata (gilteritinib) to make the time it takes for your heart to relax after it contracts become longer. This is called QT prolongation and can lead to changes in heart rhythm. Seek medical help right away if you have sudden chest pain, feel very dizzy, or pass out.

                  Your oncologist will check for heart rhythm changes before you start Xospata (gilteritinib) and during treatment. You’ll need blood work done to check your electrolyte levels because this can affect your heart rhythm. You’ll also need to get a test called an electrocardiogram (EKG) to check the electrical activity of your heart. If you have heart rhythm changes on your EKG, your oncologist might pause your treatment and then restart the medication at a lower dose.

                  risk-warning

                  Swelling of the pancreas (pancreatitis)

                  Though uncommon, some people who take Xospata (gilteritinib) can develop swelling in their pancreas, or pancreatitis. Contact a healthcare professional if you have stomach pain that might spread to your back, fever, nausea, or vomiting. These can be symptoms of pancreatitis. You might need to take a break from treatment while your care team looks into it. After your pancreas gets better, you might need to restart Xospata (gilteritinib) at a lower dose.

                  risk-warning

                  Harm to unborn baby

                  • Risk factors: Pregnancy

                    Based on animal studies and the way the medication works, Xospata (gilteritinib) might harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when it’s taken during pregnancy. Because of these risks, your oncologist might require you to have a negative pregnancy test before you start treatment.

                    It’s important to avoid becoming pregnant during your cancer treatment with Xospata (gilteritinib). If you’re a female who can get pregnant, use birth control while you’re taking this medication and for another 6 months after the last dose. And if you’re a male and your partner can get pregnant, you should use condoms while you’re taking Xospata (gilteritinib) and for 4 more months after the last dose. Contact your oncologist right away if you become pregnant while you’re taking Xospata (gilteritinib).

                    dosage

                    Xospata (gilteritinib) dosage forms

                    Typical dosing for Xospata (gilteritinib)

                    The typical dose is 120 mg by mouth once a day.

                    alternatives

                    What are alternatives to Xospata (gilteritinib)?

                    There are a number of medications that your doctor can prescribe in place of Xospata (gilteritinib). Compare a few possible alternatives below.
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                    References

                    Best studies we found

                    American Cancer Society. (2019). Chemotherapy safety.

                    American Cancer Society. (2021). How targeted therapies are used to treat cancer.

                    American Cancer Society. (2024). Neutropenia (low white blood cell counts).

                    View All References (16)

                    American Cancer Society. (2024). Targeted therapy drugs for acute myeloid leukemia (AML).

                    Astellas Pharma Inc. (2018). Xospata® (gilteritinib) approved by U.S. FDA for adult patients and relapsed/refractory acute myeloid leukemia (AML) with a FLT3 mutation.

                    Astellas Pharma US, Inc. (2022). Xospata- gilteritinib tablet [package insert]. DailyMed.

                    Fathi, A. T., et al. (2021). Differentiation syndrome with lower-intensity treatments for acute myeloid leukemia. American Journal of Hematology.

                    Kennedy, V. E., et al. (2020). FLT3 mutations in acute myeloid leukemia: Key concepts and emerging controversies. Frontiers in Oncology.

                    Leukemia & Lymphoma Society. (n.d.). Bone marrow tests.

                    National Cancer Institute. (n.d.). Leukemia–Patient version.

                    National Cancer Institute. (2024). Acute myeloid leukemia treatment (PDQ®) – Patient version.

                    National Center for Complementary and Integrative Health. (2020). St. John’s wort.

                    National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.

                    National Comprehensive Cancer Network. (2024). Acute myeloid leukemia.

                    National Institute of Diabetes and Digestive and Kidney Diseases. (2017). Symptoms & causes of pancreatitis.

                    National Institutes of Health. (n.d.). Stem cell basics.

                    Olivero, J. J., Sr. (2016). Cardiac consequences of electrolyte imbalance. Methodist DeBakey Cardiovascular Journal.

                    Patel, K., et al. (2017). Febrile neutropenia. JAMA Oncology.

                    Triplett, J. D., et al. (2022). Posterior reversible encephalopathy syndrome (PRES): Diagnosis and management. Practical Neurology.

                    GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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