Xospata (gilteritinib)

FDA warning: Differentiation syndrome

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Xospata may cause differentiation syndrome, a dangerous condition in which certain cells change and grow in number. Symptoms may include shortness of breath, fever, sudden weight gain, and low blood pressure. They may also include symptoms of kidney problems, such as urinating less than usual, or having swelling in your legs, ankles, or feet.

If your doctor thinks that you have differentiation syndrome, they will give you a steroid and may pause your treatment with Xospata. They may also monitor the blood pressure and blood flow in your heart and lungs.

What is Xospata?

Xospata is a brand-name prescription medication. It’s used to treat a specific form of acute myeloid leukemia (AML) in adults whose cancer relapsed (returned) or didn’t respond to other treatments. Leukemia is a form of cancer that affects the body’s white blood cells.

Xospata is used in adults with AML who have an FMS-like tyrosine kinase 3 (FLT3) gene mutation. A gene mutation means that a specific gene isn’t working the way it should. (If you have AML, you should be tested to see if you have the FLT3 gene mutation.)

Xospata contains the drug gilteritinib, which belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). TKIs are targeted therapies that work by “targeting” and attacking cancer cells.

Xospata is available as a tablet that you swallow. The drug comes in one strength: 40 mg.

Effectiveness

A clinical study compared Xospata to certain kinds of chemotherapy and looked at complete remission. Cancer remission is when cancer symptoms have lessened or can’t be detected.

After taking Xospata, 14.2% of people had complete remission, compared to 10.5% of people who received chemotherapy. People who took Xospata also stayed in remission longer (by about 13 months) and lived longer (by about four months) than people who received chemotherapy.

FDA approval

The Food and Drug Administration (FDA) approved Xospata in 2018.

Xospata generic

Xospata is available only as a brand-name medication. It’s not currently available in generic form.

Xospata contains the active drug ingredient gilteritinib.

Xospata side effects

Xospata can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Xospata. This list does not include all possible side effects.

For more information on the possible side effects of Xospata, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Xospata can include:

• muscle and joint pain
• increased levels of liver enzymes (can be a sign of liver damage)
• increased levels of bilirubin (broken down blood cells)
• tiredness
• cough
• fever
• edema (swelling under the skin, usually in the face, hands, feet, or limbs)
• diarrhea
• constipation
• nausea
• swelling or sores in your mouth
• vomiting
• trouble breathing
• skin rash
• headache
• dizziness
• low blood pressure

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xospata aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

• posterior reversible encephalopathy syndrome (brain swelling)
• abnormal heart rhythm
• pancreatitis (swelling of your pancreas)
• differentiation syndrome,* in which certain cells change and grow in number. Symptoms may include:
• shortness of breath
• fever
• sudden weight gain
• low blood pressure
• symptoms of kidney problems, such as urinating less than usual, or having swelling in your legs, ankles, or feet

* Xospata has a boxed warning for differentiation syndrome. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Xospata. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. According to a press release about a Xospata clinical trial, 1% of adults had a severe allergic reaction to the drug. Symptoms of a severe allergic reaction can include:

• angioedema (swelling under your skin, typically in your eyelids, lips, or cheeks)
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Xospata. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Posterior reversible encephalopathy syndrome (brain swelling)

Taking Xospata may cause posterior reversible encephalopathy syndrome (PRES). PRES is a neurological condition in which the back part of your brain swells. In a clinical study, 1% of adults treated with Xospata developed PRES. Symptoms of PRES can include:

• seizures
• severe headaches that don’t respond to medication
• confusion
• vision problems such as trouble seeing or visual hallucinations (seeing things that aren’t there)

If you have symptoms of PRES, call your doctor right away. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Abnormal heart rhythm

Taking Xospata may cause heart rhythm problems by increasing your QT interval. This is a measurement of how long it takes your heart to recharge between beats.

An abnormal heart rhythm can become severe and life-threatening if not controlled. The risk of this side effect is higher in people who have low levels of magnesium or potassium in their body. In a clinical study, 7% of adults treated with Xospata had abnormal heart rhythms.

Symptoms of an abnormal heart rhythm can include:

• heartbeat that’s too fast, too slow, or irregular
• feeling of pressure in your chest
• dizziness or lightheadedness
• fainting

If you notice symptoms of an abnormal heart rhythm, call your doctor right away. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Pancreatitis

In clinical studies, reports of pancreatitis (swelling of the pancreas) were rare. In clinical studies, 4% of people treated with Xospata had pancreatitis. Symptoms of pancreatitis can include:

• pain or tenderness in your belly
• back pain
• nausea
• vomiting
• fever
• weight loss

If you experience of these symptoms while taking Xospata, talk with your doctor. Your doctor may pause your Xospata treatment or give you a lower dose.

Xospata dosage

The Xospata dosage your doctor prescribes will depend on several factors. These include:

• the severity of your condition
• other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

If you take Xospata and begin having serious side effects, your doctor may pause your treatment. Then they may start treatment again and give you a lower dose of the drug. This may help decrease or prevent side effects.

Drug forms and strengths

Xospata is available as a tablet that you swallow. Each tablet has a strength of 40 mg.

Dosage for acute myeloid leukemia

The recommended dose of Xospata to treat acute myeloid leukemia (AML) is 120 mg. You take the tablets by mouth (swallowing them) once a day.

If you have serious side effects while taking Xospata, your doctor may pause your treatment. Once the serious side effects have eased or stopped, your doctor may have you take 80 mg of the drug once a day.

What if I miss a dose?

If you miss a dose of Xospata, take the dose as soon as you remember if it’s 12 hours or longer until your next dose. If it’s within 12 hours of your next scheduled dose, wait to take your next scheduled dose. Don’t take more than one dose within 12 hours.

Medication reminders can help make sure that you don’t miss a dose.

Will I need to use this drug long term?

Xospata is meant to be used as a long-term treatment. If you and your doctor determine that Xospata is safe and effective for you, you’ll likely take it long term. If you start having serious side effects, your doctor may have you stop taking Xospata.

Xospata cost

As with all medications, the cost of Xospata can vary. To find current prices for Xospata in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Xospata, or if you need help understanding your insurance coverage, help is available.

Astellas Pharma US, Inc., the manufacturer of Xospata, offers Xospata Support Solutions and the Xospata Copay Card Program. For more information and to find out if you’re eligible for support, call 844-632-9272 or visit the program website.

Xospata for AML

The Food and Drug Administration (FDA) approves prescription drugs such as Xospata to treat certain conditions.

Xospata is approved to treat acute myeloid leukemia (AML) in adults with an FMS-like tyrosine kinase 3 (FLT3) gene mutation. A gene mutation means that a specific gene isn’t working the way it should. To be able to take Xospata, the AML must have returned or didn’t respond to other treatments.

AML is a form of cancer that affects certain white blood cells in your bone marrow.

Bone marrow usually makes healthy cells, including red blood cells, white blood cells, and platelets. But when you have AML, the cancer makes too many blasts (immature blood cells), which crowd out healthy blood cells. This makes it harder for your body to create normal blood cells.

A clinical study compared Xospata to certain kinds of chemotherapy and looked at complete remission. Cancer remission is when cancer symptoms have lessened or can’t be detected. After taking Xospata, 14.2% of people had complete remission, compared to 10.5% of people who received chemotherapy. People who took Xospata also stayed in remission longer (by about 13 months) and lived longer (by about four months) than people who received chemotherapy.

Testing for FLT3 gene mutation

If you have AML, you should be tested to see if you have the FLT3 gene mutation. In 2018, the Food and Drug Administration (FDA) approved a test to check for this mutation. Your doctor can tell you more.

Xospata and alcohol

There aren’t any known interactions between alcohol and Xospata at this time. However, heavy alcohol use may cause pancreatitis (swelling of your pancreas). Pancreatitis is a serious side effect that can also occur when you take Xospata. Therefore, avoid heavy drinking while taking Xospata.

If you drink alcohol, talk with your doctor. They can tell you how much alcohol is safe for you to drink while taking Xospata.

Alternatives to Xospata

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Xospata, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

Alternatives for acute myeloid leukemia

Examples of other drugs that may be used to treat acute myeloid leukemia (AML) include:

• Chemotherapies, such as:
• cytarabine (Ara-C)
• daunorubicin (Cerubidine)
• idarubicin (Idamycin)
• azacitidine (Vidaza)
• decitabine (Dacogen)
• Targeted therapies, such as:
• midostaurin (Rydapt)
• sorafenib (Nexavar)

Xospata vs. Nexavar

You may wonder how Xospata compares to other medications that have similar uses. Here we look at how Xospata and Nexavar are alike and different.

Uses

The Food and Drug Administration (FDA) has approved Xospata to treat adults with acute myeloid leukemia (AML) that relapsed (returned) or didn’t respond to other treatments. Specifically, Xospata treats a certain type of AML that has an FMS-like tyrosine kinase 3 (FLT3) gene mutation. A gene mutation means that a specific gene isn’t working the way it should.

The FDA hasn’t approved Nexavar to treat adults with AML and the FLT3 gene mutation. However, based on a treatment guideline, Nexavar has been recommended for use in certain people with AML. If your doctor prescribes Nexavar for your AML, you must also take a chemotherapy drug.

Nexavar has been FDA-approved to treat other conditions, including:

• liver cancer that’s inoperable (doctors can’t remove it surgically)
• advanced kidney cancer
• progressive thyroid cancer that has returned or spread after treatment with radioactive iodine

Xospata contains the drug gilteritinib. Nexavar contains the drug sorafenib.

Drug forms and administration

Xospata is available as a tablet that you swallow. The drug has one strength: 40 mg. The recommended dosage of Xospata is 120 mg once a day. That’s a total of three tablets.

Nexavar is available as a tablet that you swallow. The drug has one strength: 200 mg. The recommended dose of Nexavar is 400 mg twice a day. That’s a total of four tablets. You take Nexavar at least one hour before a meal or two hours after a meal.

Side effects and risks

Xospata and Nexavar are both in the same class of drugs: tyrosine kinase inhibitors (TKIs). Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Xospata, with Nexavar, or with both drugs (when taken individually).

• Can occur with Xospata:
• cough
• low blood pressure
• muscle and joint pain
• increased levels of liver enzymes (can be a sign of liver damage)
• increased levels of bilirubin (broken down blood cells)
• fever
• edema (swelling under the skin, usually in the face, hands, feet, or limbs)
• constipation
• trouble breathing
• headache
• dizziness
• Can occur with Nexavar:
• Can occur with both Xospata and Nexavar:
• swelling or sores in your mouth
• diarrhea
• tiredness
• skin rash
• nausea
• vomiting

Serious side effects

These lists contain examples of serious side effects that can occur with Xospata, with Nexavar, or with both drugs (when taken individually).

• Can occur with Xospata:
• posterior reversible encephalopathy syndrome (brain swelling)
• pancreatitis (swelling of your pancreas)
• Can occur with Nexavar:
• anorexia
• heart disease
• hemorrhage (major bleeding)
• Stevens-Johnson syndrome (painful sores and rash on your mouth, throat, eyes, or genitals)
• ruptured stomach or intestine
• liver damage
• Can occur with both Xospata and Nexavar:
• abnormal heart rhythm
• severe allergic reaction

Effectiveness

The FDA has approved Xospata to treat adults with acute myeloid leukemia (AML) that relapsed (returned) or didn’t respond to other treatments. Specifically, Xospata treats a certain type of AML that has an FMS-like tyrosine kinase 3 (FLT3) gene mutation. A gene mutation means that a specific gene isn’t working the way it should.

Nexavar may be used off-label to treat AML with a FLT3 mutation, in combination with a chemotherapy drug. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

These drugs haven’t been directly compared in clinical studies, but studies have found both Xospata and Nexavar to be effective for treating AML with an FLT3 mutation.

Costs

Xospata and Nexavar are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Xospata costs more than Nexavar. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Xospata interactions

Xospata can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Xospata and other medications

Below are lists of medications that can interact with Xospata. These lists don’t contain all drugs that may interact with Xospata.

Before taking Xospata, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that may increase the effects of Xospata

Some medication can slow down your body’s ability to break down Xospata. This can raise levels of Xospata in your body. You may be at more risk for side effects if this happens.

To avoid an increase in the number or strength of side effects, don’t take Xospata with any of the medications listed below. If you’re currently taking any of these medications, talk with your doctor about your risk for side effects.

Examples of medications that may increase the effects of Xospata includes:

• Certain antimicrobials, such as:
• clarithromycin (Biaxin)
• fluconazole (Diflucan)
• itraconazole (Sporanox)
• ketoconazole (Nizoral, Extina, others)
• Certain HIV medications, such as:
• atazanavir (Reyetaz)
• ritonavir (Norvir)
• saquinavir (Invirase)
• Certain heart medications, such as:
• diltiazem (Cartia, Diltzac)
• verapamil (Calan, Ispotin)
• Certain antidepressants, such as:
• escitalopram (Lexapro)
• fluoxetine (Prozac)
• sertraline (Zoloft)
• Other medications, such as:
• tamoxifen (Nolvadex, Soltamox)
• cyclosporine (Gengraf, Neoral, Sandimmune)

Drugs that may decrease the effects of Xospata

Some medications increase your body’s ability to break down Xospata. This can decrease how well Xospata works in your body. Examples of these medications include:

• Antiseizure medications, such as:
• carbamazepine (Carbatrol, Equetro, Tegretol)
• phenytoin (Dilantin)
• fosphenytoin (Cerebyx)
• Other medications, such as:
• modafinil (Nuvigil, Provigil)
• rifampin (Rifadin, Rifamate)

Xospata and herbs and supplements

Taking St. John’s wort with Xospata can decrease how well Xospata works for you.

If you take St. John’s wort, talk with your doctor. They may want to change your dosage of Xospata or St. John’s wort. Or they may want you to stop taking St. John’s wort.

Xospata and foods

Avoid eating grapefruit or drinking grapefruit juice while taking Xospata. The fruit or juice can interfere with how Xospata breaks down in your body. This can increase the amount of the drug in your body to dangerous levels. Talk with your doctor if you have any concerns.

How to take Xospata

You should take Xospata according to your doctor or healthcare provider’s instructions.

When to take

You take Xospata once a day. Be sure to take it at the same time each day.

Medication reminders can help make sure that you don’t miss a dose.

Taking Xospata with food

You can take Xospata with or without food.

Can Xospata be crushed, split, or chewed?

No. You shouldn’t crush, split, or chew Xospata. Swallow the tablets whole with a cup of water.

How Xospata works

Acute myeloid leukemia (AML) is a form of cancer that affects certain white blood cells in your bone marrow.

Bone marrow usually makes healthy cells, including red blood cells, white blood cells, and platelets. But when you have AML, the cancer makes too many blasts (immature blood cells), which crowd out healthy blood cells. This makes it harder for your body to create normal blood cells.

Xospata is used to treat a specific form of AML in adults whose cancer relapsed (returned) or didn’t respond to other treatments. The AML must also have an FMS-like tyrosine kinase 3 (FLT3) gene mutation. A gene mutation means that a specific gene isn’t working the way it should. The FLT3 mutation makes blasts spread even more, so they’re more likely to return after treatment.

Xospata belongs to the class of drugs called tyrosine kinase inhibitors (TKIs). TKIs are targeted therapies that “target” and attack cancer cells. Xospata works by binding to cancer cells that have the FLT3 mutation. The drug kills these cancer cells, making room for normal healthy cells.

How long does it take to work?

In people who respond to Xospata, the treatment often works within two months. How fast Xospata begins to work and how effective it is depends on your body and your health history. Factors that affect how fast it works include:

• the severity of your condition
• previous treatment you’ve had for the condition
• type of FLT3 mutation you have

Your doctor can see how well your AML treatment is working by measuring the number of cancer cells in your body. You may or may not notice improvements in symptoms because anticancer drugs can have many side effects.

In a clinical study, some people had a response as early as about 27 days after they started taking Xospata. This means their cancer went into:

• complete remission (cancer symptoms lessened or couldn’t be detected), or
• complete remission with partial recovery of their blood counts (their white blood cell and platelet counts hadn’t returned to an acceptable range)

Xospata and pregnancy

You shouldn’t take Xospata if you’re pregnant or are planning to become pregnant. In animal studies, Xospata was extremely harmful to the fetus when the mother was given the drug.

Women should take a pregnancy test one week before they start using Xospata. This helps ensure that they’re not pregnant when they start treatment with the drug.

If you have concerns about pregnancy and taking Xospata, talk with your doctor.

Birth control while taking Xospata

Women should use birth control while taking Xospata and for at least six months after their last dose.

Men should also use birth control (such as condoms) while taking Xospata if their female sexual partner can become pregnant. It’s vital to do this even if the female is using birth control, too. Men should keep using birth control for at least four months after their last dose of Xospata. This helps prevent their partners from getting pregnant while being exposed to the drug.

Xospata and breastfeeding

It isn’t known whether Xospata passes into human breast milk. Animal studies showed that Xospata passed into babies through breast milk from their mothers.

Because of the possible dangers to children who are breastfed, you shouldn’t breastfeed while taking Xospata. You should also avoid breastfeeding for at least two months after you take your last dose of the drug.

If you have any concerns about breastfeeding and taking Xospata, talk with your doctor.

Common questions about Xospata

Here are answers to some frequently asked questions about Xospata.

Can I take Vitrakvi instead of Xospata?

No. The Food and Drug Administration (FDA) hasn’t approved Vitrakvi to treat the same conditions that Xospata does.

Vitrakvi is used to treat solid tumors in adults and children. Xospata is approved to treat acute myeloid leukemia (AML) in adults.

Why can’t I get Xospata at my local drugstore?

Xospata isn’t available at regular drugstores because it’s a specialty drug. Specialty drugs are typically high-cost medications that are used to treat complex health conditions. They’re usually only available through specialty pharmacies.

Your doctor will likely send your prescription to a specialty pharmacy, which will ship Xospata directly to you. It also might be possible to get Xospata in your doctor’s office. Talk with your doctor to find out more.

If you have any questions about specialty pharmacies, ask your insurance company.

Is Xospata a form of chemotherapy?

No, Xospata isn’t a kind of chemotherapy. Xospata is a type of drug called a tyrosine kinase inhibitor (TKI), which is considered a targeted therapy. Targeted therapy works by “targeting” and attacking cancer cells.

Chemotherapy medications differ from targeted therapies. Chemotherapy drugs act on all cells in the body that are growing quickly, not just cancer cells. Chemotherapy medications usually kill the growing cells and affect more cells in the body than targeted therapy does.

Can I take Xospata before or after a stem cell transplant?

Yes, you can take Xospata before or after a stem cell transplant.

A stem cell transplant is a possible treatment option for acute myeloid leukemia (AML). Stem cells help your body make new and healthy bone marrow cells. You may get stem cells from a donor. Or you can use your own if your doctor previously removed and stored some of your own stem cells.

Will Xospata cure my acute myeloid leukemia?

Xospata isn’t a cure for acute myeloid leukemia (AML), but it may help you reach remission. This is when tests no longer show any cancer cells in your blood or bone marrow. Your blood cell counts also return to a normal level, and your cancer symptoms go away.

The goal of treating leukemia is for you to go into remission. Some people stay in remission for the rest of their lives while others relapse (have a return of their cancer).

Xospata warnings

This drug comes with several warnings.

FDA warning: Differentiation syndrome

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Xospata may cause differentiation syndrome, a dangerous condition in which certain cells change and grow in number. Symptoms may include shortness of breath, fever, sudden weight gain, and low blood pressure. They may also include symptoms of kidney problems, such as urinating less than usual, or having swelling in your legs, ankles, or feet.

If your doctor thinks that you have differentiation syndrome, they will prescribe you a steroid and may pause your treatment with Xospata. They may also monitor the blood pressure and blood flow in your heart and lungs.

Other warnings

Before taking Xospata, talk with your doctor about your health history. Xospata may not be right for you if you have certain medical conditions. These include:

• Heart problems. Xospata may affect your heart rhythm. If you have a heart condition, especially long QT syndrome, talk with your doctor about possible risks before taking Xospata.
• Low levels of magnesium or potassium. If have low levels of magnesium or potassium, your doctor will work with you to address them before and while you take Xospata. If you have any questions about your magnesium or potassium levels, talk with your doctor.
• Pancreas problems. Xospata may cause pancreatitis (swelling of your pancreas). If you have a history of problems with your pancreas, talk with your doctor about possible risks before taking Xospata.
• Pregnancy. Xospata has been shown to cause life-threatening harm to fetuses in animal studies. You shouldn’t take Xospata if you’re pregnant or planning to become pregnant. Both men and women should use birth control during and after treatment with Xospata. Talk with your doctor if you have concerns about pregnancy and taking Xospata.
• History of allergic reactions. Some people had allergic reactions to Xospata in clinical trials. If you’re allergic to gilteritinib or any other ingredients in Xospata, tell your doctor.

Note: For more information about the potential negative effects of Xospata, see the “Xospata side effects” section above.

Xospata overdose

Using more than the recommended dosage of Xospata can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

• seizures
• trouble breathing
• loss of consciousness

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Xospata expiration, storage, and disposal

When you get Xospata from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Xospata tablets should be stored at room temperature. Keep Xospata away from light and moisture, and out of the reach of children.

Disposal

If you no longer need to take Xospata and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Professional information for Xospata

The following information is provided for clinicians and other healthcare professionals.

Indications

Xospata is approved by the Food and Drug Administration (FDA) to treat acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation in adults who are relapsed or refractory. The FLT3 mutation should be detected by an FDA-approved test.

Mechanism of action

Xospata is a tyrosine kinase inhibitor (TKI). This drug class works by blocking specific genes, proteins, or tissues and attacking cancer cells. Xospata inhibits FLT3 in leukemic cells by binding to their FLT3 receptors. This leads to inhibition of cell proliferation and causes apoptosis.

Pharmacokinetics and metabolism

Xospata reaches steady state within 15 days based on 120-mg daily dosing. The average steady state Cmax is 374 ng/mL, and drug exposure is proportional to dose. Fasting maximum concentration for absorption for the drug is seen between four to six hours.

Xospata’s half-life is 113 hours. It’s cleared at approximately 14.85 L/hr. Xospata is metabolized by CYP3A4 and about 64.5% is excreted in the feces. The amount excreted in the urine is 16.4%.

Contraindications

Xospata is contraindicated in people who are hypersensitive to Xospata or any of its ingredients.

Storage

Xospata tablets should be stored at controlled room temperature at 68°F to 77°F (20°C to 25°C) and kept in their original container until dispensed.

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 other 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.