Xospata

Xospata is a prescription medication used to treat acute myeloid leukemia (AML), a type of blood related cancer, caused by a certain genetic mutation.

Xospata belongs to a group of drugs called tyrosine kinase inhibitors. These work by blocking the effects of tyrosine kinase. Mutated tyrosine kinases in cancer cells regularly help cancer cells grow by providing certain growth signals.

This medication comes in tablet form and is taken once daily, with or without food. Do not chew, divide, or break Xospata tablets. Swallow tablets whole.

Common side effects include muscle pain, tiredness, and fever. Xospata can also cause dizziness. Do not drive or operate heavy machinery until you know how Xospata affects you.

Xospata is a prescription medicine used to treat adults with acute myeloid leukemia (AML) who have a FMS-like tyrosine kinase 3 (FLT3) mutation:

• when the disease has come back, or

• has not improved after previous treatment(s).

Your healthcare provider will perform a test to make sure that Xospata is right for you.

It is not known if Xospata is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xospata. See the “Xospata Precautions” section.

The most common side effects of Xospata include:

• Joint or muscle pain
• Changes in liver function tests
• Tiredness
• Fever
• Pain or sores in mouth or throat
• Swelling of arms or legs
• Diarrhea
• Shortness of breath
• Rash
• Constipation
• Nausea
• Cough
• Eye problems
• Headache
• Vomiting
• Low blood pressure
• Decreased urination

Xospata can also cause dizziness. Do not drive or operate heavy machinery until you know how Xospata affects you.

This is not a complete list of Xospata side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone

• Medications that block a receptor protein in the body (5H2b ) such as some selective serotonin reuptake inhibitors (SSRIs) (escitalopram, fluoxetine, sertraline)

This is not a complete list of Xospata drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xospata including:

Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life- threatening or lead to death if not treated. Differentiation syndrome can happen as early as 2 days after starting Xospata and during the first 3 months of treatment. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking Xospata:

• fever
• cough
• trouble breathing
• rash
• dizziness or lightheadedness
• rapid weight gain
• swelling of your arms or legs 
• decreased urination

If you develop any of these symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine and may monitor you in the hospital.

Posterior Reversible Encephalopathy Syndrome (PRES). If you take Xospata, you may be at risk of developing a condition involving the brain called PRES. Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision, or other visual problems. Your healthcare provider will do a test to check for PRES. Your healthcare provider will stop Xospata if you develop PRES.

Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before you start taking Xospata and during your treatment with Xospata. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint. The risk of QT prolongation is higher in people with low blood magnesium or low blood potassium levels. Your healthcare provider will do blood tests to check your potassium and magnesium levels before and during your treatment with Xospata.

Inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you have severe stomach (abdomen) pain that does not go away. This pain may happen with or without nausea and vomiting.

Xospata can also cause dizziness. Do not drive or operate heavy machinery until you know how Xospata affects you.

Do not take Xospata if you are allergic to Xospata or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xospata, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xospata, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have any heart problems, including a condition called long QT syndrome.

• have problems with abnormal electrolytes such as sodium, potassium, or magnesium levels.

• are pregnant or plan to become pregnant. Xospata can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with Xospata. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Xospata.

  • If you are able to become pregnant, your healthcare provider may perform a pregnancy test 7 days before you start treatment with Xospata.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Xospata and for at least 6 months after the last dose of Xospata.
  • Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Xospata and for at least 4 months after the last dose of Xospata.
• are breastfeeding or plan to breastfeed. It is not known if Xospata passes into your breast milk. Do not breastfeed during treatment with Xospata and for at least 2 months after the last dose of Xospata.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women. In animal studies, pregnant animals were given this medication and had some babies born with problems. 

Xospata can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with Xospata. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Xospata.

• If you are able to become pregnant, your healthcare provider may perform a pregnancy test 7 days before you start treatment with Xospata.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment with Xospata and for at least 6 months after the last dose of Xospata.
• Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Xospata and for at least 4 months after the last dose of Xospata.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Xospata crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment with Xospata and for at least 2 months after the last dose of Xospata.

• Take Xospata exactly as your healthcare provider tells you to. Do not change your dose or stop taking Xospata without talking to your healthcare provider.
• Take Xospata 1 time a day at about the same time each day.
• Swallow Xospata tablets whole. Do not break, crush, or chew the tablet.
• Xospata can be taken with or without food.
• If you miss a dose of Xospata, or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose. Return to your normal schedule the following day. Do not take 2 doses of Xospata within 12 hours.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Xospata (gilteritinib) for the treatment of treat acute myeloid leukemia (AML) caused by a certain genetic mutation is 120 mg once daily. Dose may be adjusted depending on certain side effects you experience.

If you take too much Xospata, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Xospata at room temperature between 68°F to 77°F (20°C to 25°C).

• Keep this and all medicines out of the reach of children.

• Keep this medication in its original container.

WARNING: DIFFERENTIATION SYNDROME

Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions and Adverse Reactions].