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Xospata Information

Xospata (Gilteritinib) is used to treat acute myeloid leukemia in adults. It is specifically for cases where the cancer has either returned after a period of improvement (relapsed) or did not respond to previous treatments (refractory). It is only effective if the leukemia cells have a specific genetic marker, a FLT3 mutation, which a doctor must confirm with a blood or bone marrow test before starting the drug. The active ingredient is gilteritinib, a tyrosine kinase inhibitor.

Acute myeloid leukemia (AML) is a fast-growing cancer where the bone marrow produces too many immature white blood cells (blast cells). These blast cells are dysfunctional; they can’t fight infection, and they crowd out healthy blood cells, leading to fatigue, bruising, and frequent illness. When FLT3 is mutated, leukemia is typically more aggressive. This mutation basically sends a constant signal to the cell to keep dividing and growing uncontrollably. Gilteritinib is a tyrosine kinase inhibitor that blocks FLT3 signaling and also inhibits AXL, a kinase associated with treatment resistance. This cuts off the growth signals, causing the cancer cells to stop multiplying and eventually die. By inhibiting FLT3 signaling, Xospata can slow leukemia cell growth and help reduce leukemic blasts in the bone marrow, which may allow normal blood cell production to recover and may lead to remission in some patients. For many, this provides a vital window of time to become healthy enough for a bone marrow transplant, which is often the ultimate goal for a long-term cure. Xospata is also uniquely able to block a second protein, AXL, which cancer cells sometimes use to become resistant to other treatments.

Xospata Side Effects

Like other medications, gilteritinib is associated with some side effects. Some common side effects of this medication include constipation, cough, decreased appetite, diarrhea, dizziness, fatigue, general feeling of being unwell, headache, joint pain, muscle pain, nausea, skin rash, strange taste in the mouth, stomach pain, swelling in the feet, ankles, and hands, vomiting, and weakness. Contact your doctor if these mild side effects persist or worsen.

Stop taking this medicine and contact your doctor immediately if you experience any serious side effects, including the following:
• Allergic reactions such as breathing difficulties, body itching, body rash, skin blistering, swelling of the face, mouth, tongue, lips, or throat;
• Anemia (low red blood cells) with symptoms like dizziness, pale skin, unusual tiredness or weakness;
• Clotting problems with symptoms like unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums;
• Electrolyte imbalances with symptoms such as weakness, tremor, muscle cramps, seizures, irregular heartbeat;
• Fluid build-up around the lungs with symptoms like chest pain, cough, hiccups, and rapid breathing;
• Heart problems with symptoms like fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing;
• Inflammation of the mouth and lips;
• Kidney problems with symptoms like a change in the amount or colour of urine, increased urination at night, and blood in the urine;
• Posterior reversible encephalopathy syndrome with symptoms such as headache, seizures, weakness, confusion, and high blood pressure;
• Signs of infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck

Inform your doctor about any other side effects you notice that are not listed here.

Xospata Precautions

Do not use this medication if you are allergic to gilteritinib, other ingredients in Xospata, or any other medications. Before you start taking this medication, ensure that you inform your doctor about any prior or current medical conditions, including the following:
• Breathing problems;
• Electrolyte imbalances such as abnormal potassium or magnesium levels;
• Heart disease;
• Liver disease;
• Pancreatitis

Gilteritinib can cause severe dizziness or fainting, which may impair your ability to drive or operate machinery safely. Therefore, do not drive or perform hazardous tasks such as operating machinery until you know how this medication affects you. Do not use this medication during pregnancy as gilteritinib can cause fetal harm or death. A pregnancy test is required 7 days before starting this medication. You must use highly effective birth control during treatment and for 6 months after your last dose. If you use hormonal birth control (the pill/patch), you should add a barrier method (like condoms) because Xospata might make hormonal contraceptives less effective. It is unknown if the drug passes into breast milk, but because of the risk of serious side effects in an infant, you should not breastfeed during treatment and for at least 2 months after the final dose. Men with female partners who could become pregnant should use effective contraception (condoms) during treatment and for 4 months after the last dose to prevent any potential risk to a fetus. It is not recommended for use in children.

Medicines like certain antifungals (itraconazole, voriconazole) or antibiotics (clarithromycin) can raise Xospata levels in your blood to dangerous, toxic levels. Therefore, before taking this medication, inform your doctor about any other medications you are currently taking, including herbal medicines, to determine if it is safe to use along with Xospata. Take your Xospata tablets at the same time every single day to keep the medicine level steady in your blood. Swallow the tablets whole with a full glass of water. You may choose to take them with food or on an empty stomach, but you must never crush or chew them. It is important to take this medication exactly as prescribed by your doctor. Check out the leaflet in the medication pack for more usage instructions. Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do I need a prescription to order Xospata?

Yes, a prescription is required from your physician to order Xospata.