Patient Medication Information: uses, side effects, how to take - Xospata
Serious Warnings and Precautions
Differentiation Syndrome Differentiation syndrome is a condition that affects your blood cells which may be life threatening or lead to death if not treated. Differentiation syndrome has happened after starting Xospata. Call your healthcare professional or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking Xospata:
If you develop any of these symptoms of differentiation syndrome, your healthcare professional may start you on a medicine called corticosteroids and may monitor you in the hospital. |
What is Xospata used for?
Xospata is used to treat adults with acute myeloid leukemia (AML) with a FLT3 gene mutation. AML is a type of cancer of white blood cells. A test will confirm if you have the FLT3 kind of AML. It is used when:
- your AML has come back (relapsed) or;
- your AML has not improved after previous treatment (refractory).
How does Xospata work?
Xospata works by blocking certain enzymes of the cells that are not normal. It prevents cancer cells from growing and dividing. Xospata may also slow down or stop the cancer from growing. It also kills cancer cells.
What are the ingredients in Xospata?
Medicinal ingredients: gilteritinib
Non-medicinal ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, polyethylene glycol, talc, titanium dioxide
Xospata comes in the following dosage forms:
40 mg tablets
Do not use Xospata if:
- You are allergic to gilteritinib or any of the other ingredients.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Xospata. Talk about any health conditions or problems you may have, including if you:
- are under 18 years of age.
- have fever, trouble breathing, rapid weight gain, swelling of the arms and legs.
- have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, or eye problems.
- have heart disorders; irregular heartbeat, have severe pain in the upper abdomen and back, nausea and vomiting.
- have a history of low levels of potassium or magnesium in your blood.
- have liver problems.
- have kidney problems.
Other warnings you should know about:
Driving and using machines:
You may feel dizzy while using Xospata. Give yourself time after taking Xospata to see how you feel before driving a vehicle or using machinery.
Breast-feeding and pregnancy:
Tell your doctor if you:
- are breast-feeding.
- are pregnant.
- think you might be pregnant.
- are planning to have a baby.
Do not take Xospata if you are pregnant. Xospata may harm your unborn baby. If you could get pregnant, take a pregnancy test 7 days before taking Xospata. You must use effective birth control while you are taking Xospata and for 6 months after you stop taking it. Male patients should use condoms during sex during treatment and for 4 months after stopping Xospata.
Your doctor will talk to you about the risks of taking Xospata if you are breast-feeding or pregnant. Breast-feeding should be stopped during treatment and for at least 2 months after stopping Xospata.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Xospata:
- medicines that are used to treat heart problems, such as digoxin;
- medicines that are used for the prevention of blood clots, such as dabigatran etexilate;
- medicines that are used to treat diabetes, such as metformin;
- medicines that are used to treat elevated cholesterol level, such as rosuvastatin;
- medicines that are used to treat multiple sclerosis, such as mitoxantrone;
- medicines used to treat tuberculosis, such as rifampicin;
- medicines used to treat epilepsy, such as phenytoin;
- St. John’s Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression;
- medicines used to treat fungal infections such as voriconazole, posaconazole or itraconazole;
- medicines used to treat bacterial infections such as erythromycin, clarithromycin or azithromycin;
- medicines used to treat high blood pressure (hypertension) such as captopril or carvedilol;
- medicines used to treat infections with the human immunodeficiency virus (HIV) such as ritonavir;
- medicines used to treat depression such as escitalopram, fluoxetine or sertraline.
How to take Xospata:
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking Xospata
- 1 time per day at the same time each day.
- Swallow the tablets whole with water.
- Do not break or crush the tablets.
Take with or without food.
- Continue taking Xospata for as long as your doctor tells you.
Usual dose:
The usual dose is 120 mg (three tablets) once a day.
Your doctor may adjust your treatment based on how you react to Xospata. Your doctor may also stop your treatment for a period of time. Continue treatment at the dose prescribed by your doctor.
Overdose:
| If you think you have taken too much Xospata, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed dose:
If you forget to take Xospata at the usual time, take your usual dose as soon as you remember on the same day and take your next dose at the usual time on the next day. If you miss your dose, and it is within 12 hours to your next dose, skip the dose and take the next dose at the usual time on the next day. Do not take a double dose to make up for a forgotten dose. If you throw up the drug, do not take another dose on the same day; take your next dose at the usual time on the next day.
What are possible side effects from using Xospata?
These are not all the possible side effects you may feel when taking Xospata. If you experience any side effects not listed here, contact your healthcare professional.
- Diarrhea
- Feeling tired (fatigue)
- Nausea
- Constipation
- Cough
- Swelling due to fluid retention
- Dizziness
- Headache
- Low appetite
- Stomach pain
- Vomiting
- Inflammation of the mouth and lips
- Fever
- Feeling weak
- Pain, numbness, or weakness in hands and feet
- Muscle pain
- Joint pain
- Vague feeling of discomfort or feeling unwell
- Skin rash
- Strange taste in the mouth
During Xospata treatment, you may also have side effects of abnormal blood test results (very common). This can give your doctor information on the workings of some parts of your body, for example:
- High levels of enzymes related to the liver, muscle, or heart
- Low level of potassium and magnesium in the blood
- High blood sugar level
- Low levels of red, white, or platelet cells in the blood
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Dyspnea: shortness of breath | |||
| COMMON | |||
| Acute kidney injury (kidney failure or kidney damage): including swelling in the legs, tiredness, shortness of breath, nausea, little urine leaving the body | |||
| Allergic Reaction: Severe allergic reaction including swelling in the mouth, tongue, face and throat, itching, hives | |||
| Cardiac (heart): including collection of fluid around the heart, low blood pressure, inflammation of the heart, heart failure, heart rhythm problems | |||
| Increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) levels: High levels of enzymes related to the liver | |||
| Syncope: fainting or passing out | |||
| UNCOMMON | |||
| Posterior Reversible Encephalopathy Syndrome: headache, loss of speech or vision, confusion, seizure |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature 15 to 30°C.
Keep container tightly closed, and protect from light, moisture and humidity. Keep out of reach and sight of children.
If you want more information about Xospata:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.astellas.ca, or by calling 1-888-338-1824.