This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00166/0423.
Xospata 40 mg film coated tablets
Xospata 40 mg film-coated tablets
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Xospata is and what it is used for
2. What you need to know before you take Xospata
3. How to take Xospata
4. Possible side effects
5. How to store Xospata
6. Contents of the pack and other information
Xospata belongs to a class of cancer medicines called protein kinase inihibitors. It contains the active substance gilteritinib.
Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells. Xospata is used if AML is linked to an alteration of a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment.
In AML, patients develop large numbers of abnormal white blood cells. Gilteritinib blocks the action of certain enzymes (kinases) needed for the abnormal cells to multiply and grow, thus preventing the growth of the cancer.
Talk to you doctor, pharmacist or nurse straight away:
Talk to your doctor, pharmacist or nurse before taking Xospata:
Your doctor will carry out regular blood tests before and during treatment with Xospata. Your doctor will also regularly check your heart function before and during treatment.
Do not give Xospata to children and adolescents under 18 years because it is not known whether it is safe and effective in this age group.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Xospata may affect the way these medicines work, or these medicines may affect how Xospata works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
If you normally take any of these medicines, your doctor might change it and prescribe a different medicine for you during your treatment with Xospata.
Xospata may harm your unborn baby and should not be used during pregnancy. Women taking Xospata who are able to become pregnant should use an effective method of contraception during treatment with Xospata and for at least 6 months after stopping Xospata. If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm. Men taking Xospata whose partners are able to become pregnant should use an effective method of contraception during treatment with Xospata and for at least 4 months after stopping the treatment.
It is not known if Xospata passes into your breast milk and could harm your baby. You should not breast-feed during treatment with Xospata and for at least 2 months after stopping the treatment.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
You may feel dizzy after taking Xospata. If this happens, do not drive or use machines.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Xospata is taken by mouth as tablets.
Your doctor will tell you what dose of Xospata to take. The recommended dose is 120 mg (three tablets) once a day. Your doctor may decide to increase or lower your dose or temporarily interrupt treatment. Continue treatment at the dose prescribed by your doctor.
If you take more tablets than you should, stop taking Xospata and contact your doctor.
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 following day. Do not take a double dose to make up for a forgotten dose.
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Xospata 40 mg film-coated tablets are round, light yellow film-coated tablets with the company logo and ‘235’ debossed on one side of the tablet.
The tablets are provided in blisters and are available in packs containing 84 film-coated tablets (4-blisters of 21 film-coated tablets).
This leaflet was last revised in 12/2022