XOSPATA 40 mg FILM-COATED TABLETS

2. What you need to know before you take Xospata

Do not take Xospata

• If you are allergic to gilteritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist, or nurse immediately:

• If you have any of the following symptoms: fever, difficulty breathing, rash, dizziness or fainting, rapid weight gain, swelling of the arms or legs. These may be signs of a complication called differentiation syndrome (see section 4 - Possible side effects). Differentiation syndrome can occur from the first day after starting treatment with Xospata and at any time during the first 3 months of treatment. If this happens, your doctor will monitor your health and may give you a medicine to treat this complication. You may also have your treatment with Xospata interrupted until the symptoms have decreased. You can also find this information in the patient information card included in the pack. It is important that you carry this patient information card with you and show it to any healthcare professional who treats you.

• If you have a seizure or symptoms that worsen rapidly, such as headache, decreased alertness, confusion, blurred vision, or other vision problems. These may be signs of a complication called Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4 - Possible side effects). To check if you have developed PRES, your doctor may perform a test, and if it is confirmed that you have PRES, they will interrupt your treatment with Xospata.

Tell your doctor, pharmacist, or nurse before you start taking Xospata:

• If you have a heart rhythm disorder, such as an irregular heartbeat or a complication called QT interval prolongation (see section 4 - Possible side effects).
• If you have a history of low levels of potassium or magnesium in your blood, as this may increase the risk of an abnormal heart rhythm.
• If you have severe pain in the upper abdomen and back, nausea, and vomiting. These may be signs of pancreatitis (inflammation of the pancreas).

Additional monitoring during treatment with Xospata

Your doctor will regularly perform blood tests before and during treatment with Xospata. Your doctor will also regularly check your heart function before and during treatment.

Children and adolescents

Xospata should not be given to children and adolescents under 18 years of age because it is not known if it is safe and effective in this age group.

Other medicines and Xospata

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Xospata may affect the way other medicines work, or these medicines may affect the way Xospata works.

In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Medicines to treat certain types of cancer, such as mitoxantrone or methotrexate.
• Medicines used to treat tuberculosis, such as rifampicin.
• Medicines used to treat epilepsy, such as phenytoin.
• 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 high blood sugar levels (hyperglycemia), such as metformin.
• Medicines used to lower cholesterol levels, such as rosuvastatin.
• Medicines used to treat HIV infection, such as ritonavir.
• Medicines used to treat depression, such as escitalopram, fluoxetine, or sertraline.
• Medicines used to treat heart problems, such as digoxin.
• Medicines used to prevent blood clots, such as dabigatran etexilate.
• St. John's Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.

If you are taking any of these medicines, your doctor may change them and prescribe a different one during treatment with Xospata.

Pregnancy and breastfeeding

Xospata may harm the fetus and should not be used during pregnancy. Women who receive Xospata and may become pregnant should use an effective contraceptive method during treatment with Xospata and for at least 6 months after finishing treatment with Xospata. If you use a hormonal contraceptive, you should also use a barrier method, such as a condom or diaphragm. Men treated with Xospata whose partners may become pregnant should use an effective contraceptive method during treatment with Xospata and for at least 4 months after finishing treatment.

It is not known if Xospata passes into breast milk and if it could harm your baby. You should not breastfeed during treatment with Xospata and for at least 2 months after finishing treatment.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Driving and using machines

You may feel dizzy after taking Xospata. If this happens, do not drive or use machines.

3. How to take Xospata

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

Xospata is taken by mouth, in the form of 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 reduce your dose or temporarily interrupt treatment. Take the treatment at the dose prescribed by your doctor.

How to take Xospata

• Take Xospata once a day, at the same time each day.
• Swallow the tablets whole with water.
• Do not break or crush the tablets.
• Xospata can be taken with or without food.
• Take Xospata for as long as your doctor tells you.

If you take more Xospata than you should

If you take more tablets than you should, stop taking Xospata and consult your doctor.

If you forget to take Xospata

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 the next dose at the usual time the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Xospata

Do not stop taking this medicine unless your doctor tells you to. The response may be delayed, so continue taking Xospata for as long as your doctor tells you.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of the possible side effects can be serious:

• Differentiation syndrome.Tell your doctor immediately if you have any of the following symptoms: fever, difficulty breathing, rash, dizziness or fainting, rapid weight gain, swelling of the arms or legs. These may be signs of a complication called differentiation syndrome (may affect up to 1 in 10 people).
• Posterior Reversible Encephalopathy Syndrome (PRES).Tell your doctor immediately if you have a seizure, rapid worsening of headache, confusion, or vision problems. In patients treated with Xospata, rare cases of a complication that affects the brain, called PRES, have been reported (may affect up to 1 in 100 people).
• Heart rhythm problems (QT interval prolongation).Tell your doctor immediately if you have changes in your heartbeat, or if you feel dizzy, faint, or pass out. Xospata may cause a heart problem called QT interval prolongation (may affect up to 1 in 10 people).

Other possible side effects

Very common (may affect more than 1 in 10 people):

• diarrhea
• nausea
• constipation
• fatigue
• swelling due to fluid retention (edema)
• lack of energy, weakness (asthenia)
• abnormal laboratory results: elevated levels in the blood of creatine phosphokinase (indicating muscle or heart function), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (indicating liver function)
• pain in the limbs
• joint pain (arthralgia)
• muscle pain (myalgia)
• cough
• shortness of breath (dyspnea)
• dizziness
• low blood pressure (hypotension)

Common (may affect up to 1 in 10 people):

• fluid accumulation around the heart, which if severe can reduce the heart's ability to pump blood (pericardial effusion)
• a vague feeling of being unwell, not feeling well (general malaise)
• a severe allergic reaction that can be life-threatening, e.g., swelling of the mouth, tongue, face, and throat, itching, hives (anaphylactic reaction)
• muscle stiffness
• reduced urine output, swelling of the legs (signs of sudden kidney injury)
• inflammation of the heart (pericarditis)
• heart failure

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Xospata

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 blister after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Xospata contains

• The active substance is gilteritinib. Each film-coated tablet contains 40 mg of gilteritinib (as fumarate).
• The other ingredients are: mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, yellow iron oxide (E172).

Appearance and packaging

Xospata 40 mg film-coated tablets (tablets) are round, light yellow, and marked with the company logo and "235" on the same side of the tablet.

The tablets come in blisters and are available in packs of 84 film-coated tablets (4 blisters of 21 film-coated tablets).

Marketing authorization holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet: MM/AAAA

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu