Xospata 40 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Xospata 40mg film-coated tablets

gilteritinib

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Xospata is and what it is used for
2. What you need to know before taking Xospata
3. How to take Xospata
4. Possible side effects
5. How to store Xospata
6. Contents of the pack and other information

1. What Xospata is and what it is used for

What Xospata is

Xospata belongs to a class of anticancer medicines called protein kinase inhibitors. The active substance it contains is gilteritinib.

What Xospata is used for

Xospata is used to treat adults with acute myeloid leukemia (AML), a cancer affecting certain white blood cells. Xospata is used when AML is associated with a genetic alteration in a gene called FLT3, and is administered to patients whose disease has relapsed or has not improved with prior treatment.

How Xospata works

In AML, patients develop a high number of abnormal white blood cells. Gilteritinib blocks the action of certain enzymes (kinases) that the abnormal cells need in order to multiply and grow, thereby inhibiting cancer growth.

2. What you need to know before starting to take Xospata

Do not take Xospata

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

Warnings and precautions

Contact your doctor, pharmacist, or nurse immediately:

• If you experience 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 may occur as early as the first day after starting treatment with Xospata and at any time during the first 3 months of treatment. If this occurs, your doctor will monitor your condition and may give you medication to treat this complication. Your doctor may also interrupt your treatment with Xospata until symptoms have improved. This information is also available on the patient information card included in the package. It is important that you carry this card with you and show it to any healthcare professional treating you.

• If you have a seizure or rapidly worsening symptoms such as headache, decreased level of consciousness, confusion, blurred vision, or other vision problems. These may be signs of a complication called SEPR (see section 4 – Possible side effects). To determine whether you have developed SEPR, your doctor may perform tests, and if SEPR is confirmed, your treatment with Xospata will be discontinued.

Contact your doctor, pharmacist, or nurse before starting to take Xospata:

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

Additional monitoring during treatment with Xospata

Your doctor will perform regular 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 must not be given to children and adolescents under 18 years of age, as it is not known whether it is safe and effective in this age group.

Other medicines and Xospata

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

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

• Medicines used 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 human immunodeficiency virus (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 regularly take any of these medicines, your doctor may switch you to a different medicine during treatment with Xospata.

Pregnancy and breastfeeding

Xospata may harm the unborn baby and must not be used during pregnancy. Women of childbearing potential who are receiving Xospata must use an effective method of contraception during treatment with Xospata and for at least 6 months after the end of treatment. If you use hormonal contraception, you must also use a barrier method, such as a condom or diaphragm. Men treated with Xospata whose partners may become pregnant must use an effective method of contraception during treatment with Xospata and for at least 4 months after the end of treatment.

It is unknown whether Xospata passes into breast milk and whether it could harm your baby. You must not breastfeed during treatment with Xospata and for at least 2 months after the end of 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 occurs, do not drive or operate machinery.

3. How to take Xospata

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Xospata is administered orally 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 daily. 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 daily, at the same time each day.
• Swallow the tablets whole with water.
• Do not split or crush the tablets.
• Xospata may be taken with or without food.
• Take Xospata for as long as your doctor instructs.

If you take more Xospata than you should

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

If you forget to take Xospata

If you forget to take Xospata at your usual time, take your usual dose as soon as you remember on the same day, and then take your next dose at the usual time the following day. Do not take a double dose to make up for a missed dose.

If you stop taking Xospata

Do not stop taking this medicine unless your doctor tells you to. Response may be delayed; therefore, continue taking Xospata for as long as your doctor instructs.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Some of the possible adverse effects may be serious:

• Differentiation syndrome. Contact your doctor immediately if you have any of the following symptoms: fever, difficulty breathing, rash, dizziness or fainting, rapid weight gain, swelling of 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). Contact your doctor immediately if you have a seizure, rapidly worsening headache, confusion, or vision problems. Rare cases of a brain-related complication called PRES have been reported in patients treated with Xospata (may affect up to 1 in 100 people).
• Heart rhythm problems (QT interval prolongation). Contact your doctor immediately if you notice changes in your heartbeat, or if you feel dizzy, lightheaded, or faint. Xospata may cause a heart problem called QT interval prolongation (may affect up to 1 in 10 people).

Other possible adverse effects

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

• diarrhoea
• nausea
• constipation
• tiredness
• swelling due to fluid retention (oedema)
• lack of energy, weakness (asthenia)
• abnormal blood test results: increased blood levels of creatine phosphokinase (indicator of muscle or heart function), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (indicators of liver function)
• pain in limbs
• joint pain (arthralgia)
• muscle pain (myalgia)
• cough
• shortness of breath (dyspnoea)
• dizziness
• low blood pressure (hypotension)

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

• fluid accumulation around the heart, which in severe cases may reduce the heart's ability to pump blood (pericardial effusion)
• a general feeling of being unwell (malaise)
• severe, potentially life-threatening allergic reaction, e.g., swelling of mouth, tongue, face and throat, itching, hives (anaphylactic reaction)
• muscle stiffness
• reduced urine output, leg swelling (signs of sudden kidney injury)
• inflammation of the heart (pericarditis)
• heart failure

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xospata

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused packaging and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xospata

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

Appearance of the product and contents of the pack

Xospata 40 mg film-coated tablets (tablets) are round, light yellow film-coated tablets, 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 each).

Marketing Authorization Holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

The Netherlands

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: MM/YYYY

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