40 mg film-coated tablets
gilteritinib
What Xospata is and what it is used for
What Xospata is
Xospata belongs to a group of cancer medicines called protein kinase inhibitors. It contains the active substance gilteritinib.
What Xospata is used for
Xospata is used to treat adults with acute myeloid leukemia (AML), which is a form of cancer of certain types of white blood cells. Xospata is used if AML is linked to a change in a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment.
How Xospata works
In AML, patients develop a large number of abnormal white blood cells. Gilteritinib blocks the action of certain enzymes ( kinases ) that are needed for the abnormal cells to multiply and thus prevent cancer from growing.
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
Talk to a doctor, pharmacist, or nurse immediately:
- if you get any of the following symptoms: fever, difficulty breathing, rash, dizziness or fainting, rapid weight gain, swollen arms or legs. It may be a sign of a condition called differentiation syndrome (see section 4 – Possible side effects ). Differentiation syndrome can occur at any time during the first 3 months of treatment with Xospata, as early as 1 day after starting treatment. If that happens, the doctor will keep you under observation and may give medicine to treat your condition. The doctor may also pause Xospata treatment until symptoms have improved. You will also find this information on the patient card included in the package. You must carry the patient card with you and show it to healthcare professionals you meet.
- if you have a seizure or symptoms that get worse quickly, such as headache, reduced attention, confusion, blurred vision, or other problems with seeing. It may be a sign of a condition called PRES (see section 4 – Possible side effects ). Your doctor may do a test to see if you have developed PRES. If it shows that you have PRES, the doctor will stop Xospata treatment.
Talk to your doctor, pharmacist, or nurse before taking Xospata:
- if you have a heart rhythm disorder, such as irregular heartbeats or a condition called QT prolongation (see section 4 – Possible side effects ).
- if you have previously had low levels of the salts potassium or magnesium in your blood, as this may increase the risk of abnormal heart rhythms.
- if you have severe pain in the upper abdomen and back, are nauseated, and are vomiting. It can be a sign of an inflammation of the pancreas ( pancreatitis ).
Additional monitoring during treatment with Xospata
The doctor will regularly take blood samples before and during treatment with Xospata. The doctor will also regularly check your heart function before and during treatment.
Children and young people
Do not give Xospata 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
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Xospata can affect how these medicines work, or these medicines can affect how Xospata works.
In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- medicines used to treat tuberculosis, eg rifampicin
- medicines used to treat epilepsy, eg phenytoin,
- medicines used to treat fungal infections, e.g. voriconazole, posaconazole or itraconazole,
- medicines used to treat bacterial infections, eg erythromycin, clarithromycin, or azithromycin,
- medicines used to treat high blood pressure ( hypertension ), e.g. captopril or carvedilol,
- medicines used to treat infection with the human immunodeficiency virus ( HIV ), e.g. ritonavir,
- medicines used to treat depression, eg escitalopram, fluoxetine, or sertraline,
- medicines used to treat heart problems, eg digoxin,
- medicines used to prevent blood clots, e.g. dabigatran etexilate,
- St. John’s wort (also called Hypericum perforatum), is a herbal medicine used to treat mild depression and mild anxiety.
If you usually take one of these medicines, your doctor may switch it and prescribe another medicine for you during treatment with Xospata.
Pregnancy and breastfeeding
Xospata can harm an unborn baby and should not be used during pregnancy. Women taking Xospata who may become pregnant should use effective contraception during treatment with Xospata and for at least 6 months after stopping treatment with Xospata. If you use a hormonal contraceptive, you must also use a barrier method, e.g. condom or pessary. Men taking Xospata who have a partner who could become pregnant should use an effective method of contraception during treatment with Xospata and for at least 4 months after stopping treatment.
It is not known whether Xospata passes into breast milk and could harm your baby. You should not breastfeed during treatment with Xospata and for at least 2 months after treatment stops.
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 using this medicine.
Driving ability and use of machinery
You may feel dizzy after taking Xospata. If this happens, do not drive or use machines.
How to take Xospata
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Xospata is tablets to be swallowed.
Your doctor will tell you what dose of Xospata you should take. The recommended dose is 120 mg (three tablets) once daily. The doctor may decide to increase or decrease your dose, or temporarily stop the treatment. Continue the treatment with the dose prescribed by the doctor.
Take Xospata
- Take Xospata once a day at the same time each day.
- Swallow the tablets whole with water.
- The tablets should not be split or crushed.
- Xospata can be taken with or without food.
- Keep taking Xospata for as long as your doctor tells you to.
If you have taken too much Xospata
If you have taken too many tablets, stop taking Xospata and contact 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. Take the 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.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some possible side effects can 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, or swollen arms or legs. These may be signs of a condition called differentiation syndrome (which may affect up to 1 in 10 people).
- Posterior reversible encephalopathy syndrome (PRES). Contact your doctor immediately if you experience a seizure, rapidly worsening headache, confusion, or other vision problems. Uncommonly, there have been reports in patients treated with Xospata of a condition called PRES involving the brain (which may affect up to 1 in 100 people).
- Heart rhythm problems ( QT prolongation). Contact your doctor immediately if your heartbeat changes or if you feel dizzy, faint, or dizzy. Xospata can cause a heart problem called QT prolongation (may affect up to 1 in 10 people).
Other possible side effects are
Very common (may affect more than 1 in 10 users):
- diarrhea
- nausea
- constipation
- fatigue
- swelling due to fluid retention ( edema )
- decreased energy, weakness ( asthenia )
- abnormal blood values: high levels of creatine phosphokinase in the blood (indicates muscle or heart function), alanine aminotransferase ( ALT ), aspartate aminotransferase ( AST ), and/or alkaline phosphatase in the blood (indicates liver function)
- aching in arms and legs
- joint pain ( arthralgia )
- muscle pain ( myalgia )
- cough
- shortness of breath ( dyspnea )
- dizziness
- low blood pressure ( hypotension )
Common (may affect up to 1 in 10 users):
- accumulation of fluid around the heart, which, if severe, can affect the heart’s ability to pump blood (pericardial effusion)
- a vague feeling of discomfort, general malaise
- a serious life-threatening allergic reaction, e.g. swelling of the mouth, tongue, face, and throat, itching, hives ( anaphylactic reaction )
- muscle stiffness
- urinating less, leg swelling (a sign of sudden kidney damage)
- inflammation of the heart (pericarditis)
- heart failure
How to store Xospata
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister pack after “EXP”. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is gilteritinib. Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
- Other ingredients are mannitol (E421), hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, macrogol, titanium dioxide, yellow iron oxide (E172).
Appearance and package sizes of the medicine
Xospata 40 mg film-coated tablets are round, pale yellow film-coated tablets, with the company logo and “235” debossed on one side of the tablet.
The tablets are in blister packs and are available in packs containing 84 film-coated tablets (4 blister packs of 21 film-coated tablets).
Astellas Pharma Europe BV
Sylviusweg 62
2333 BE Leiden
Netherlands