Xospata

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

gilteritinib fumarate

Available from:

Astellas Pharma Europe B.V.

ATC code:

L01EX13

INN (International Name):

gilteritinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Myeloid, Acute

Therapeutic indications:

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.,

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2019-10-24

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XOSPATA 40 MG FILM
-
COATED TABLETS
gilteritinib
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
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
1.
WHAT XOSPATA IS AND WHAT IT IS USED FOR
WHAT XOSPATA IS
Xospata belongs to a class of cancer medicines called protein kinase
inihibitors. It contains the active
substance gilteritinib.
WHAT XOSPATA IS USED FOR
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.
HOW XOSPATA WORKS
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.
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Xospata 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg gilteritinib (as fumarate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, light yellow film-coated tablet, debossed with the company logo
and ‘235’ on the same side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xospata is indicated as monotherapy for the treatment of adult
patients who have relapsed or refractory
acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Xospata should be initiated and supervised by a
physician experienced in the use of
anti-cancer therapies.
Before taking gilteritinib, relapsed or refractory AML patients must
have confirmation of FMS-like
tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD]
or tyrosine kinase domain
[TKD]) using a validated test.
Xospata may be re-initiated in patients following haematopoietic stem
cell transplantation (HSCT)
(see Table 1).
Posology
The recommended starting dose is 120 mg gilteritinib (three 40 mg
tablets) once daily.
Blood chemistries, including creatine phosphokinase, should be
assessed prior to initiation of
treatment, on day 15 and monthly for the duration of treatment.
An electrocardiogram (ECG) should be performed before initiation of
gilteritinib treatment, on day 8
and 15 of cycle 1 and prior to the start of the next three subsequent
months of treatment (see sections
4.4 and 4.8).
Treatment should continue until the patient is no longer clinically
benefiting from Xospata or until
unacceptable toxicity occurs. Response may be delaye