XOSPATA 40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GILTERITINIB AS FUMARATE

Available from:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC code:

L01XE54

Pharmaceutical form:

FILM COATED TABLETS

Composition:

GILTERITINIB AS FUMARATE 40 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS

Therapeutic area:

GILTERITINIB

Therapeutic indications:

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

Authorization date:

2020-09-07

Patient Information leaflet

XOSPATA
™
(GILTERITINIB)
HCP EDUCATIONAL
INFORMATION BROCHURE
This HCP Educational Information Brochure is an Additional Risk
Minimisation Measure of the
XOSPATA
TM
Risk Management Plan provided by Astellas Pharma International B.V.
Israel
HCP – healthcare professional
 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 reaction.
For prescribing information, please refer to the XOSPATA
TM
physician leaflet provided
with this brochure or please refer to the physician leaflet available
in MOH site
Date of preparation: January 2021 XOS_2020_0021_IL
v.02: This Prescriber Brochure format and content have been updated
and approved
by the Ministry of Health on Feb 2021.
3
2
XOSPATA
TM
...............................................................................................
4
Indication
Adverse reactions
Important information on Differentiation Syndrome associated with
XOSPATA
TM
DIFFERENTIATION SYNDROME
..............................................................
5
Incidence of Differentiation Syndrome in AML patients treated with
XOSPATA
TM
Aetiology and pathogenesis
Signs and symptoms
Diagnosis
Differential diagnosis
Treatment
PATIENT ALERT
CARD..............................................................................
7
REPORTING OF SUSPECTED ADVERSE REACTIONS
..............................
7
CONTACT DETAILS
..................................................................................
7
REFERENCES
...........................................................................................
8
This HCP Educational Information Brochure aims to provide
information about Differentiation Syndrome related to XOSPATA
TM
,
to minimise the risk associated with this safety concern.
Every healthcare professional must read and understand this HCP
Educational tool before
prescribing XOSPATA
TM
.
Please refer to this brochure to support the health and safety of your
patient

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Xospata 40 mg
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).
PATIENT GUIDE
The marketing of Xospata is subject to a risk management plan (RMP)
including a Patient
guide. The Patient guide, emphasizes important safety information that
the patient should be
aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
PRESCRIBER GUIDE
This product is marketed with prescriber providing important safety
information. Please ensure
you are familiar with this material as it contains important safety
information.
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
tr