XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

gilteritinib fumarate, Quantity: 44.2 mg

Commercializzato da:

Astellas Pharma Australia Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: hyprolose; magnesium stearate; mannitol; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow

Via di somministrazione:

Oral

Confezione:

84

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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

Dettagli prodotto:

Visual Identification: Round, light yellow film-coated tablet, debossed with the company logo and 235 on the same side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2020-04-02

Foglio illustrativo

XOSPATA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING XOSPATA?
XOSPATA contains gilteritinib, a protein kinase inhibitor, which is
used to treat adults with acute myeloid leukaemia (AML) who have
a defect in a gene called FLT3 when the disease has come back or has
not improved after previous treatment(s).
For more information, see Section 1. Why am I using XOSPATA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XOSPATA?
Do not use if you have ever had an allergic reaction to XOSPATA or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
XOSPATA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XOSPATA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE XOSPATA?
•
The usual dose is three 40 mg film-coated tablets (120 mg) taken at
the same time once a day.
•
Your doctor may decide to increase or lower your dose or temporarily
interrupt treatment depending on your medical conditions.
More instructions can be found in Section 4. How do I use XOSPATA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XOSPATA?
THINGS YOU
SHOULD DO
•
IF YOU ARE ABOUT TO BE STARTED ON ANY NEW MEDICINE, REMIND YOUR
DOCTOR, DENTIST AND PHARMACIST
THAT YOU ARE TAKING XOSPATA.
•
IF YOU ARE GOING TO HAVE SURGERY, TELL THE SURGEON OR ANAESTHETIST
THAT YOU ARE TAKING THIS
MEDICINE.
•
KEEP ALL OF YOUR DOCTOR'S APPOINTMENTS SO THAT YOUR PROGRESS CAN BE
CHECKED.
THINGS YOU
SHOULD NOT DO
•
Do not take XOSPATA to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even i

Scheda tecnica

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - XOSPATA
® (GILTERITINIB
FUMARATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
gilteritinib fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 44.2 mg gilteritinib fumarate
(corresponding to 40 mg gilteritinib).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Round, light yellow film-coated tablet, debossed with the Astellas
logo and ‘235’ on the same side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XOSPATA is indicated for the treatment of adult patients who have
relapsed or refractory acute
myeloid leukaemia (AML) with a FLT3 mutation.
4.2
D
OSE 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 XOSPATA, 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]).
DOSAGE
The recommended starting dose of XOSPATA is 120 mg (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
XOSPATA treatment, on day 8
and 15 and prior to the start of the next three subsequent months of
treatment. In addition, an ECG
should be performed following the same schedule in case of dose
increase (see section 4.4 Special
warnings and precautions for use and section 4.8 Adverse effects
(Undesirable effects)).
▼

2
Treatment should continue until the patient is no longer clinically
benefiting from XOSPATA or until
unaccep