XTANDI enzalutamide 40 mg soft capsule blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

enzalutamide, Quantity: 40 mg

Διαθέσιμο από:

Astellas Pharma Australia Pty Ltd

INN (Διεθνής Όνομα):

enzalutamide

Φαρμακοτεχνική μορφή:

Capsule, soft

Σύνθεση:

Excipient Ingredients: Gelatin; purified water; caprylocaproyl macrogolglycerides; butylated hydroxyanisole; butylated hydroxytoluene; titanium dioxide; sorbitol; glycerol; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; iron oxide black; macrogol 400; polyvinyl acetate phthalate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

112

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

XTANDI is indicated for:,? the treatment of patients with metastatic hormone-sensitive prostate cancer.,? the treatment of patients with non-metastatic castration-resistant prostate cancer (see PROSPER, section 5.1 Clinical trials).,? the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated.,? the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Περίληψη προϊόντος:

Visual Identification: XTANDI 40 mg capsules are supplied as white to off-white oblong soft gelatin capsules imprinted with ENZ in black ink on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2014-07-01

Φύλλο οδηγιών χρήσης

XTANDI
®
X
T
A
N
D
I
®
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 XTANDI?
XTANDI contains the active ingredient enzalutamide. XTANDI is used to
treat adult men with prostate cancer that no longer
responds to hormone therapy or surgical treatment to lower
testosterone, or has spread to other parts of the body and is
considered
"hormone sensitive".
For more information, see Section 1. Why am I using XTANDI? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XTANDI?
Do not use if you have ever had an allergic reaction to XTANDI 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. XTANDI IS NOT FOR USE IN WOMEN.
For more information, see Section 2. What should I know before I use
XTANDI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XTANDI 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 XTANDI?
•
The usual dose is four 40 mg capsules taken at the same time once a
day. Your doctor may reduce your dose depending on
your medical conditions.
More instructions can be found in Section 4. How do I use XTANDI? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XTANDI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
XTANDI.
•
THINGS YOU
SHOULD NOT DO
•
Do not take XTANDI to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or alter the dosage without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Do not drive or operate machinery until you know how XTANDI affects
you.
•
XTANDI may have a mode

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
XTANDI
® (ENZALUTAMIDE) SOFT CAPSULES
1
NAME OF THE MEDICINE
Enzalutamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XTANDI is provided as liquid-filled soft gelatin capsules for oral
administration. Each soft capsule
contains 40 mg of enzalutamide as a solution in caprylocaproyl
macrogolglycerides.
Excipient(s) with known effect
Each soft capsule contains 57.8 mg of sorbitol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capsule, soft
Supplied as white to off-white oblong soft gelatin capsules imprinted
with “ENZ” in black ink on one
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XTANDI is indicated for:
•
the treatment of patients with metastatic hormone-sensitive prostate
cancer.
•
the treatment of patients with non-metastatic castration-resistant
prostate cancer (see
PROSPER, section 5.1 Clinical trials).
•
the treatment of patients with metastatic castration resistant
prostate cancer following
failure of androgen deprivation therapy in whom chemotherapy is not
yet indicated.
•
the treatment of patients with metastatic castration-resistant
prostate cancer who have
previously received docetaxel.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
The recommended dose of XTANDI is 160 mg (four 40 mg capsules) as a
single oral daily dose.
XTANDI can be taken with or without food. XTANDI should be taken at
the same time each day.
Medical castration with a luteinising hormone-releasing hormone (LHRH)
analogue should be
continued during treatment of patients not surgically castrated.
2
If a patient misses taking XTANDI at the usual time, the prescribed
dose should be taken as close as
possible to the usual time. If a patient misses a dose for a whole
day, treatment should be resumed
the following day with the daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, withhold dosing for
one week or until symptoms improve to ≤ Grade 2, then resume at the
same or a reduced dose
(120 m