XTANDI 40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENZALUTAMIDE

Available from:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC code:

L02BB04

Pharmaceutical form:

CAPSULES SOFT

Composition:

ENZALUTAMIDE 40 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS

Therapeutic area:

ENZALUTAMIDE

Therapeutic indications:

xtandi is indicated for:• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).• the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.• the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

Authorization date:

2015-11-16

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
XTANDI 40 MG.
_SOFT CAPSULES. _
COMPOSITION:
Each Xtandi 40 mg soft capsule contains: enzalutamide 40 mg.
INACTIVE INGREDIENTS AND ALLERGENS - see section 6 "Further
information".
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, consult
the doctor or pharmacist.
This medicine has been prescribed for the treatment of your
ailment
. Do not pass it on to others. It
may harm them even if it seems to you that their ailment is similar.
The medicine is intended for adult men only.
The medicine is not intended for use by women.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to treat men with prostate cancer that:
-
No longer responds to a hormone therapy or surgical treatment to lower
testosterone
Or
-
Has spread to other parts of the body and responds to a hormone
therapy or surgical
treatment to lower testosterone.
THERAPEUTIC GROUP: androgen receptor antagonist.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
-
if you are sensitive (allergic) to the active ingredient or to any of
the other ingredients
included in the medicine (see section 6).
-
If you are pregnant or may become pregnant (see ‘Pregnancy,
breast-feeding and
fertility’).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
-
Seizures:
Seizures were reported in 5
in every
1,000 patients taking Xtandi, and in
fewer
than 1 in 1,000 pa-
tients receiving placebo (see ‘Other medicines and Xtandi’ below
and section 4 ‘Possible side ef-
fects’).

If you are taking medicines that may cause seizures or that can
increase the chance of
having seizures (the list of medicines is provided below, see section
"IF YOU CURRENTLY TAKE,
OR HAVE TAKEN LATELY, OTHER DRUGS INCLUDING NON-PRESCRIPTION MEDICINES
AND NUTRITIONAL
SUPPLEMENTS ").
IF YOU HAVE SEIZURES DURING TREATMENT

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Xtandi 40 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xtandi 40 mg soft capsules
Each soft capsule contains 40 mg of enzalutamide.
Excipient with known effect:
Each soft capsule contains 57.8 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
White to off-white oblong soft capsules (approximately 20 mm x 9 mm)
imprinted with “ENZ” in
black ink on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xtandi is indicated for:

the treatment of adult men with metastatic hormone-sensitive prostate
cancer (mHSPC) in
combination with androgen deprivation therapy (see section 5.1).

the treatment of adult men with high-risk non-metastatic
castration-resistant prostate cancer
(CRPC) (see section 5.1).

the treatment of adult men with metastatic CRPC who are asymptomatic
or mildly
symptomatic after failure of androgen deprivation therapy in whom
chemotherapy is not yet
clinically indicated (see section 5.1)

the treatment of adult men with metastatic CRPC whose disease has
progressed on or after
docetaxel therapy.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with enzalutamide should be initiated and supervised by
specialist physicians experienced
in the medical treatment of prostate cancer.
_ _
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg soft capsules)
as a single oral daily dose.
Medical castration with a luteinising hormone-releasing hormone (LHRH)
analogue should be
continued during treatment of patients not surgically castrated.
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 usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, dosing should be
withheld for one week or until symptoms improve to ≤ Grade 2, then
resumed at the same