Xtandi

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

enzalutamide

Saatavilla:

Astellas Pharma Europe B.V.

ATC-koodi:

L02BB04

INN (Kansainvälinen yleisnimi):

enzalutamide

Terapeuttinen ryhmä:

Endocrine therapy

Terapeuttinen alue:

Prostatic Neoplasms

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 21

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-06-21

Pakkausseloste

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XTANDI 40 MG SOFT CAPSULES
enzalutamide
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.
-
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xtandi is and what it is used for
2.
What you need to know before you take Xtandi
3.
How to take Xtandi
4.
Possible side effects
5.
How to store Xtandi
6.
Contents of the pack and other information
1.
WHAT XTANDI IS AND WHAT IT IS USED FOR
Xtandi contains the active substance enzalutamide. Xtandi is used to
treat adult 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.
HOW XTANDI WORKS
Xtandi is a medicine that works by blocking the activity of hormones
called androgens (such as
testosterone). By blocking androgens, enzalutamide stops prostate
cancer cells from growing and
dividing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XTANDI
DO NOT TAKE XTANDI
-
If you are allergic to enzalutamide or any of the other ingredients of
this medicine (listed in
section 6)
-
If you are pregnant or may become pregnant (see ‘Pregnancy,
breast-feeding and fertility’)
WARNINGS AND PRECAUTIONS
Seizures
Seizures were reported in 5 in every 1,000 people taking Xtandi, and
fewer than 3 in every 1,000
people taking placebo (see ‘Other medicines and Xtandi’ below and
section 4 ‘Possible side effects’).
If you are taking a medicine that can cause seizures or that can
increase the susceptibility for h

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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(s) 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