Enzalutamide Adalvo 40 mg soft capsules

البلد: مالطا

اللغة: الإنجليزية

المصدر: Malta Medicines Authority

العنصر النشط:

LENALIDOMIDE

متاح من:

Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta

ATC رمز:

L02BB04

INN (الاسم الدولي):

ENZALUTAMIDE 40 mg

الشكل الصيدلاني:

SOFT CAPSULE

تركيب:

ENZALUTAMIDE 40 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

ENDOCRINE THERAPY

ملخص المنتج:

Licence number in the source country: NOT APPLICAPABLE

الوضع إذن:

Authorised

تاريخ الترخيص:

2022-05-24

نشرة المعلومات

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENZALUTAMIDE ADALVO 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 Enzalutamide Adalvo is and what it is used for
2.
What you need to know before you take Enzalutamide Adalvo
3.
How to take Enzalutamide Adalvo
4.
Possible side effects
5.
How to store Enzalutamide Adalvo
6.
Contents of the pack and other information
1.
WHAT ENZALUTAMIDE ADALVO IS AND WHAT IT IS USED FOR
Enzalutamide Adalvo contains the active substance enzalutamide. This
medicine 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 ENZALUTAMIDE ADALVO WORKS
Enzalutamide Adalvo 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 ENZALUTAMIDE ADALVO
DO NOT TAKE ENZALUTAMIDE ADALVO
-
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 enzalutamide
and fewer than one in every
1,000 people taking placebo (see ‘Other medicines and Enza

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enzalutamide Adalvo 40 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 40 mg of enzalutamide.
Excipient(s) with known effect
Each soft capsule contains 91.6 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
White to off-white opaque, oblong-shaped, unmarked, 22.0 (± 2.5) mm
long and 9.5 (± 2.5) mm wide
soft gelatin capsule containing colourless to slightly yellow,
transparent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enzalutamide Adalvo 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 Enzalutamide Adalvo
_ _
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 shoul