Xtandi 40mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Enzalutamide

Dostopno od:

Astellas Pharma Ltd

Koda artikla:

L02BB04

INN (mednarodno ime):

Enzalutamide

Odmerek:

40mg

Farmacevtska oblika:

Capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 08030402; GTIN: 5013346098797

Navodilo za uporabo

1
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 has spread to other parts of the body.
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 one in every 1,000
people taking placebo (see also ‘Other medicines and Xtandi’ below
and section 4 ‘Possible side
effects’).
Some situations in which you may have a higher risk of seizure
include:
-
If you had earlier episodes of seizure
-
If you have had a serious head injury or a history of head trauma
-
If you have had certain kinds of stroke
-
If you have had a brain tumour or cancer which has spread

Lastnosti izdelka

OBJECT 1
XTANDI 40MG SOFT CAPSULES
Summary of Product Characteristics Updated 15-Feb-2018 | Astellas
Pharma Ltd
1. Name of the medicinal product
Xtandi 40 mg soft capsules
2. Qualitative and quantitative composition
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 castration-resistant
prostate cancer (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 or a reduced dose (120
mg or 80 mg) if warranted.
_Concomitant use with strong CYP2C8 inhibitors_
The concomitant use of strong CYP2C8 inhibitors should be avoided if
possi