XTANDI 40 mg CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Astellas Pharma (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

Authorization status:

Registered

Authorization date:

2018-06-09

Patient Information leaflet

Xtandi 40 mg
Soft gelatine capsule
1.3.2 Final PIL
November 2023
Astellas
Page 1 of 10
SCHEDULING STATUS:
S4
XTANDI 40 MG
(ENZALUTAMIDE)
soft gelatine capsules
contains Sugar: Each capsule contains 57,8 mg Sorbitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING XTANDI
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
XTANDI has been prescribed for you personally and you should not share
your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
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
The active substance in Xtandi is 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
Xtandi 40 mg
Soft gelatine capsule
1.3.2 Final PIL
November 2023
Astellas
Page 2 of 10
-
Has spread to other parts of the body and responds to hormone therapy
or surgical
treatment to lower testosterone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XTANDI
DO NOT TAKE XTANDI:
•
if you are hypersensitive (allergic) to the active ingredient,
enzalutamide or to any of the
other ingredients.
•
if you have poorly controlled seizures.
•
XTANDI is not for use by women._ _
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or other healthcare professional
before taking XTANDI:
•
If you are taking any medicines to prevent blood clots (e.g. warfarin)
•
If you use chemotherapy like docetaxel.
•
If you have problems with your liver.
•
If you have problems with your kidneys.
•
If you had or are at risk of having a seizure (fit).
_Seizures _
XTANDI has been shown to cause seizures.
Some situations in which you may have a higher risk of seizures
include:
- If you had earlier epi

Summary of Product characteristics

Xtandi 40 mg
Soft gelatine capsule 1.3.1.1 Final PI
November 2023
Astellas
Page 1 of 19
SCHEDULING STATUS
S4
1 NAME OF THE MEDICINE
XTANDI 40 mg soft gelatine capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 40 mg of enzalutamide.
Contains sugar: Each capsule contains 57,8 mg sorbitol.
For the full list of excipients, (see section 6.1).
3 PHARMACEUTICAL FORM
Soft capsule.
Opaque white to off-white oblong soft gel capsule, printed with
“ENZ” in black ink.
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 (ADT).
-
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.
Xtandi 40 mg
Soft gelatine capsule 1.3.1.1 Final PI
November 2023
Astellas
Page 2 of 19
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of Xtandi is 160 mg (four 40 mg 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 a reduced dose
(120 mg or 80 mg) if warranted._ _The patient then requires frequent
monitoring for the return of that