XTANDI

Main information

  • Trade name:
  • XTANDI enzalutamide 40 mg soft capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XTANDI enzalutamide 40 mg soft capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210494
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210494

XTANDI enzalutamide 40 mg soft capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Astellas Pharma Australia Pty Ltd

Postal Address

PO BOX 353,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

1/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. XTANDI enzalutamide 40 mg soft capsule blister pack

Product Type

Single Medicine Product

Effective date

23/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer following failure of androgen deprivation therapy in

whom chemotherapy is not yet indicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. XTANDI enzalutamide 40 mg soft capsule blister pack

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

XTANDI 40 mg capsules are supplied as white to off-white oblong soft

gelatin capsules imprinted with ENZ in black ink on one side.

Active Ingredients

enzalutamide

40 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 20.10.2017 at 08:15:22 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

XTANDI

®

(ex-TAN-dee)

Enzalutamide (enza-LOOT-ah-mide)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about XTANDI.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking XTANDI

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What XTANDI is used

for

XTANDI contains enzalutamide, an

androgen receptor inhibitor, which is

used to treat adult men with prostate

cancer that has spread to other parts

of the body.

This medicine works by blocking the

activity of hormones called

androgens (such as testosterone). By

blocking androgens, XTANDI stops

prostate cancer cells from growing

and dividing.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

XTANDI is not for use in children

and adolescents.

Safety and effectiveness in children

and adolescents have not been

established.

Before you take

XTANDI

When you must not take it

Do not take XTANDI if you have

an allergy to:

any medicine containing

enzalutamide

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

XTANDI is not for use in women.

This medicine may cause harm to the

unborn child or potential loss of

pregnancy if it is taken by women

who are pregnant. It must not be

taken by women who are pregnant,

may become pregnant, or who are

breast feeding.

This medicine could possibly have an

effect on male fertility.

If you are having sex with a woman

who can become pregnant, you must

use a condom and another effective

birth control method, during

treatment and for 3 months after

stopping treatment with this

medicine. Men who are sexually

active with a pregnant woman must

use a condom during and for 3

months after stopping treatment with

XTANDI to protect the unborn child.

Talk with your doctor if you have

questions about birth control.

Your doctor can discuss with you

the risks and benefits involved.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

a history of seizures

a serious head injury or a history

of head trauma

a stroke

a brain tumour, or cancer which

has spread to the brain

drink very large amounts of

alcohol either regularly or from

time to time

are taking a medicine that can

cause seizures or that increases

risks for having seizures (see

Taking other medicines)

In some of these situations you may

have a higher risk of having a

seizure.

XTANDI

Tell your doctor if you have:

heart or blood pressure problems

kidney problems

a partner who is pregnant or is

planning to become pregnant.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

XTANDI.

Taking other medicines

Tell your doctor if you are taking

any of the following medicines.

When taken at the same time as

XTANDI, these medicines may

increase the risk of a seizure:

certain medicines used to treat

asthma and other respiratory

diseases (e.g. aminophylline,

theophylline)

medicines used to treat certain

psychiatric disorders such as

depression and schizophrenia

(e.g. clozapine, olanzapine,

risperidone, ziprasidone,

bupropion, lithium,

chlorpromazine, thioridazine,

amitriptyline, desipramine,

doxepin, imipramine,

mirtazapine)

certain medicines for the

treatment of pain (e.g. pethidine)

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and XTANDI may

interfere with each other. These

include certain medicines used to:

treat pain (e.g. fentanyl, tramadol,

paracetamol)

thin the blood, or to prevent blood

clots (e.g. warfarin)

lower cholesterol (e.g.

gemfibrozil, atorvastatin,

simvastatin)

treat cancer (e.g. cabazitaxel)

treat epilepsy (e.g.

carbamazepine, clonazepam,

phenytoin, primidone, valproic

acid)

treat certain psychiatric disorders

such as severe anxiety or

schizophrenia (e.g. diazepam,

midazolam, haloperidol)

treat sleep disorders (e.g.

zolpidem)

treat heart conditions or lower

blood pressure (e.g. bisoprolol,

digoxin, diltiazem, felodipine,

nicardipine, nifedipine,

propanolol, verapamil)

treat serious disease related to

inflammation (e.g.

dexamethasone, prednisolone)

lower your immunity (e.g.

cyclosporin, tacrolimus)

treat HIV infection (e.g.

indinavir, ritonavir)

treat bacterial infections (e.g.

clarithromycin, doxycycline,

rifampicin)

treat thyroid disorders (e.g.

levothyroxine)

treat gout (e.g. colchicine)

prevent heart conditions or

strokes (dabigatran etexilate).

These medicines may be affected by

XTANDI or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take XTANDI

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The usual dose is four 40 mg

capsules taken at the same time once

a day. Your doctor may reduce your

dose depending on your medical

conditions.

Reduced dose:

If you are taking a reduced dose of

XTANDI, you may use the

remaining capsules in the open dose

compartment for your next scheduled

dose, provided that the capsules have

been otherwise stored under the

conditions described below (see

After Taking XTANDI, Storage).

How to take it

Swallow the capsules whole with a

full glass of water. Do not chew,

dissolve or open the capsules before

swallowing.

You can take XTANDI with or

without food.

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

It is important to keep taking your

medicine even if you feel well.

Do not stop treatment with XTANDI

unless your doctor tells you to.

If you forget to take it

Take it as soon as you remember, and

then go back to taking your medicine

as you would normally.

If you forget to take XTANDI for the

whole day, take your usual dose the

following day.

If you forget to take XTANDI for

more than one day, talk to your

doctor immediately.

Do not take a double dose to make

up for the dose that you missed.

XTANDI

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much XTANDI. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

You may be at increased risk of

experiencing a seizure.

While you are taking

XTANDI

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking XTANDI.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

If your partner becomes pregnant

while taking this medicine, tell

your doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not take XTANDI to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or alter the dosage without

checking with your doctor.

Do not drive or operate machinery

until you know how XTANDI

affects you.

XTANDI may have a moderate

effect on your ability to drive or use

any tools or machinery as the side

effects for XTANDI includes

seizures.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking XTANDI.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or go to Accident

and Emergency at your nearest

hospital immediately if you have a

seizure.

Seizures are more likely if you take

more than the recommended dose of

this medicine, if you take some other

medicines, or if you are at higher

than usual risk of seizures. If you

have a seizure during treatment, stop

taking XTANDI and see your doctor

as soon as possible.

Posterior Reversible

Encephalopathy Syndrome (PRES)

There have been rare reports of

PRES, a rare, reversible condition

involving the brain, in patients

treated with XTANDI. If you have a

seizure, worsening headache,

confusion, blindness or other vision

problems, please contact your doctor

as soon as possible.

Tell your doctor or pharmacist if

you notice or experience any of the

following:

headache

weakness

fatigue, tiredness

dizziness

breathlessness

swelling of the hands, ankles or

feet

rash

pain in back, muscles or joints

hot flushes

falls

broken bones

hallucinations

feeling anxious

dry skin

itching

high blood pressure

constipation

diarrhoea

feeling sick

decreased appetite

difficulty remembering things

difficulty thinking clearly

forgetfulness

reduced concentration.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

The above list includes the more

common side effects of your

medicine.

Other side effects not listed above

may also occur in some people.

After taking XTANDI

Storage

Keep your capsules in the pack

until it is time to take them.

XTANDI

If you take the capsules out of the

pack they may not keep as well.

If you are taking a reduced dose of

XTANDI, you may store the

remaining capsules in the open dose

compartment until the next dose,

provided that the capsules have been

otherwise stored under the conditions

described below.

Keep your capsules in the original

packaging in a cool dry place

where the temperature stays below

25°C.

Do not store XTANDI or any other

medicine in the bathroom or near a

sink. Do not leave it on a window

sill or in the car.

Heat and dampness can destroy some

medicines.

Do not take any capsule that is

leaking, damaged, or shows signs

of tampering.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Do not throw away any medicines

via wastewater or household waste.

Product description

What it looks like

XTANDI capsules are white to off-

white, oblong soft gelatin capsules

with "ENZ" written on one side in

black ink.

XTANDI is available in packs of 112

capsules (in 4 wallets of 28 capsules

each).

Ingredients

XTANDI contains 40 mg of

enzalutamide as the active ingredient.

Each capsule also contains:

caprylocaproyl

macrogolglycerides

butylated hydroxyanisole

butylated hydroxytoluene

gelatin

sorbitol sorbitan solution

glycerol

titanium dioxide

purified water

OPACODE WB monogramming

ink NSP-78-17827 BLACK

Supplier

XTANDI is distributed in Australia

Astellas Pharma Australia Pty Ltd

6 Eden Park Drive

Macquarie Park, NSW 2113

Medical Information:

1800 751 755

® = Registered Trademark

Australian registration number:

AUST R 210494

This leaflet was prepared in June

2017.

XTANDI

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety