XOFIGO

Main information

  • Trade name:
  • XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208905
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208905

XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

20/05/2014

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. XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial

Product Type

Single Medicine Product

Effective date

3/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XOFIGO is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral

metastatic disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

28 Days

Store below 40

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

Not scheduled. Not considered by committee

Components

1. XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear and colourless solution

Active Ingredients

radium (223Ra) dichloride

6600 kBq

© 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 27.11.2017 at 10:48:45 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

151007 XOFIGO CMI

Page 1 of 4

XOFIGO

®

(zo-fee-go)

Radium (223Ra) dichloride

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about XOFIGO. 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 being given

XOFIGO against the benefits your

doctor expects it will have for you.

If you have any concerns about

being given this medicine, ask

your doctor.

Keep this leaflet.

You may need to read it again.

WHAT XOFIGO IS USED

FOR

XOFIGO is used to treat prostate

cancer that has not responded to

hormone therapy. XOFIGO is only

used when the disease has spread to

the bone but is not known to have

spread to other internal organs, and

is causing symptoms (e.g. pain).

XOFIGO contains small amounts of

the radioactive isotope radium-223

[223Ra] (as radium-223 dichloride)

which mimics calcium.

Radium-223 goes to where the

tumour cells are growing in the

bone and releases short-ranging

radioactivity (alpha particles) which

is toxic to the cells.

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.

BEFORE YOU ARE

GIVEN XOFIGO

When you must not be

given it

If you are not sure whether you

should be given this medicine,

talk to your doctor.

There are no known medical

conditions in which you must not be

given XOFIGO.

You must not be given XOFIGO

if:

the packaging is torn or shows

signs of tampering

the expiry date printed on the

pack after “EXP” has passed

If you are given XOFIGO after the

expiry date has passed, it may not

work as well.

The hospital or clinic where you

will be receiving XOFIGO will

make sure that XOFIGO is not used

if the expiry date printed on the

pack has passed or if the packaging

is torn or shows signs of tampering.

XOFIGO is not to be used in

women.

The safety and efficacy in children

and adolescents under 18 years of

age have not been studied.

Before you are given it

Tell your doctor if you have any

of the following medical

conditions:

bone marrow suppression (a

severe problem with your bone

marrow which can lead to a

decreased production of blood

cells)

untreated spinal cord

compression which is already

established or is about to

happen (this can be caused by a

tumour or other lesion)

a bone fracture

Crohn’s disease (chronic

inflammatory disease of the

intestines)

ulcerative colitis (chronic

inflammation of the colon)

XOFIGO can lead to a decrease in

the number of white blood cells

(which are necessary to help fight

infection) and/or platelets (which

are necessary to control blood

clotting).

Before starting treatment with

XOFIGO, your doctor will perform

blood tests to check your blood

cells and platelet levels. Some of

these tests will be repeated before

each subsequent treatment

(injection). Depending on the

results of these tests, your doctor

will decide if the treatment can be

started, continued or needs to be

postponed or discontinued.

Tell your doctor if you are

intending to have children.

Radiation may have an effect on the

production or development of your

sperm.

151007 XOFIGO CMI

Page 2 of 4

Ask your doctor how this may

affect you, especially if you are

planning to have children in the

future. You may wish to seek

advice on conservation of sperm

prior to treatment.

If you have not told your doctor

about any of the above, tell your

doctor before you are given

XOFIGO.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket,

naturopath or health food shop.

Tell your doctor if you are taking

chemotherapy (other medicines to

treat your cancer).

In some cases, using XOFIGO and

chemotherapy together may cause a

more severe decrease in the number

of your white blood cells and/or

platelets.

Your doctor or treatment provider

has more information on medicines

to be careful with or avoid when

you are given XOFIGO.

HOW XOFIGO IS GIVEN

There are strict laws on the use,

handling and disposal of products

like XOFIGO. XOFIGO can only

be used in specialised hospitals or

clinics.

XOFIGO must only be handled and

given to you by a qualified doctor

or other qualified healthcare

professional who is trained and

licensed to use it safely.

If you have any questions, ask

your doctor.

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions given, ask your

doctor for help.

How much is given

The dose you receive depends on

your body weight. The qualified

doctor supervising the procedure

will calculate the quantity of

XOFIGO to be used in your case.

The recommended quantity to be

administered is 55 kBq of XOFIGO

per kilogram of your body weight.

No dosage adjustment is needed in

elderly patients, or if you have poor

kidney or liver function.

How it is given

XOFIGO is injected slowly

(generally up to 1 minute) into your

veins (intravenously).

The healthcare professional

administering XOFIGO will flush

the intravenous access line or

cannula before and after the

injection with a saline solution.

XOFIGO is a ready-to-use solution

and should not be diluted or mixed

with any solutions.

When it is given

Your doctor will decide when you

will be given XOFIGO.

How long to continue

treatment

Continue treatment with

XOFIGO for as long as your

doctor tells you.

You will usually be given an

injection of XOFIGO once every 4

weeks for a total of 6 injections.

If you forget a treatment

If you miss a treatment with

XOFIGO, contact your doctor to

make a new appointment for

injection as soon as possible.

Do not stop treatment with

XOFIGO unless your doctor tells

you to do so.

If you are given too much

(overdose)

It is unlikely that you will be given

too much XOFIGO. The dose of

XOFIGO you will receive will be

calculated by a qualified doctor and

given to you in a highly specialised

setting by the qualified doctor or

other qualified healthcare

professional.

If you receive too much XOFIGO,

you will need to be monitored for

gastrointestinal symptoms and your

doctor will need to perform blood

tests on you to check for any

changes in your blood counts.

If an overdose is suspected,

immediately telephone your

doctor or the Poisons Information

Centre (Australia: 13 11 26 or

New Zealand: 0800 POISON or

0800 764 766) or go to Accident

and Emergency at your nearest

hospital.

WHILE YOU ARE

BEING TREATED WITH

XOFIGO

Things you must do

Your doctor who supervises the

procedure will let you know if you

need to take any special precautions

after receiving XOFIGO.

Follow good hygiene after

receiving XOFIGO

XOFIGO is excreted from your

body mainly via the faeces.

You should adhere to good personal

hygiene practices while receiving

XOFIGO and for at least 4 weeks

151007 XOFIGO CMI

Page 3 of 4

after the last injection in order to

minimise radiation exposure from

bodily fluids to household members

and caregivers.

Flush the toilet twice and wash

your hands well after going to the

bathroom.

Clothing soiled with bodily fluids,

such as faecal matter or urine,

should be washed promptly and

separately from other clothing.

When handling bodily fluids, you

and your caregiver should wear

protective gloves and

wash your

hands thoroughly afterwards.

Contact your doctor if you have

any questions.

Make sure you keep all your

doctor's appointments so your

progress can be checked.

Your doctor will need to perform

blood tests to check your blood

cells and platelet levels before

giving each dose of XOFIGO.

If you are told that your blood

count has become abnormally

low, ask your doctor for advice on

the precautions you can take to

reduce the risk of infection or

bleeding.

Use an effective birth control

method during and for 6 months

after treatment with XOFIGO if

you are having sex with a woman

who can become pregnant.

Your partner should also use an

effective contraceptive method.

SIDE EFFECTS

Tell your doctor as soon as

possible if you do not feel well

while you are being treated with

XOFIGO.

XOFIGO helps most people, but it

may have unwanted side effects in a

few people.

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 to answer any

questions you may have.

Tell your doctor if you notice any

of the following and they worry

you:

diarrhoea

vomiting

nausea (feeling sick)

Tell your doctor as soon as

possible if you notice any of the

following:

redness of the skin, pain and

swelling at the injection site

symptoms of anaemia like

tiredness, being short of breath

and looking pale

The most serious side effects in

patients receiving XOFIGO are:

low platelet count in the blood

(thrombocytopenia)

low number of neutrophils

which are a class of white blood

cells (neutropenia)

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

bleeding or bruising more easily

than normal

frequent infections such as

fever, severe chills, sore throat

or mouth ulcers

The above side effects may be signs

that your blood cells and/or platelet

levels are too low. You may need

urgent medical attention.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some people.

AFTER YOU ARE

TREATED WITH

XOFIGO

Storage

You will not have to store

XOFIGO.

The hospital or clinic where you

will be receiving XOFIGO will be

responsible for storing XOFIGO

properly.

Disposal

Each XOFIGO vial is to be used for

one injection only and then

discarded.

The hospital or clinic where you

will be receiving XOFIGO will be

responsible for discarding any

unused contents properly.

PRODUCT

DESCRIPTION

What it looks like

XOFIGO is a clear and colourless

solution for injection, supplied in a

glass vial and packed in a lead

container.

Each pack of XOFIGO contains one

single-dose vial. Each vial contains

6 mL of radium-223 solution for

injection corresponding to a total

activity of 6.6 MBq (1100 kBq/mL)

at the reference date.

151007 XOFIGO CMI

Page 4 of 4

Ingredients

Active ingredient:

radium (223Ra) dichloride

Inactive ingredients:

hydrochloric acid

sodium chloride

sodium citrate

water for injection

Supplier

Made in Norway for:

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble, NSW 2073

Bayer New Zealand Ltd

3 Argus Place

Hillcrest

North Shore

Auckland 0627

Australian registration

number

AUST R 208905

Date of preparation

October 2015

See TGA website

(www.ebs.tga.gov.au) for latest

Australian Consumer Medicine

Information.

Registered Trademark of the

Bayer Group, Germany.

Bayer Australia Ltd.

All rights reserved.

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

25-6-2018

Xofigo (Bayer AG)

Xofigo (Bayer AG)

Xofigo (Active substance: Radium Ra 223 dichloride) - Centralised - Renewal - Commission Decision (2018)4018 of Mon, 25 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2653/R/30

Europe -DG Health and Food Safety