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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

radium (223Ra) dichloride, Quantity: 6600 kBq

Disponible depuis:

Bayer Australia Ltd

DCI (Dénomination commune internationale):

radium (223Ra) dichloride

forme pharmaceutique:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; sodium citrate dihydrate

Mode d'administration:

Intravenous

Unités en paquet:

1 vial

Type d'ordonnance:

Not scheduled. Not considered by committee

indications thérapeutiques:

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

Descriptif du produit:

Visual Identification: Clear and colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 28 Days; Container Temperature: Store below 40 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Licence status A

Date de l'autorisation:

2014-05-20

Notice patient

190102 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.
You should not be given XOFIGO
if you are taking abiraterone acetate
together with prednisone or
prednisolone.
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 effic

Résumé des caractéristiques du produit

1901 XOFIGO PI
1
AUSTRALIAN PRODUCT INFORMATION
XOFIGO SOLUTION FOR INJECTION
(Radium (223Ra) dichloride 6.6 MBq/6 mL)
1
NAME OF THE MEDICINE
XOFIGO Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 1100 kBq radium (223Ra) dichloride
(Ra-223
dichloride), corresponding to 0.58 ng Ra-223, at the reference date.
Radium is
present in the solution as a free ion.
Ra-223 is an alpha particle-emitter with a half-life of 11.4 days. The
specific activity
of Ra-223 is 1.9 MBq/ng.
The six-stage-decay of Ra-223 to lead-207 occurs via short-lived
daughters and is
accompanied by a number of alpha, beta and gamma emissions with
different
energies and emission probabilities. The fraction of energy emitted
from Ra-223 and
its daughters as alpha-particles is 95.3% (energy range of 5.0 - 7.5
MeV). The
fraction emitted as beta-particles is 3.6% (average energies are 0.445
MeV and
0.492 MeV), and the fraction emitted as gamma-radiation is 1.1%
(energy range of
0.01 - 1.27 MeV).
FIGURE 1: RADIUM-223 DECAY CHAIN WITH PHYSICAL HALF-LIVES AND MODE OF
DECAY:
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
1901 XOFIGO PI
2
3
PHARMACEUTICAL FORM
XOFIGO is a clear, colourless and sterile isotonic solution for
injection with pH
between 6 and 8.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XOFIGO is indicated for the treatment of castration-resistant prostate
cancer patients
with symptomatic bone metastases and no known visceral metastatic
disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The dose regimen of XOFIGO is 55 kBq per kg body weight, given at 4
week
intervals for 6 injections.
Safety and efficacy beyond 6 injections have not been studied.
For details on the calculation of the volume to be administered, see
Method of
administration.
_Additional information on special populations _
No dose adjustment is considered necessary in the elderly or in
patients with renal or
hepatic impairment (see Section 5.2 PHARMACOKINETIC PROPERTIES).
METHOD OF