Xofigo
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
30-10-2023
Vara einkenni
(SPC)
30-10-2023
Opinber matsskýrsla
(PAR)
11-10-2018
Virkt innihaldsefni:
radium (223Ra) dichloride
Fáanlegur frá:
Bayer AG
ATC númer:
V10XX03
INN (Alþjóðlegt nafn):
radium Ra223 dichloride
Meðferðarhópur:
Therapeutic radiopharmaceuticals
Lækningarsvæði:
Prostatic Neoplasms
Ábendingar:
Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Vörulýsing:
Revision: 14
Leyfisstaða:
Authorised
Leyfisdagur:
2013-11-13
Upplýsingar fylgiseðill
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XOFIGO 1100 KBQ/ML SOLUTION FOR INJECTION
radium Ra 223 dichloride
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 who will supervise
the procedure.
-
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 Xofigo is and what it is used for
2.
What you need to know before Xofigo is used
3.
How Xofigo is used
4.
Possible side effects
5.
How Xofigo is stored
6.
Contents of the pack and other information
1.
WHAT XOFIGO IS AND WHAT IT IS USED FOR
This medicine contains the active substance radium Ra
223
dichloride (radium-223
dichloride).
Xofigo is used to treat adults with advanced castration-resistant
prostate cancer in progression after at least
two other cancer treatments apart from treatments to maintain reduced
levels of male hormone (hormone
therapy), or who cannot take any other cancer treatment.
Castration-resistant prostate cancer is a cancer of
the prostate (a gland of the male reproductive system) that does not
respond to treatment that reduces male
hormones. 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 the radioactive substance radium-223 which mimics the
calcium found in bones. When
injected into the patient, radium-223 reaches the bone where the
cancer has spread to and emits short-range
radiation (alpha particles) which kills the surrounding tumour cells.
2.
WHAT YOU NEED TO KNOW BEFORE XOFIGO IS USED
X
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Xofigo 1100 kBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 1100 kBq radium Ra 223 dichloride
(radium-223 dichloride), corresponding to
0.58 ng radium-223 at the reference date. Radium is present in the
solution as a free ion.
Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at
the reference date).
Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
The specific activity of radium-223 is
1.9 MBq/ng.
The six-stage-decay of radium-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 radium-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:
Excipients with known effect
Each mL of solution contains 0.194 mmol (equivalent to 4.5 mg) of
sodium.
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless isotonic solution with pH between 6.0 and 8.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xofigo monotherapy or in combination with luteinising hormone
releasing hormone (LHRH) analogue is
indicated for the treatment of adult patients with metastatic
castration-resistant prostate cancer (mCRPC),
symptomatic bone metastases and no known visceral metastases, in
progression after at least two prior lines
o
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