XOFIGO

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

RADIUM-223 DICHLORIDE

Dostupné z:

BAYER ISRAEL LTD

ATC kód:

V10XX03

Forma lieku:

SOLUTION FOR INJECTION

Zloženie:

RADIUM-223 DICHLORIDE 1100 KBQ/ML AT REFERENCE DATE

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

BAYER AS, NORWAY

Terapeutické oblasti:

RADIUM (223 RA) DICHLORIDE

Terapeutické indikácie:

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 of systemic therapy for advanced PC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.

Dátum Autorizácia:

2019-02-28

Príbalový leták

Page
1
of
4
08
רבמבונ
2018
אפור
ה/
,ה/דבכנ
,ה/דבכנ ת/חקור
:ןודנה
XOFIGO
-
וגיפוסק
Solution for injection
at reference date
L
m
/
q
B
k
1100
223 dichloride
-
adium
R
ונא
םישקבמ
םכעידוהל
ש
תנוכתמב הזיראה ןולע
ל ןולע
אפור
רישכתה לש
ןכדוע
.
םג ללוכ ןוכדעה
עדימ
רקחמל עגונה
ERA-223
.
היוותהה
ה
תרשואמ
רישכתל
:
Treatment of adults with castration-resistant prostate cancer,
symptomatic bone metastases
and no known visceral metastases.
טוריפב
עיפומ ןלהלש
,
הנושש קרפ לכ ךותמ
ולעב
ן
,
קר
עדימה
נמוסמ טסקט תפסות .ןכדעתהש
ת
ןותחת וקב
.
תנמוסמ טסקט תקיחמ
.הצוח וקב
ב םינוכדעה תנוכתמב הזיראה ןולע
אפורל ןולע
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Combination with abiraterone and prednisone/prednisolone or with
second generation _
_androgen receptor antagonists such as enzalutamide systemic cancer
therapies other _
_than LHRH analogues _
An interim analysis from a clinical trial in chemotherapy-naïve
patients with asymptomatic
or mildly symptomatic castration resistant prostate cancer and
progressive disease with
bone metastases showed an increased incidence risk
_ _of fractures and deaths a trend for
increased mortality among patients receiving Xofigo in combination
with abiraterone
acetate and prednisone/prednisolone compared to patients receiving
placebo in
combination with abiraterone acetate and prednisone/prednisolone (see
section 5.1).
Concurrent use of bisphosphonates or denosumab reduced the incidence
of fractures in
both treatment arms.
Therefore, Xofigo is contraindicated in combination with abiraterone
acetate and
prednisone/prednisolone (see section 4.3).
The sSafety and efficacy of Xofigo in combination with second
generation androgen receptor
antagonists such as enzalutamide cancer therapies other than LHRH
analogues have not
been established; a

Súhrn charakteristických

1
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.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless isotonic solution with pH between 6.0 and 8.0.
2
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
of systemic therapy for advanced PC (other than LHRH analogues), or
ineligible for any available systemic
mCRPC treatment (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xofigo should be administered only by persons authorised to handle
radiopharmaceuticals in designated
clinical setting