FASLODEX

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

FULVESTRANT

Tilgængelig fra:

ASTRAZENECA (ISRAEL) LTD

ATC-kode:

L02BA03

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

FULVESTRANT 250 MG / 5 ML

Indgivelsesvej:

I.M

Recept type:

Required

Fremstillet af:

ASTRA ZENECA UK LIMITED

Terapeutisk gruppe:

FULVESTRANT

Terapeutisk område:

FULVESTRANT

Terapeutiske indikationer:

MonotherapyFaslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:* not previously treated with endocrine therapy,or* with disease relapse on or after adjuvant endocrine therapy;or* with disease progression on endocrine therapy.Combination Therapy Faslodex is indicated for the treatment of:- HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in men and postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.- HR- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.

Autorisation dato:

2020-03-31

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FASLODEX
®
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
For intramuscular injection
Composition:
Each pre-filled syringe (5 ml) contains:
Fulvestrant 250 mg
For the list of inactive ingredients in the preparation, see section 2
"Important information regarding
some of the medicine ingredients" and section 6 - “Further
Information”.
Read the leaflet carefully in its entirety before using the medicine.
Keep the leaflet; you may need it again.
This leaflet contains concise information about the medicine. If you
have further questions, please refer
to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may harm them
even if it seems to you that their ailment is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
•
Faslodex is indicated for the treatment of estrogen receptor positive,
locally advanced or
metastatic breast cancer in postmenopausal women not previously
treated with hormonal therapy,
or with disease relapse/progression on or after adjuvant endocrine
therapy.
•
Faslodex, in combination with the preparation Palbociclib or
Abemaciclib, is intended for women
with advanced or metastatic estrogen receptor-positive and
HER2-negative breast cancer, whose
disease has progressed after receiving prior hormonal treatment for
this ailment.
•
Faslodex, in combination with Ribociclib, is intended for men and
postmenopausal women with
advanced or metastatic estrogen receptor-positive and HER2-negative
breast cancer, whose
disease has progressed after receiving prior endocrine treatment for
this ailment or as initial
endocrine treatment.
When used in combination with Palbociclib (Ibrance), Abemaciclib
(Verzenio) or Ribociclib (Kisqali)
please read the Palbociclib (Ibrance), Abemaciclib (Verzenio) or
Ribociclib (Kisqali) patient package
insert as well.
Therapeutic group:
Estrogen antagonist.
Faslo

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Faslodex
®
250 mg/5 ml solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Excipients with known effect (per 5 ml)
Ethanol (96%. 500mg)
Benzyl alcohol (500 mg)
Benzyl benzoate (750 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to yellow, viscous solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Monotherapy
Faslodex is indicated for the treatment of estrogen receptor positive,
locally advanced or metastatic
breast cancer in postmenopausal women:
-
Not previously treated with endocrine therapy, or
-
With disease relapse on or after adjuvant endocrine therapy; or
-
disease progression on endocrine therapy
Combination Therapy
FASLODEX is indicated for the treatment of:
•
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced or
metastatic breast cancer in men and postmenopausal women in
combination with ribociclib as
initial endocrine based therapy or following disease progression on
endocrine therapy.
•
HR-positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced or
metastatic breast cancer in combination with palbociclib or
abemaciclib in women with
disease progression after endocrine therapy.
4.2
Posology and method of administration
Monotherapy
Adult females (including the elderly):
The recommended dose is 500 mg at intervals of one month, with an
additional 500 mg dose given
two weeks after the initial dose.
Combination Therapy with Palbociclib
When FASLODEX is used in combination with palbociclib, abemaciclib, or
ribociclib, the recommended
dose of FASLODEX is 500 mg to be administered intramuscularly into the
buttocks (gluteal area)
slowly (1-2 minutes per injection) as two 5 mL injections, one in each
buttock, on Days 1, 15, 29 and
once monthly thereafter.
When FASLODEX is used in combination with Palbociclib, the recommended
dos