Faslodex
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
21-03-2024
Produktets egenskaber
(SPC)
21-03-2024
Offentlige vurderingsrapport
(PAR)
27-01-2018
Aktiv bestanddel:
fulvestrant
Tilgængelig fra:
AstraZeneca AB
ATC-kode:
L02BA03
INN (International Name):
fulvestrant
Terapeutisk gruppe:
Endocrine therapy, Anti-estrogens
Terapeutisk område:
Breast Neoplasms
Terapeutiske indikationer:
Faslodex is indicated , as monotherapy 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 antiestrogen therapy, or disease progression on antiestrogen therapy., , , in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. , In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.,
Produkt oversigt:
Revision: 23
Autorisation status:
Authorised
Autorisation dato:
2004-03-09
Indlægsseddel
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
FASLODEX 250 MG SOLUTION FOR INJECTION
fulvestrant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Faslodex is and what it is used for
2.
What you need to know before you use Faslodex
3.
How to use Faslodex
4.
Possible side effects
5.
How to store Faslodex
6.
Contents of the pack and other information
1.
WHAT FASLODEX IS AND WHAT IT IS USED FOR
Faslodex contains the active substance fulvestrant, which belongs to
the group of estrogen blockers.
Estrogens, a type of female sex hormones, can in some cases be
involved in the growth of breast
cancer.
Faslodex is used either:
alone, to treat postmenopausal women with a type of breast cancer
called estrogen receptor
positive breast cancer that is locally advanced or has spread to other
parts of the body
(metastatic), or
in combination with palbociclib to treat women with a type of breast
cancer called hormone
receptor-positive, human epidermal growth factor receptor 2-negative
breast cancer, that is
locally advanced or has spread to other parts of the body
(metastatic). Women who have not
reached menopause will also be treated with a medicine called a
luteinizing hormone releasing
hormone (LHRH) agonist.
When Faslodex is given in combination with palbociclib, it is
important that you also read the package
leaflet for palbociclib. If you have any questions about palbociclib,
please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FASLODEX
DO NOT USE FASLODE
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Faslodex 250 mg 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%, 500 mg)
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
Faslodex is indicated:
as monotherapy 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 antiestrogen therapy, or
disease progression on
antiestrogen therapy.
in combination with palbociclib for the treatment of hormone receptor
(HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative locally advanced or
metastatic breast
cancer in women who have received prior endocrine therapy (see section
5.1).
In pre- or perimenopausal women, the combination treatment with
palbociclib should be combined
with a luteinizing hormone releasing hormone (LHRH) agonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult females (including 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.
When Faslodex is used in combination with palbociclib, please also
refer to the Summary of Product
Characteristics of palbociclib.
Prior to the start of treatment with the combination of Faslodex plus
palbociclib, and throughout its
duration, pre/perimenopausal women should be treated with LHRH
agonists according to local clinical
practice.
3
Special populations
_Renal impairment_
No dose adjustments are recommended for patients with mild to moderate
renal impairment (creatinine
clearance
30 ml/min). Safety and efficacy have not been eval
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