Fulvestrant Mylan
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
24-02-2023
Fachinformation
(SPC)
24-02-2023
Öffentlichen Beurteilungsberichts
(PAR)
21-02-2018
Wirkstoff:
fulvestrant
Verfügbar ab:
Mylan Pharmaceuticals Limited
ATC-Code:
L02BA03
INN (Internationale Bezeichnung):
fulvestrant
Therapiegruppe:
Endocrine therapy
Therapiebereich:
Breast Neoplasms
Anwendungsgebiete:
Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.
Produktbesonderheiten:
Revision: 5
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2018-01-08
Gebrauchsinformation
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
FULVESTRANT MYLAN 250 MG SOLUTION FOR INJECTION IN PREFILLED SYRINGE
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 Fulvestrant Mylan is and what it is used for
2.
What you need to know before you use Fulvestrant Mylan
3.
How to use Fulvestrant Mylan
4.
Possible side effects
5.
How to store Fulvestrant Mylan
6.
Contents of the pack and other information
1.
WHAT FULVESTRANT MYLAN IS AND WHAT IT IS USED FOR
Fulvestrant Mylan 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.
Fulvestrant Mylan 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 fulvestrant is given in combination with palbociclib, it is
important that you also read the
package leaflet for palbociclib. If you have any questions about
palbocicli
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
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, anhydrous (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
Fulvestrant 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 fulvestrant 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 fulvestrant
plus palbociclib, and throughout
its duration, pre/perimenopausal women should be treated with LHRH
agonists according to local
clinical practice.
_ _
Special populations
_Renal impairment _
No dose adjustments are recommended for patients with mild to moderate
renal impairment
(creatinine clearance
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