Fulvestrant 250 mg Solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fulvestrant

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L02BA; L02BA03

INN (International Name):

Fulvestrant

Dosage:

250mg millilitre(s)

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anti-estrogens; fulvestrant

Authorization status:

Marketed

Authorization date:

2017-10-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FULVESTRANT 250 MG SOLUTION FOR INJECTION IN PRE-FILLED 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 is and what it is used for
2.
What you need to know before you use Fulvestrant
3.
How to use Fulvestrant
4.
Possible side effects
5.
How to store Fulvestrant
6.
Contents of the pack and other information
1.
WHAT
Fulvestrant IS AND WHAT IT IS USED FOR
Fulvestrant 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 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 palbociclib,
please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE F

Summary of Product characteristics

Health─Products─Regulatory─Authority
30─August─2022
CRN00D4NP
Page─1─of─16
SUMMARY─OF─PRODUCT─CHARACTERISTICS
1─NAME─OF─THE─MEDICINAL─PRODUCT
Fulvestrant─250─mg─Solution─for─injection─in─pre-filled─syringe
2─QUALITATIVE─AND─QUANTITATIVE─COMPOSITION
Each─ml─of─solution─for─injection─in─pre-filled─syringe─contains─50─mg─fulvestrant
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─in─pre-filled─syringe─(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