FULVESTRANT TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FULVESTRANT

Available from:

TEVA ISRAEL LTD

ATC code:

L02BA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FULVESTRANT 50 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic area:

FULVESTRANT

Therapeutic indications:

MonotherapyFulvestrant Teva 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 TherapyFulvestrant Teva 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.

Authorization date:

2024-01-31

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Fulvestrant Teva
Solution for injection in a pre-filled syringe
For intramuscular injection
Active ingredient:
Each pre-filled syringe )5 ml( contains:
Fulvestrant 250 mg
Inactive
ingredients
and
allergens:
see
section
2
under
-
‘Important information about some of this medicine’s
ingredients’,
and section 6 - ‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine.
Keep the leaflet; you may need it again.
This leaflet contains concise information about this medicine.
If you have any further questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do
not pass it on to others. It may harm them, even if it seems to
you that their illness is similar to yours.
1. What is this medicine intended for?
Fulvestrant Teva is indicated for the treatment of estrogen
receptor positive, 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.
Fulvestrant
Teva,
in
combination
with
the
preparation
palbociclib,
is
indicated
for
women
with
advanced
or
m e t a s t a t i c
e s t r o g e n
r e c e p t o r - p o s i t i v e
a n d
H E R 2 - n e g a t i v e
breast
cancer,
whose
disease
has
progressed
after
receiving
prior
hormonal
treatment
for
this
ailment.
When Fulvestrant Teva is used in combination with palbociclib,
please read the palbociclib patient information leaflet as well.
Therapeutic group: Estrogen antagonist.
Fulvestrant Teva contains the active ingredient fulvestrant,
which belongs to the group of medicines that block the activity
of estrogen. Estrogen is a female sex hormone that can, in
some cases, be involved in development of breast cancer.
2. Before using this medicine
Do not use this medicine if:
You are sensitive (allergic) to fulvestrant or to any