FULVESTRANT 250 MG S.K.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FULVESTRANT

Available from:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC code:

L02BA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FULVESTRANT 50 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

DR. REDDY'S LABORATORIES LIMITED, INDIA

Therapeutic area:

FULVESTRANT

Therapeutic indications:

Monotherapy Fulvestrant 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 - disease progression on endocrine therapy Combination Therapy Fulvestrant 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:

2020-07-29

Patient Information leaflet

PATIENT INFORMATION LEAFLET IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS
(PREPARATIONS) 1986
The medicine is dispensed with a doctor’s prescription only
FULVESTRANT 250 MG S.K.
INJECTION SOLUTION FOR INTRAMUSCULAR INJECTION IN A READY-TO-USE
SYRINGE
COMPOSITION:
Fulvestrant 50mg/ml
Each (5ml) ready-to-use syringe contains:
Fulvestrant 250 mg
For the list of inactive ingredients in this preparation, see Section
2 “important information
regarding some of medicine ingredients” and section 6 - "Additional
information"
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep the leaflet as you may need it again.
This leaflet contains concise information about the medicine. If you
have additional
questions, consult the doctor or pharmacist.
This medicine was prescribed for the treatment of your disease. Do not
pass it on to others.
It may harm them even if it seems to you that their disease is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
•
Fulvestrant 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 disease progression on endocrine
therapy.
•
Combination Therapy with Palbociclib:
Fulvestrant is indicated for the treatment of HR-positive, human
epidermal growth factor
receptor 2 (HER2)- negative advanced or metastatic breast cancer in
combination with
palbociclib in women with disease progression after endocrine therapy
When using
Fulvestrant
S.K.
combined
with
Palbociclib
(Ibrance),
please
also
read
the
Patient
Information Leaflet for Palbociclib (Ibrance).
THERAPEUTIC GROUP:
Estrogen antagonist.
The drug Fulvestrant S.K. contains the active ingredient Fulvestrant,
which belongs to the
group of medicines that block the activity of estrogen. Estrogen is a
female sex hormone,
which in some cases can be involved in the development of breast
cancer.
2. BEFORE USING THE MEDICATION
X Do not use the