Faslodex Solution For Injection 250 mg5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fulvestrant

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

L02BA03

Dosage:

50 mg/ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Fulvestrant 50 mg/ml

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH and Co. KG

Authorization status:

ACTIVE

Authorization date:

2006-09-06

Patient Information leaflet























































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Summary of Product characteristics

1
FASLODEX
®
(Fulvestrant)
1.
NAME OF THE MEDICINAL PRODUCT
FASLODEX 250 mg
Fulvestrant
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
For a full list of excipients, see “List of excipients”.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to yellow, viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FASLODEX is indicated 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.
COMBINATION THERAPY WITH PALBOCICLIB
FASLODEX is indicated 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 with disease progression following
endocrine therapy.
COMBINATION THERAPY WITH ABEMACICLIB
FASLODEX is indicated in combination with abemaciclib for the
treatment of hormone
receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative locally
advanced or metastatic breast cancer in women with disease progression
after endocrine
therapy.
COMBINATION THERAPY WITH RIBOCICLIB
FASLODEX is indicated in combination with ribociclib for the treatment
of hormone receptor
(HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative locally advanced or
metastatic breast cancer in postmenopausal women as initial endocrine
based therapy or
following disease progression on endocrine therapy.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULT FEMALES (INCLUDING THE 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.
COMBINATION THERAPY WITH PALBOCICLIB
When
FASLODEX
is
used
in
combination
with
palbociclib,
refer
to
monotherapy
recomm