VERZENIO FILM-COATED TABLET 150MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Abemaciclib

Διαθέσιμο από:

DKSH SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

L01EF03

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

Abemaciclib 150.0mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Lilly del Caribe, Inc.

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2019-08-26

Αρχείο Π.Χ.Π.

Page 1 of 42
NAME OF THE MEDICINAL PRODUCT
VERZENIO FILM-COATED TABLET 50MG
VERZENIO FILM-COATED TABLET 100MG
VERZENIO FILM-COATED TABLET 150MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
VERZENIO FILM-COATED TABLET 50MG
Each film-coated tablet contains 50 mg abemaciclib.
VERZENIO FILM-COATED TABLET 100MG
Each film-coated tablet contains 100 mg abemaciclib.
VERZENIO FILM-COATED TABLET 150MG
Each film-coated tablet contains 150 mg abemaciclib.
1
INDICATIONS AND USAGE
1.1
EARLY BREAST CANCER
Verzenio (abemaciclib) in combination with endocrine therapy is
indicated for the adjuvant treatment of
adult patients with hormone receptor (HR) positive, human epidermal
growth factor receptor 2 (HER2)
negative, node-positive early breast cancer at high risk of recurrence
(see section 14.1).
1.2
ADVANCED OR METASTATIC BREAST CANCER
Verzenio (abemaciclib) is indicated:
•
in combination with an aromatase inhibitor as initial endocrine-based
therapy for the treatment of
postmenopausal women, and men, with hormone receptor (HR)-positive,
human epidermal growth
factor receptor 2 (HER2)-negative advanced or metastatic breast
cancer.
•
in combination with fulvestrant for the treatment of adult patients
with hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer with
disease progression following endocrine therapy.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSE AND SCHEDULE
Page 2 of 42
•
When used in combination with fulvestrant, tamoxifen or an aromatase
inhibitor, the recommended dose
of Verzenio is 150mg taken orally twice daily. Refer to the Full
Prescribing Information for the
recommended dose of fulvestrant, or tamoxifen or aromatase inhibitor
being used.
•
Pre/perimenopausal women treated with the combination of Verzenio plus
endocrine therapy should be
treated with a gonadotropin-releasing hormone agonist according to
current clinical practice standards.
•
For early breast cancer, Verzenio should be taken continuously for two
years or until disea