YULAREB FILM-COATED TABLET 100MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Abemaciclib

Boleh didapati daripada:

DKSH SINGAPORE PTE. LTD.

Kod ATC:

L01EF03

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

Abemaciclib 100.0mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Lilly del Caribe, Inc.

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2022-08-22

Ciri produk

Page 1 of 43
NAME OF THE MEDICINAL PRODUCT
YULAREB FILM-COATED TABLET 50MG
YULAREB FILM-COATED TABLET 100MG
YULAREB FILM-COATED TABLET 150MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
YULAREB FILM-COATED TABLET 50MG
Each film-coated tablet contains 50 mg abemaciclib.
YULAREB FILM-COATED TABLET 100MG
Each film-coated tablet contains 100 mg abemaciclib.
YULAREB FILM-COATED TABLET 150MG
Each film-coated tablet contains 150 mg abemaciclib.
1
INDICATIONS AND USAGE
1.1
EARLY BREAST CANCER
Yulareb (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
Yulareb (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 43
•
When used in combination with fulvestrant, tamoxifen or an aromatase
inhibitor, the recommended dose
of Yulareb 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 Yulareb plus
endocrine therapy should be
treated with a gonadotropin-releasing hormone agonist according to
current clinical practice standards.
•
For early breast cancer, Yulareb should be taken continuously for two
years or until disease recurren