Yulareb 150mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Abemaciclib

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

Abemaciclib

Unit dalam pakej:

14 Tablets

Dikeluarkan oleh:

LILLY DEL CARIBE, INC

Risalah maklumat

YULAREB FILM-COATED TABLETS
Abemaciclib (50 mg, 100 mg and 150 mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Yulareb is used for
2.
How Yulareb works
3.
Before you use Yulareb
4.
How to use Yulareb
5.
While you are using Yulareb
6.
Side effects
7.
Storage and Disposal of Yulareb
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
What Yulareb is used for
Yulareb is a prescription medicine used:
- in combination with endocrine therapy
(tamoxifen or an aromatase inhibitor)
to treat adults with hormone receptor
(HR)-positive,
human
epidermal
growth
factor
receptor
2
(HER2)-
negative, node-positive, early breast
cancer with a high risk of coming back
as determined by your doctor.
- in
combination
with
an
aromatase
inhibitor as the first endocrine-based
therapy
to
treat
adult
patients,
with
hormone
receptor
(HR)-positive,
human
epidermal
growth
factor
receptor
2
(HER2)-negative
breast
cancer that has worsened or that has
spread
to
other
parts
of
the
body
(metastatic).
- in combination with fulvestrant to treat
adult
with
hormone
receptor
(HR)-
positive,
human
epidermal
growth
factor
receptor
2
(HER2)-negative
breast cancer that has worsened or that
has spread to other parts of the body
(metastatic)
and
whose
disease
has
progressed after endocrine therapy.
When Yulareb is used in combination
with
fulvestrant,
tamoxifen,
or
an
aromatase inhibitor, also read the Patient
Information for the prescribed product.
Ask your doctor or pharmacist if you are
not sure.
How Yulareb works
Yulareb
contains
the
active
substance
abemaciclib. It belongs
to a group of
medicines
called
cyclin-dependent
kinases
4
and
6
(CDK4
and
CDK6)
inhibitors. A kinase is a type of protein in
the body that helps control cell division.
Yularebo works by interfering with the
kinase and stopping cancer cells from
dividing and growing.
Before you use Yulareb
- When you must not use it
Do not take Yulareb:
- if you are allergic to abemaciclib or any
of the other ingredients of th

Ciri produk

Yulareb PI_USPI Mar2023_EUSPC-eBC June 2023_10Aug2023
Page 1 of 28
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
YULAREB safely and effectively. See full prescribing information
for YULAREB.
YULAREB (abemaciclib) tablets, for oral use
---------------------------- INDICATIONS AND USAGE
---------------------------
YULAREB
®
is a kinase inhibitor indicated:
•
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 (1.1, 2.1, 14.1). In pre- or perimenopausal women,
aromatase inhibitor endocrine therapy should be combined with a
luteinising hormone-releasing hormone (LHRH) agonist
•
in combination with an aromatase inhibitor as initial endocrine-
based therapy for the treatment of adult patients with hormone
receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative advanced or metastatic breast cancer. (1.2)
•
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.
(1.2)
------------------------DOSAGE AND
ADMINISTRATION-----------------------
YULAREB tablets are taken orally with or without food. (2.1)
•
Recommended starting dose in combination with fulvestrant,
tamoxifen, or an aromatase inhibitor: 150 mg twice daily. (2.1)
•
Dosing interruption and/or dose reductions may be required based
on individual safety and tolerability. (2.2)
----------------------DOSAGE FORMS AND STRENGTHS---------------------
Tablets: 50 mg, 100 mg, and 150 mg. (3)
------------------------------- CONTRAINDICATIONS
------------------------------
Hypersensitivity to the active substance or to any of the excipients
listed.
(11)
------------------------ WARNINGS AND PR