Afinitor 5mg Dispersible Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EVEROLIMUS

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

EVEROLIMUS

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
AFINITOR
®
TABLET
EVEROLIMUS (2.5MG, 5MG, 10MG)
AFINITOR
®
DISPERSIBLE TABLET
EVEROLIMUS (2 MG, 3 MG, 5 MG)
1
WHAT IS IN THIS LEAFLET
1.
WHAT IS AFINITOR/AFINITOR
DISPERSIBLE USED FOR
2.
HOW AFINITOR/AFINITOR
DISPERSIBLE WORKS
3.
BEFORE YOU USE AFINITOR/
AFINITOR DISPERSIBLE
4.
HOW TO USE AFINITOR/AFINITOR
DISPERSIBLE
5.
WHILE YOU ARE USING
AFINITOR/AFINITOR DISPERSIBLE
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
AFINITOR/AFINITOR DISPERSIBLE
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT AFINITOR/ AFINITOR
DISPERSIBLE IS USED FOR
WHAT IS AFINITOR USED FOR?
AFINITOR is a prescription
medicine used to treat:
•
Advanced hormone receptor-
positive, HER2-negative breast
cancer, along with the medicine
_exemestane_
, in postmenopausal
women who have already
received certain other medicines
for their cancer.
•
Adults with a type of pancreatic
cancer known as pancreatic
neuroendocrine tumor (PNET)
that has progressed and cannot
be treated with surgery.
•
Adults with a type of cancer
known as neuroendocrine tumor
(NET) of the stomach and
intestine (gastrointestinal), or
lung that has progressed and
cannot be treated with surgery.
AFINITOR is not for use in
people with carcinoid tumors
that actively produce hormones.
•
Adults with advanced kidney
cancer (renal cell carcinoma or
RCC) when certain other
medicines have not worked.
•
People with the following types
of tumors that are seen with a
genetic condition called
tuberous sclerosis complex
(TSC):
_-_
_ _
Adults with a kidney tumor
called angiomyolipoma,
when their kidney tumor
does not require surgery
right away.
_-_
_ _
Adults and children 1 year
of age and older with a
brain tumor called
subependymal giant cell
astrocytoma (SEGA) when
the tumor cannot be
removed completely by
surgery.
WHAT IS AFINITOR
DISPERSIBLE USED FOR?
AFINITOR DISPERSIBLE is a
prescription medicine used to treat:
•
Adults and children 1 year of
age and older with a genetic
co

Ciri produk

Novartis
Page 2
Malaysia Package Insert
31-May-2021
Afinitor
®
1
INDICATIONS AND USAGE
AFINITOR tablets are indicated for the
•
treatment of postmenopausal women with advanced hormone
receptor-positive, HER2-negative
breast cancer (advanced HR+BC) in combination with exemestane, after
failure of treatment with
letrozole or anastrozole.
•
treatment of patients with advanced renal cell carcinoma, whose
disease has progressed on or
after treatment with VEGF-targeted therapy.
•
treatment of progressive neuroendocrine tumors of pancreatic origin
(PNET) in patients with
unresectable, locally advanced or metastatic disease. AFINITOR is not
indicated for the treatment
of patients with functional carcinoid tumors.
•
treatment of adult patients with progressive, well-differentiated
(Grade 1 or Grade 2), non-
functional neuroendocrine tumors (NET) of gastrointestinal (GI) or
lung origin with unresectable,
locally advanced or metastatic disease. AFINITOR is not indicated for
the treatment of patients
with functional carcinoid tumors.
•
treatment of adult and pediatric patients, 1 years of age and older,
with subependymal giant cell
astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
who require therapeutic
intervention
but
are
not
candidates
for
curative
surgical
resection.
The
effectiveness
of
AFINITOR is based on an analysis of change in SEGA volume (see section
CLINICAL
STUDIES). Clinical benefit such as improvement in disease-related
symptoms or increase in
overall survival has not been demonstrated.
•
treatment of adult patients with renal angiomyolipoma (AML) and
tuberous sclerosis complex
(TSC), not requiring immediate surgery. The effectiveness of AFINITOR
in the treatment of renal
angiomyolipoma is based on an analysis of durable objective responses
in patients treated for a
median of 8.3 months. Further follow-up of patients is required to
determine long-term outcomes.
AFINITOR DISPERSIBLE tablets are indicated for the
•
treatment of adult and pediatric patients, 1 years of age and ol