AFINITOR everolimus 2.5 mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

everolimus, Quantity: 2.5 mg

Disponibil de la:

Novartis Pharmaceuticals Australia Pty Ltd

INN (nume internaţional):

Everolimus

Forma farmaceutică:

Tablet

Compoziție:

Excipient Ingredients: magnesium stearate; lactose; lactose monohydrate; hypromellose; butylated hydroxytoluene; crospovidone

Calea de administrare:

Oral

Unități în pachet:

30, 90, 10

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Afinitor is indicated for the treatment of:,? Postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? Advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. ? Patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. Afinitor is indicated for the: ? Treatment of postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? Treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? Treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. ? Treatment of patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. ? Adjunctive treatment of patients aged 2 years and older with TSC and associated refractory seizures.

Rezumat produs:

Visual Identification: White to slightly yellowish elongated tablet with a bevelled edge, engraved with LCL on one side and NVR on the other; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2012-01-30

Prospect

AFINITOR
®
_everolimus_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Afinitor.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Afinitor
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AFINITOR IS USED
FOR
Afinitor is used in the treatment of
renal cell carcinoma, a type of kidney
cancer; neuroendocrine tumours
(NETs), a type of cancer located in
the stomach and intestine, lung or
pancreas; tuberous sclerosis complex
(TSC) with angiomyolipoma of the
kidney (a kidney tumour) not
requiring immediate surgery; or TSC
with subependymal giant cell
astrocytoma (sometimes called
'SEGA'), a specific type of brain
tumour not requiring immediate
surgery.
Afinitor is also used in the treatment
of hormone receptor-positive HER2
negative advanced breast cancer in
postmenopausal women, in
conjunction with exemestane after
failure of letrozole or anastrozole.
It is only used in patients whose
tumour has tested negative to HER2.
Everolimus is the active substance in
Afinitor.
TREATMENT OF KIDNEY CANCER
Afinitor stops the cancer from
making new cells and cuts off the
blood supply. This slows the growth
and spread of the cancer.
TREATMENT OF NETS
Afinitor is used to control the growth
of these tumours located in the

Caracteristicilor produsului

Page 1 of 52
AFINITOR
®
(EVEROLIMUS)
NAME OF THE MEDICINE
The active ingredient of Afinitor is everolimus.
The chemical name is 40-O-(2-hydroxyethyl)-rapamycin or
40-O-(2-hydroxyethyl)-sirolimus.
Its molecular formula is C
53
H
83
NO
14
and its molecular weight is 958.2.
The structural formula of everolimus is:
N
O
O
O
O
O
O
O
OH
O
O
O
OH
OH
O
DESCRIPTION
Everolimus is a white to faintly yellow powder practically insoluble
in water but soluble in
organic solvents such as ethanol and methanol.
CAS number: 159351-69-6
Excipients: (Tablets) Butylated hydroxytoluene, magnesium stearate,
lactose monohydrate,
hypromellose, crospovidone, lactose anhydrous.
Page 2 of 52
Excipients: (dispersible tablets) Butylated hydroxytoluene, magnesium
stearate, lactose
monohydrate, hypromellose, crospovidone, mannitol, cellulose
microcrystalline, and silica
colloidal anhydrous.
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
Everolimus is a signal transduction inhibitor targeting mTOR
(mammalian target of
rapamycin), or more specifically, mTORC1 (mammalian 'target of
rapamycin' complex 1).
mTOR is a key serine-threonine kinase playing a central role in the
regulation of cell growth,
proliferation and survival. The regulation of mTORC1 signalling is
complex, being modulated
by mitogens, growth factors, energy and nutrient availability. mTORC1
is an essential
regulator of global protein synthesis downstream on the PI3K/AKT
pathway, which is
dysregulated in the majority of human cancers.
Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to
endocrine
resistance in breast cancer.
_In vitro_
studies show that oestrogen-dependent and HER2+ breast
cancer cells are sensitive to the inhibitory effects of everolimus,
and that combination of
everolimus with Akt, HER2, or aromatase inhibitors synergistically
enhances the anti-tumour
effect of everolimus.
Two primary regulators of mTORC1 signaling are the oncogene
suppressors tuberin-sclerosis
complexes 1 & 2 (TSC1, TSC2). Loss or inactivation of either TSC1 or
TSC2 leads to
e