AFINITOR everolimus 2 mg dispersible tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

everolimus, Quantity: 2 mg

Disponibil de la:

Novartis Pharmaceuticals Australia Pty Ltd

INN (nume internaţional):

Everolimus

Forma farmaceutică:

Tablet, dispersible

Compoziție:

Excipient Ingredients: butylated hydroxytoluene; crospovidone; hypromellose; lactose monohydrate; mannitol; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica

Calea de administrare:

Oral

Unități în pachet:

120, 60, 100, 50, 30

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. ? 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 yellow round flat tablet with bevelled edge engraved D2 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: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2013-08-28

Prospect

AFINITOR
®
A
f
i
n
i
t
o
r
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING AFINITOR?
Afinitor contains the active ingredient everolimus. Afinitor is used
to treat various types of cancer by slowing the growth of cancer-
causing cells.
For more information, see Section 1. Why am I using Afinitor? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AFINITOR?
Do not use if you have ever had an allergic reaction to Afinitor or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Afinitor? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Afinitor and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE AFINITOR?
•
Your doctor will tell you the dose of Afinitor that you should take.
More instructions can be found in Section 4. How do I use Afinitor? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AFINITOR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Afinitor.
•
Avoid becoming pregnant while using Afinitor and for up to 8 weeks
after you stop using it.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take Afinitor to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
It is not known if Afinitor will influence your ability to drive and
use machines.
DRINKING
ALCOHOL
•
There are no known interactions bet

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