Afinitor
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
27-06-2019
Active ingredient:
Everolimus 5mg; ;
Available from:
Novartis New Zealand Ltd
INN (International Name):
Everolimus 5 mg
Dosage:
5 mg
Pharmaceutical form:
Tablet
Composition:
Active: Everolimus 5mg Excipient: Butylated hydroxytoluene Crospovidone Hypromellose Lactose Lactose monohydrate Magnesium stearate
Units in package:
Blister pack, PA/AL/PVC, 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Lek Pharmaceuticals d.d.
Therapeutic indications:
The treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on change in SEGA volume. Further clinical benefit, such as improvement of disease-related symptoms, has not been demonstrated.
Product summary:
Package - Contents - Shelf Life: Blister pack, PA/AL/PVC - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, PA/AL/PVC - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, PA/AL/PVC - 90 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture
Authorization date:
2008-07-31
Patient Information leaflet
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Afinitor
_2.5MG, 5MG AND 10MG TABLETS _
_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.MEDSAFE.GOVT.NZ
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; pancreatic neuroendocrine
tumours (pNET), a type of cancer
located in the pancreas; or
subependymal giant cell astrocytoma
(sometimes called ‘SEGA’), a specific
type of brain tumour) associated with a
disease called tuberous sclerosis.
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 pNET
Afinitor is used to control the growth
of these tumours located in the
pancreas.
Treatment of SEGA
Afinitor reduces the size of brain s
(SEGA) that are caused by a genetic
disorder called tuberous sclerosis. This
may stop the tumours from causing
problems as they grow, such as
hydrocephalus (excessive
accumulation of fluid within the brain).
THE MEDICINE IS STARTED BY A
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
1
1.
PRODUCT NAME
Afinitor 2.5 mg tablets
Afinitor 5 mg tablets
Afinitor 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to slightly yellow, elongated tablets with a bevelled edge and
no score.
2.5 MG:
The tablets are engraved with “LCL” on one side and “NVR” on
the other.
5 MG
: The tablets are engraved with “5” on one side and “NVR” on
the other.
10 MG:
The tablets are engraved with “UHE” on one side and “NVR” on
the other.
ACTIVE SUBSTANCE
Tablets
2.5 MG:
Each tablet contains 2.5 mg everolimus.
5 MG
: Each tablet contains 5 mg everolimus.
10 MG:
Each tablet contains 10 mg everolimus.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Afinitor is indicated for the treatment of patients with:
•
Progressive, unresectable or metastatic, well or moderately
differentiated neuroendocrine
tumours (NETs) of pancreatic origin
•
Advanced renal cell carcinoma in patients who have received prior
VEGF-targeted therapy
•
Subependymal giant cell astrocytoma (SEGA) associated with tuberous
sclerosis complex
(TSC) who require therapeutic intervention but are not amenable to
surgery. The evidence is
based on change in SEGA volume. Further clinical benefit, such as
improvement in disease-
related symptoms, has not been demonstrated.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Afinitor should be administered orally once daily at the same time
every day, either consistently with or
consistently without food (see section 5 Pharmacological properties).
Afinitor tablets should be swallowed whole with a glass of water. The
tablets should not be chewed or
crushed. For patients unable to swallow tablets, Afinitor tablet(s)
should be dispersed completely in a
glass of water (conta
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