AVONEX interferon beta-1a (rch) 30microgram/0.5mL injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Interferon beta-1a, Quantity: 60 microgram/mL

Available from:

Biogen Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: arginine hydrochloride; polysorbate 20; sodium acetate; water for injections; glacial acetic acid

Administration route:

Intramuscular

Units in package:

4 x 0.5mL syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AVONEX is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). AVONEX is indicated in patients who have experienced a single demyelinating event and are at risk of developing clinically definite MS based on the presence of brain MRI abnormalities characteristic of MS. AVONEX 60 mcg is indicated for the treatment of secondary progressive MS in patients in whom relapse is still a feature of disease. AVONEX 60 mcg should not be initiated in patients with secondary progressive MS who have not experienced relapse in the previous 12 months.

Product summary:

Visual Identification: Clear colourless solution in a type I glass syringe barrel with ceramic coated tip, grey elastomeric stopper and grey ribbed plastic cap, a blue 23G 1 1/4 needle and a plunger rod, sealed in a blister tray.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-05-04

Patient Information leaflet

AVONEX
®
_Interferon beta-1a_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AVONEX Solution
for Injection (also known as 'Pre-
Filled Syringe'). It does not contain
all the available information. It does
not take the place of talking to your
specialist, doctor or pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.biogen.com.au. The
updated leaflet may contain
important information about
AVONEX and its use that you should
be aware of.
All medicines have benefits and
risks. Your doctor has weighed the
benefits AVONEX is expected to
have for you, against the risks of
using it.
IF YOU HAVE ANY QUESTIONS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST OR CONTACT
THE MULTIPLE SCLEROSIS (MS) SOCIETY
IN YOUR STATE.
You can also telephone the MS
ALLIANCE Helpline on 1800 286
639 in Australia or 0800 286 639 in
New Zealand (NZ) for additional
assistance on using AVONEX.
KEEP THIS LEAFLET, YOU MAY NEED TO
READ IT AGAIN.
WHAT AVONEX IS USED
FOR
AVONEX is used for the treatment
of relapsing forms of Multiple
Sclerosis (MS). AVONEX treatment
has been shown to:
•
Slow the progression of disability
•
Reduce the number of relapses
•
Delay the onset of definite MS
after an illness suggesting MS
The cause of MS is not yet known.
MS affects the brain and spinal cord.
In MS, the body's immune system
reacts against its own myelin (the
'insulation' surrounding nerve fibres).
In relapsing forms of MS, people
have 'exacerbations' from time to
time (e.g. blurred vision, weakness in
the legs or arms, or loss of control of
bowel or bladder function). They are
followed by periods of recovery.
Recovery may be complete or
incomplete. If it is incomplete there
is 'progression of disability'.
AVONE

Summary of Product characteristics

AVONEX PI (version 10122)
1
AUSTRALIAN PRODUCT INFORMATION
AVONEX (INTERFERON BETA 1-A (RCH)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Interferon beta-1a (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AVONEX is supplied as a sterile solution for injection containing
interferon beta-1a for
intramuscular injection. Each 0.5 mL Solution for Injection contains
30 µg of interferon beta-1a
with 6 million IU of antiviral activity.
AVONEX Solution for Injection also contains sodium acetate, glacial
acetic acid, arginine
hydrochloride, polysorbate 20 and water for injections.
AVONEX Solution for Injection is available as AVONEX Pre-filled
Syringe and AVONEX PEN.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AVONEX is indicated for the treatment of relapsing forms of multiple
sclerosis (MS).
AVONEX is indicated in patients who have experienced a single
demyelinating event and are
at risk of developing clinically definite MS based on the presence of
brain MRI abnormalities
characteristic of MS.
AVONEX 60 µg is indicated for the treatment of secondary progressive
MS in patients in whom
relapse is still a feature of the disease. AVONEX 60 µg should not be
initiated in patients with
secondary progressive MS who have not experienced a relapse in the
previous 12 months.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The optimal dosing of AVONEX has not been fully resolved. The
following recommendations
for AVONEX are based on the major placebo-controlled studies performed
to date.
The recommended dosage of AVONEX is 30 µg (6 million IU) injected IM
once a week.
One dose comparison study (C94-805) did not show a benefit of 60 µg
once weekly over 30 µg
once weekly in early disease but there may be a requirement for higher
doses at more
advanced stages of the disease. The efficacy of more frequent dosing
regimens has not been
assessed.
AVONEX PI (version 10122)
2
_RELAPSING-REMITTING MS AND PATIENTS WITH ONE DEMYELINATING EVENT AND
AT RISK OF _
_DEVELOPING MS:_ the recommende