Avonex Pen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Interferon beta-1a 60 µg/mL

Available from:

Biogen NZ Biopharma Ltd

INN (International Name):

Interferon beta-1a 60 µg/mL

Dosage:

30 mcg/0.5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Interferon beta-1a 60 µg/mL Excipient: Arginine hydrochloride Glacial acetic acid Polysorbate 20 Sodium acetate trihydrate Water for injection

Units in package:

Syringe, glass, in pen injector 0.5 mL, 4 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Biogen Inc

Therapeutic indications:

Indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Product summary:

Package - Contents - Shelf Life: Syringe, glass, in pen injector 0.5 mL - 4 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. may include 1 week at or below 30°C

Authorization date:

2011-03-18

Patient Information leaflet

avoNZcmi092023
1
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
‘AVONEX Pre-filled Syringe’ or
‘AVONEX PEN’. 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

Summary of Product characteristics

AVONEX Data Sheet September 2023
Page 1 of 16
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
AVONEX® interferon beta-1a (rch) Solution for Injection Pre-filled
Syringe
AVONEX® interferon beta-1a (rch) Solution for Injection Pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Interferon beta-1a is a 166 amino acid glycoprotein with a specific
activity of approximately
200 million international units (IU) of antiviral activity per mg. It
has a predicted molecular
weight of approximately 22,500 Daltons and is produced by mammalian
(Chinese Hamster
Ovary) cells into which the human interferon beta gene has been
introduced. The amino
acid sequence of AVONEX

is identical to that of natural human interferon beta.
AVONEX is produced by recombinant DNA technology and is manufactured
as a 30
microgram solution for injection.
AVONEX is supplied as a sterile solution for injection containing
interferon beta-1a for
intramuscular injection.
Each 0.5 mL AVONEX Solution for Injection pre-filled syringe contains
30 µg of interferon
beta-1a with 6 million IU of antiviral activity.
Each 0.5 mL AVONEX Solution for Injection pen contains 30 µg of
interferon beta-1a with 6
million IU of antiviral activity.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
AVONEX Pre-filled Syringe is supplied in a single use pre-filled
syringe, available in packs of
4 blister trays. Each blister tray contains one pre-filled syringe of
AVONEX and one needle
used for IM administration.
AVONEX PEN is supplied as a single use pre-filled pen, available in
packs of 4 individual
cartons. Each individual carton contains one AVONEX pre-filled pen,
one 16 mm, 25 gauge
needle and an AVONEX PEN cover.
Not all presentations are being distributed in New Zealand.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AVONEX (Interferon beta-1a) is indicated for the treatment of
relapsing forms of multiple
sclerosis (MS).
AVONEX is also indicated in patients who have experienced a single
demyelinating event
and are at risk of developing clinically definit