ROFERON-A interferon alfa-2a 9 million IU/0.5mL injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Interferon alfa-2a

Available from:

Roche Products Pty Ltd

INN (International Name):

Interferon alfa-2a

Authorization status:

Registered

Patient Information leaflet

ROFERON-A 170927
1
ROFERON
®
-A
_PRE FILLED SYRINGES _
_contains the active ingredient interferon alfa-2a (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Roferon-A pre-filled
syringes.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Roferon-A
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROFERON-A IS
USED FOR
Roferon-A contains the active
ingredient interferon alfa-2a.
Roferon-A belongs to a group of
medicines called interferons.
Roferon-A is a similar form of
interferon to one of the interferons
made naturally by your own immune
system as a defence against viruses
and tumours. Roferon-A works by
slowing the growth of certain tumour
cells and viruses and also by boosting
the effects of your own immune
system to fight these.
Roferon-A is used in the treatment of
viral infections of the liver (chronic
active hepatitis B and chronic
hepatitis C).
Roferon-A treatment will not prevent
a hepatitis B or C infected person
from giving another person hepatitis
B or C.
Roferon-A may be used in
combination with ribavirin for the
treatment of chronic hepatitis C in
patients who have relapsed to
previous interferon monotherapy
treatment.
Roferon-A is also used in the
treatment of various types of cancer
such as, kidney cancer (renal cell
carcinoma), cancer of the lymph
glands (cutaneous T-cell lymphoma),
blood cancer (hairy cell leukaemia,
chronic myelogenous leukaemia
(CML) and other bone marrow
conditions causing platelet
disorders), AIDS-related cancer
(Kaposi's sarcoma), and low-grade
non-Hodgkin's lymphoma.
Roferon-A may be used in
combination with AVASTIN for the
treatment of kidney cancer.
Your doctor, however, may have
prescribed Roferon-A

Summary of Product characteristics

Roferon-A
®
170908
1
NAME OF THE MEDICINE
ROFERON-A

_interferon alfa-2a _
CAS-76543-88-9
_ _
DESCRIPTION
Roferon-A (interferon alfa-2a) is a sterile protein product for use by
injection. ROFERON-A is
produced biosynthetically using recombinant DNA technology, and is the
product of a cloned
human leucocyte interferon gene inserted into and expressed in
_E.coli_
. Interferon alfa-2a is a highly
purified protein containing 165 amino acids. It has an approximate
molecular weight of 19 kD.
Roferon-A solution for injection is supplied as pre-filled syringes
containing interferon alfa-2a, sodium
chloride, ammonium acetate, benzyl alcohol, polysorbate 80, glacial
acetic acid, sodium hydroxide and
water for injections. Fermentation is carried out in a defined
nutrient medium containing the antibiotic
tetracycline hydrochloride, 5 mg/L. However, the presence of the
antibiotic is not detectable in the
final product.
Each pre-filled syringe of Roferon-A solution for injection contains 3
or 9 million international units
(MIU) of interferon alfa-2a. The specific activity of interferon
alfa-2a is approximately 270 MIU/mg
protein. Roferon-A should be administered by subcutaneous injection.
PHARMACOLOGY
PHARMACODYNAMICS
_Mechanism of action: _
The mechanism by which interferon alfa-2a, or any other interferon,
exerts anti-
tumour activity is not clearly understood. However, it is believed
that direct anti-proliferative action
against tumour cells and modulation of the host immune response play
important roles in the anti-
tumour activity.
Roferon-A exerts its antiviral effects by inducing a state of
resistance to viral infections in cells and
by modulating the effector arm of the immune system to neutralise
viruses or eliminate virus-
infected cells.
Roferon-A
®
170908
2
The biological activities of interferon alfa-2a are
species-restricted, i.e. they are expressed in a very
limited number of species other than humans. As a consequence,
preclinical evaluation of
interferon alfa-2a has involved
_in vitro_
experiments with hu