ZINBRYTA daclizumab 150 mg/mL solution for injection pre-filled pen

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Daclizumab

Sẵn có từ:

Biogen Australia Pty Ltd

INN (Tên quốc tế):

Daclizumab

Tờ rơi thông tin

ZINBRYTA
®
(ZIN-BRY-TUH)
_daclizumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zinbryta. 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 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 Zinbryta
and its use that you should be aware
of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Zinbryta
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZINBRYTA IS USED
FOR
_WHAT ZINBRYTA IS USED FOR_
Zinbryta is used for the management
of relapsing forms of Multiple
Sclerosis (MS). Zinbryta treatment
has been shown to:
•
Slow the usual progression of
disability
•
Reduce the risk of relapse
Zinbryta is available only with a
doctor's prescription. Your first
prescription should be written
following a recommendation from a
neurologist.
USE ONLY FOR THE PERSON FOR WHOM
IT HAS BEEN PRESCRIBED.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZINBRYTA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Zinbryta has not been tested in
clinical trials in people with MS who
are below 18 years of age or 65 years
and over.
_HOW IT WORKS_
The active substance in Zinbryta is
daclizumab. Zinbryta slows down the
progression of physical disability in
people with relapsing forms of MS
and decreases the number of flare-
ups (relapses) in patients with
Multiple Sclerosis (MS) by reducing
the inflammation in the central
nervous system (CNS).
The cause of MS

Đặc tính sản phẩm

ZINBRYTA PI (version 10517, supersedes 10916)
Page
1
of
23
PRODUCT INFORMATION
ZINBRYTA
®
(DACLIZUMAB)
NAME OF THE MEDICINE
ZINBRYTA (
daclizumab)
Solution for injection, in pre-filled pen
Solution for injection, in pre-filled syringe
ZINBRYTA is supplied as 150 milligrams of daclizumab per 1.0 mL.
The CAS Registry Number is 152923-56-3.
DESCRIPTION
Daclizumab is a humanized IgG1 monoclonal antibody that binds
specifically to the alpha subunit
of the interleukin-2 receptor (IL-2Rα, CD25).
Daclizumab has immunomodulatory effects by selectively blocking
signaling through high affinity
IL-2 receptors, a receptor that is up-regulated on the surface of
activated lymphocytes, while
leaving IL-2 signaling by intermediate affinity IL-2 receptors intact.
Daclizumab is produced by recombinant DNA technology and consists of
90% material from the
human IgG1 constant domains and 10% material from the
complementarity-determining region
(CDR) sequences of a murine monoclonal antibody that binds CD25.
Daclizumab is produced in a
mammalian cell line (NS0) using animal component-free medium.
Daclizumab is composed of two
humanized gamma-1 heavy chains and two humanized kappa light chains
and has a molecular
weight of approximately 144 kilodaltons (kDa).
ZINBRYTA is supplied as a sterile, preservative-free, colourless to
slightly yellow, clear to slightly
opalescent liquid. The drug product is supplied in a single-use
pre-filled pen or as a single-use pre-
filled syringe.
EXCIPIENTS
Sodium
succinate,
anhydrous
5.94 mg;
Succinic
acid
0.35 mg;
Sodium
chloride
5.84 mg;
Polysorbate 80 0.30 mg; Water for Injection; 0.14 mmol sodium per
dose.
PHARMACOLOGY
MECHANISM OF ACTION
Daclizumab is a humanized monoclonal antibody that binds to CD25
(IL-2Rα), and prevents IL-2
binding to CD25. Daclizumab modulates IL-2 signaling by blocking
CD25-dependent, high-affinity
IL-2 receptor signaling, resulting in higher levels of IL-2 available
for signalling through the
intermediate-affinity IL-2 receptor.
ZINBRYTA PI (version 10517, supersedes 10916