ARZERRA ofatumumab (rmc)1000mg/50mL injection concentrate vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Ofatumumab, Quantity: 20 mg/mL
Available from:
Novartis Pharmaceuticals Australia Pty Ltd
INN (International Name):
Ofatumumab
Pharmaceutical form:
Injection, concentrated
Composition:
Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80
Administration route:
Intravenous Infusion
Units in package:
1 vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
1. Previously Untreated CLL : ARZERRA is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. Refractory CLL: ARZERRA, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (CLL) refractory to fludarabine and alemtuzumab.
Product summary:
Visual Identification: A clear to hazy, colourless to pale yellow liquid, practically free of visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2014-10-02
Patient Information leaflet
ARZERRA
®
20 MG/ML INJECTION CONCENTRATE VIAL
_Ofatumumab (rmc)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ ALL 5 PAGES IN THIS
LEAFLET CAREFULLY BEFORE YOU START
USING ARZERRA.
This leaflet answers some common
questions about Arzerra
(ofatumumab). 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.NOVARTIS.COM.AU.
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 Arzerra
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 ARZERRA IS USED
FOR
Arzerra contains ofatumumab, which
belongs to a group of medicines
called monoclonal antibodies.
Arzerra is used to treat chronic
lymphocytic leukaemia (CLL). CLL
is a cancer of the blood which affects
a type of white blood cell called a
lymphocytes. The lymphocytes
multiply too quickly and live too
long, so there are too many of them
circulating in your blood.
The disease can also affect other
organs in your body. The antibody in
Arzerra recognises a substance on the
surface of lymphocytes and binds to
them, decreasing the amount of
lymphocytes in the body.
Your doctor may have prescribed
Arzerra for another reason.
This medicine is available only with
a doctor's prescription.
ARZERRA is not recommended for
use in children and adolescents,
under the age of 18 years.
Arzerra is not addictive.
BEFORE YOU ARE GIVEN
ARZERRA
_WHEN YOU MUST NOT RECEIVE_
_ARZERRA_
YOU MUS
Read the complete document
Summary of Product characteristics
Page 1
PRODUCT INFORMATION
ARZERRA
® CONCENTRATED INJECTION
Ofatumumab (rmc) Concentrated Injection
NAME OF THE MEDICINE
Active ingredient:
ofatumumab
Structure:
Molecular weight:
approximately 149 kDa.
CAS number:
679818-59-8
Ofatumumab is a human monoclonal antibody (IgG1ĸ) that is generated
via transgenic
mouse and hybridoma technology and produced in a recombinant murine
cell line (NS0).
DESCRIPTION
ARZERRA
is
a
sterile,
clear
to
slightly
opalescent,
colourless,
preservative-free,
concentrated solution (20 mg/mL) for intravenous infusion.
Each single-use vial of ARZERRA contains either 100 mg of ofatumumab
in 5 mL of
solution or 1000 mg of ofatumumab in 50 mL of solution. The
excipients: arginine, sodium
acetate, sodium chloride (see PRECAUTIONS – Sodium content),
polysorbate 80, edetate
disodium, hydrochloric acid, and water for injections.
PHARMACOLOGY
Pharmacotherapeutic group: antineoplastic agents, monoclonal
antibodies
Humanised Vl-regions
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Humanised V -ns
-s-s-
Inter Chain Disulphide Bonds
-s-s-
-s-s-
-s-s-
-s-s-
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Vh regions
Vl regions
-s-s-
Inter Chain Disulphide Bonds
-s-s-
-s-s-
-s-s-
-s-s-
● ●
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Carbohydrate
Humanised Vl-regions
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Humanised V -ns
-s-s-
Inter Chain Disulphide Bonds
-s-s-
-s-s-
-s-s-
-s-s-
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Vh regions
Vl regions
-s-s-
Inter Chain Disulphide Bonds
-s-s-
-s-s-
-s-s-
-s-s-
Humanised Vl-regions
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Humanised V -ns
-s-s-
Inter Chain Disulphide Bonds
-s-s-
-s-s-
-s-s-
-s-s-
Complementarity Determining Regions
Human CH constant regions
Human Ck constant regions
Vh regions
Vl regions
-s-s-
Inter Chain Disulphide Bonds
Humanised Vl-regions
Complementarity Dete
Read the complete document
