MABCAMPATH alemtuzumab 30mg/mL concentrate solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alemtuzumab, Quantity: 30 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Alemtuzumab

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: disodium edetate; water for injections; polysorbate 80; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride

Administration route:

Intravenous

Units in package:

3 x 1 mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) who have relapsed after failure of two prior therapies.,MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL).

Product summary:

Visual Identification: clear, colourless to slightly yellow concentrate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 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:

2006-05-10

Patient Information leaflet

MABCAMPATH
_Alemtuzumab (a-lem-too-zoo-mab)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MabCampath.
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 MabCampath
against the benefits they expect it
will have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MABCAMPATH IS
USED FOR
This medicine is an anti-cancer drug
used to treat a form of leukaemia
known as B cell chronic lymphocytic
leukaemia (B-CLL). This is a cancer
of the type of white blood cells called
lymphocytes.
Patients with B-CLL have too many
abnormal lymphocytes, which
displace healthy cells in the bone
marrow (where most new blood cells
are formed) in addition to the blood
stream and other organs. Without
enough healthy blood cells,
infections, anaemia, bruising,
excessive bleeding or even organ
failure can result.
_HOW IT WORKS_
MabCampath is a monoclonal
antibody that specifically recognises
and binds to a unique protein located
on the surface of abnormal
lymphocytes.
After binding, MabCampath destroys
the abnormal lymphocytes, which are
then gradually removed from the
body by normal biological processes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MABCAMPATH
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is not enough information to
recommend the use of this medicine
for children.
There is not enough information to
recommend the use of this medicine
in patients who have kidney or liver
disorders.
BEFORE YOU ARE GIVEN
MABCAMPATH
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE MABCAMPATH IF YOU
HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
ALEMTUZUMAB OR MURINE
PROTEINS
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelli

Summary of Product characteristics

MabCampath-ccdsv18-piv3-10jan20
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION SHEET – MABCAMPATH
(ALEMTUZUMAB)
1
NAME OF THE MEDICINE
Alemtuzumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30 mg/mL alemtuzumab as a concentrated solution for
infusion. See
Section 6.1 for list of excipients.
_ _
3
PHARMACEUTICAL FORM
Alemtuzumab (rch) is a recombinant DNA-derived humanized monoclonal
antibody directed
against the 21-28 kD cell surface glycoprotein, CD52. Alemtuzumab
(rch) is an IgG1 kappa
antibody with human variable framework and constant regions, and
complementarity-
determining regions from a murine monoclonal antibody. The antibody
has an approximate
molecular weight of 150 kD. Alemtuzumab (rch) is produced in mammalian
cell (Chinese
hamster ovary) suspension culture in a nutrient medium.
Alemtuzumab (rch) is a sterile, clear, colourless to slightly yellow,
injection concentrate. It is
intended for dilution prior to infusion.
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MabCampath is indicated for the treatment of patients with B - cell
chronic lymphocytic
leukaemia (B - CLL).
4.2
DOSE AND METHOD OF ADMINISTRATION
_GENERAL CONSIDERATIONS _
MabCampath should be administered under the supervision of a physician
experienced in the
use of cancer therapy.
Medications for the treatment of hypersensitivity reactions as well as
preparedness for
institution of emergency measures is necessary.
MabCampath solution must be prepared according to the instructions
provided under
‘Instructions for use and handling and disposal’. All doses should
be administered by
intravenous infusion over approximately 2 hours.
MabCampath-ccdsv18-piv3-10jan20
Page 2 of 22
Patients should be pre-medicated with an appropriate antihistamine and
analgesic prior to the
first dose at each escalation and prior to subsequent infusions, as
clinically indicated (see
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Antibiotics and antivirals should be administered routinely to all
patients throughout and
foll