LEMTRADA alemtuzumab 10 mg/mL injection concentrated vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alemtuzumab, Quantity: 10 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Alemtuzumab

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

Product summary:

Visual Identification: Clear liquid, colourless to slightly yellow; 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:

Licence status A

Authorization date:

2013-12-18

Patient Information leaflet

LEMTRADA
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LEMTRADA?
Lemtrada contains the active ingredient alemtuzumab. Lemtrada is used
to treat relapsing forms of multiple sclerosis (MS) in adults
with active disease who are not stable on current therapy.
For more information, see Section 1. Why am I using Lemtrada? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEMTRADA?
Do not use if you have ever had an allergic reaction to Lemtrada or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Lemtrada? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lemtrada and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LEMTRADA?
Lemtrada will be given to you as an infusion into a vein. Each
infusion will take approximately 4 hours.
More instructions can be found in Section 4. How do I use Lemtrada? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEMTRADA?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are taking
Lemtrada.
•
Woman of childbearing potential should use effective contraceptive
methods during treatment with
Lemtrada and for 4 months after each course of treatment.
THINGS YOU
SHOULD NOT DO
•
Do not take Lemtrada if you have an allergy to alemtuzumab (the active
ingredient) or proteins of mouse
origin, or any of the ingredients listed at the end of this leaflet.
DRIVING
OR USING
MACHINES
•
Lemtrada does not directly affect your ability to drive or use
machines. However, you may experience a
side-effect during the treatment

Summary of Product characteristics

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Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION – LEMTRADA
®
(ALEMTUZUMAB)
1
NAME OF THE MEDICINE
Alemtuzumab (rch)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1.0 mL of concentrate solution contains 10 mg Alemtuzumab (rch).
Refer to Section 6.1 for
list of excipients.
3
PHARMACEUTICAL FORM
Alemtuzumab (rch) is a recombinant DNA-derived humanised 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 with pH 7.0 - 7.4. It is
intended for dilution prior to infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lemtrada is indicated for the treatment of relapsing forms of multiple
sclerosis (MS) for patients
with active disease defined by clinical or imaging features to slow
the accumulation of physical
disability and reduce the frequency of clinical relapses.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lemtrada treatment should be initiated and supervised by a
neurologist. Specialists and equipment
required for the timely diagnosis and management of serious adverse
reactions, especially
autoimmune conditions and infections, should be available.
Facilities for the management of hypersensitivity and/or anaphylactic
reactions should be
available.
lem-ccdv19-piv15-10feb22
Page 2 of 31
Patients treated with Lemtrada must be given the Patient Wallet Card
and Patient Guide and be
informed about the risks of Lemtrada.
The recommended dose of Lemtrada is 12 mg/day administered by IV
infusion for 2 or more
treatment courses.
Initial treatment of two courses
•
First treatment course: 12 mg/day on 5 consecutive days (60 mg total
dose)
•
Se