LEMTRADA

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

ALEMTUZUMAB

Disponible des:

SANOFI ISRAEL LTD

Codi ATC:

L01XC04

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ALEMTUZUMAB 12 MG / 1.2 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

SANOFI BELGIUM, BELGIUM

Área terapéutica:

ALEMTUZUMAB

indicaciones terapéuticas:

LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: • Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Data d'autorització:

2019-09-30

Informació per a l'usuari

PATIENT GUIDE TO LEMTRADA
®
Important safety information
you should know when starting
therapy with LEMTRADA
(alemtuzumab)
THIS GUIDE IS TO BE CAREFULLY REVIEWED WITH YOUR
DOCTOR WHEN YOU’RE FIRST PRESCRIBED LEMTRADA AND
ON A REGULAR BASIS AT FOLLOW-UP VISITS.
Risk minimisation information for patients
CONTENTS
04–11
Executive summary
12–15
Introduction to LEMTRADA
16–21
Overview of LEMTRADA treatment
22–33
Side effects
34–37
Other helpful information
38–41
Medical monitoring to minimise side effects
42–45
Helpful terms to know
46–49
How to reach your doctors
03
EXECUTIVE
SUMMARY
A guide to your LEMTRADA (alemtuzumab) for
treating relapsing remitting multiple sclerosis (MS).
This is an abbreviated guide – please refer to the full guide
for more information. This guide is not intended to replace
discussions you have with your doctor or other healthcare
professionals who are treating you with LEMTRADA.
05
Executive
summary
LEMTRADA is a prescription medicine
used to treat adults with relapsing remitting
multiple sclerosis (MS). LEMTRADA can only
be used in patients with highly active disease,
despite treatment with at least one disease
modifying therapy, or in patients with rapidly
evolving severe MS.
Receiving LEMTRADA can put you at risk of experiencing
serious side effects that may occur within 1-3 days of
infusion, or later, or delayed autoimmune side effects which
can occur months to years after infusion.
Early identification of these side effects is vital, because
a delay in diagnosis and treatment can increase the risk
of complications. This is why it’s so important to remain
vigilant and immediately report any signs or symptoms of
these conditions to your doctor.
It is also important to inform your relatives or caregivers
about your treatment, since they may notice symptoms
that you are not aware of.
See the following tables for a summary of signs and
symptoms to look out for.
AS WITH ANY MEDICINE, USE OF LEMTRADA MAY CAUSE
SIDE EFFECTS IN SOME USERS. DO NOT BE ALARMED WHEN
READING TH

Fitxa tècnica

1
_Lemtrada SPC version 13.0 dated 09.2023 _
_ _
LEMTRADA
1.
NAME OF THE MEDICINAL PRODUCT
LEMTRADA
Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Alemtuzumab is a monoclonal antibody produced in mammalian cell
(Chinese Hamster Ovary) suspension
culture in a nutrient medium by recombinant DNA technology.
Excipients with known effect
This medicine contains less than 1 mmol potassium (39 mg) per
infusion, i.e., it is essentially ‘potassium-
free’.
This medicine contains less than 1 mmol sodium (23 mg) per infusion,
i.e., it is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear, colourless to slightly yellow concentrate with pH 7.0–7.4.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
LEMTRADA is indicated as a single disease modifying therapy in adults
with highly active relapsing
remitting multiple sclerosis (RRMS) for the following patient groups:

Patients with highly active disease despite a full and adequate course
of treatment with at least one
disease modifying therapy (DMT) or

Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more
disabling relapses in one year, and with 1 or more Gadolinium
enhancing lesions on brain MRI or a
significant increase in T2 lesion load as compared to a previous
recent MRI.
4.2
Posology and method of administration
LEMTRADA treatment should only be initiated and supervised by a
neurologist experienced in the treatment
of patients with
multiple sclerosis (MS) in a hospital with ready access to intensive
care. Specialists and
equipment required for the timely diagnosis and management of adverse
reactions, especially myocardial
Patient safety information card
The marketing of LEMTRADA is subject to a risk management plan (RMP)
including a 'Patient
information card'.
The 'Patient information card' emphasizes impo