LEMTRADA INFUSION (PARENTERAL)

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INFUSION (PARENTERAL)

Composition:

EACH VIAL CONTAINS ALEMTUZUMAB 12,0 mg

Authorization status:

Registered

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
Lemtrada (12 mg alemtuzumab/1,2 mL vial)
Date of revision: 20 November 2023
Concentrate for solution for infusion
Page 1 of 19
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
LEMTRADA
® CONCENTRATE FOR SOLUTION FOR INFUSION
ALEMTUZUMAB
Sugar free.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING LEMTRADA.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
LEMTRADA has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What LEMTRADA is and what it is used for
2.
What you need to know before you receive LEMTRADA
3.
How LEMTRADA will be administered
4.
Possible side effects
5.
How to store LEMTRADA
6.
Contents of the pack and other information.
1.
WHAT LEMTRADA IS AND WHAT IT IS USED FOR
LEMTRADA contains the active substance alemtuzumab, which is used to
treat relapsing forms of
multiple sclerosis (MS) in adults. LEMTRADA does not cure MS but it
can decrease the number of
MS relapses. It can also help to slow down or reverse some of the
signs and symptoms of MS.
LEMTRADA is used if your MS is highly active despite that you have
been treated with at least one
sanofi-aventis south africa (pty) ltd
Lemtrada (12 mg alemtuzumab/1,2 mL vial)
Date of revision: 20 November 2023
Concentrate for solution for infusion
Page 2 of 19
other medicine for MS or if your MS is rapidly evolving.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE LEMTRADA
DO NOT RECEIVE LEMTRADA:
•
If you are allergic to alemtuzumab or any of the other ingredients of
LEMTRADA (see section
6).
•
If you are infected with the human immunodeficiency virus (HIV).
•
If you are suffering from a serious infection.
•
If you have any of the following conditions:
o
uncontrolled high blood pressure
o
history of tears in blood vessels supplying the brain
o
history of stro

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
Lemtrada (12 mg alemtuzumab/1,2 mL vial)
Date of revision: 20 November 2023
Concentrate for solution for infusion
Page 1 of 29
PROFESSIONAL INFORMATION
TUBERCULOSIS SCREENING FOR ACTIVE AND INACTIVE ("LATENT")
TUBERCULOSIS, AND IF REQUIRED, THE
PRESCRIBING OF APPROPRIATE TREATMENT IF THE PATIENT HAS AN ACTIVE
TUBERCULOSIS INFECTION, OR
APPROPRIATE PROPHYLACTIC TREATMENT IF THE PATIENT PRESENTS WITH LATENT
TUBERCULOSIS TO
PREVENT TUBERCULOSIS INFECTION, SHOULD BE UNDERTAKEN ACCORDING TO THE
RELEVANT SOUTH
AFRICAN GUIDELINES PRIOR TO INITIATION OR RE-ADMINISTRATION OF
LEMTRADA TREATMENT.
HEALTH CARE PROVIDERS SHOULD DELAY INITIATION OR RE-ADMINISTRATION OF
LEMTRADA TREATMENT
IN PATIENTS AT RISK, WITH DETECTED ACTIVE OR LATENT TUBERCULOSIS UNTIL
THE INFECTION IS FULLY
CONTROLLED.
FURTHER, PREVENTATIVE AND POST-TREATMENT MONITORING APPROACHES FOR
ACTIVE AND LATENT
TUBERCULOSIS SHOULD BE TAILORED TO INDIVIDUAL PATIENT AND TREATMENT
RISK FACTORS AS
ASSESSED BY THE TREATING HEALTH CARE PROVIDER.
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE
LEMTRADA
® concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains 12 mg/1,2 mL alemtuzumab (10 mg/mL).
Sugar free.
EXCIPIENTS WITH KNOWN EFFECT
LEMTRADA contains less than 1 mmol potassium (39 mg) per infusion,
i.e. it is essentially
potassium-free.
LEMTRADA contains less than 1 mmol sodium (23 mg) per infusion, i.e.
it is essentially sodium-
free.
sanofi-aventis south africa (pty) ltd
Lemtrada (12 mg alemtuzumab/1,2 mL vial)
Date of revision: 20 November 2023
Concentrate for solution for infusion
Page 2 of 29
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless to slightly yellow concentrate with pH 7,0 –
7,4, containing no antimicrobial
preservatives.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LEMTRADA is indicated as a single disease modifying therapy in adults
with highly active
relapsing remittin