Fabrazyme

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

agalsidase beta

Available from:

Sanofi B.V.

ATC code:

A16AB04

INN (International Name):

agalsidase beta

Therapeutic group:

Other alimentary tract and metabolism products,

Therapeutic area:

Fabry Disease

Therapeutic indications:

Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).

Product summary:

Revision: 34

Authorization status:

Authorised

Authorization date:

2001-08-03

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
FABRAZYME 35 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
agalsidase beta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fabrazyme is and what it is used for
2.
What you need to know before you use Fabrazyme
3.
How to use Fabrazyme
4.
Possible side effects
5.
How to store Fabrazyme
6.
Contents of the pack and other information
1.
WHAT FABRAZYME IS AND WHAT IT IS USED FOR
Fabrazyme contains the active substance agalsidase beta and is used as
enzyme replacement therapy
in Fabry disease, where the level of

-galactosidase enzyme activity is absent or lower than normal. If
you suffer from Fabry disease a fat substance, called
globotriaosylceramide (GL-3), is not removed
from the cells of your body and starts to accumulate in the walls of
the blood vessels of your organs.
Fabrazyme is indicated for use as long-term enzyme replacement therapy
in patients with a confirmed
diagnosis of Fabry disease.
Fabrazyme is indicated in adults, children and adolescents aged 8
years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FABRAZYME
DO NOT USE FABRAZYME
-
if you are allergic to agalsidase beta or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Fabrazyme.
If you are treated with Fabrazyme, you may develop infusion associated
reactions. An infusion-
associated reaction is any side effect occurring during the infusion
or until the end of the

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fabrazyme 35 mg powder for concentrate for solution for infusion
Fabrazyme 5 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fabrazyme 35 mg powder for concentrate for solution for infusion
Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase
beta. After reconstitution
with 7.2 ml water for injections, each vial of Fabrazyme contains 5
mg/ml (35 mg/7 ml) of agalsidase
beta. The reconstituted solution must be diluted further (see section
6.6).
Fabrazyme 5 mg powder for concentrate for solution for infusion
Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase
beta. After reconstitution with
1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml
of agalsidase beta. The
reconstituted solution must be diluted further (see section 6.6).
Agalsidase beta is a recombinant form of human

-galactosidase A and is produced by recombinant
DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell
culture. The amino acid
sequence of the recombinant form, as well as the nucleotide sequence
which encoded it, are identical
to the natural form of

-galactosidase A.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilisate or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fabrazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Fabry disease (α-galactosidase A deficiency).
Fabrazyme is indicated in adults, children and adolescents aged 8
years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fabrazyme treatment should be supervised by a physician experienced in
the management of patients
with Fabry disease or other inherited metabolic diseases.
Posology
The recommended dose of Fabrazyme is 1 mg/kg body weight administered
once every 2 weeks as an
intravenous infusion.
Infusion of Fabra