Elfabrio

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Pegunigalsidase alfa

Available from:

Chiesi Farmaceutici S.p.A

ATC code:

A16AB20

INN (International Name):

pegunigalsidase alfa

Therapeutic group:

Other alimentary tract and metabolism products,

Therapeutic area:

Fabry Disease

Therapeutic indications:

Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2023-05-04

Patient Information leaflet

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELFABRIO 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
pegunigalsidase alfa
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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 Elfabrio is and what it is used for
2.
What you need to know before you are given Elfabrio
3.
How Elfabrio is given
4.
Possible side effects
5.
How to store Elfabrio
6.
Contents of the pack and other information
1.
WHAT ELFABRIO IS AND WHAT IT IS USED FOR
Elfabrio contains the active substance pegunigalsidase alfa, and is
used as enzyme replacement
therapy in adult patients with confirmed Fabry disease. Fabry disease
is a rare genetic disease that can
affect many parts of the body. In patients with Fabry disease, a fat
substance is not removed from the
cells of their body, and builds up in the walls of blood vessels which
can cause organ failure. This fat
builds up in the cells of these patients because they do not have
enough of an enzyme called α-
galactosidase-A, the enzyme responsible for breaking it down Elfabrio
is used long-term to
supplement or replace this enzyme in adult patients who have confirmed
Fabry disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ELFABRIO
_ _
DO NOT USE ELFABRIO
•
if you are severely allergic to pegunigalsidase alfa or any of the
other ingredie

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Elfabrio 2 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg of pegunigalsidase alfa in a volume of 10 mL
at a concentration of 2 mg/mL.
The strength indicates the quantity of the pegunigalsidase alfa with
consideration of the pegylation.
Pegunigalsidase alfa is produced in tobacco cells (_Nicotiana tabacum_
BY2 cells) using recombinant
DNA technology.
The active substance, pegunigalsidase alfa, is a covalent conjugate of
prh-alpha-GAL-A with
polyethylene glycol (PEG).
The potency of this medicinal product should not be compared to the
one of another pegylated or non-
pegylated protein of the same therapeutic class. For more information,
see section 5.1.
Excipient with known effect
Each vial contains 48 mg sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless, solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Elfabrio is indicated for long-term enzyme replacement therapy in
adult patients with a confirmed
diagnosis of Fabry disease (deficiency of alpha-galactosidase).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Elfabrio treatment must be managed by a physician experienced in the
treatment of patients with
Fabry disease.
Appropriate medical support measures should be readily available when
Elfabrio is administered to
patients who have not had treatment before, or who have experienced
severe hypersensitivity reactions
to Elfabrio in the past.
Pre-treatment with antihistamines and/or corticosteroids may be
advisable for patients who had
previously experienced hypersensitivity reactions to Elfabrio or to
another enzyme replacement
therap