Nexviadyme

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Avalglucosidase alfa

Tilgængelig fra:

Sanofi B.V.

ATC-kode:

A16

INN (International Name):

Avalglucosidase alfa

Terapeutisk gruppe:

Other alimentary tract and metabolism products,

Terapeutisk område:

Glycogen Storage Disease Type II

Terapeutiske indikationer:

Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency).

Produkt oversigt:

Revision: 2

Autorisation status:

Authorised

Autorisation dato:

2022-06-24

Indlægsseddel

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEXVIADYME 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
avalglucosidase 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, pharmacist. or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist. or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nexviadyme is and what it is used for
2.
What you need to know before you are given Nexviadyme
3.
How Nexviadyme is given
4.
Possible side effects
5.
How to store Nexviadyme
6.
Contents of the pack and other information
1.
WHAT NEXVIADYME IS AND WHAT IT IS USED FOR
WHAT NEXVIADYME IS
Nexviadyme contains an enzyme called avalglucosidase alfa – it is a
copy of the natural enzyme called
acid alpha-glucosidase (GAA) that is lacking in people with Pompe
disease.
WHAT NEXVIADYME IS USED FOR
Nexviadyme is used to treat people of all ages who have Pompe disease.
People with Pompe disease have low levels of the enzyme acid
alpha-glucosidase (GAA). This
enzyme helps control levels of glycogen (a type of carbohydrate) in
the body. Glycogen provides the
body with energy, but in Pompe disease high levels of glycogen build
up in different muscles and
damages them. The medicine replaces the missing enzyme so that the
body can reduce the build-up of
glycogen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NEXVIADYME
_ _
DO NOT USE NEXVIADYME
If you have had life-threatening allergic (hypersensitive) reactions
to avalglucosidase alfa or any of the
other ingredients of this medicine (listed in section 6) and these
react

Produktets egenskaber

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
Nexviadyme 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of avalglucosidase alfa.
After reconstitution, each vial contains a total extractable volume of
10.0 ml at a concentration of
10 mg of avalglucosidase alfa* per ml.
*Avalglucosidase alfa is a human acid α-glucosidase produced in
Chinese hamster ovary cells (CHO)
by recombinant DNA technology, which is subsequently conjugated with
approximately 7
hexamannose structures (each containing two terminal
mannose-6-phosphate (M6P) moieties) to
oxidised sialic acid residues on the molecule, thereby increasing
bis-M6P levels.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White to pale yellow lyophilised powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme
replacement therapy for the
treatment of patients with Pompe disease (acid α-glucosidase
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nexviadyme treatment should be supervised by a physician experienced
in the management of patients
with Pompe disease or other inherited metabolic or neuromuscular
diseases.
Posology
Patients may be pre-treated with antihistamines, antipyretics, and/or
corticosteroids to prevent or
reduce allergic reactions.
The recommended dose of avalglucosidase alfa is 20 mg/kg of body
weight administered once every
2 weeks.
_Dose modification for IOPD patients _
For IOPD (infantile-onset Pompe disease) patients who experience lack
of improvement or insufficient
response in cardiac, respiratory, and/or motor function while
receiving