Voxzogo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Vosoritide

Available from:

BioMarin International Limited

ATC code:

M05BX

INN (International Name):

vosoritide

Therapeutic group:

Drugs for treatment of bone diseases

Therapeutic area:

Achondroplasia

Therapeutic indications:

Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2021-08-26

Patient Information leaflet

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOXZOGO 0.4 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VOXZOGO 0.56 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
VOXZOGO 1.2 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
vosoritide
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 or
your child 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 or your child has any further questions, ask your doctor.
-
This medicine has been prescribed for you or your child 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 or your child gets any side effects, talk to your doctor. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Voxzogo is and what it is used for
2.
What you need to know before you use Voxzogo
3.
How to use Voxzogo
4.
Possible side effects
5.
How to store Voxzogo
6.
Contents of the pack and other information
1.
WHAT VOXZOGO IS AND WHAT IT IS USED FOR
WHAT VOXZOGO IS
Voxzogo contains the active substance vosoritide. It is similar to a
protein in the body called C type
natriuretic peptide (CNP). Vosoritide is made by recombinant
technology involving bacteria that have
been modified to include the gene for producing the protein.
WHAT VOXZOGO IS USED FOR
This medicine is used for the treatment of achondroplasia in patients
4 months of age and older whose
bones are still growing. Achondroplasia is a genetic condition that
affects growth of almost all bones
in the body including the skull, spine, arms and legs resulting in
very short stature with a characteristic
appearance
_._
The product is indicated only in achondroplasia which is caused by
mutations i

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
Voxzogo 0.4 mg powder and solvent for solution for injection
Voxzogo 0.56 mg powder and solvent for solution for injection
Voxzogo 1.2 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voxzogo 0.4 mg powder and solvent for solution for injection
Each vial of powder contains 0.4 mg of vosoritide*.
After reconstitution, each vial contains 0.4 mg vosoritide in 0.5 mL
of solution, corresponding to a
concentration of 0.8 mg/mL.
Voxzogo 0.56 mg powder and solvent for solution for injection
Each vial of powder contains 0.56 mg of vosoritide*.
After reconstitution, each vial contains 0.56 mg vosoritide in 0.7 mL
of solution, corresponding to a
concentration of 0.8 mg/mL.
Voxzogo 1.2 mg powder and solvent for solution for injection
Each vial of powder contains 1.2 mg of vosoritide*.
After reconstitution, each vial contains 1.2 mg vosoritide in 0.6 mL
of solution, corresponding to a
concentration of 2 mg/mL.
*produced in
_Escherichia coli_
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white to yellow and the solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voxzogo is indicated for the treatment of achondroplasia in patients 4
months of age and older whose
epiphyses are not closed. The diagnosis of achondroplasia should be
confirmed by appropriate genetic
testing.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with vosoritide should be initiated and directed by a
physician appropriately qualified in the
management of growth disorders or skeletal dysplasias.
3
Posology
Voxzogo is given as a