Crysvita

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Burosumab

Διαθέσιμο από:

Kyowa Kirin Holdings B.V.

Φαρμακολογική κατηγορία (ATC):

M05BX05

INN (Διεθνής Όνομα):

burosumab

Θεραπευτική ομάδα:

Drugs for treatment of bone diseases

Θεραπευτική περιοχή:

Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia

Θεραπευτικές ενδείξεις:

Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Περίληψη προϊόντος:

Revision: 11

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-02-19

Φύλλο οδηγιών χρήσης

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
CRYSVITA 10 MG SOLUTION FOR INJECTION
CRYSVITA 20 MG SOLUTION FOR INJECTION
CRYSVITA 30 MG SOLUTION FOR INJECTION
burosumab
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.
•
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CRYSVITA is and what it is used for
2.
What you need to know before you use CRYSVITA
3.
How to use CRYSVITA
4.
Possible side effects
5.
How to store CRYSVITA
6.
Contents of the pack and other information
1.
WHAT CRYSVITA IS AND WHAT IT IS USED FOR
WHAT CRYSVITA IS
CRYSVITA contains the active substance burosumab. This is a type of
medicine called a human
monoclonal antibody.
WHAT IS CRYSVITA USED FOR
CRYSVITA is used to treat X-linked hypophosphataemia (XLH). It is used
in children and adolescents
aged 1 to 17 years, and in adults.
CRYSVITA is used to treat Tumour-induced Osteomalacia (TIO) where the
tumour causing this
condition cannot be successfully removed or found, in children and
adolescents aged 1 to 17 years and
in adults.
WHAT IS X-LINKED HYPOPHOSPHATAEMIA (XLH)
X-Linked Hypophosphataemia (XLH) is a genetic disease.
•
People with XLH have higher levels of a hormone called fibroblast
growth factor 23 (FGF23).
•
FGF23 lowers the amount of phosphate in the blood.
•
The low level of phosphate may:
-
lead to bones that may not harden properly and, in children and
adolescents, cannot grow
properly
-
result in pain and stiffness in bones and joints
WHAT IS TUMOUR-INDUCED OSTEOMALACIA (TIO)
•
People with TIO have higher levels of a hormone called FGF23

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CRYSVITA 10 mg solution for injection
CRYSVITA 20 mg solution for injection
CRYSVITA 30 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CRYSVITA 10 mg solution for injection
Each vial contains 10 mg of burosumab in 1 ml solution.
CRYSVITA 20 mg solution for injection
Each vial contains 20 mg of burosumab in 1 ml solution.
CRYSVITA 30 mg solution for injection
Each vial contains 30 mg of burosumab in 1 ml solution.
Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23
and is produced by
recombinant DNA technology using Chinese hamster ovary (CHO) mammalian
cell culture.
Excipient with known effect
Each vial contains 45.91 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to slightly opalescent, colourless to pale brownish-yellowish
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRYSVITA is indicated for the treatment of X-linked hypophosphataemia,
in children and adolescents
aged 1 to 17 years with radiographic evidence of bone disease, and in
adults.
CRYSVITA is indicated for the treatment of FGF23-related
hypophosphataemia in tumour-induced
osteomalacia associated with phosphaturic mesenchymal tumours that
cannot be curatively resected or
localised in children and adolescents aged 1 to 17 years and in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
management of patients with metabolic
bone diseases.
3
Posology
Oral phosphate and active vitamin D analogues (e.g. calcitriol) should
be discontinued 1 week prior to
initiation of treatment. Vitamin D replacement or supplementation with
inactive forms may be started or
continued as per local guidelines under monitoring of serum calcium
and phosphate. At initiation,
fasting serum phosphate concentration should be below the reference
range for age (see section 4.3).
_ _
X-LINKED HYPOPHOSPHATAEMIA (X