Xgeva

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

denosumab

Διαθέσιμο από:

Amgen Europe B.V.

Φαρμακολογική κατηγορία (ATC):

M05BX04

INN (Διεθνής Όνομα):

denosumab

Θεραπευτική ομάδα:

Drugs for treatment of bone diseases

Θεραπευτική περιοχή:

Fractures, Bone; Neoplasm Metastasis

Θεραπευτικές ενδείξεις:

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.  

Περίληψη προϊόντος:

Revision: 24

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-07-13

Φύλλο οδηγιών χρήσης

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XGEVA 120 MG SOLUTION FOR INJECTION
denosumab
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
Your doctor will give you a patient reminder card, which contains
important safety information
you need to be aware of before and during your treatment with XGEVA.
WHAT IS IN THIS LEAFLET
1.
What XGEVA is and what it is used for
2.
What you need to know before you use XGEVA
3.
How to use XGEVA
4.
Possible side effects
5.
How to store XGEVA
6.
Contents of the pack and other information
1.
WHAT XGEVA IS AND WHAT IT IS USED FOR
XGEVA contains denosumab, a protein (monoclonal antibody) that works
to slow down bone
destruction caused by cancer spreading to the bone (bone metastasis)
or by giant cell tumour of bone.
XGEVA is used in adults with advanced cancer to prevent serious
complications caused by bone
metastasis (e.g. fracture, pressure on the spinal cord or the need to
receive radiation therapy or
surgery).
XGEVA is also used to treat giant cell tumour of bone, which cannot be
treated by surgery or where
surgery is not the best option, in adults and adolescents whose bones
have stopped growing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE XGEVA
DO NOT USE XGEVA
-
if you are allergic to denosumab or any of the other ingredients of
this medicine (listed in
section 6).
Your healthcare professional will not administer XGEVA to you if you
have a very low level of
calcium in your blood which has not been treated.
Your healthcare professional will not administe

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
XGEVA 120 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 120 mg of denosumab in 1.7 mL of solution (70
mg/mL).
_ _
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian
cell line (Chinese
hamster ovary cells) by recombinant DNA technology.
Excipient with known effects
Each 1.7 mL of solution contains 78 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution and may contain trace
amounts of translucent to white
proteinaceous particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of skeletal related events (pathological fracture,
radiation to bone, spinal cord compression
or surgery to bone) in adults with advanced malignancies involving
bone (see section 5.1).
Treatment of adults and skeletally mature adolescents with giant cell
tumour of bone that is
unresectable or where surgical resection is likely to result in severe
morbidity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
XGEVA should be administered under the responsibility of a healthcare
professional.
Posology
Supplementation of at least 500 mg calcium and 400 IU vitamin D daily
is required in all patients,
unless hypercalcaemia is present (see section 4.4).
Patients treated with XGEVA should be given the package leaflet and
the patient reminder card.
_Prevention of skeletal related events in adults with advanced
malignancies involving bone _
The recommended dose is 120 mg administered as a single subcutaneous
injection once every 4 weeks
into the thigh, abdomen or upper arm.
_Giant cell tumour of bone _
The recommended dose of XGEVA is 120 mg administered as a single
subcutaneous injection once
every 4 weeks into the thigh, abdomen or upper arm with additional 120
mg doses on days 8 and 15 of
treatment of the first month of therapy.
3
Patients in the phase II study who underwent complete