XGEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DENOSUMAB

Available from:

AMGEN EUROPE B.V.

ATC code:

M05BX04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

DENOSUMAB 120 MG / 1.7 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

AMGEN EUROPE B.V., NETHERLANDS

Therapeutic group:

DENOSUMAB

Therapeutic area:

DENOSUMAB

Therapeutic indications:

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with multiple myeloma and in adults with bone metastases from solid tumours.Treatment of adult and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Authorization date:

2016-11-30

Patient Information leaflet

Page 1 of 6
Internal Use Only Medical and Scientific Affairs
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
– 1986
The medicine is dispensed according to a physician's prescription only
XGEVA
®
, SOLUTION FOR SUBCUTANEOUS INJECTION
EACH VIAL CONTAINS 120 MG OF DENOSUMAB IN 1.7 ML OF SOLUTION
(CORRESPONDING TO 70 MG/ML).
List of the additional ingredients detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information
about the medicine. If you have any other questions, refer to the
physician or the pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if it
seems to you that their medical condition is similar.
XGEVA is not intended for children and adolescents under 18 years of
age except for adolescents with giant
cell tumor of the bone whose bones have stopped growing.

WHAT IS THE MEDICINE INTENDED FOR?
XGEVA is used in adults with 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) and in adults with
multiple myeloma. In adults and adolescents whose bones have stopped
growing, XGEVA is also used to
treat giant cell tumor of bone, which cannot be treated by surgery or
where surgery is not the best option.
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 tumor of bone.
THERAPEUTIC GROUP:
Drugs for the treatment of bone disease-other drugs affecting bone
structure and mineralization.

BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
-
if you are sensitive (allergic) to denosumab or to any of the
additional ingredients contained in the
medicine (listed in section 6).
-
your physician will not administer XGEVA to you if you have a very low
level of calcium in your blood
which has not been treated.
-
your physician will

Summary of Product characteristics

Page 1 of 16
Internal Use Only Medical and Scientific Affairs
XGEVA
®
1.
NAME OF THE MEDICINAL PRODUCT
XGEVA 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colorless 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 multiple myeloma and in adults with bone
metastases from solid tumors.
Treatment of adults and skeletally mature adolescents with giant cell
tumor 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
hypercalcemia is present (see section 4.4).
Patients treated with XGEVA should be given the package leaflet and
the 'patient safety information card'.
PATIENT SAFETY INFORMATION CARD
The
marketing
of
XGEVA
is
subject
to
a
risk
management
plan
(RMP)
including
a
'Patient
safety
information card'. The 'Patient safety information card', emphasizes
important safety information that the
patient should be aware of before and during treatment. Please explain
to the patient the need to review the
card before starting treatment.
Page 2 of 16
Internal Use Only Medical and Scientific Affairs
_Prevention of skeletal related events in adults with multiple myeloma
and in