EVENITY

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

ROMOSOZUMAB

Доступна з:

AMGEN EUROPE B.V.

Код атс:

M05BX06

Фармацевтична форма:

SOLUTION FOR INJECTION

Склад:

ROMOSOZUMAB 90 MG / 1 ML

Адміністрація маршрут:

S.C

Тип рецепту:

Required

Виробник:

AMGEN INC. (REFERRED TO AS AMGEN THOUSAND OAKS OR ATO), USA

Терапевтична области:

ROMOSOZUMAB

Терапевтичні свідчення:

EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Дата Авторизація:

2020-06-17

інформаційний буклет

EVENITY
®
(romosozumab 105 mg)
Prescriber Guide
Important information on
minimising risk to ensure safe
and effective use.
This Prescriber guide format and
content were approved by the Ministry
of Health in September 2020
Evenity_Israel_English_Prescriber Guide_v2.0 dated September 2020
page | 2
EVENITY
®
(romosozumab) Prescriber Guide
1.
ABOUT THIS GUIDE
•
EVENITY
®
(romosozumab) is indicated for the treatment of severe
osteoporosis in postmenopausal women at high risk for fracture;
for fracture; or patients who have failed or are intolerant to other
available osteoporosis therapy.
•
This guide contains important safety information for healthcare
professionals to aid with minimizing key risks when prescribing
romosozumab.
•
The patient
if
their caregiver should be educated
about treatment risks and provided with a Patient Alert Card.
•
Refer to the Israel Prescribing Information (PI) for more details.
2.
ABOUT ROMOSOZUMAB
Romosozumab
in bone
decreases bone resorption.
Limitations of Use
the duration of EVENITY use should be limited to 12 monthly doses. If
osteoporosis
-resorptive agent should be
considered.
The first dose of EVENITY should be administered by a healthcare
provider only.
jection can be performed by an individual who
has been properly trained by a healthcare provider only.
ld be
given immediately after the first one but at a different injection
site.
ons of the Israel package leaflet.
page | 3
EVENITY
®
(romosozumab) Prescriber Guide
EACH DOSE COMPRISES TWO INJECTIONS AT DIFFERENT SITES
Two pre-
= 1 DOSE
OUTER
AREA
OF
UPPER
ARM
STOMACH AREA (ABDOMEN)
THIGH
DIFFERENT
3.
KEY RISKS
This guide covers the risks of hypocalcaemia and myocardial infarction
For detailed information
about these and other
please refer to the romosozumab Israel
Prescribing Information.
ROMOSOZUMAB IS CONTRAINDICATED IN PATIENTS WITH HYPOCALCAEMIA.
PATIENTS SHOULD HAVE THEIR SERUM CALCIUM LEVELS MEASURED BEFORE
INITIATING ROMOSOZUMAB THERAPY AND SHOULD BE MONITORED FOR SIGNS AND
SYMPTOMS OF HYPOCALCAEMIA THROUGHOUT

Характеристики продукта

EVENITY
®
ROMOSOZUMAB 105 MG/1.17 ML (90 MG / ML)
SOLUTION FOR SUBCUTANEOUS INJECTION IN PRE-FILLED SYRINGE
FULL PRESCRIBING INFORMATION
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR DEATH
•
EVENITY MAY INCREASE THE RISK OF MYOCARDIAL INFARCTION, STROKE, AND
CARDIOVASCULAR
DEATH _[SEE CONTRAINDICATIONS (4)]_. EVENITY SHOULD NOT BE INITIATED
IN PATIENTS WHO HAVE
HAD A MYOCARDIAL INFARCTION OR STROKE WITHIN THE PRECEDING YEAR.
CONSIDER WHETHER THE
BENEFITS OUTWEIGH THE RISKS IN PATIENTS WITH OTHER CARDIOVASCULAR RISK
FACTORS. IF A PATIENT
EXPERIENCES A MYOCARDIAL INFARCTION OR STROKE DURING THERAPY, EVENITY
SHOULD BE
DISCONTINUED.
1
INDICATIONS AND USAGE
TREATMENT OF POSTMENOPAUSAL WOMEN WITH SEVERE OSTEOPOROSIS AT HIGH
RISK FOR FRACTURE
EVENITY is indicated for the treatment of severe osteoporosis in
postmenopausal women at high risk for
fracture, defined as a history of osteoporotic fracture, or multiple
risk factors for fracture; or patients who
have failed or are intolerant to other available osteoporosis therapy.
LIMITATIONS OF USE
The anabolic effect of EVENITY wanes after 12 monthly doses of
therapy. Therefore, the duration of
EVENITY use should be limited to 12 monthly doses. If osteoporosis
therapy remains warranted,
continued therapy with an anti-resorptive agent should be considered
_[see Dosage and Administration _
_(2.2) and Clinical Studies (14.1)]_
.
PATIENT SAFETY INFORMATION CARD AND
PRESCRIBER GUIDE
The marketing of EVENITY is subject to a risk management plan (RMP)
including a
Patient safety
information Card (Patient Alert card) and a
Prescriber guide providing important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
The Patient alert 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 and the implications of this treatment including the need
for compliance.