EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105MG1.17ML

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ROMOSOZUMAB

Available from:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

INN (International Name):

ROMOSOZUMAB

Units in package:

2 Pre-Filled Syringes

Manufactured by:

Amgen Manufacturing Limited

Patient Information leaflet

EVENITY
® SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE 105MG/1.17ML
Romosozumab (105 mg/1.17 ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET?
1.
What EVENITY is Used for
2.
How EVENITY Works
3.
Before You Use EVENITY
4.
How to Use EVENITY
5.
While You are Using EVENITY
6.
Side Effects
7.
Storage and Disposal of EVENITY
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS THE MOST IMPORTANT
INFORMATION I SHOULD KNOW ABOUT
EVENITY?
EVENITY CAN CAUSE SERIOUS SIDE
EFFECTS, INCLUDING:
•
increased risk of having a heart
attack, stroke, or death from a
cardiovascular (heart or blood
vessel) problem.
Before you receive EVENITY, tell your
doctor if you have had a heart attack or
stroke, especially if it has happened in
the past year.
See “
WHILE YOU ARE USING EVENITY
”
WHAT EVENITY IS USED FOR
EVENITY is used to treat:
•
severe osteoporosis in women after
menopause, at high risk of fracture
Osteoporosis is a disease that makes
your bones thin and fragile. Osteoporosis
is most common in women following
menopause. Many patients with
osteoporosis have no symptoms, but they
are still at risk of breaking a bone
because osteoporosis has made their
bones weak.
HOW EVENITY WORKS
EVENITY contains romosozumab, a
medicine that helps build bone, which
makes bone stronger and less likely to
break.
EVENITY inhibits a protein called
sclerostin. By binding and preventing the
activity of sclerostin, EVENITY rapidly
promotes bone building and also
decreases break down of bone.
EVENITY’s dual effect of both building
new bone and also decreasing break
down of existing bone will strengthen
your bones, improve your bone mass and
structure, and lower your chance of
breaking bones.
BEFORE YOU USE EVENITY
Tell your doctor if you had a heart attack
or stroke, especially if it happened in the
past year.
-
_When you must not use it_
DO NOT
use if you have low calcium
levels in your blood. Your doctor can tell
you if your levels are too low.
DO NOT
use if you ar

Summary of Product characteristics

1
Amgen Proprietary - Confidential
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR DEATH
•
EVENITY MAY INCREASE THE RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR
DEATH _[SEE WARNINGS AND PRECAUTION (4.4)]. _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 A HISTORY OF
MI OR STROKE AND
OTHER CARDIOVASCULAR RISK FACTORS. IF A PATIENT EXPERIENCES A
MYOCARDIAL INFARCTION OR
STROKE DURING THERAPY, EVENITY SHOULD BE DISCONTINUED.
1.
NAME OF THE MEDICINAL PRODUCT
EVENITY
®
solution for injection in pre-filled syringe 105 mg/1.17 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EVENITY solution for injection in pre-filled syringe 105 mg
Each pre-filled syringe contains 105 mg romosozumab in 1.17 mL (90
mg/mL) solution.
EVENITY (romosozumab) is a humanised monoclonal antibody (IgG2) with
high affinity and specificity for
sclerostin. Romosozumab has an approximate molecular weight of 145 kDa
and is produced in a mammalian
cell line (Chinese hamster ovary) by recombinant DNA technology.
For the full list of excipients, see List of Excipients (6.1).
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection.
EVENITY is a sterile, preservative-free, clear to opalescent,
colourless to light yellow solution, pH 5.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Postmenopausal Osteoporosis
EVENITY is indicated in treatment of severe osteoporosis in
postmenopausal women at high risk of
fracture (see section 5.1).
4.2
DOSAGE AND ADMINISTRATION
Dosage
The recommended dose of EVENITY is 210 mg administered subcutaneously.
Administer EVENITY once
every month for 12 doses.
Patients should be adequately supplemented with calcium and vitamin D
[see Contraindications (4.3),
Special Warnings and Precautions for Use (4.4), and Pharmacodynamic
properties, clinical data
(5.1)]
If the EVENITY dose is missed, administer as soon as it can be
rescheduled. Thereafter,