Repatha Solution for Injection in Pre-filled Syringe 140mgmL (evolocumab)

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Evolocumab

Saatavilla:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

INN (Kansainvälinen yleisnimi):

Evolocumab

Kpl paketissa:

1x1ml mL

Valmistaja:

Amgen manufactuirng ,Ltd

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
REPATHA
® SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE/AUTOINJECTOR
Evolocumab 140 mg/mL
1
WHAT IS IN THIS LEAFLET?
1.
What REPATHA is used for
2.
How REPATHA works
3.
Before you use REPATHA
4.
How to use REPATHA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of REPATHA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REPATHA IS USED FOR
REPATHA is used:
•
along with diet and other
cholesterol-lowering medicines to
reduce the risk of heart attack,
stroke and certain types of heart
surgery in adults with
cardiovascular disease.
•
to reduce low-density lipoprotein
(LDL) or bad cholesterol in adults
with high blood cholesterol levels
called primary hyperlipidemia
(including a type of high cholesterol
called heterozygous familial
hypercholesterolemia [HeFH]):
-
along with diet and a statin,
with or without other
cholesterol-lowering medicines,
where additional lowering of
LDL cholesterol is required,
-
along with diet, alone or
together with other cholesterol-
lowering medicines, when
statins do not work well or
cannot be used.
•
Along with diet and other LDL-
cholesterol-lowering therapies in
pediatric patients aged 10 years and
older with HeFH to reduce LDL-C
•
along with diet and other LDL-
lowering medicine in adults and
pediatric patients aged 10 years and
older with a type of high cholesterol
called homozygous familial
hypercholesterolemia (HoFH), who
need additional lowering of LDL
cholesterol.
It is not known if REPATHA is safe and
effective in children with HeFH or HoFH
who are younger than 10 years of age or
in children with other types of
hyperlipidemia.
HOW REPATHA WORKS
REPATHA is a medicine that lowers
levels of ‘bad’ cholesterol, a type of fat,
in the blood.
REPATHA contains the active substance
evolocumab, a monoclonal antibody (a
type of specialized protein designed to
attach to a target substance in the body).
Evolocumab is designed to attach to a
substance called PCSK9 t

Valmisteyhteenveto

1
REPATHA
® (EVOLOCUMAB) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE/
PRE-FILLED AUTOINJECTOR 140 MG/ML
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
PREVENTION OF CARDIOVASCULAR EVENTS
REPATHA
®
is indicated as an adjunct to diet and standard of care therapy
(including moderate- to
high-intensity statin therapy alone or in combination with other
lipid-lowering therapy), to reduce the risk of
myocardial infarction, stroke, and coronary revascularization in adult
patients with atherosclerotic
cardiovascular disease.
PRIMARY HYPERLIPIDEMIA (INCLUDING HETEROZYGOUS FAMILIAL
HYPERCHOLESTEROLEMIA)
REPATHA is indicated for the reduction of elevated low-density
lipoprotein cholesterol (LDL-C) in adult
patients with primary hyperlipidemia (including heterozygous familial
hypercholesterolemia [HeFH]):
•
as an adjunct to diet and statin therapy, with or without other
lipid-lowering therapies, in patients
who require additional lowering of LDL-C,
•
as an adjunct to diet, alone or in combination with non-statin
lipid-lowering therapies, in patients for
whom a statin is contraindicated.
PEDIATRIC PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
REPATHA is indicated as an adjunct to diet and other LDL-C-lowering
therapies (e.g., statins, ezetimibe) in
pediatric patients aged 10 years and older with HeFH who require
additional lowering of LDL-C.
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
REPATHA is indicated as an adjunct to diet and other LDL-lowering
therapies (e.g., statins, ezetimibe, LDL
apheresis) in adult and pediatric patients aged 10 years and older
with homozygous familial
hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
The recommended subcutaneous dosage of REPATHA in adults with
established cardiovascular disease or in
adults with primary hyperlipidemia (including heterozygous familial
hypercholesterolemia [HeFH]) is either
140 mg every 2 weeks OR 420 mg once monthly, based on patient
preference for dosing frequency and
injec